Skip to main navigationSkip to News Headlines
NJ Division of Consumer Affairs
Global Navigation
Division of Consumer Affairs
The State of New Jersey Office of The Attorney General (Dept. of Law & Public Safety) The State of New Jersey NJ Home Services A to Z Departments/Agencies OAG Frequently Asked Questions
OAG Home
OAG Contact
Division of Consumer Affairs Alerts and Recalls
Division of Consumer Affairs Alerts and Recalls
Office of the Attorney General Homepage Division of Consumer Affairs, Director
Division of Consumer Affairs, Director
Division of Alcoholic Beverage Control
Division of Consumer Affairs
Division of Consumer Affairs Highlights
Division of Consumer Affairs Topics in a A-Z List Format
Office of Consumer Protection (OCP)
New Jersey Bureau of Securities
Office of Weights and Measures
Legalized Games of Chance Control Commission
Alternative Dispute Resolution
Professions and Occupations List
Contact the Division of Consumer Affairs
Division of Consumer Affairs in Spanish
Division of Criminal Justice
Division on Civil Rights
Division of Gaming Enforcement
Division of Highway Traffic Safety
Division of Law
Juvenile Justice Commission
NJ Racing Commission
State Athletic Control Board
Division of NJ State Police
Victims of Crime Compensation Office
Subscribe to Buyer Beware Alerts
OPRA - Open Public Records Act
 

RULE PROPOSALS
VOLUME 45, ISSUE 5
ISSUE DATE:MARCH 4, 2013
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF PHARMACY

Proposed Amendments: N.J.A.C. 13:39-11.1, 11.2, and 11.5 through 11.14

Proposed Repeals and New Rules: N.J.A.C. 13:39-11.3, 11.11, 11.15, and 11.19

Proposed New Rules: N.J.A.C. 13:39-11.8, 11.9, 11.14, 11.18, and 11A

Proposed Repeals: N.J.A.C. 13:39-11.4, 11.21, 11.23, 11.24, 11.25, and 11.26

Proposed Recodifications with Amendments: N.J.A.C. 13:39-11.16, 11.17, 11.18, 11.20, and 11.22 as 13:39-11.4, 11.5, 11.7, 11.6, and 11.10, respectively


Compounding Sterile and Non-Sterile Preparations in Retail and Institutional Pharmacies

Authorized By: New Jersey State Board of Pharmacy, Anthony Rubinaccio, Executive Director.

Authority: N.J.S.A. 45:14-47 and 48.

Calendar Reference: See Summary for explanation of exception to calendar requirement.

Proposal Number: PRN 2013-036.

Submit comments by April 3, 2013 to:

Anthony Rubinaccio
New Jersey State Board of Pharmacy
124 Halsey Street
P.O. Box 45013
Newark, NJ 07101

The agency proposal follows:

Summary

The State Board of Pharmacy (Board) is proposing amendments, repeals, recodifications, and new rules governing the compounding of sterile and non-sterile preparations in both retail and institutional pharmacy practice settings. The Board undertook a review of its existing compounding rules, set forth in N.J.A.C. 13:39-11, following the publication of the latest revisions to the United States Pharmacopeia's (USP) General Chapter 797 - Pharmaceutical Compounding of Sterile Preparations (USP 797). USP 797 establishes practice standards designed to ensure that compounded sterile preparations are of high quality in order to prevent patient harm. As part of this review, the Board also examined the practice standards established in USP's General Chapter 795 - Pharmaceutical Compounding of Nonsterile Preparations (USP 795). The Board believes that extensive changes to the existing rules in Subchapter 11 are necessary to ensure that the Board's rules are consistent with the best practice standards established in USP 797 and 795. The Board notes that, although the existing requirements in Subchapter 11 apply to both the compounding of sterile and non-sterile preparations, the proposed amendments, repeals, recodifications, and new rules divide the requirements for sterile and non-sterile preparations into separate subchapters to ensure clarity.

The Board published a notice of pre-proposal soliciting comments from members of the regulated community about these changes. The notice of pre-proposal was published in the New Jersey Register on February 6, 2012 at 44 N.J.R. 202(a). The Board received one comment. Rodney Prosser R.Ph. expressed concern over pre-proposed N.J.A.C. 13:39-11.10, which would permit an institutional pharmacy to use an ISO class 5 laminar air flow workbench in an area that is not a buffer area to prepare low-risk level compounded sterile preparations, provided the administration of such preparation begins within the lesser of 12 hours of the preparation or as recommended by the manufacturer. Pre-proposed N.J.A.C. 13:39-11.10 would also require that the workbench be located in an area that is maintained under sanitary conditions and traveled by only persons engaged in compounding of sterile preparations.

Mr. Prosser believed that this provision was inconsistent with USP Chapter 797, and that the pre-proposed rule would not adequately segregate the compounding or sterile products from patient care areas. He was concerned that the pre-proposed rule would circumvent many of the practices that are part of USP 797 and would place patients at risk for acquiring infections in a health care setting. He noted, as an example, that in today's world, sterile compounds are often prepared by technicians under the indirect supervision of physicians. Throughout the day these technicians might be in contact with patients in various diseased states. The technicians might be wearing the same lab coats to prepare the sterile compounds as when coming into contact with patients. Additionally, the technicians may not adequately wash their hands before preparing and injecting sterile products into patients. The commenter stressed that the implementation of the buffer area and ante area provides a mechanism that forces compounders to properly garb prior to performing compounding activities. Mr. Prosser was also concerned that the laminar flow hoods may be placed in close proximity to the heating, ventilation, and air conditioning (HVAC) ducts that contain unfiltered air.

In response to Mr. Prosser's comment, the Board is proposing to change pre-proposed N.J.A.C. 13:39-11.10 to require in these circumstances, that laminar flow hoods be restricted to segregated compounding areas in locations where there are no unsealed windows or doors that connect to the outdoors or high traffic flow, or that are adjacent to areas such as construction sites, warehouses, or areas that are used for food preparation. Additionally, N.J.A.C. 13:39-11.10 is being changed from the notice of pre-proposal to provide that sinks may not be located adjacent to the ISO class 5 primary engineering control environments and must be separated from the immediate area of ISO class 5 primary engineering control devices. Furthermore, upon proposal, the Board will require that personnel preparing low-risk level compounded sterile preparations pursuant to N.J.A.C. 13:39-11.10 follow the personnel cleansing and garbing requirements of N.J.A.C. 13:39-11.14.

The following is a summary of the amendments, repeals, recodifications, and new rules that the Board is proposing at this time. The notice of proposal includes extensive recodification. Throughout the notice of proposal, citations have been amended to reflect the proposed amendments and new rules as recodified. Furthermore, various sections of proposed amendments to Subchapter 11 have deleted references to non-sterile preparations.

Subchapter 11 is proposed to be amended to reflect the Board's determination to separate the rules for the compounding of sterile and non-sterile preparations into two subchapters to ensure clarity. Proposed amended Subchapter 11 contains the rules relating to the compounding of sterile preparations (and the subchapter heading is amended to reflect such) and proposed new Subchapter 11A contains the rules relating to the compounding of non-sterile preparations.

N.J.A.C. 13:39-11.1 is proposed for amendment to delete a reference to non-sterile preparations, and sets forth the purpose and scope of the subchapter as it relates to standards for quality and control of processes, components, and environments associated with the preparation of sterile compounds.

[page=440] N.J.A.C. 13:39-11.2 contains definitions of words and terms used in Subchapter 11. It is proposed to be amended to add definitions relating to the preparation of sterile compounds. The following terms have been added: "ante area," "biological safety cabinet," "buffer area," "cleanroom," "compounding," "compounding aseptic containment isolator," "compounding aseptic isolator," "immediate use compounded sterile preparations," "ISO class 8 air quality conditions," "negative pressure room," "positive pressure room," "primary engineering control," and "risk levels for compounded sterile preparations," which include the following three sub-definitions: "low-risk level compounded sterile preparations," "medium-risk level compounded sterile preparations," and "high-risk level sterile preparations." Additionally, the definitions of "ISO class 5 air quality conditions" and "ISO class 7 air quality conditions" are proposed to be amended to clarify that the air being measured is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air. Furthermore, the definition of "ISO class 6 air quality conditions" is being deleted from the section.

Proposed new N.J.A.C. 13:39-11.3 relates to application and pre-approval requirements for compounding sterile preparations. Subsection (a) sets forth the requirements that an applicant for a new pharmacy must meet in order to obtain approval to compound sterile preparations. Subsection (b) sets forth the requirements that the holders of an existing pharmacy permit must meet in order to compound sterile preparations. Subsection (c) sets forth the requirements that must be met if a pharmacy permit holder approved to compound sterile preparations is planning to remodel, change location, or change the size of a cleanroom. Subsection (d) sets forth the requirements that an institutional pharmacy permit holder that is approved to compound sterile preparations must meet if using a laminar air flow workbench not located in a buffer area as provided in N.J.A.C. 13:39-11.10. Subsection (e) sets forth the requirements that must be met if a pharmacy permit holder approved to compound sterile preparations intends to use compounding aseptic isolators or compounding aseptic containment isolators not located in a buffer area.

N.J.A.C. 13:39-11.16 is proposed for recodification as N.J.A.C. 13:39-11.4. The Board is proposing to amend the section heading to use the term "cleanroom" instead of "controlled environment for compounded sterile preparations" and to add "air pressure" to the heading. Subsection (a) is proposed for amendment to use the term "cleanroom" instead of "controlled environment consisting of a clean room and an anteroom" to refer to the designated area for sterile preparation compounding. Subsection (a) also contains a new provision setting forth the physical criteria that a cleanroom must meet to minimize airborne contamination from contacting critical sites. Proposed new subsection (b) requires that all sterile compounding take place within the confines of a buffer area unless it meets one of the exceptions set forth in paragraphs (b)1 through 3. Recodified subsection (c) is amended to substitute the term "cleanroom" for "controlled environment," and paragraph (c)4 is amended to add that 66 degrees Fahrenheit is the ideal temperature for a cleanroom. Proposed new subsection (d) requires a pressure indicator or air velocity meter to monitor the room for correct room pressurization or air velocity. Proposed new paragraphs (d)1 through 3 set forth the technical airflow requirements that must be met for the compounding of non-hazardous drugs and antineoplasic agents and other hazardous substances. Proposed new subsection (e) prohibits food, drink, chewing gum, and candy in a cleanroom.

N.J.A.C. 13:39-11.17 is proposed for recodification as N.J.A.C. 13:39-11.5. Subsection (a) is being amended to substitute the term "cleanroom" for "controlled environment." Subsection (b) adds a new provision describing the types of materials that can be used for cleanroom surfaces. This subsection is also amended to require that work surfaces be resistant to damage from cleaning agents, as well as sanitizing agents. Subsection (c) is amended to clarify that junctures where ceilings meet walls must be covered, caulked, or sealed to avoid cracks and crevices where microorganisms and other contaminates can accumulate. The current rule refers only to dirt accumulation. Subsection (e) is amended to refer to "walls" instead of "solid walls" and to permit walls to be constructed of flexible materials such as heavy gauge polymer in addition to the other materials currently specified in the regulation. Subsection (f) is amended to prohibit the use of floor drains. Subsection (g) is amended to state that ledges (such as windowsills) should be avoided, but are not strictly prohibited as in the existing regulation. Subsection (i) is proposed for deletion and its requirements regarding penetrated ceiling and wall surfaces are added to subsection (c). Proposed new subsection (i) prescribes the materials that are to be used in the construction of carts used in cleanrooms. Existing subsection (j) is proposed for deletion. This subsection required Board approval for cleanroom construction other than that specified in N.J.A.C. 13:39-11.5(a) through (i) prior to installation and use. Proposed new subsection (j) requires that refrigerators be within, or reasonably accessible to, cleanrooms in order to ensure the integrity of the compounded preparations.

N.J.A.C. 13:39-11.20 is proposed for recodification as N.J.A.C. 13:39-11.6 and amended to refer to "ante areas" instead of "anterooms" and sets forth the requirements for ante areas. Subsection (a) is amended to require that the ante area have appropriate environmental control devices capable of maintaining ISO class 8 air quality conditions for non-hazardous drug compounding activities and ISO class 7 air quality conditions for hazardous drug compounding activities. The existing regulation requires only that the anteroom have an air quality of ISO class 7 or better, and does not differentiate between non-hazardous and hazardous drug compounding activities. Paragraph (b)1 is amended to require that an ante area contain a sink with hot and cold running water with an integrated and closed plumbing system. Existing subsection (c) is proposed for deletion. This subsection requires that a refrigerator be reasonably accessible to the anteroom.

