VOLUME 48, ISSUE 5
ISSUE DATE: September 29, 2016
Law and Public Safety
Division of Consumer Affairs
State Board of Optometrists
Proposed Amendment: N.J.A.C. 13:38-2.4
Requirements for Issuing Prescriptions and Dispensing of Medications
Authorized By: New Jersey State Board of Optometrists, Renee Clark, Executive Director.
Authority: N.J.S.A. 45:12-1 et seq. and P.L. 2015, c. 65.
Proposal Number: PRN 2016-034.
Submit written comments by
October 28, 2016, to:
Renee Clark, Executive Director
New Jersey State Board of Optometrists
124 Halsey Street
PO Box 45012
Newark, NJ 07101
The agency proposal follows:
The State Board of Optometrists (Board) is proposing to amend N.J.A.C. 13:38-2.4 to harmonize it with recently amended N.J.S.A. 45:12-9.11, which permits optometrists who have been certified to prescribe oral therapeutic pharmaceutical agents (TPAs) and authorized to prescribe controlled dangerous substances, to prescribe TPAs containing hydrocodone, regardless of the agent's placement on the Drug Enforcement Administration's (DEA) schedule of controlled dangerous substances. For many years, certified optometrists had the authority to prescribe, administer, and dispense TPAs containing hydrocodone. However, on October 6, 2014, the DEA rescheduled products containing hydrocodone from Schedule III to Schedule II. Optometrists are prohibited by N.J.S.A. 45:12-1 and N.J.A.C. 13:38-2.4(i) from prescribing controlled dangerous substances set forth in Schedules I or II. On June 26, 2015, P.L. 2015, c. 65 became effective, amending N.J.S.A. 45:12-9.11 to permit appropriately certified optometrists to prescribe, administer, and dispense TPAs containing hydrocodone, regardless of schedule, as well as TPAs classified as Schedule III, IV, and V controlled dangerous substances. Because of this statutory change, a regulatory amendment is required to prevent a conflict between N.J.S.A. 45:12-9.11 and N.J.A.C. 13:38-2.4(i).
The Board is also proposing to delete existing N.J.A.C. 13:38-2.4(f). This subsection provides that licensees who are certified to prescribe TPAs on a topical level only must include the following language on the prescription blank: "NOT VALID FOR CONTROLLED SUBSTANCES. VALID FOR TOPICAL PHARMACEUTICAL AGENTS (IF TPA CERTIFIED) AND PRESCRIPTION EYEWEAR ONLY."
The Board believes it is unnecessary to include this statement because the prescription blank currently used by optometrists identifies their prescriptive authority: optometrists certified to prescribe topical medications can be identified by the prefix TO (topical only), and optometrists certified to prescribe oral medications can be identified by the prefix OM (oral medications). Furthermore, licensees who are authorized to prescribe controlled dangerous substances have been assigned a New Jersey Controlled Dangerous Substance number and a Federal DEA number that also appear on the prescription blank. These prefixes and numbers identify the level of the licensee's prescriptive authority, making it unnecessary to include the restrictive language contained in subsection (f) on prescription blanks used by optometrists authorized to prescribe topical agents only.
Additionally, the Board believes that licensees know what they may and may not prescribe, and any licensee who practices outside his or her scope of practice would be deemed to have engaged in professional misconduct pursuant to N.J.A.C. 13:38-2.4(g), and subject to discipline by the Board.
The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
The Board believes that the proposed amendment permitting certified optometrists to prescribe TPAs containing hydrocodone will have a positive social impact because it will resolve an inconsistency between the rule and the statute. The Board believes that deleting the mandatory language set forth in N.J.A.C. 13:38-2.4(f) on prescription blanks will have little social impact on either licensees or consumers.
The proposed amendment does not impose additional costs on optometrists in New Jersey because they do not contain any proposed fee increases. Licensees who have existing prescription blanks containing the language set forth in N.J.A.C. 13:38-2.4(f) may continue to use those [page=375] blanks until they are ready to order new ones. The Board believes that the proposed amendment should not have any economic impact on consumers.
Federal Standards Statement
A Federal standards analysis is not required because the proposed amendment is governed by N.J.S.A. 45:12-1 et seq. Although TPAs are classified by schedule under Federal law, State law determines optometrists' scope of practice including prescriptive authority.
The Board does not anticipate that the proposed amendment will increase or decrease jobs in the State.
Agriculture Industry Impact
The proposed amendment will have no impact on the agriculture industry in the State.
Regulatory Flexibility Analysis
If, for the purposes of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., the approximately 1,445 Board licensees are considered "small businesses," then the following analysis applies.
The proposed amendment to N.J.A.C. 13:38-2.4 will not impose any new reporting or recordkeeping requirements upon optometrists. No new professional services will be needed to comply with the proposed amendment. The Board believes that the proposed amendment should be uniformly applied to all certified licensees in order to ensure the health, safety, and welfare of the general public in the provision of optometric services. Therefore, no differing compliance requirements for any certified licensed optometrists are provided based upon the size of the business.
Housing Affordability Impact Analysis
The proposed amendment will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the amendment would evoke a change in the average costs associated with housing because the proposed amendment concerns optometrists' prescriptive authority and the elimination of certain mandatory language on optometrists' prescription blanks.
Smart Growth Development Impact Analysis
The proposed amendment will have an insignificant impact on smart growth and there is an extreme unlikelihood that the amendment 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 amendment concerns optometrists' prescriptive authority and the elimination of certain mandatory language on optometrists' prescription blanks.
Full text of the proposal follows (additions indicated in boldface
thus; deletions indicated in brackets [thus]):
SUBCHAPTER 2. GENERAL RULES OF OPTOMETRIC PRACTICE
13:38-2.4 Requirements for issuing prescriptions and dispensing of medications
(a)-(e) (No change.)
[(f) All licensees who are certified to prescribe therapeutic pharmaceutical agents on a topical level only, shall include the following language on the prescription blank:
"NOT VALID FOR CONTROLLED SUBSTANCES. VALID FOR TOPICAL PHARMACEUTICAL AGENTS (IF TPA CERTIFIED) AND PRESCRIPTION EYEWEAR ONLY."]
Recodify existing (g) and (h) as
(f) and (g) (No change in text.)
(h) All licensees are prohibited from prescribing controlled dangerous substances as outlined in N.J.S.A. 24:21-5, Schedule I, and 24:21-6, Schedule II, except that licensees may prescribe controlled dangerous substances containing hydrocodone, regardless of schedule.
Recodify existing (j) and (k) as
(i) and (j) (No change in text.)
In order to ensure your comments are received, please send your comments
concerning any rule proposals via email to
Please include the following in your email:
Email Subject Line: Rule Proposal Subject
BodyComments to the Rule Proposal, Name, Affiliation and Contact Information (email address and telephone number)