Pharmacist FAQsFrequently Asked Questions for Pharmacists on Schedule II Controlled Substances PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES Q: May I dispense partial fills of a Schedule II controlled substance prescription? A: Yes. Under the Comprehensive Addiction and Recovery Act of 2016 (“CARA”), a pharmacy may provide a partial fill of a Schedule II controlled substance prescription if: (1) state law does not prohibit partial fills of Schedule II prescriptions (North Carolina law does not prohibit partial fills of this sort); (2) the prescription is written and filled in compliance with federal and state law; (3) the partial fill is requested by the patient or the prescriber; and (4) the total quantity dispensed in all partial fills does not exceed the total quantity prescribed.
Q: For how long may I provide partial fills of a Schedule II controlled substance prescription? A: In general, under CARA, the total amount of a Schedule II controlled substance prescription may be filled no later than 30 days from the date the prescription was written. DEA rules have long allowed a Schedule II controlled substance prescription for a patient in a Long Term Care Facility, or a patient with a documented terminal illness diagnosis, to be dispensed by partial fills for up to 60 days from the date of the prescription. There is nothing in CARA’s language that indicates an intent to change this long-standing rule. If a pharmacist receives a verbal Schedule II controlled substance prescription pursuant to an emergency, the pharmacist may provide a partial fill, but must provide the remainder of the prescription amount within 72 hours. After 72 hours, no further dispensing on the emergency prescription is allowed. All other requirements regarding the need to receive a hard copy (or valid electronic) prescription within seven days remain.
Q: I thought that I could only do a partial fill of a Schedule II prescription if the pharmacy is “unable to supply the full quantity” and that I had only 72 hours to provide the remainder of the prescription? A: Prior to CARA’s enactment in October 2016, DEA rules did so limit partial fills of Schedule II prescriptions. CARA superseded DEA’s rules on this matter.
----------------------------------------------------------------------------------------------- Changes to Prescriptions for Combination Products containing a Schedule II drug and Acetaminophen Q: Can a pharmacist change or add the correct amount of acetaminophen to a prescription for a combination product containing a schedule II drug and acetaminophen? A: Yes. If a pharmacist receives a prescription for a combination product containing a schedule II drug and acetaminophen that appears to have a missing, incorrect, or unavailable acetaminophen dosage, the pharmacist may add or change the amount of acetaminophen written on the prescription after speaking directly with the prescriber and documenting the clarification on the prescription. Examples: (a) A prescriber writes for “Vicodin 5/325.” As pharmacists know, Vicodin is now formulated as hydrocodone 5mg /acetaminophen 300 mg. The pharmacist may call the prescriber to clarify which product was intended – e.g., Vicodin 5/300 or another hydrocodone 5 mg/acetaminophen product containing 325 mg of acetaminophen per dosage unit (see (b) below). The pharmacist must document on the prescription the changes made after consultation with the prescriber. (b) A prescriber writes for “Vicodin 5/325,” but the prescriber intended to write for Norco (hydrocodone 5 mg /acetaminophen 325 mg). The pharmacist may change the brand name to match the correct combination product intended. The pharmacist must document the clarification after consultation with the prescriber. ---------------------------------------------------------------------------------- Q. Doesn’t the Drug Enforcement Administration (DEA) prohibit the kind of clarifications described above? A. No. DEA advises that “pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber. . . .[W]hen information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.” http://www.deadiversion.usdoj.gov/faq/prescriptions.htm#rx-7
FRIDAY, AUGUST 22, 2014 DRUG ENFORCEMENT ADMINISTRATION PLACES ALL HYDROCODONE CONTAINING PRODUCTS INTO SCHEDULE II EFFECTIVE OCTOBER 6, 2014. On August 22, 2014 the federal Drug Enforcement Administration issued a final rule placing all hydrocodone-containing drug products into Schedule II. The rule is effective October 6, 2014. Hydrocodone-only products already were Schedule II controlled substances. This rule places all hydrocodone combination products into Schedule II. The full text of the rule, including the DEA’s response to various concerns raised about the rescheduling is found here: http://www.ncbop.org/PDF/DEAHydrocodoneCombinationProductReschedule082214.pdf. Some questions likely to arise:
A: During recent pharmacy inspections, Board investigators have noted that multiple pharmacies have not properly documented receipt of schedule II controlled substance orders when using the CSOS. Board investigators have found the CSOS orders were properly placed in accordance with 21 Code of Federal Regulations (CFR) 1305.21 and 1305.22(a). However, upon receipt of the controlled substances, a copy of the E-222 form was printed and receipt of the order manually noted on paper. This paper receipt process violates 21 CFR 1305.22(g), although Board investigators have found these violations to be unintentional and are treating them as an educational issue, not a disciplinary one. Under that federal rule, when a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received, and that record must be electronically linked to the original order and archived. Board staff strongly recommend that pharmacies ordering Schedule II controlled substances using CSOS, but unsure how to electronically link the receipt with the original order, contact the schedule II controlled substance supplier for assistance. -------------------------------------------------------------------------------- Q: May a prescribing practitioner prescribe other medications on a prescription that already includes a Schedule II medication? A: Yes, a practitioner may prescribe other medications on the same prescription blank along with Schedule II medications. -------------------------------------------------------------------------------- Q: Can I fill Schedule II prescriptions bearing a "do not fill until" date? A: Yes, within limits established by DEA: Effective December 19, 2007 prescribers will be authorized to write multiple prescriptions on the same day to be filled sequentially for schedule II controlled substances. The Drug Enforcement Agency (DEA) issued the final rule on Monday, November 19, which reflects APhA's recommendation to remove language that could have been interpreted to add an additional duty on health providers (including pharmacists) for schedule II prescriptions. However, the DEA chose not to defer to prescribers on the most appropriate time limitation, instead retaining the 90-day the prescription order limit in the original proposed rule. The new regulation does not affect State laws and regulations, which may be more restrictive. Specifically, the new rule amends Title 21 of the Code of Federal Regulations, Part 1306 as follows:
3. Section 1306.14 is amended by adding a new paragraph (e) to read as follows:
-------------------------------------------------------------------------------- Q: What changes can be made to Schedule II Prescriptions? A: After consulting with the prescribing practitioner (you must speak directly to the practitioner, not his/her agent), the pharmacist may modify or add the following:
A pharmacist may never change the name of the drug (except to generic when appropriate), name of the patient, or the signature of the practitioner. -------------------------------------------------------------------------------- Q: Do prescription orders or prescription documents have an expiration date? A: There is no specific provision in statute or rule that says 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. Effective October 1, 2013, North Carolina law provides that “No Schedule II substance shall be dispensed pursuant to a written prescription more than six months after the date it was prescribed.” 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. -------------------------------------------------------------------------------
A: Board Rule .1809 allows a pharmacist to give up to a 30 day supply of any drug except a Schedule II controlled substance under these circumstances. You do need to contact the prescriber or the prescriber's office within 72 hours to notify them of what you have done. You can find the rule here: http://www.ncbop.org/ch46-18.htm. -------------------------------------------------------------------------------- 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; see http://www.deadiversion.usdoj.gov/drugreg/change_requests/order_form.htm) 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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