N.J.A.C. 13:39-11.18 is proposed for recodification as N.J.A.C. 13:39-11.7. The heading of this section heading is proposed to be amended to refer to "buffer area requirements." The existing rule refers to controlled environment for compounded sterile preparations and maintenance and supplies. Proposed new subsection (a) requires that a buffer area have appropriate environmental control devices capable of maintaining ISO class 7 air-quality conditions during normal activity. Recodified subsection (b) restricts the items that may be contained in a buffer area. Paragraph (b)1 changes the term "goods" to "materials." Paragraph (b)2 requires that items be "cleanable," as well as non-permeable, nonshedding, and resistant to disinfectants. Paragraph (b)3 substitutes the word "disinfected" for "sanitized" and "buffer area" for "clean room." Recodified subsection (c) prohibits removal of any equipment or other items from the buffer area, with certain exceptions. The existing regulation discourages equipment removal but does not strictly prohibit it. Recodified subsections (d) and (e) are amended to substitute the term "buffer area" for "controlled environment." Existing subsection (e) is proposed for deletion. The existing regulation sets forth a list of supplies to be kept in a "controlled environment." Proposed new subsection (f) prohibits a buffer area from containing any sinks, proposed new subsection (g) sets forth the minimum size for a buffer area, and proposed new subsection (h) sets forth standards that must be followed for the disposal of waste. The rule requires buffer areas contain waste containers meeting the standards set forth by the Occupational Safety and Health Administration (OSHA) in 29 CFR 1910.1030, relating to the disposal of used needles and syringes, and in 29 CFR 1910.1200, relating to the disposal of chemotherapy waste. Both of these standards have been incorporated by reference into the rule.

Proposed new N.J.A.C. 13:39-11.8 sets forth the use of compounding aseptic isolators and compounding aseptic containment isolators located outside a cleanroom or buffer area.

Proposed new N.J.A.C. 13:39-11.9 sets forth new rules regarding the compounding of antineoplastic agents and other hazardous substances. Subsection (a) refers to Appendix A of the National Institute for Occupational Safety and Health (NIOSH) Publication No. 2004-165 for a definition of hazardous substances. This subsection also incorporates by reference, as amended and supplemented, the sample list of drugs to be handled as hazardous from the Centers for Disease Control and Prevention's website. Subsection (b) prohibits pharmacies from preparing antineoplastic agents and other hazardous substances as immediate use compounded sterile preparations. Subsection (c) requires that the compounding of hazardous drugs be done with certain equipment under certain conditions. Subsection (d) requires correct room pressurization at all times when compounding hazardous substances. Subsection (e) sets forth the standards that personnel who compound and dispense [page=441] antineoplastic agents and other hazardous substances must follow. This regulation requires that personnel who compound and dispense antineoplastic agents and other hazardous substances comply with the standards set forth in OSHA's technical manual pertaining to health-care facilities, specifically, Controlling Occupational Exposure to Hazardous Drugs, which has been incorporated by reference into the regulation. Personnel must also comply with the standards established by NIOSH in its publication, Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, which has also been incorporated by reference into this regulation. Subsection (f) sets forth the storage and handling requirements for antineoplastic agents and other hazardous substances used for compounding sterile preparations.

N.J.A.C. 13:39-11.22 is proposed for recodification as N.J.A.C. 13:39-11.10. This section has been amended to permit a pharmacy holding an institutional pharmacy permit to use ISO class 5 laminar airflow workbenches not located in a buffer area to prepare low-risk level compounded sterile preparations under certain conditions. The existing rule refers to the use of "laminar air flow hoods" rather than "airflow benches" and requires that the hoods be certified by an independent certification company prior to use when first installed or after being moved and at six-month intervals, and that requirement is proposed to be deleted.

Proposed new N.J.A.C. 13:39-11.11 permits a pharmacy holding an institutional pharmacy permit to prepare non-hazardous immediate use compounded sterile preparations outside of an ISO class 5 laminar airflow workbench when the delay resulting from the use of the workbench would harm the patient, including situations in which the patient experiences a sudden change in clinical status.

N.J.A.C. 13:39-11.5 is proposed for recodification as N.J.A.C. 13:39-11.12. The rule sets forth the responsibilities of the pharmacist-in-charge. The section heading is amended to delete references to permit holders' responsibilities. Subsection (a) is amended to delete all references to non-sterile compounding and to clarify that the pharmacist-in-charge is responsible for supervising all sterile compounding performed by pharmacy personnel. Subsection (b) sets forth the minimum responsibilities of the pharmacist-in-charge. This subsection is amended to delete a reference to "the section of the pharmacy where sterile and/or non-sterile preparations are compounded." Paragraph (b)1, under which the pharmacist-in-charge is responsible for "the compounding of all preparations within the pharmacy or pharmacy satellite, including the compounding of individual medication orders or prescriptions, the formulation of products in response to special drug needs, and batch compounding," is proposed for deletion. Proposed new paragraphs (b)1 through 3 set forth responsibilities for pharmacists-in-charge relating to sterile compounding. Recodified paragraph (b)4 is amended to make pharmacists-in-charge responsible for the storage of all materials pertinent to the compounding of "sterile" preparations and the establishment of "specific procedures" for procurement of materials in accordance with State and Federal laws and regulations. Recodified paragraph (b)3 is amended to delete a reference to "drugs" and replace it with a reference to "sterile preparations." Recodified paragraph (b)4, under which the pharmacist-in-charge is responsible for recording all transactions of the pharmacy as may be necessary under applicable State, Federal, and local laws and rules, to maintain accurate control over, and accountability for, all pharmaceutical materials, is proposed to be recodified as paragraph (b)7. Recodified paragraph (b)7 is also amended to require that the pharmacist-in-charge ensure that policies and procedures exist to maintain the audit trail required pursuant to N.J.A.C. 13:39-11.20.

Recodified N.J.A.C. 13:39-11.12(b)6 states that a pharmacist-in-charge is responsible for ensuring that the preparation and compounding of sterile preparations be performed only by "licensed" pharmacists trained in aseptic manipulation skills, or by pharmacy technicians, interns, or externs who have been trained in aseptic manipulation skills working under the immediate personal supervision of a "licensed" pharmacist trained in aseptic manipulation skills. This paragraph is proposed for amendment to delete the reference to "licensed" pharmacist because it is unnecessary and redundant; N.J.A.C. 13:39-1.2 defines "pharmacist" as "an individual holding an active license to engage in the practice of pharmacy in the State." Existing Paragraph (b)6 is proposed for deletion as this paragraph relates to a pharmacist-in-charge's responsibilities with respect to the preparation and compounding of non-sterile compounds.

Proposed new N.J.A.C. 13:39-11.12(b)8 requires that pharmacists-in-charge ensure that all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs who compound sterile preparations are trained and evaluated consistent with the requirements of N.J.A.C. 13:39-11.16. Recodified paragraph (b)9 requires that pharmacists-in-charge establish procedures for maintaining the integrity "of the product" and the manufacturer's control identity "when repackaging sterile products." The existing regulation refers to maintaining the integrity and manufacturer's control identity of the "packaged material" rather than "sterile products." The regulation is also amended to require a pharmacist to check all repackaging and initial the repackaging records. The existing regulation requires only that the supervising pharmacist initial the repackaging record.

Proposed new N.J.A.C. 13:39-11.12(b)10 through 16 set forth additional responsibilities of the pharmacist-in-charge. Paragraph (b)10 requires the pharmacist-in-charge to dispose of all unused drugs and materials used in compounding sterile preparations, including hazardous substances, in accordance with N.J.S.A. 13:1E-48.1 et seq. Paragraph (b)11 requires that the pharmacist-in-charge ensure that the compounding area and its contents and other areas where compounded sterile preparations are present are secured from unauthorized persons. Paragraph (b)12 requires the pharmacist-in-charge to ensure that the reference library contain references pertinent to compounding sterile preparations. Paragraph (b)13 requires the pharmacist-in-charge to ensure that records are maintained that document, at least once daily, that appropriate controlled cold (refrigerated), controlled freezer, and controlled room temperatures, as these terms are defined in USP 797, are maintained. This paragraph also requires that the records be maintained for at least five years and be available to the Board for inspection upon request. Paragraph (b)14 requires the pharmacist-in-charge to ensure that information required to be maintained as part of a patient's profile record system is maintained for all compounded sterile preparations. Paragraph (b)15 requires the pharmacist-in-charge to ensure that initial and ongoing multidisciplinary clinical monitoring and comprehensive care plans are maintained and readily available. Paragraph (b)16 requires the pharmacist-in-charge to maintain a policy and procedures manual detailing the pharmacy's standard operating procedures with regard to compounded sterile preparations, consistent with N.J.A.C. 13:39-11.23 and to maintain a written quality assurance program, consistent with N.J.A.C. 13:39-11.24.

Recodified N.J.A.C. 13:39-11.13 is amended to change all references to "dispensing pharmacists" to "pharmacists," to omit the word "delegated" from performing delegated sterile compounding, to match defined terms, and to delete reference to non-sterile preparation.

Proposed new N.J.A.C. 13:39-11.14 sets forth the cleansing and garbing requirements for personnel who engage in compounding sterile preparations. Subsection (a) sets forth the cleansing and garbing requirements for such personnel before entering the buffer area. Subsection (b) sets forth the steps that must be taken once inside the buffer area. Subsection (c) sets forth the rules for disposal of garb upon exiting the cleanroom.

Proposed new N.J.A.C. 13:39-11.15 sets forth the cleaning and disinfection requirements for the cleanroom, buffer area, and ante area. This rule requires that all cleaning and disinfection be performed consistent with the standards established in USP 797, Appendix II, which sets forth the types of disinfectants to be used for the cleaning and disinfection of cleanrooms, buffer areas, and ante rooms.

N.J.A.C. 13:39-11.7 is proposed for recodification as N.J.A.C. 13:39-11.16. Existing subsection (a) requires that the pharmacist-in-charge and all personnel involved in compounding sterile preparations have practical or academic training in sterile preparation compounding, cleanroom technology, laminar flow technology, and quality assurance techniques. This subsection is amended to list the personnel who must be trained and sets forth additional required trainings. Subsection (b) is amended to require that, prior to compounding sterile preparations, and annually thereafter, pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs must pass a written test demonstrating competence in [page=442] the areas set forth in N.J.A.C. 13:39-11.16(a) and in the pharmacy's standard operating procedures with regard to compounding sterile preparations, rather than just being trained and able to demonstrate a comprehensive knowledge of the pharmacy's standard operating procedures. The subsection is further amended to remove the requirement for batch testing. Additionally, under subsection (c), the pharmacist-in-charge is responsible for testing aseptic technique consistent with the methods set forth in UPS 797 concerning "Aseptic Manipulation Competency Evaluation," as amended and supplemented, which is incorporated by reference, rather than by means of a test batch of culture media, media fill, or the equivalent. Retesting is required semi-annually for personnel compounding high-risk level preparations and annually for all others. New subsection (d) sets forth the requirements for pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs relating to gloved fingertip/thumb samplings. New subsection (e) prohibits individuals who have failed the written test or the test of aseptic technique from compounding sterile preparations until both tests have been passed. New subsection (f) prescribes the length of time that permit holders must retain test results.

N.J.A.C. 13:39-11.8 is proposed for recodification as N.J.A.C. 13:39-11.17 and relates to batch preparation. Subsection (a) is amended to delete references to non-sterile preparations. The regulation is being amended to set forth in linear fashion, the conditions that must be met in order to compound sterile preparations prior to receipt of a valid written prescription or medication order. This subsection is also amended to require compliance with the labeling requirements set forth at N.J.A.C. 13:39-11.21(a)1, 2, 7, 9, and 10. New subsection (b) sets forth the conditions under which pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs may compound sterile preparations without a prescription for use by a licensed prescriber for use in his or her practice.

Proposed new N.J.A.C. 13:39-11.18 permits a pharmacy to prepare compounded sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.

Proposed new N.J.A.C. 13:39-11.19 contains stability criteria and beyond-use dating for compounded sterile preparations. Subsection (a) defines stability for the purposes of the section. Subsection (b) sets forth the dates and times for storage and for the initiation of administration of compounded sterile preparations in the absence of supporting valid scientific sterility testing and stability information that is directly applicable to specific preparations. Subsection (c) prohibits extension of the dates and times set forth in subsection (b) without verifiable supporting valid scientific sterility and stability information that is directly applicable to the specific preparation or compound. Subsection (d) requires a pharmacist to determine the beyond-use date for a sterile preparation consistent with subsection (b), and to assign the preparation an appropriate discard-after date. The discard-after date must appear on the label consistent with proposed N.J.A.C. 13:39-11.21. Subsection (e) sets forth a time limit on the use of opened or needle-punctured single-dose sterile products used in the compounding of sterile preparations for immediate use, if opened in worse than ISO class 5 air quality. Subsection (f) sets forth a time limit on the use of single-dose vials used in the compounding of sterile preparations exposed to ISO class 5 or cleaner air quality. Subsection (g) prohibits opened single-dose ampules used in the compounding of sterile preparations, from being stored for any period of time. Subsection (h) sets forth a time limit on the use of opened or needle-punctured multiple-dose vials used in the compounding of sterile preparations.

