Pharmacist FAQsFrequently Asked Questions for Pharmacists on Schedule IV Controlled Substances:
A: On December 12, 2011, DEA published a Final Rule (76 FR 77330) in the Federal Register making carisoprodol a schedule IV controlled substance. The Final Rule states that effective January 11, 2012, all prescriptions for drugs containing carisoprodol shall comply with 21 C.F.R. §§ 1306.03–1306.06, 1306.21, and 1306.22–1306.27. Accordingly, as of January 11, 2012, a pharmacy may only fill or refill a prescription for a drug containing carisoprodol if all of the following requirements are met: the prescription was issued for a legitimate medical purpose by a DEA-registered practitioner acting in the usual course of professional practice (21 C.F.R. § 1306.04); the prescription contains all the information required by 21 C.F.R. § 1306.05; and the number of refills authorized by the prescribing practitioner is five or less (21 U.S.C. § 829(b)). Practitioners and pharmacists are responsible for ensuring the prescription conforms to all requirements of the law and regulations, both federal and state. As 21 C.F.R. § 1306.04 states, “The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” The Controlled Substances Act (CSA) also provides that a prescription for a schedule IV controlled substance may not be filled or refilled more than six months after the date the prescription was issued. 21 U.S.C. § 829(b). Therefore, if a prescription for a drug containing carisoprodol was issued before January 11, 2012, and refills were authorized, as of January 11, 2012 those refills (no more than five) must be dispensed no later than six months after the date the prescription was issued. As stated in the December 12, 2011, Final Rule, effective January 11, 2012, any person who engages in any activity involving carisoprodol is subject to the criminal, civil, and administrative provisions of the CSA and DEA regulations. This means, among other things, that as of January 11, 2012, persons who prescribe, administer, or dispense carisoprodol by means of the Internet are subject to all applicable provisions of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (74 FR 15596), and the regulations issued thereunder. For a detailed explanation of the DEA’s scheduling decision please see: http://www.ncbop.org/PDF/SomaSchedulingFederalRegisterNotice121211.pdf. -------------------------------------------------------------------------------- Q: Do prescription orders or prescription documents have an expiration date? A: There is no specific provision in statute or rule which says that a prescription document or order has an expiration date. Federal regulations provide that prescriptions for drugs in Schedules III and IV shall not be filled or refilled more than 6 months after the date of issue. Prescriptions for drugs in Schedule II have no specific expiration date. Board rule provides that a pharmacist can refuse to fill or refill a prescription if they believe it is harmful to the patient, not in the patient’s best interest or there is a question as to its validity. Q: What is the procedure in North Carolina for physicians when ordering Schedule II, III, and IV controlled substances for office use? A: The physician needs to complete a Schedule II Order form (DEA 222) for a drug in Schedule II and send it to the supplier which can be a pharmacy. The supplier keeps one copy and send the other copy to DEA. Note the instructions in the margin of the form. Orders for drugs in Schedule III or IV can occur on an invoice and the supplier (pharmacy) keeps these invoices with other CS records noting that these are outgoing items. These transactions should not occur pursuant to a prescription because prescriptions need to be patient specific.
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