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Frequently Asked Questions
New Jersey Controlled Dangerous Substances (CDS)

  1. What does the acronym "C.D.S." stand for?
  2. What is the criterion for a Schedule I controlled dangerous substance?
  3. What is the criterion for a Schedule II controlled dangerous substance?
  4. What is the criterion for a Schedule III controlled dangerous substance?
  5. What is the criterion for a Schedule IV controlled dangerous substance?
  6. What is the criterion for a Schedule V controlled dangerous substance?
  7. What controlled dangerous substance "Schedules" should I check off on my application, if I am a typical health care practitioner who prescribes or who will need to prescribe controlled dangerous substances?
  8. For what period of time may a C.D.S. prescription be held, before it can no longer be legally "filled"?
  9. May a C.D.S. prescription, with refills remaining to be dispensed, be transferred from one pharmacy to another?
  10. How do I destroy unwanted or outdated controlled dangerous substances?
  11. How do I report a loss or theft of controlled dangerous substances?
  12. What is the maximum quantity of Schedule II C.D.S. that I may prescribe?
  13. How often must I take a controlled dangerous substances inventory?
  14. How long must I maintain controlled dangerous substance records?
  15. May an out-of-state prescription be filled in New Jersey?
  16. May a prescriber issue more than one controlled substance on a single prescription blank?
  17. May a prescriber pre-date C.D.S. prescriptions?
  18. Can an animal humane shelter or an incorporated animal shelter maintain controlled substances other than sodium pentobarbital?
  19. Do I have to register with the Drug Control Unit if I do not handle controlled dangerous substances as a manufacturer or wholesaler?
  20. Are there accountability and security requirements that must first be satisfied, in order to store the Schedule I CDS gamma butyrolactone (a/k/a G.B.L.) in New Jersey, in connection with any commercial manufacturing, processing or distribution enterprise?
  21. Can a physician order Schedule II controlled dangerous substances by telephone?

 


 


  1. What does the acronym "C.D.S." stand for?
    Controlled Dangerous Substance
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  2. What is the criterion for a Schedule I controlled dangerous substance?
    The substance has high potential for abuse and has no accepted medical use in treatment in the United States, or it lacks accepted safety for use in treatment under medical supervision. (N.J.S.A. 24:21-5)
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  3. What is the criterion for a Schedule II controlled dangerous substance?
    The substance has a high potential for abuse and has currently accepted medical use in the United States with severe restrictions. In addition, abuse of a Schedule II C.D.S. may lead to psychic or physical dependence. (N.J.S.A.24:21-6)
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  4. What is the criterion for a Schedule III controlled dangerous substance?
    The substance has a potential for abuse less than the substances listed in Schedule I and II and has currently accepted medical use in treatment in the United States. In addition, abuse of a Schedule III C.D.S. may lead to moderate or low physical dependence or high psychological dependence. ( N.J.S.A. 24:21-7)
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  5. What is the criterion for a Schedule IV controlled dangerous substance?
    The substance has low potential for abuse relative to the substances listed in Schedule III and has currently accepted medical use in treatment in the United States. In addition, abuse of a Schedule IV C.D.S. may lead to limited physical dependence or psychological dependence relative to the substances listed in Schedule III. (N.J.S.A. 24:21-8)
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  6. What is the criterion for a Schedule V controlled dangerous substance?
    The substance has low potential for abuse relative to the substances listed in Schedule IV and has currently accepted medical use in treatment in the United States. In addition, abuse of a Schedule V C.D.S. may cause limited physical dependence or psychological dependence relative to the substances listed in Schedule IV. (N.J.S.A. 24-21-8.1)
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  7. What controlled dangerous substance "Schedules" should I check off on my application, if I am a typical health care practitioner who prescribes or who will need to prescribe controlled dangerous substances?
    Schedules II, III, IV and V. (Presently, registrations involving Schedule I controlled dangerous substances are only issued to qualified researchers and analytical laboratories and a special registration process is required which must be initiated with D.E.A. authorities.)
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  8. For what period of time may a C.D.S. prescription be held, before it can no longer be legally "filled"?
    A C.D.S. prescription must be presented for filling no more than 30 days after the date on which it was written, regardless of the schedule. (N.J.A.C. 8:65-7.5(a))
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  9. May a C.D.S. prescription, with refills remaining to be dispensed, be transferred from one pharmacy to another?
    Yes, if the transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records the following information:
    1. Write the word "VOID" on the face of the invalidated prescription.