N.J.A.C. 13:39-11.9 is proposed for recodification as N.J.A.C. 13:39-11.20. This section relates to the documentation that a pharmacist must complete and the audit trail that he or she must maintain for all compounded sterile preparations. Subsection (a) is amended to delete a reference to N.J.A.C. 13:39-11.5 and to add provisions requiring that pharmacists ensure that compounded sterile preparations have been properly prepared "consistent with the assigned risk level of the preparation" and that filled prescriptions are accurate and appropriate. Existing subsections (b) through (e), relating to documentation of the dispensing process and the maintenance of an audit trail, are proposed to be deleted. The Board proposes to add new subsection (b), requiring that a pharmacy maintain an audit trail for all compounded sterile preparations consistent with N.J.A.C. 13:39-7.6. The Board also proposes to add new subsection (c), setting forth the information that a pharmacy must maintain as part of the compounding record for each compounded sterile preparation that it prepares.

N.J.A.C. 13:39-11.10 is proposed for recodification as N.J.A.C. 13:39-11.21. This section sets forth the information that is required to appear on a prescription label. Subsection (a) is amended to clarify that the subsection relates to sterile preparations. Paragraph (a)5 is amended to require that the label of a compounded sterile preparation now indicate the strength of all active ingredients and the name and volume of the diluent, vehicle, and base solution(s), if applicable. Paragraph (a)7 is amended to require that labels contain the phrase "use by" followed by the preparation's use by date. Paragraph (a)9 replaces "cytotoxic products" with "antineoplastic agents and other hazardous substances." New paragraph (a)11 requires that preparations prepared by a retail pharmacy not dispensed pursuant to the requirements of N.J.A.C. 13:39-9 contain the prescription number. New subsection (b) relates to the labeling of a compounded sterile preparation when not administered by the person who prepared it, or its administration not witnessed by the person who prepared it.

N.J.A.C. 13:39-11.12 is proposed for recodification as N.J.A.C. 13:39-11.22. This section relates to a pharmacy's responsibilities in the proper handling, packaging, and delivery of compounded sterile preparations. The Board proposes to amend this section to clarify that the rule relates to sterile preparations, that the pharmacist-in-charge must ensure that tamper-evident packaging is used, and that delivery must be made to the patient or patient care location within a reasonable time.

N.J.A.C. 13:39-11.13 is proposed for recodification as N.J.A.C. 13:39-11.23. This section sets forth the topics that must be covered by a pharmacy's policy and procedures manual. Subsection (a) is amended to require that a pharmacy's policy and procedures manual set forth in detail the pharmacy's standard operating procedures with respect to compounded sterile preparations. The existing rule requires the pharmacist-in-charge to maintain a policy and procedures manual that relates to the licensee's standard operating procedures regarding compounded sterile preparations. The Board proposes to amend subsection (b) to make several non-substantive changes to language for clarity. The Board is proposing to amend paragraph (b)1 to require that pharmacies' risk management programs require that the pharmacist-in-charge report all incidents of confirmed contamination to the New Jersey Board of Pharmacy within 48 hours of becoming aware of such incidents. The Board is also proposing to amend paragraph (b)17 to specify that the policy and procedures manual must contain protocol and procedures to maintain the integrity of the interior work area of laminar airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets used to compound sterile products. The existing regulation applies only to laminar flow hoods. The Board is proposing to amend subsection (c) to require review of the policy and procedures manual at a minimum of once every 24 months, and to require updating on a continuous basis to reflect current practice. The existing regulation requires the pharmacist-in-charge to review the manual at least once every two years and to amend the manual as needed.

N.J.A.C. 13:39-11.14 is proposed for recodification as N.J.A.C. 13:39-11.24. This section sets forth the requirements for a pharmacy's quality assurance program. The Board is proposing to delete existing subsection (a). Existing subsection (a) states that the section applies to both commercially available sterile drug products that are dispensed to patients without compounding or other manipulation, and to sterile preparations that have been repackaged, reconstituted, diluted, admixed, blended, or otherwise manipulated. Recodified paragraphs (a)1 through 10 set forth the minimum requirements for a pharmacy's quality assurance program. Paragraph (a)1 is amended to delete a reference to a "dispensing pharmacist" and refers only to a "pharmacist," because "dispensing pharmacist" is an outdated term and all pharmacists can now dispense. Recodified paragraph (a)2 no longer sets forth examples of the phases of sterile compounding and requires the quality assurance program to encompass all phases of sterile compounding for each unique type of compounded sterile preparation dispensed. Existing paragraph (a)3 is [page=443] proposed for deletion as the content of the paragraph has been relocated to recodified N.J.A.C. 13:39-11.16. Proposed new paragraph (a)3 requires inspection after preparation of every admixture. Proposed new paragraph (a)4 requires that all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations have their aseptic technique tested consistent with N.J.A.C. 13:39-16. Existing paragraph (b)3, which requires that all compounding processes representative of all types of manipulations, products, and batches be sterile tested and validated at least every 12 months, is proposed to be deleted. It is replaced with recodified paragraph (a)5, which specifies under what conditions high-risk level compounded sterile preparations are required to be tested to ensure that they are sterile before dispensed or administered. This paragraph also sets forth the methods of verification that may be used. New subparagraph (a)5i sets forth the quality assurance procedure to be followed when high-risk level compounded sterile preparations are dispensed before receiving the results of the sterility tests outlined in proposed N.J.A.C. 13:39-11.24(a)5. New subparagraph (a)5ii requires that all high-risk sterile preparations, except those for inhalation and ophthalmic administration, be tested to ensure that they do not contain excessive bacterial endotoxins.

The Board proposes to amend recodified N.J.A.C. 13:39-11.24(a)6 to require that air and surface sampling for microbial organisms in ISO class 5 primary engineering controls, such as laminar airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets and all other ISO classified areas be done once every six months and at any time when microbial contamination is suspected. The existing regulation refers to laminar hoods and ISO class 6 clean rooms, and requires cleaning to be done twice annually. Proposed new (a)7 sets forth requirements for pressure differential monitoring and documentation. The Board also proposes to amend recodified paragraph (a)8 to refer to laminar airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets instead of laminar flow hoods, and to require that these primary engineering controls meet appropriate ISO classifications. The Board proposes to delete paragraph (b)6 to remove references to ISO class 6 clean rooms and ISO class 7 anterooms, and to delete paragraph (b)7 regarding the disposal of unused drugs and materials used in the compounding of sterile preparations because this requirement was incorporated into N.J.A.C. 13:39-11.2(a)10. Proposed new paragraph (a)9 requires that cleanrooms be certified every six months, or whenever the room or a primary engineering control in the room is relocated or altered, or whenever a major service to the facility is performed. The Board proposes to incorporate by reference procedures outlined in the Controlled Environment Testing Association (CETA) Certification Guide for Sterile Testing Compounding Facilities, as amended and supplemented. The CETA Certification Guide recommends specific tests and relevant standards for performance evaluation and certification of facility and environmental controls used for compounding sterile preparations. The guide recommends room segregation, various types of airflow testing, room pressurization testing, induction leak/backstreaming testing, particle count survey testing, room pressurization testing, induction leak/backstreaming testing, lighting level and uniformity testing, noise level testing, and general temperature and moisture uniformity testing. The guide also discusses various certifications, such as biological safety cabinet certification, compounding aseptic isolator certification, and laminar air flow workstation certification. Proposed new paragraph (a)10 sets forth the procedure to be followed whenever test results indicate that a cleanroom or any primary engineering controls do not meet the standards established in N.J.A.C. 13:39-11.24.

Proposed new Subchapter 11A relates to the compounding of non-sterile preparations in retail and institutional pharmacies.

Proposed new N.J.A.C. 13:39-11A.1 states that the rules in this subchapter apply to all retail and institutional pharmacies that compound and dispense non-sterile preparations. The subchapter establishes standards for quality and control of processes, components, and environments associated with compounded non-sterile preparations, as well as for the skill and knowledge of personnel. The subchapter also establishes minimum good compounding practices.

Proposed new N.J.A.C. 13:39-11A.2 is a definitions section and contains the words and terms used in Subchapter 11A.

Proposed new N.J.A.C. 13:39-11A.3 relates to prohibited compounding. Subsection (a) prohibits pharmacists from compounding preparations containing drug products appearing on the Federal Food and Drug Administration's "List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness." Subsection (b) prohibits pharmacists from compounding any commercially available drug products with limited exceptions.

Proposed new N.J.A.C. 13:39-11A.4 contains exceptions to the prohibitions against compounding commercially available products. Subsection (a) prohibits the compounding of commercially available products unless the product is modified to produce a significant difference or the commercially product is not available in a timely manner to meet the patient's needs. Subsection (b) requires a pharmacist who compounds a commercially available product pursuant to subsection (a) to maintain documentation of the reason for making the compound.

Proposed new N.J.A.C. 13:39-11A.5 sets forth the conditions under which a pharmacist may compound non-sterile preparations in batch before receiving a valid written prescription or medication order.

Proposed new N.J.A.C. 13:39-11A.6 permits a pharmacy to prepare compounded non-sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.

Proposed new N.J.A.C. 13:39-11A.7 provides for the preparation of pharmacy generated products (PGPs) for over-the-counter sale. Subsection (a) sets forth the conditions under which a pharmacist may prepare a PGP to be sold over-the-counter without a prescription or medication order. Subsection (b) details what information must appear on the label of a finished product to be sold over-the-counter. Subsection (c) provides that a PGP may be sold to a consumer only after professional interaction or consultation between a pharmacist and the consumer. Subsection (d) states that a PGP must be stored in a manner inaccessible to the public. Subsection (e) prohibits the sale of a PGP to any entity for resale. Subsection (f) requires pharmacies to prepare documentation relating to PGPs in accordance with the audit and compounding record documentation provisions set forth in proposed new N.J.A.C. 13:39-11A.15(b)1 and 6 through 14.

Proposed new N.J.A.C. 13:39-11A.8 sets forth the requirements for compounding areas. Subsection (a) requires pharmacies that engage in compounding on a regular basis to have an area specifically designated for safe and orderly compounding. Subsection (b) requires pharmacies that engage in compounding on an occasional basis to prepare an area prior to each compounding activity that allows for safe and orderly compounding. Subsection (c) sets forth requirements for compounding areas relating to lighting, ventilation, sanitation, climate control, refuse maintenance and disposal, and accessibility to running water, soap, and drying sources.

Proposed new N.J.A.C. 13:39-11A.9 contains requirements pertaining to equipment and supplies as they relate to non-sterile compounding. Subsection (a) requires a pharmacy to possess equipment appropriate to the type of compounding performed at the pharmacy. Subsection (b) requires that equipment used in compounding drug products be of appropriate design and capacity, and suitably located to facilitate operations for their intended use, cleaning, and maintenance. Subsection (c) requires that equipment be of suitable composition and subsection (d) requires that the equipment be cleaned and sanitized after each use, and when appropriate, prior to each use to prevent cross-contamination of ingredients and preparations. Subsection (e) sets forth the storage requirements for equipment used in compounding drug products. Subsection (f) permits the use of automated, mechanical, or electronic equipment in the compounding of non-sterile preparations. Subsection (g) sets forth the standards to be used when compounding preparations that contain antineoplastic and hazardous substances. This subsection incorporates by reference, as amended and supplemented, the standards set by the Occupational Health and Safety Administration (OSHA) in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs. This subsection also incorporates by reference, as amended and supplemented, the standards established by the National Institute for Occupational Safety and Health [page=444] (NIOSH) in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. For purposes of this subsection, the Board has defined hazardous substances in accordance with Appendix A of NIOSH publication 2004-165.

Proposed new N.J.A.C. 13:39-11A.10 sets forth the responsibilities of the compounding pharmacist. Subsection (a) specifically details the 11 responsibilities of the compounding pharmacist. Subsection (b) requires that the pharmacist-in-charge report any incidents of confirmed product contamination of non-sterile compounded products to the New Jersey Board of Pharmacy within 48 hours of becoming aware of any such incidents.

Proposed new N.J.A.C. 13:39-11A.11 relates to beyond-use dates. Subsection (a) defines "beyond-use date" and establishes how it is to be determined. Subsection (b) sets forth the maximum beyond-use dates for various types of non-sterile compounded drug preparations packaged in tight, light-resistant containers and stored at controlled room temperature, in the absence of stability information relating to that specific drug product and preparation. Subsection (c) sets forth the conditions when beyond-use dates may be exceeded.

Proposed new N.J.A.C. 13:39-11A.12 relates to ingredient selection. Subsection (a) sets forth standards for ingredients to be used in the compounding of non-sterile preparations. Subsection (b) sets forth rules relating to the utilization of active ingredients. Subsection (c) permits components used in the compounding of non-sterile ingredients such as aliquots, triturates, stock solutions, buffering agents, or isotonic solutions to be prepared in advance and stored as pharmacy stock, provided their preparation is properly documented.

Proposed new N.J.A.C. 13:39-11A.13 sets forth the information that must appear on prescription labels of compounded non-sterile preparations dispensed from retail pharmacies and from institutional pharmacies.

Proposed new N.J.A.C. 13:39-11A.14 contains required supervision of pharmacy staff. Subsection (a) sets forth the supervisory responsibilities of a compounding pharmacist with respect to pharmacy technicians, pharmacy interns, or pharmacy externs who perform non-sterile preparation compounding. Subsection (b) details what tasks a compounding pharmacist may delegate to pharmacy technicians, pharmacy interns, or pharmacy externs.

Proposed new N.J.A.C. 13:39-11A.15 sets forth the audit trail and record documentation requirements. Subsection (a) requires a pharmacy to maintain an audit trail for all non-sterile compounded preparation prescriptions that it dispenses. Subsection (b) sets forth the information that must be included in the compounding record. Subsection (c) sets forth exceptions when a compounding record is not required.

As the Board has provided a notice of pre-proposal on this notice of proposal (see 44 N.J.R. 202(a)), this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)4.

Social Impact

The Board of Pharmacy believes that the proposed amendments, repeals, recodifications, and new rules will have a positive impact upon pharmacists who engage in sterile and non-sterile compounding by clearly setting standards for the practice of sterile compounding consistent with the latest revisions to USP 797, which became effective in 2008, and with the standards for non-sterile compounding consistent with USP 795. The Board believes that separating the rules for sterile and non-sterile compounding into separate subchapters will help ensure clarity. The Board also believes that the proposed amendments, repeals, recodifications, and new rules will have a positive social impact on the patients served by pharmacists in this State because the rules set forth clear standards designed to ensure the integrity and safety of compounded sterile and non-sterile preparations.

Economic Impact

The Board notes that the latest version of USP 797, setting forth the requirements for sterile compounding, has been in effect since 2008. The Board believes that most pharmacies have already spent the money necessary to upgrade their cleanrooms to be in compliance with Federal standards. Therefore, the Board believes that it is unlikely that the proposed amendments, repeals, recodifications, and new rules, making the Board's rules consistent with UPS 797, will have a significant economic impact on pharmacies and pharmacists in the State. However, to the extent that the proposed amendments, repeals, recodifications, and new rules will have an economic impact on pharmacies and pharmacists who have not yet upgraded their cleanrooms, the Board believes that any such impact is outweighed by the protection that the proposed amendments, repeals, recodifications, and new rules will provide to the patients of these pharmacists.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments, repeals, recodifications, and new rules do not exceed, and in some cases, incorporate by reference, standards and requirements set forth in USP 797 and USP 795, which may be viewed as establishing and setting forth Federal standards and requirements for sterile and non-sterile compounding.

Jobs Impact

The Board of Pharmacy does not believe that the proposed amendments, repeals, recodifications, and new rules will result in the creation or loss of jobs in the State.

Agriculture Industry Impact

The Board of Pharmacy believes that the proposed amendments, repeals, recodifications, and new rules will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

The Board of Pharmacy licenses approximately 13,800 pharmacists. If licensees are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed amendments, repeals, recodifications, and new rules will require pharmacists-in-charge to report all confirmed incidents of product contamination of sterile and non-sterile compounded preparations to the Board of Pharmacy within 48 hours of becoming aware of such incidents. The proposed amendments, repeals, recodifications, and new rules will also impose various recordkeeping and compliance requirements upon licensees of the Board of Pharmacy who engage in the practice of compounding sterile and non-sterile preparations. These requirements are discussed in the Summary above.

No additional professional services will be needed to comply with the proposed amendments, repeals, recodifications, and new rules. The costs of compliance with the proposed amendments, repeals, recodifications, and new rules are discussed in the Economic Impact statement above. The Board believes that the proposed amendments, repeals, recodifications, and new rules should be uniformly applied to all pharmacists engaging in sterile and non-sterile compounding in order to ensure the health, safety, and welfare of the general public. Therefore, no differing compliance requirements for any pharmacists are provided based upon the size of the business.

Housing Affordability Impact Analysis

The proposed amendments, repeals, recodifications, and new rules will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed amendments, repeals, recodifications, and new rules concern standards for sterile and non-sterile compounding.

Smart Growth Development Impact Analysis

The proposed amendments, repeals, recodifications, and new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendments, repeals, recodifications, and new rules concern standards for sterile and non-sterile compounding.

Full text of the rules proposed for repeal may be found in the New Jersey Administrative Code at N.J.A.C. 13:39-11.3, 11.4, 11.11, 11.15, 11.19, 11.21, and 11.23 through 11.26.

[page=445] Full text of the proposed amendments, recodifications, and new rules follow (additions indicated in boldface thus; deletions indicated in brackets [thus]):

SUBCHAPTER 11. COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES [FOR STERILE AND/OR NON-STERILE PREPARATIONS]

13:39-11.1 Purpose and scope

[This] The rules in this subchapter regulate the practice of sterile compounding and shall apply to all retail and institutional pharmacies [which] that compound and dispense sterile [and/or non-sterile] preparations. This subchapter establishes standards for the quality and control of processes, components, and environments associated with compounded sterile preparations and for the skill and knowledge of pharmacy personnel who prepare compounded sterile preparations.

13:39-11.2 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings:

"Ante area" means an ISO class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, labeling, and other high-particulate-generating activities are performed. The "ante area" is also a transition area that:

1. Provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and

2. Reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to respond to large disturbances.

"Biological safety cabinet" means a ventilated cabinet for compounded sterile preparations that has an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhaust air for environmental protection.

"Buffer area" means an ISO class 7 area where the primary engineering control is physically located and where the preparation and staging of components and supplies used in compounding sterile preparations occurs.

"Cleanroom" means a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness (ISO) class. Microorganisms in the environment are monitored, so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class. A "cleanroom" includes a buffer area or room and an ante area or room.

"Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner's prescription or medication order or initiative based on the relationship of the practitioner or the patient with the pharmacist in the course of professional practice, or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescriptions or medication orders based on routine, regularly-observed prescribing patterns. Compounding includes mixing, reconstituting, or assembling a drug according to the product's labeling or to the manufacturer's directions.

"Compounding aseptic containment isolator" means a compounding aseptic isolator designed to provide worker protection from exposure to undesirable levels of airborne hazardous drugs throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter (high-efficiency particulate air (HEPA) minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded.

"Compounding aseptic isolator" means a form of isolator specifically designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer process. Air exchanges into the isolator from the surrounding environment should not occur unless the air has first passed through a microbially retentive filter (high-efficiency particulate air (HEPA) minimum).

"Immediate use compounded sterile preparations" means preparations intended for emergency patient care and involve only simple aseptic measuring and transfer manipulations of no more than three sterile non-hazardous commercial drug and diagnostic radiopharmaceutical drug products, including an infusion or diluent solution. Unless required for the preparation, the compounding process occurs continuously without delays or interruptions and does not exceed one hour. Administration of immediate use compounded sterile preparations shall begin within one hour of preparation or the compounded sterile preparations shall be discarded. Immediate use compounded sterile preparations shall not be compounded and stored for anticipated needs and shall not be compounded as batch preparations. At no time during the compounding process, nor prior to administration, are critical sites and ingredients of the compounded sterile preparation directly exposed to contact contamination, such as human touch, cosmetic flakes, or particulates, blood, human body substances, and non-sterile inanimate sources.

"ISO class 5 air quality conditions" means conditions in which the air particle count is no greater than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air (100 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air.

["ISO class 6 air quality conditions" means conditions in which the air particle count is no greater than a total of 35,200 particles of 0.5 micrometers and larger per cubic meter of air (1,000 particles per cubic foot).]

"ISO class 7 air quality conditions" means conditions in which the air particle count is no greater than a total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air (10,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air.

"ISO class 8 air quality conditions" means conditions in which the air particle count is no greater than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air (100,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air.

"Negative pressure room" means a room that is at a lower pressure than the adjacent spaces and, therefore, the net airflow is into the room.

"Positive pressure room" means a room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.

"Primary engineering control" means a device or room that provides an ISO class 5 environment for the exposure of critical sites when compounding sterile preparations. Such devices include laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators.

"Risk levels for compounded sterile preparations" means the established classification for compounded sterile preparations based on the potential for microbial, chemical, and physical contamination of the preparations and are defined as follows:

1. "Low-risk level compounded sterile preparations" means preparations compounded with aseptic manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products, components, and devices. The compounding process involves only assembling, transferring, measuring, and mixing, using no more than three commercially manufactured sterile products, and not more than two entries into one sterile container or package to make the compounded sterile preparations. The compounding process is limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring [page=446] sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.

2. "Medium-risk level compounded sterile preparations" means preparations compounded under low-risk level conditions but which require multiple individual or small doses of sterile products to be combined or pooled to prepare compounded sterile preparations that will be administered either to multiple patients or to one patient on multiple occasions. The compounding process includes complex aseptic manipulations other than single volume transfer, and requires an unusually long duration, such as that required to complete dissolution or homogeneous mixing.

3. "High-risk level compounded sterile preparations" means preparations compounded from non-sterile ingredients or from ingredients that are incorporated using non-sterile equipment before terminal sterilization, or from commercially manufactured sterile products that lack effective antimicrobial preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality worse than ISO class 5 for more than one hour. Water-containing preparations that are stored for more than six hours before terminal sterilization are also classified as high-risk level compounded sterile preparations.

13:39-11.3 Application and pre-approval requirements for compounding sterile preparations

(a) An applicant for a new pharmacy who wishes to compound sterile preparations shall satisfy all pharmacy permit application requirements set forth in N.J.A.C. 13:39-4.1. As part of the permit application, the applicant shall submit plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. An applicant for a pharmacy permit shall not dispense sterile preparations compounded at the site until receiving written approval from the Board to engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection of the pharmacy to ensure compliance with the requirements in this subchapter.

(b) The holder of an existing pharmacy permit who wishes to compound sterile preparations shall submit an amended pharmacy permit application to the Board. The amended permit application shall contain plans detailing the physical arrangements necessary to ensure compliance with the requirements in this subchapter. The holder of an existing pharmacy permit shall not dispense sterile preparations compounded at the site until receiving written approval from the Board to engage in such activities. Prior to issuing the written approval, the Board shall conduct an inspection of the pharmacy to ensure compliance with the requirements in this subchapter.

(c) A pharmacy permit holder who is approved to compound sterile preparations shall notify the Board at least 60 days in advance of any remodeling, change of location, or change in size of the pharmacy cleanroom, consistent with the requirements of N.J.A.C. 13:39-4.7 and 4.8. Such notification shall include the pharmacy's remodeling or relocation plans, as appropriate, the pharmacy's interim plans for the continuation of sterile compounding operations, which the Board shall review and approve, and the anticipated date of completion. The pharmacy permit holder and the pharmacist-in-charge shall ensure compliance with all requirements set forth in this subchapter while compounding operations continue during the remodeling or relocation process. The pharmacy permit holder shall notify the Board upon completion of the remodeling or relocation process, at which time the Board shall inspect the premises.

(d) A pharmacy holding an institutional permit that is approved to compound sterile preparations and that intends to compound sterile preparations using a laminar air flow workbench not located in a buffer area, as provided in N.J.A.C. 13:39-11.10, shall notify the Board at least 60 days in advance of its intention and of all locations where such equipment will be installed. The pharmacy permit holder shall notify the Board upon completion of such installation, at which time the Board shall inspect the equipment. The pharmacy shall not utilize such equipment to compound sterile preparations until receiving Board approval.

(e) A pharmacy permit holder who is approved to compound sterile preparations and who intends to utilize compounding aseptic isolators or compounding aseptic containment isolators not located in a buffer area, as provided in N.J.A.C. 13:39-11.8, shall notify the Board at least 60 days in advance of its intention and of all locations where such equipment will be installed. The pharmacy permit holder shall notify the Board upon completion of such installation, at which time the Board shall inspect the equipment. The pharmacy shall not utilize such equipment to compound sterile preparations until receiving Board approval.

13:39-[11.16]11.4 [Controlled environment for compounded sterile preparations:] Cleanroom: use, access, location; temperature; air pressure

(a) The pharmacy shall have a designated area for sterile preparation compounding, known as the ["controlled environment," consisting of a clean room and an anteroom unless the pharmacy meets the requirements of N.J.A.C. 13:39-11.22 or 11.23.] "cleanroom." A cleanroom shall be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. Critical sites are locations that include any component or fluid pathway surfaces (for example, vial septa, injection ports, beakers), openings (for example, opened ampules, needle hubs), exposed and at risk of direct contact with air (for example, ambient room or HEPA-filtered), moisture (for example, oral and mucosal secretions), or touch contamination. A cleanroom shall include a buffer area and an ante area. The buffer area shall contain an ISO class 5 or better primary engineering control, such as a laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, and/or compounding aseptic containment isolator, unless the buffer area has ISO class 5 or better air quality.