    2. Record on the reverse side of the invalidated prescription the name, address and D.E.A. registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information.
    3. Record the date of the transfer and the name of the pharmacist receiving the prescription information.
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  10. How do I destroy unwanted or outdated controlled dangerous substances?
    Any person in possession of any controlled substances and desiring or required to dispose of such substances, may request assistance from the D.E.A. (1-888-346-1071) for authority and instructions to dispose of such substances. If the person is a registrant, he/she shall list the controlled substance or substances which he/she desires to dispose of on D.E.A. Form 41, and submit three copies of that form to the D.E.A. Special Agent in Charge in his/her area; or registrants may contact the State's Drug Control Unit, receive instructions, complete a D.D.C. Form 51, and submit same. (21 C.F.R.- 1307.21 and N.J.A.C. 8:65-8.10)
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  11. How do I report a loss or theft of controlled dangerous substances?
    Contact the Drug Control Unit and complete a D.D.C. Form 52 report. (N.J.A.C. 8:65-2.4(c))
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  12. What is the maximum quantity of Schedule II C.D.S. that I may prescribe?
    The longstanding rule remains that the maximum quantity of Schedule II C.D.S. that may be prescribed is limited to 30 days or 120 dosage units, whichever is less. However, there are some exceptions. If there is a diagnosis of intractable pain or terminal illness, then the quantity may be increased to a 30-day supply regardless of the amount. In addition, for patients housed in long-term care facilities, the quantity of Schedule II C.D.S. which may be dispensed may be any quantity subject to pharmacist verification of necessity not to exceed a 60-day supply. (N.J.A.C. 8:65-7.8(e), N.J.A.C. 8:65-7.10(d) and N.J.A.C. 13:35-7.6)
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  13. How often must I take a controlled dangerous substances inventory?
    Every two years on May 1st, if you were registered on or before May 1, 1971, or every two years from the date you were first registered.
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  14. How long must I maintain controlled dangerous substance records?
    For a minimum of two years. However, it is important to understand that some professional boards may require a longer time period. For example, the Board of Pharmacy requires that C.D.S. prescription records be maintained for at least a five-year period. (21 C.F.R.-1304.04)
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  15. May an out-of-state prescription be filled in New Jersey?
    Yes, if the presenting patient and/or prescribing practitioner is known to the pharmacy and there is no reason to question the prescription's authenticity. Specific questions may be answered by contacting the Board of Pharmacy at 973-504-6450.
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  16. May a prescriber issue more than one controlled substance on a single prescription blank?
    No. (N.J.A.C. 13:35-7.12)
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  17. May a prescriber pre-date C.D.S. prescriptions?
    No, C.D.S. prescriptions are required to be dated to correspond with the date of issuance. In other words, C.D.S. prescriptions are required to be dated as of, and signed on, the date when issued. (N.J.A.C. 8:65-7.5(a))
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  18. Can an animal humane shelter or an incorporated animal shelter maintain controlled substances other than sodium pentobarbital?
    No, shelters may not have any product other than sodium pentobarbital on the premises. Any other controlled dangerous substances on the premises must be the property of a registered veterinarian with C.D.S. and D.E.A. registrations for that address. (N.J.A.C. 8:65-1.2(g))
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  19. Do manufacturers and wholesalers have to register with the Drug Control Unit if they do not handle controlled dangerous substances?
    No, registration is not required with the Drug Control Unit, but if they handle prescription legend drugs or prescription medical devices, they must be licensed by the New Jersey Department of Health and Senior Services, P.O. Box 369, Trenton, NJ 08605-0369 (609-585-3213).
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  20. Are there accountability and security requirements that must first be satisfied, in order to store the Schedule I CDS gamma butyrolactone (a/k/a G.B.L.) in New Jersey, in connection with any commercial manufacturing, processing or distribution enterprise?
    Yes, there are certain special accountability and security requirements regarding this substance. G.B.L. is the chemical precursor to G.H.B. (gamma hydroxybutyric acid) which is commonly referred to as the "date rape drug". In 1999, the New Jersey legislature enacted a law making G.B.L. a Schedule I CDS in this State, and made that product subject to very stringent accountability, security and distribution requirements. In that the Drug Control Unit has primary jurisdiction in the registration of manufacturers and distributors handling G.B.L., a special application is required to be filed. The Division's Enforcement Bureau extensively reviews applications for registration by such applicants, performs on-site inspections of the applicant's facilities to ensure compliance with the various requirements, and conducts background checks on the applicants as well as employees who will have access to the G.B.L.
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  21. Can a physician order Schedule II controlled dangerous substances by telephone?
    Yes, In the case of an emergency situation ONLY, and limited to a 72 hour quantity of medication. Specifically, a pharmacist may dispense a controlled substance listed in schedule II upon receiving the oral authorization of a prescribing individual practitioner, provided that:
    1. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period not to exceed 72 hours (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner);
    2. The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in N.J.A.C. 8:65-7.4, except for the signature of the prescribing individual practitioner;
    3. If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and
    4. Within 72 hours after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed (not to exceed the amount for a 72 hour period) to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of N.J.A.C. 8:65-7.4, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 72-hour period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the Drug Control Unit and the nearest office of the D.E.A. in his district if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority to dispense with a written prescription of a prescribing individual practitioner. (N.J.A.C. 8:65-7.9(d))

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