(b) All sterile compounding shall take place within the confines of the buffer area, except for the following:

1. Compounding in a compounding aseptic isolator or a compounding aseptic containment isolator pursuant to N.J.A.C. 13:39-11.8;

2. Compounding in a laminar air flow workbench in an institutional pharmacy pursuant to N.J.A.C. 13:39-11.10; and

3. Compounding immediate use compounded sterile preparations in an institutional pharmacy pursuant to N.J.A.C. 13:39-11.11.

[(b)] (c) A [controlled environment] cleanroom shall be:

1. (No change.)

2. Used only for the compounding of sterile preparations[,] or such other tasks that require a [controlled environment] cleanroom;

3. (No change.)

4. Air conditioned to maintain a temperature of 59 to 77 degrees Fahrenheit with an ideal temperature of 66 degrees Fahrenheit.

(d) A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity, respectively, consistent with the following:

1. For compounding of non-hazardous drugs, if the buffer area and the ante area are physically separated through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02 inch to 0.05 inch water column shall be required. For buffer areas not physically separated from the ante area, the principle of displacement airflow shall be employed. Using displacement airflow, an air velocity of 40 feet per minute or more from the buffer area across the line of demarcation into the ante area is required.

2. For compounding of antineoplastic agents and other hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall be placed in an ISO class 7 buffer room that is physically separated from other preparation areas and has not less than 0.01 inch water column negative pressure to adjacent positive pressure ISO class 7 or better ante room, thus providing inward airflow to contain any airborne drug.

3. For compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment isolator is used outside of a [page=447] buffer area, the compounding area shall be physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch water column and have a minimum of 12 air exchanges per hour.

(e) No chewing gum, drinks, candy, or food items shall be brought into the cleanroom.

13:39-[11.17]11.5 [Controlled environment for compounded sterile preparations: construction] Cleanroom requirements

(a) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the [controlled environment] cleanroom shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby minimizing spaces in which microorganisms and other contaminants may accumulate.

(b) Work surfaces shall be constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that the work surfaces may be readily cleaned and sanitized. All work surfaces shall be resistant to damage from cleaning and sanitizing agents.

(c) Junctures where ceilings meet walls shall be covered, caulked, or sealed to avoid cracks and crevices [where dirt] in which microorganisms and other contaminates can accumulate. All areas in ceilings and walls where the surface has been penetrated shall be sealed.

(d) Ceilings [which] that consist of inlaid panels shall be impregnated with a polymer to render them impervious and hydrophobic and shall either be caulked or weighted and clipped.

(e) [Solid walls] Walls shall [consist either] be constructed of flexible material (for example, heavy gauge polymer), panels locked together and sealed, or of epoxy-coated gypsum board.

(f) Floors shall have vinyl floor covering and shall be seamless or have heat-welded seams and coving to the sidewall. There shall be no floor drains.

(g) There shall be no dust-collection overhangs (such as ceiling utility pipes) [or] and ledges (such as window sills) should be avoided. All sprinkler heads shall be flush with the ceiling.

(h) (No change.)

[(i) All areas in ceilings and walls where the surface has been penetrated shall be sealed.

(j) Any clean room construction other than that specified in (a) through (i) above (for example, softwall, prefabricated, modular, portable clean rooms) shall be approved by the Board prior to installation and use.]

(i) Carts shall be of stainless steel wire, nonporous plastic, or sheet metal construction with good quality, cleanable casters to promote mobility.

(j) Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to ensure the integrity of the compounded sterile preparations, consistent with the requirements of N.J.A.C. 13:39-11.12(b)3.

13:39-[11.20]11.6 [Controlled environment for compounded sterile preparations: anteroom] Ante area requirements

(a) The [anteroom] ante area shall have [an air quality of ISO class 7 or better.] appropriate environmental control devices capable of maintaining ISO class 8 air quality conditions for non-hazardous drug compounding activities and ISO class 7 air quality conditions for hazardous drug compounding activities as provided in N.J.A.C. 13:39-11.4(d)2.

(b) The [anteroom] ante area shall contain the following equipment:

1. A sink with hot and cold running water with an integrated and closed plumbing system;

2.-4. (No change.)

[(c) A refrigerator, as required by United States Pharmacopoeia Standards, shall be reasonably accessible to the anteroom to ensure the integrity of the compounded sterile preparations, but shall not be located within the controlled environment.]

13:39-[11.18]11.7 [Controlled environment for compounded sterile preparations: stocking, maintenance and supplies] Buffer area requirements

[(a) The controlled environment shall contain only the following:]

(a) The buffer area shall have appropriate environmental control devices capable of maintaining ISO class 7 air quality conditions during normal activity consistent with the requirements of N.J.A.C. 13:39-11.4(d).

(b) The buffer area shall contain only the following:

1. Items such as furniture, equipment, supplies, and other [goods which] materials that are required for the tasks to be performed there;

2. Items [which] that are nonpermeable, nonshedding, cleanable, and resistant to disinfectants; and

3. Items [which] that have been cleaned and [sanitized] disinfected immediately prior to their being placed in the [clean room] buffer area.

[(b)] (c) [Whenever possible, equipment] Equipment and other items used in the [controlled environment should] buffer area shall not be taken from these [rooms] areas except for calibration, servicing, or other [activity] activities associated with the proper maintenance of the item.

[(c)] (d) The [controlled environment] buffer area shall be kept clean and arranged in an orderly fashion. All required equipment shall be maintained in good operating condition.

[(d)] (e) The [controlled environment] buffer area shall not be used for bulk storage, warehousing, or clerical and secretarial functions.

[(e) The controlled environment area shall contain the following supplies:

1. Gloves, masks, gowns, and other personal protective equipment;

2. Needles and syringes of various sizes;

3. Disinfectant cleaning agents;

4. Clean towels;

5. Hand-washing materials, including antimicrobial skin cleaner; and

6. Any and all supplies necessary for the aseptic compounding of sterile preparations.]

(f) The buffer area shall not contain any sinks.

(g) The buffer area shall be a minimum of 100 square feet in size and shall be compatible with the volume of compounding being conducted.

(h) The buffer area shall contain waste containers in compliance with Occupational Safety and Health Administration (OSHA) standards for disposal of used needles and syringes set forth in 29 CFR 1910.1030 and for disposal of chemotherapy waste set forth at 29 CFR 1910.1200, incorporated herein by reference, and available at www.osha.gov.

13:39-11.8 Use of compounding aseptic isolators and compounding aseptic containment isolators located outside of a cleanroom

A pharmacy may utilize compounding aseptic isolators and compounding aseptic containment isolators not located in a cleanroom to prepare compounded sterile preparations, provided the compounding aseptic isolators and compounding aseptic containment isolators can provide isolation from the room and maintain ISO class 5 air quality during dynamic operating conditions, including transferring ingredients, components, and devices into and out of the isolator and during preparation of compounded sterile preparations. A pharmacy utilizing a compounding aseptic containment isolator not located in a cleanroom to compound antineoplastic agents and other hazardous substances shall comply with the requirements of N.J.A.C. 13:39-11.4(d)3. Particle counts sampled approximately six to 12 inches upstream of the critical exposure site must maintain ISO class 5 air quality levels during compounding operations. Compounding personnel shall obtain documentation from the manufacturer that the compounding aseptic isolator or compounding aseptic containment isolator will meet this standard when located in worse than ISO class 7 environments. A compounding aseptic isolator and compounding aseptic containment isolator not located in a buffer area shall be located in an area that is maintained under sanitary conditions and such area shall only be traveled by persons engaging in the compounding of sterile preparations.

13:39-11.9 Compounding of antineoplastic agents and other hazardous substances

(a) For purposes of this section, hazardous substances are those substances identified as hazardous by the National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. [page=448] 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, Appendix A (2012 Edition). The sample list of drugs that shall be handled as hazardous (Appendix A) is incorporated herein by reference, as amended and supplemented, and can be found at the Centers for Disease Control and Prevention website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/.

(b) Pharmacies shall not prepare antineoplastic agents and other hazardous substances as immediate use compounded sterile preparations.

(c) Pharmacies shall compound antineoplastic agents and other hazardous substances only in:

1. A compounding aseptic containment isolator or a Class II or Class III biological safety cabinet in a negative pressure cleanroom. When handling volatile hazardous drugs, such devices shall be vented to the outside air; or

2. A compounding aseptic containment isolator located outside of a negative pressure cleanroom, consistent with N.J.A.C. 13:39-11.8. When handling volatile hazardous drugs, such devices shall be vented to the outside air.

(d) Correct room pressurization shall be maintained at all times when compounding antineoplastic agents and other hazardous substances, consistent with N.J.A.C. 13:39-11.4(d).

(e) Personnel who compound and dispense antineoplastic agents and other hazardous substances shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by NIOSH in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH Publication No. 2004-165 (2012 Edition) is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/.

(f) Antineoplastic agents and other hazardous substances used to compound sterile preparations shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. Such storage is preferable within a containment area such as a negative pressure room. The storage area shall have sufficient general exhaust, at least 12 air exchanges per hour to dilute and remove any airborne contaminants. Antineoplastic agents and hazardous substances used to compound sterile preparations shall be handled with caution using appropriate chemotherapy gloves during distribution, receiving, stocking, inventorying, preparing for administration, and disposal.

13:39-[11.22]11.10 [Laminar air flow hoods not in a clean room] Institutional pharmacy use of airflow workbenches not in a buffer area for low-risk level compounded sterile preparations

[Institutional] A pharmacy holding an institutional pharmacy permit may utilize ISO class 5 laminar [air flow hoods] airflow workbenches not located in a [clean room may only be] buffer area to prepare low-risk level compounded sterile preparations provided that the administration of such preparations commences within 12 hours of the preparation or as recommended by the manufacturer, whichever is less. Such workbenches shall be located in an area which is maintained under sanitary conditions and which is traveled only by persons engaging in the compounding of sterile preparations. [Such hoods shall be certified by an independent certification company prior to use when first installed or after being moved and at six-month intervals.] Such workbenches shall not be in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or that is adjacent to areas including, but not limited to, construction sites, warehouses, or food preparation. Sinks may not be located adjacent to the ISO class 5 workbench environments and must be separated from the immediate area of ISO class 5 workbenches. Personnel engaged in sterile compounding in such areas shall follow the procedures relating to cleansing and garbing set forth in N.J.A.C. 13:39-11.14.

13:39-11.11 Compounding immediate use compounded sterile preparations in an institutional pharmacy

A pharmacy holding an institutional pharmacy permit may prepare non-hazardous immediate use compounded sterile preparations outside of an ISO class 5 laminar airflow workbench when the delay resulting from the use of the workbench would harm the patient, including situations in which the patient experiences a sudden change in clinical status.

13:39-[11.5]11.12 [Pharmacist in charge and permitholders'] Pharmacist-in-charge responsibilities

(a) The pharmacist-in-charge shall supervise all sterile [and/or non-sterile] compounding performed by pharmacy personnel. [For purposes of supervising sterile compounding, the] The pharmacist-in-charge shall be trained in aseptic manipulation skills.

(b) The [pharmacist in charge] pharmacist-in-charge shall [have the responsibility, in that section of the pharmacy where sterile and/or non-sterile preparations are compounded,] be responsible for, at a minimum, the following:

[1. Compounding of all preparations within the pharmacy or pharmacy satellite, including compounding of individual medication orders or prescriptions, the formulation of products in response to special drug needs, and batch compounding;]

1. Determining the procedural, environmental, and quality control practices that are necessary for the risk levels he or she assigns to specific compounded sterile preparations;

2. Ensuring that the selected sterilization method both sterilizes and maintains the strength, purity, quality, and packaging integrity of the compounded sterile preparations;

3. Ensuring the placement in buffer areas and ante areas of equipment (for example, refrigerators), devices (for example, computers and printers) and objects (for example, carts and cabinets) that are not essential to compounding is dictated by their effect on the required environmental quality of air atmospheres and surfaces, which shall be verified by monitoring;

[2.] 4. Storage of all materials pertinent to the compounding of sterile preparations, including drugs, chemicals, and biologicals, and the establishment of [specifications] specific procedures for procurement of the materials in accordance with State and Federal laws and regulations;

[3.] 5. Ensuring that all packaging and labeling of all [drugs] compounded [with] sterile preparations in the pharmacy are performed under the immediate personal supervision of a pharmacist;

[4. Recording all transactions of the pharmacy as may be applicable to State, Federal and local laws and rules, as may be necessary to maintain accurate control over, and accountability for, all pharmaceutical materials;]

[5.] 6. Ensuring that preparation and compounding of sterile preparations is performed only by [licensed] pharmacists who have been trained in aseptic manipulation skills, or by pharmacy technicians, pharmacy interns, or pharmacy externs who have been trained in aseptic manipulation skills working under the immediate personal supervision of a [licensed] pharmacist trained in aseptic manipulation skills;

[6. Ensuring that preparation and compounding of non-sterile preparations is performed only by licensed pharmacists or by pharmacy technicians, intern or externs working under the immediate personal supervision of a licensed pharmacist; and]

7. Recording all transactions of the pharmacy as may be necessary under applicable State, Federal, and local laws and rules, to maintain accurate control over, and accountability for, all pharmaceutical materials, and ensuring that policies and procedures exist with respect to the maintenance of the audit trail required pursuant to N.J.A.C. 13:39-11.20;

8. Ensuring that all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs who compound sterile preparations [page=449] are trained and evaluated consistent with the requirements of N.J.A.C. 13:39-11.16;

[7.] 9. Establishing procedures for maintaining the integrity of the product and the manufacturer's control identity [of packaged material] when repackaging sterile products. [The packaging] A pharmacist shall check all repackaging and shall initial the repackaging records [shall be initialed by the supervising pharmacist.];

10. Disposal of all unused drugs and materials used in compounding sterile preparations, including antineoplastic agents and other hazardous substances, in accordance with accepted professional standards, and the Medical Waste Act, N.J.S.A. 13:1E-48.1 et seq., so as not to endanger the public health;

11. Ensuring that the compounding area and its contents and other areas where compounded sterile preparations are present are secured, so as to prevent access by unauthorized personnel;

12. Ensuring that the pharmacy contains, in addition to the minimum reference library mandated in N.J.A.C. 13:39-5.8(a)1, references pertinent to compounding sterile preparations;

13. Ensuring that records are maintained that document, at least once daily, that appropriate controlled cold (refrigerator), controlled freezer, if applicable, and controlled room temperatures, as these terms are defined in United States Pharmacopeia 797, are maintained. Such records shall be maintained for no less than five years and shall be made available to the Board for inspection upon request;

14. Ensuring that all information required to be maintained as part of a pharmacy's patient profile record system pursuant to N.J.A.C. 13:39-7.19 or 9.19 is maintained for all compounded sterile preparations;

15. Ensuring that initial and ongoing multidisciplinary clinical monitoring and comprehensive care plans are maintained and readily available; and

16. Maintaining a policy and procedures manual detailing the pharmacy's standard operating procedures with regard to compounded sterile preparations, consistent with the requirements of N.J.A.C. 13:39-11.23, and maintaining a written quality assurance program, consistent with the requirements of N.J.A.C. 13:39-11.24.

13:39-[11.6]11.13 Pharmacy technicians, pharmacy interns, and pharmacy externs; required supervision

(a) [Dispensing pharmacists] Pharmacists shall provide immediate personal supervision to pharmacy technicians, pharmacy interns, or pharmacy externs who are performing [delegated] sterile [and non-sterile preparation] compounding. The ratio of [dispensing] pharmacists to pharmacy technicians shall not exceed 1:2 at any given time unless all of the requirements of N.J.A.C. 13:39-[6.6(d) and (e)]6.15 are met.

1. (No change.)

(b) The [dispensing] pharmacist may delegate to pharmacy technicians, pharmacy interns, or pharmacy externs only the following tasks: recording of the prescription, selection of the drugs, container, and diluent, [typing of labels] labeling, and compounding of preparations. The [dispensing] pharmacist shall ensure that each task has been performed correctly [in the dispensing process].

13:39-11.14 Personnel cleansing and garbing requirements

(a) All personnel who engage in compounding sterile preparations shall comply with the following requirements before entering the buffer area:

1. Personnel shall remove personal outer garments (for example, bandanas, coats, hats, jackets, scarves, sweaters, vests), all cosmetics, and hand, wrist, and other visible jewelry or piercings (for example, earrings, or lip or eyebrow piercings);

2. The wearing of artificial nails or extenders is prohibited while working in the compounding area. Natural nails shall be kept neat and trimmed;

3. Personnel protective equipment shall be donned in the following order:

i. Dedicated shoes or shoe covers;

ii. Head and facial hair covers (for example, beard covers in addition to face masks);

iii. Face masks; and

iv. Eye shields, if required;

4. A hand and forearm cleansing procedure shall be performed. Personnel shall remove debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using either lint-free disposable towels or an electric hand dryer; and

5. Personnel shall wear non-shedding gowns with sleeves that fit snugly around the wrists and enclosed at the neck, that are designed for buffer area use.

(b) Following the completion of all steps in (a) above, and once inside the buffer area, personnel shall perform antiseptic hand cleansing, using a waterless alcohol-based surgical hand scrub with persistent activity following manufacturers' recommendations. Once hands are dried thoroughly, personnel shall don sterile gloves. Gloves shall be routinely inspected for holes, punctures, or tears, and shall be replaced immediately if any are detected.

1. Gloves become contaminated when they make contact with non-sterile surfaces during compounding activities. Disinfection of contaminated gloved hands may be accomplished by wiping or rubbing sterile 70 percent Isopropyl Alcohol (IPA) on all contact surface areas of the gloves and letting the gloved hands dry thoroughly. Routine application of sterile 70 percent IPA shall occur throughout the compounding process and whenever non-sterile surfaces (for example, vials, counter tops, chairs, and carts) are touched.

(c) When compounding personnel exit the cleanroom during a work shift, the exterior gown may be removed and retained in the cleanroom if not visibly soiled, and may be re-donned during that same work shift only. Shoe covers, hair and facial hair covers, face masks/eye shields, and gloves, however, shall be replaced with new ones before re-entering the buffer area, and proper hand hygiene shall be performed, consistent with (a) and (b) above.

13:39-11.15 Cleaning and disinfection requirements for cleanroom, buffer area, and ante area

(a) The cleanroom, buffer area, and ante are shall be cleaned and disinfected consistent with the following requirements:

1. All surfaces in laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators shall be cleaned and disinfected at the beginning of each work shift, before each batch preparation is started, after spills, and when surface contamination is known or suspected;

2. All counters, work surfaces, and floors shall be cleaned and disinfected daily; and

3. All walls, ceilings, and storage shelving shall be cleaned monthly.

(b) All cleaning and disinfection shall be performed consistent with the standards established in USP 797 Appendix II, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org.

(Agency Note: N.J.A.C. 13:39-11.16, 11.17, and 11.18 are proposed for recodification with amendments as N.J.A.C. 13:39-11.4, 11.5, and 11.7, respectively.)

13:39-[11.7]11.16 Training and evaluation requirements [for compounding sterile preparations]

(a) The [pharmacist in charge] pharmacist-in-charge and all [personnel] pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations shall have didactic and practical [or academic] training in sterile preparation compounding, [clean room] including proper personnel cleansing and garbing, and cleaning and disinfecting the sterile compounding areas, cleanroom technology, laminar flow technology, isolator technology, if applicable, and quality assurance techniques. Such training shall be documented for each person before that individual begins to compound sterile preparations and annually thereafter for all pharmacists, pharmacy technicians, pharmacy interns, and [page=450] pharmacy externs who compound sterile preparations. That documentation shall be maintained by the permitholder for five years and made available to the Board upon request.

(b) The [pharmacist in charge] pharmacist-in-charge shall be responsible for ensuring that, prior to compounding sterile preparations and annually thereafter, all [personnel are trained and can successfully demonstrate:] pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall have passed a written test that demonstrates competency in all areas set forth in (a) above, and in the pharmacy's standard operating procedures with regard to compounding sterile preparations as set forth in the policy and procedure manual required to be maintained pursuant to N.J.A.C. 13:39-11.23.

[1. Comprehensive knowledge of the pharmacy's standard operating procedures with regard to compounding sterile preparations as set forth in the policy and procedure manual required to be maintained pursuant to N.J.A.C. 13:39-11.13;

2. Familiarity with the necessary compounding techniques; and

3. Appropriate aseptic technique, which shall be proven by means of a test batch of culture media, media fill or the equivalent.]

(c) [At least annually, the pharmacist in charge] The pharmacist-in-charge shall be responsible for testing of the aseptic technique of all [personnel] pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations, [by means of a test batch of culture media, media fill or the equivalent. Test results shall be maintained for five years, and shall be made available for the Board's inspection upon request. Individuals who fail to demonstrate acceptable aseptic technique shall be prohibited from engaging in sterile preparation compounding until demonstrating acceptable technique by means of a test batch of culture media, media fill or the equivalent.] consistent with the methods set forth in USP 797 concerning "Aseptic Manipulation Competency Evaluation," incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org, prior to compounding sterile preparations. Aseptic technique retesting shall be conducted annually for all personnel engaged in compounding low- and medium-risk level preparations and semi-annually for all personnel engaged in compounding high-risk level preparations.

(d) All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs engaging in the compounding of sterile preparations shall successfully complete an initial gloved fingertip/thumb sampling procedure prior to compounding sterile preparations. Gloved fingertip/thumb sampling shall be conducted annually for all personnel engaged in compounding low- and medium-risk level preparations and semi-annually for all personnel engaged in compounding high-risk level preparations.

(e) Individuals who fail the written test and/or the test of aseptic technique shall be prohibited from compounding sterile preparations until passing both tests.

(f) All test results shall be maintained by the permit holder for five years and shall be made available to the Board for inspection upon request.

13:39-[11.8]11.17 Batch preparation

(a) Pharmacists, [and] pharmacy technicians, pharmacy interns, and pharmacy externs, consistent with N.J.A.C. 13:39-11.13, may compound sterile [and non-sterile] preparations [consistent with the provisions of N.J.A.C. 13:39-11.6] in a quantity that is supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided the pharmacist: [can document a history of valid prescriptions subsequently received shortly thereafter or medication orders that have been generated solely within an established professional prescriber-patient-pharmacist relationship, and provided they maintain the prescription on file for all such products dispensed at the pharmacy as required by state law. The pharmacist shall document the batch preparation process in accordance with N.J.A.C. 13:39-11.9(d).]

1. Documents a history of valid prescriptions or medication orders subsequently received, within the beyond-use dating time of each product, which have been generated solely within an established professional prescriber-patient-pharmacist relationship;

2. Maintains the prescription or medication order on file for all such products dispensed at the pharmacy;

3. Documents the batch preparation process, including selection of the drugs, containers, and diluents, lot numbers and expiration dates of the drugs, containers, and diluents, if any, and verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling. Each batch shall be given a unique batch number to identify the specific batch; and

4. Ensures that the labeling requirements set forth at N.J.A.C. 13:39-11.21(a)1, 5, 7, 9, and 10 are satisfied.

(b) Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs, consistent with N.J.A.C. 13:39-11.13, may batch prepare compounded sterile preparations for use by a licensed prescriber in his or her practice without a prescription, pursuant to N.J.A.C. 13:39-11.18, provided the pharmacist:

1. Complies with all requirements of N.J.A.C. 13:39-11.18; and

2. Documents the batch preparation process in accordance with N.J.A.C. 13:39-11.20(c).

13:39-11.18 Compounded sterile preparations for prescriber practice use

A pharmacy may prepare compounded sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.

13:39-11.19 Stability criteria and beyond-use dating

(a) For purposes of this section, stability means the extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

(b) In the absence of supporting valid scientific sterility testing and stability information that is directly applicable to specific preparations, the following dates and times for storage and initiation of administration of the compounded sterile preparations shall apply, according to the assigned risk level of the preparation, unless the manufacturer's package indicates a different stability time:

1. For low-risk level compounded sterile preparations, in the absence of passing a sterility test:

i. Administration shall begin within 48 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

ii. Administration shall begin within 14 days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius);

iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius); and

iv. For products prepared in an airflow workbench not located in a buffer area in accordance with N.J.A.C. 13:39-11.10, administration shall begin within 12 hours or less of preparation;

2. For medium-risk level compounded sterile preparations, in the absence of passing a sterility test:

i. Administration shall begin within 30 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

ii. Administration shall begin within nine days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius); and

iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius);

3. For high-risk level compounded sterile preparations, in the absence of passing a sterility test:

i. Administration shall begin within 24 hours when the preparation is stored at controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

[page=451] ii. Administration shall begin within three days when the preparation is stored at cold temperatures (two degrees Celsius to eight degrees Celsius); and

iii. Administration shall begin within 45 days when the preparation is stored in a solid frozen state (-20 degrees Celsius); and

4. For immediate use compounded sterile preparations, administration shall begin no less than one hour following the start of preparing the compounded sterile preparation.

(c) The administration dates and times established in (b) above shall not be exceeded or extended for compounded sterile preparations without verifiable supporting valid scientific sterility and stability information that is directly applicable to the specific preparation or compound.

(d) A pharmacist shall determine the beyond-use date for a compounded sterile preparation consistent with (b) above and assign an appropriate discard-after date for the compounded sterile preparation. The discard-after date shall appear on the label consistent with the requirements of N.J.A.C. 13:39-11.21.

(e) Opened or needle-punctured single-dose containers of sterile products (for example, bags, bottles, syringes, and vials) used in the compounding of sterile preparations for immediate use in an institutional pharmacy pursuant to N.J.A.C. 13:39-11.11, shall be used within one hour if opened in worse than ISO Class 5 air quality, and any remaining contents shall be discarded.

(f) Single-dose vials used in the compounding of sterile preparations exposed to ISO Class 5 or cleaner air quality may be used up to six hours after initial puncture.

(g) Opened single-dose ampules used in the compounding of sterile preparations shall not be stored for any period of time.

(h) Opened or needle-punctured multiple-dose vials used in the compounding of sterile preparations shall be used within 28 days after initially entering the vial, unless otherwise specified by the manufacturer.

(Agency Note: N.J.A.C. 13:39-11.20 is proposed for recodification with amendment as N.J.A.C. 13:39-11.6.)

13:39-[11.9]11.20 Documentation; audit trail

(a) [Consistent with the provisions of N.J.A.C. 13:39-11.5, the dispensing] The pharmacist shall ensure that compounded sterile preparations have been properly prepared, consistent with the assigned risk level of the preparation, labeled, controlled, stored, dispensed, and distributed in accordance with the provisions of this subchapter. The pharmacist shall be responsible for the accuracy and appropriateness of the compounded prescription. When more than one pharmacist is involved in the steps of the compounding process, the pharmacist shall be responsible for the accuracy and appropriateness of each step he or she performed or he or she approved and reviewed, and his or her unique and secure user identifier(s) shall be recorded in the audit trail.

[(b) The pharmacist in charge shall be responsible for ensuring that policies and procedures exist so that all aspects of the dispensing process set out in (d) below are documented and that the pharmacist responsible for each preparation can be identified.

(c) On or after April 5, 2011, a pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or extern(s) involved, consistent with the requirements of this chapter, in the steps of the compounding process set out in (d) below. All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail. All entries to the audit trail made by a pharmacy technician, intern or extern shall be reviewed and approved by the pharmacist. When more than one pharmacist is involved in the steps of the compounding process, the unique and secure user identifier(s) of the pharmacist(s) responsible for the accuracy and appropriateness of each step shall be recorded in the audit trail. Audit trail documentation shall be generated at the time each step is performed.

(d) Compounding steps which shall be documented are as follows:

1. Receipt of prescription or medication order;

2. Recording of prescription or medication order in the patient record profile system, pursuant to N.J.A.C. 13:39-11.15;

3. Correct selection of the drugs, container, and diluent prior to their being compounded;

4. Verification that all pharmacy sterile preparation compounding is performed within a ISO class 5 laminar air flow hood or ISO class 5 clean room and that proper aseptic procedures are being used at all times to prevent bacterial contamination of this product;

5. Verification that ingredients comply with the prescription or medication order;

6. Verification that the prescription or medication order label complies with the requirements of N.J.A.C. 13:39-11.10; and

7. Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies.

(e) The audit trail information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for not less than five years from the date of the last entry in the record. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.]

(b) A pharmacy shall maintain an audit trail for all compounded sterile preparations consistent with the requirements of N.J.A.C. 13:39-7.6.

(c) A pharmacy shall maintain a compounding record for each compounded sterile preparation that contains the following information:

1. Selection of the drugs, container, and diluent prior to their being compounded, including documentation of lot numbers and expiration dates of the drugs, containers, and diluents, if applicable;

2. Verification that ingredients comply with the prescription or medication order;

3. Verification that the prescription or medication order label complies with the requirements of N.J.A.C. 13:39-11.21;

4. Verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling; and

5. Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies.

13:39-[11.10]11.21 Information required to appear on prescription label

(a) The dispensed container for any compounded sterile preparation shall bear a permanently affixed label with at least the following information:

1. The date and[, for sterile preparations, the] time prepared;

2.-4. (No change.)

5. The name and strength or quantity of all active ingredients, and the name and volume of the diluent, vehicle, and base solution(s), if applicable;

6. (No change.)

7. The phrase "use by" followed by the preparation's use by date and[, for sterile preparations, the use by] time ([If] if no time is stated, it is presumed to be 11:59 P.M. of the stated use by date).

8. (No change.)

9. As pertinent, a warning, consistent with applicable Federal and State law, that [cytotoxic products] antineoplastic agents and other hazardous substances are biohazardous; [and]

10. As pertinent, the requirements for proper storage[.]; and

11. In a retail pharmacy, for those medications not dispensed pursuant to the requirements of N.J.A.C. 13:39-9, the prescription number.

(b) For immediate use compounded sterile preparations, when the preparation is not administered by the person who prepared it, or its administration is not witnessed by the person who prepared it, the compounded sterile preparation shall be labeled consistent with the [page=452] requirements of (a) above and shall also include the name or identifier of the person who prepared the compounded sterile preparation.

(Agency Note: N.J.A.C. 13:39-11.22 is proposed for recodification with amendment as N.J.A.C. 13:39-11.10.)

13:39-[11.12]11.22 Handling, packaging, and delivery

(a) The pharmacy shall be responsible for the proper handling and packaging of compounded sterile preparations for delivery from the pharmacy to the patient in order to assure and maintain the integrity, efficacy, stability, and[, where applicable,] sterility[,] of these preparations. The [pharmacist in charge] pharmacist-in-charge shall ensure that:

[1. A reasonable effort is made to provide tamper-evident packing;]

1. Tamper-evident packaging is utilized;

2. [Retail delivery] Delivery is made from the pharmacy to the patient or patient care location within a reasonable time; and

3. (No change.)

13:39-[11.13]11.23 Policy and procedures manual [for compounded sterile preparations]

(a) The [pharmacist in charge shall maintain a] pharmacy's policy and procedures manual [which] shall set forth in detail the [licensee's] pharmacy's standard operating procedures with regard to compounded sterile preparations.

(b) The policy and procedures manual shall include policies and procedures governing the following:

1. A risk-management program, [(]including, but not limited to, [incident report procedures, an adverse drug reaction system, and a product contamination system);] documentation of incidents, adverse drug reactions, and product contamination.

i. The risk-management program shall require that the pharmacist-in-charge report all confirmed incidents of product contamination to the New Jersey Board of Pharmacy within 48 hours of becoming aware of such incidents;

2.-3. (No change.)

4. [Sanitation] Cleaning and disinfecting standards and procedures, consistent with the requirements of N.J.A.C. 13:39-11.15;

5. Reference materials as set out in N.J.A.C. 13:39-5.8 and [11.24] 11.12(b)12;

6. (No change.)

7. Patient recordkeeping as set forth in N.J.A.C. 13:39-[11.15]11.12(b)14;

8. (No change.)

9. A quality assurance program as set forth in N.J.A.C. 13:39-[11.14]11.24;

10. Verification of training and competency guidelines as set forth in N.J.A.C. 13:39-[11.7]11.16;

11. (No change.)

12. Documentation as set forth in N.J.A.C. 13:39-[11.9]11.20;

13. Description of appropriate garb and garbing procedures, consistent with the requirements of N.J.A.C. 13:39-11.14;

14. Conduct guidelines for personnel in the [controlled areas] cleanroom;

15. (No change.)

16. Patient education [(retail patients)];

17. Protocol and procedures to maintain the integrity of the interior work area of the laminar [air flow hoods] airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets; and

18. (No change.)

(c) [The pharmacist in charge shall review at least every two years and, if necessary, amend the policy and procedure manual as needed.] The policy and procedures manual shall be reviewed, at a minimum, once every 24 months and shall be updated, on a continuous basis, to reflect current practice. Documentation of the review shall be made available to the Board upon request.

13:39-[11.14]11.24 Quality assurance program [for compounded sterile preparations]

[(a) This section shall apply both to commercially available sterile drug products that are dispensed to patients without compounding or other manipulation, and to sterile preparations which, prior to dispensing, have been in any way repackaged, reconstituted, diluted, admixed, blended, or otherwise manipulated (collectively referred to as "compounded").]

[(b)] (a) The [dispensing pharmacist shall ensure that the compounded sterile preparation retains its quality attributes within acceptable limits through a written] pharmacy's quality assurance program[. The quality assurance program] shall require [at least], at a minimum, that:

1. A reasonable effort shall be made by the [dispensing] pharmacist to assure that compounded sterile preparations shall be kept under appropriate controlled conditions at the location of use by providing adequate labeling and verbal or written instructions regarding proper storage and administration as set forth by the product manufacturer, with each compounded sterile preparation dispensed;

2. The quality assurance program encompasses all phases of sterile compounding[, including preparation, distribution, storage, administration, and directions for use] for each unique type of [product] compounded sterile preparation dispensed;

3. After the preparation of every admixture, the contents of the container are thoroughly mixed and then visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, or any other defects, and the accuracy and thoroughness of labeling;

4. All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations shall have their aseptic technique tested consistent with the requirements of N.J.A.C. 13:39-11.16;

[3. All compounding processes representative of all types of manipulations, products and batches must be sterile tested and validated at least every 12 months;]

5. All high-risk level compounded sterile preparations that are prepared in groups of more than 25 identical individual single-dose packages (for example, ampules, bags, syringes, vials), or in multiple-dose vials for administration to multiple patients, or that are exposed longer than 12 hours at two degrees to eight degrees Celsius and longer than six hours at warmer than eight degrees Celsius before they are sterilized, and all compounded sterile preparations whose beyond-use date has been exceeded, shall be tested to ensure that they are sterile before they are dispensed or administered. The USP membrane filtration method shall be used where feasible. Another method may be used if verification results demonstrate that the alternative is at least as effective and reliable as the membrane filtration method or the USP direct inoculation of the culture medium method, consistent with the standards set forth in USP 797 concerning "Sterility Testing," 2012 edition, incorporated herein by reference, as amended and supplemented, and available for purchase at the United States Pharmacopeia website, www.usp.org.

i. When high-risk level compounded sterile preparations are dispensed before receiving the results of the sterility tests set forth in (a)5 above, the written quality assurance procedure shall require daily observation of the incubating test specimens and immediate recall of the dispensed compounded sterile preparations when there is any evidence of microbial growth in the test specimens. The patient and the physician of the patient to whom a potentially contaminated compounded sterile preparation was administered shall be notified immediately of the potential risk. Positive sterility tests shall require rapid and systematic investigation of aseptic technique, environmental control, and other sterility assurance controls in order to identify sources of contamination and to take corrective action.

ii. All high-risk level compounded sterile preparations, except those for inhalation and ophthalmic administration, shall be tested to ensure that they do not contain excessive bacterial endotoxins;

[4.] 6. Air and surface sampling for microbial organisms in ISO class 5 primary engineering controls, such as laminar [air flow hoods and ISO class 6 clean rooms] airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological [page=453] safety cabinets, and in all other ISO classified areas is done [twice annually] once every six months and at any time when microbial contamination is suspected [pursuant to United States Pharmacopoeia/National Formulary guidelines];

7. Pressure differential monitoring shall be conducted consistent with the requirements of N.J.A.C. 13:39-11.4(d). A pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante area and between the ante area and the general environment outside the cleanroom. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be at least daily) or by a continuous recording device;

[5.] 8. Laminar [air flow hoods] airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets shall be certified every six months, and every time they are moved, by an independent certification company to ensure that these primary engineering controls meet appropriate ISO classifications;

[6. The ISO class 6 clean room and ISO class 7 anteroom shall be certified every six months by an independent certification company; and

7. All unused drugs and materials used in the compounding of sterile preparations, including antineoplastic agents, are disposed of properly in accordance with accepted professional standards and applicable laws, including the Medical Waste Act (N.J.S.A. 13:1E-48.1 et seq., P.L. 1989, c.34).]

9. A cleanroom shall be certified by an independent certification company every six months and whenever the room or a primary engineering control in the room is relocated or altered, or whenever major service to the facility is performed, to ensure that the cleanroom meets appropriate ISO classifications. Such certifications shall be performed consistent with procedures outlined in the Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding Facilities (CAG-003-2006) (revised December 8, 2008), incorporated herein by reference, as amended and supplemented, and which may be found at the CETA website, www.cetainternational.org, specifically, www.cetainternational.org/reference/CETAAsepticCompoundingCertificationGuide.pdf; and

10. Whenever test results indicate that the cleanroom or any primary engineering controls do not meet the standards established in this section, the pharmacy shall immediately cease using the cleanroom or primary engineering control that is out of compliance until such time that the cleanroom and/or the primary engineering control meets the requisite standards. Test results indicating non-compliance with the requisite standards shall require re-evaluation of all procedures associated with the production of compounded sterile preparations in the impacted cleanroom or primary engineering control and documentation with respect to the period of time that the cleanroom and/or primary engineering control was out of compliance.

SUBCHAPTER 11A. COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES

13:39-11A.1 Purpose and scope

The rules in this subchapter regulate the practice of non-sterile compounding and shall apply to all retail and institutional pharmacies that compound and dispense non-sterile preparations. This subchapter establishes standards for the quality and control of processes, components, and environments associated with compounded non-sterile preparations, and for the skill and knowledge of pharmacy personnel who prepare compounded non-sterile preparations. The requirements in this subchapter establish minimum good compounding practices that will enhance a pharmacist's ability to compound non-sterile preparations that are of acceptable strength, quality, and purity.

13:39-11A.2 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings:

"Compounding" means the preparation, mixing, assembling, packaging, and labeling of a drug or device as the result of a practitioner's prescription or medication order or initiative based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescriptions or medication orders based on routine, regularly observed, prescribing patterns.

"Compounding pharmacist" means a pharmacist who performs or supervises any part of the compounding process.

13:39-11A.3 Prohibited compounding

(a) A pharmacist shall not compound preparations that contain drug products that appear on the Federal Food and Drug Administration's list of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness, codified at 21 CFR 216.24.

(b) A pharmacist shall not compound any commercially available drug products except as provided in N.J.A.C. 13:39-11A.4.

13:39-11A.4 Compounding commercially available products

(a) A pharmacist shall not compound commercially available products unless:

1. The commercially available product is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded product for the patient and the comparable commercially available product; or

2. The commercially available product is not available from normal distribution channels in a timely manner to meet the patient's needs, and the dispensing of the compounded product has been approved by the prescriber and the patient.

(b) A pharmacist who compounds a commercially available product consistent with the requirements of (a) above shall maintain documentation of the reason for such compounding.

13:39-11A.5 Batch preparation

A pharmacist may compound non-sterile preparations in a quantity that is supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided the pharmacist can document a history of valid prescriptions subsequently received shortly thereafter or medication orders that have been generated solely within an established professional prescriber-patient-pharmacist relationship, and provided the prescription or medication order is retained on file at the pharmacy, consistent with the requirements of N.J.A.C. 13:39-7.19. The pharmacist shall document the batch preparation process in accordance with the requirements of N.J.A.C. 13:39-11A.15.

13:39-11A.6 Compounded non-sterile preparations for prescriber practice use

A pharmacy may prepare compounded non-sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.

13:39-11A.7 Preparation of pharmacy generated products (PGPs) for over-the-counter sale

(a) A pharmacist may prepare a pharmacy generated product to be sold over-the-counter without a prescription or medication order provided that:

1. The product does not contain an ingredient that exceeds allowable strengths and doses for over-the-counter drugs; and

2. The finished product is not one for which a prescription or medication order is required.

(b) A finished product that is prepared pursuant to (a) above shall be properly labeled with the following:

1. The product name;

2. The name of all ingredients;

3. The strength or quantity of all active ingredients;

4. The package size;

5. Directions for use;

[page=454] 6. The use by date, consistent with the requirements of N.J.A.C. 13:39-11A.11;

7. The name, address, and telephone number of the pharmacy;

8. Any ancillary and cautionary instructions, as needed; and

9. As pertinent, the requirements for proper storage.

(c) A pharmacy generated product shall be sold directly to the consumer only after professional interaction or consultation between a pharmacist and the consumer.

(d) A pharmacy generated product shall be stored in such a manner as to be inaccessible to the public.

(e) A pharmacy generated product shall not be sold to any entity for resale purposes.

(f) The preparation of pharmacy generated products shall be documented in accordance with the requirements of N.J.A.C. 13:39-11A.15(b)1 and 6 through 14.

13:39-11A.8 Compounding area

(a) A pharmacy that regularly engages in compounding shall have an area specifically designated for the safe and orderly compounding of drug products. Such area shall allow for the orderly placement of equipment and materials in order to minimize the potential for errors.

(b) A pharmacy that engages in occasional compounding shall prepare an area prior to each compounding activity that allows for the safe and orderly compounding of drug products. The area shall allow for the orderly placement of equipment and materials in order to minimize the potential for errors.

(c) A pharmacy engaged in compounding shall ensure that:

1. All compounding areas are well-lighted and ventilated and are maintained in a clean and sanitary condition;

2. Heating and air conditioning systems are controlled to avoid decomposition of chemicals;

3. Sewage, trash, and other refuse in and from the pharmacy and immediate drug compounding area are maintained, and disposed of, in a timely, safe, and sanitary manner; and

4. The compounding area is easily accessible to hot and cold running water, exclusive of the bathroom sink; soap or detergent; and air dryers or single source towels.

13:39-11A.9 Equipment and supplies

(a) A pharmacy shall possess equipment appropriate to the type of compounding performed at the pharmacy.

(b) Equipment used in compounding drug products shall be of appropriate design and capacity, and shall be suitably located to facilitate operations for the intended use, cleaning, and maintenance of the equipment.

(c) Equipment used in compounding drug products shall be of suitable composition. Equipment surfaces that contact components shall not be reactive, additive, or adsorptive, so as to alter the safety, identity, strength, quality, and purity of the compounded product.

(d) Equipment used in compounding drug products shall be thoroughly cleaned and sanitized after each use, and when necessary, prior to use, in order to prevent cross-contamination of ingredients and preparations.

(e) Equipment used in compounding drug products shall be stored in a manner to prevent cross-contamination of ingredients and preparations.

(f) Automated, mechanical, or electronic equipment may be used in compounding non-sterile preparations. All equipment utilized in compounding non-sterile preparations shall be inspected, maintained, and validated at appropriate intervals, consistent with manufacturer's recommendations, to ensure the accuracy and reliability of equipment performance.

(g) When antineoplastic agents and hazardous substances are utilized in the compounding of non-sterile preparations, a pharmacy shall adhere to standards established by the Occupational Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA's Technical Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20, 1999). OSHA's Technical Manual is incorporated herein by reference, as amended and supplemented, and can be found at the OSHA website, www.osha.gov, specifically, www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the standards established by National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. The NIOSH standard is incorporated herein by reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/.

1. For purposes of this subsection, hazardous substances are those substances identified as hazardous in NIOSH Publication No. 2004-165, Appendix A.

13:39-11A.10 Responsibilities of the compounding pharmacist; reporting requirement

(a) A compounding pharmacist shall be responsible for the ensuring that:

1. Compounded non-sterile preparations have been properly prepared, labeled, controlled, stored, dispensed, and distributed in accordance with the provisions of this subchapter;

2. All aspects of the compounding process set out in N.J.A.C. 13:39-11A.15 are documented and that accurate compounding records for all compounded non-sterile preparations prepared by the pharmacy are maintained;

3. Compounding personnel are capable of performing and qualified to perform their assigned duties;

4. Ingredients used in compounding have their expected identity, quality, and purity consistent with the requirements of N.J.A.C. 13:39-11A.12;

5. Compounded preparations are of acceptable strength, quality, and purity, with appropriate packaging and labeling, and are prepared in accordance with good compounding practices, official standards, and relevant scientific data and information;

6. Critical processes are recorded and validated to ensure that procedures will consistently result in the expected qualities in the finished preparation;

7. The compounding environment is suitable for its intended purpose;

8. Appropriate stability evaluation is performed or is determined from the literature for establishing reliable beyond-use dating to ensure that the finished preparations have their expected potency, purity, quality, and characteristics, at least until the labeled beyond-use date;

9. Compounding conditions and procedures are in place to minimize the potential for errors;

10. Adequate procedures and records exist for investigating and correcting failures or problems in compounding, testing, or in the preparation itself; and

11. The patient is advised that the product dispensed is a compounded preparation.

(b) Any confirmed incidents of product contamination shall be reported by the pharmacist-in-charge to the New Jersey Board of Pharmacy within 48 hours of becoming aware of any such incidents.

13:39-11A.11 Beyond-use dates

(a) The beyond-use date is the date after which a compounded non-sterile preparation shall not be used. The beyond-use date shall be determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following short-term storage, beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.

(b) In the absence of stability information that is applicable to a specific drug product and preparation, the following are the maximum beyond-use dates for non-sterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated:

1. For nonaqueous liquids and solid formulations:

i. Where the manufactured drug product is the source of the active ingredient, the beyond-use date shall not be later than 25 percent of [page=455] the time remaining until the product's expiration date or six months, whichever is earlier;

ii. Where a United States Pharmacopeia-National Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substance is the source of the active ingredient, the beyond-use date shall not be later than six months or the expiration date of the ingredient, whichever is earlier; and

iii. Where there is more than one ingredient, the beyond-use date shall be no longer than six months or the expiration date of the first ingredient to expire, whichever is earlier;

2. For water-containing formulations (prepared from ingredients in solid form), the beyond-use date shall not be later than 14 days for liquid preparations when stored at cold temperatures between two degrees and eight degrees Celsius (36 degrees and 46 degrees Fahrenheit); and

3. For all other formulations, the beyond-use date shall not be later than the intended duration of therapy or 30 days, whichever is earlier.

(c) The beyond-use date limits established in this section may be exceeded only when there is supporting valid scientific stability information that is directly applicable to the specific preparation (that is, the same drug concentration range, pH, excipients, vehicle, water content, etc.).

13:39-11A.12 Ingredient selection

(a) All ingredients used to compound non-sterile preparations shall be United States Pharmacopeia-National Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substances. If a USP-NF, AR, ACS, or FCC grade substance ingredient is not available, the pharmacist shall establish the purity and safety of the ingredient by reasonable means, which may include lot analysis, manufacturer reputation, or reliability of source study.

(b) A manufactured drug product may be utilized as the source of an active ingredient. Only manufactured drug products from containers labeled with a batch control number and an unexpired expiration date shall be utilized as sources of active ingredients. When compounding with manufactured drug products, the compounding pharmacist shall consider all ingredients present in the drug product relative to the intended use of the compounded non-sterile preparation.

(c) Components used in the compounding of non-sterile preparations such as aliquots, triturates, stock solutions, buffering agents, or isotonic solutions may be prepared in advance and stored as pharmacy stock. The preparation of such products shall be documented in accordance with the requirements of N.J.A.C. 13:39-11A.15(b)1 and 6 through 14.

13:39-11A.13 Information required to appear on prescription label

(a) The dispensed container for any compounded non-sterile preparation shall bear a permanently affixed label with at least the following information:

1. In a retail pharmacy only, the name of the prescriber.

i. An institutional pharmacy compounding non-sterile preparations for out-patient use shall include the name of the prescriber on the label, consistent with the requirements of N.J.A.C. 13:39-9.1(b);

2. The name of the patient;

3. The name of all active ingredients;

4. Directions for use;

5. The use by date, consistent with the requirements of N.J.A.C. 13:39-11A.11;

6. The name, address, and telephone number of the pharmacy;

7. Any ancillary and cautionary instructions as needed; and

8. As pertinent, the requirements for proper storage.

13:39-11A.14 Pharmacy technicians, pharmacy interns, and pharmacy externs; required supervision

(a) The compounding pharmacist shall provide immediate personal supervision to pharmacy technicians, pharmacy interns, or pharmacy externs who are performing non-sterile preparation compounding.

1. Supervision shall include, but is not limited to, the checking of each ingredient used, the quantity of each ingredient whether weighed, measured, or counted, and the finished label.

(b) The compounding pharmacist may delegate to pharmacy technicians, pharmacy interns, or pharmacy externs only the following tasks: recording of the prescription, selection of the drugs and container, typing of labels, and compounding of preparations. The compounding pharmacist shall ensure that each task has been performed correctly.

13:39-11A.15 Audit trail; compounding record documentation

(a) A pharmacy shall maintain an audit trail for all non-sterile compounded preparation prescriptions dispensed consistent with the requirements of N.J.A.C. 13:39-7.6.

(b) Except as provided in (c) below, a pharmacy shall maintain a compounding record for each compounded non-sterile preparation that contains the following information:

1. Selection of the ingredients and documentation of source, lot numbers, and expiration dates of all ingredients used;

2. Verification that ingredients comply with the prescription or medication order;

3. Verification that the prescription or medication order label complies with the requirements of N.J.A.C. 13:39-11A.13;

4. Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies;

5. Strength of preparation;

6. Date of preparation;

7. Name or personal identifier of the person(s) who performed each step of the compounding process and the compounding pharmacist(s) who verified the preparation;

8. Reference(s) for formulation, if available;

9. Total quantity;

10. Detailed steps of the compounding process to ensure that the exact same compound can be duplicated at a future date;

11. Type of dispensing container used when a drug has specific storage requirements;

12. Beyond-use date of the finished product consistent with the requirements in N.J.A.C. 13:39-11A.11;

13. The assigned internal identification number for the preparation or the prescription number; and

14. Instructions for use, storage, and handling of the compounded preparation.

(c) A compounding record shall not be required for:

1. Mixing, reconstituting, or assembling a drug according to the product's labeling or the manufacturer's directions; and

2. Product flavoring.

 


 

If you wish to submit comments about this rule proposal, please fill out the form below. When you have completed the form, click the "Submit Your Comments" button below.

Last Name :

First Name:

Professional Organization, Association or Affiliation, if any:

E-Mail Address:

Comments:

       

   
Contact Us | Privacy Notice | Legal Statement | Accessibility Statement
NJ Home Logo
Divisional: DCA Home | Complaint Forms | Proposals | Adoptions | Contact DCA
Departmental: OAG Home | Contact OAG | About OAG | OAG News | OAG FAQs
Statewide: NJ Home | Services A to Z | Departments/Agencies | FAQs
Copyright State of New Jersey
This page is maintained by DCA. Comments/Questions: email

Page last modified: