How long is a schedule 2 CS prescription valid for?
ANSWER: A prescription for a schedule 2 controlled substance should not be filled more than 90 days after the date on which the prescription was issued. Reference: MCL 333.7333; CFR 1306.12
How long are schedule 3-5 CS prescriptions valid for?
ANSWER: Schedule 3 or 4 controlled substance prescriptions are valid six months from the date on which the prescription was written. In addition, no more than five refills can be granted within those six months. Prescriptions for schedule 5 controlled substances are valid for one year with no limitation on the number of refills within that year. Reference: MCL 333.7333; R 338.3168; CFR1306.22
What are the rules for issuance of multiple schedule 2 CS prescriptions?
ANSWER: Prescribers may issue as many schedule 2 controlled substance prescriptions as they deem appropriate, up to a 90-day supply, so long as each prescription complies with controlled substance prescription requirements and that doing so does not create undue risk of diversion or abuse. Each prescription must be dated and signed on the day the prescription is issued (the date the patient was seen by the prescriber) as well as the earliest permissible fill date, with the exception of the one intended for first fill. This “do not fill until” date is, by law, the earliest date on which the prescription may be filled. Each prescription expires 90 days from the date written. The prescriber is never allowed to post-date prescriptions for controlled substances. Reference: CFR 1306.12; MCL 333.7333
What are the legal requirements for transferring or receiving schedule 3-5 controlled substance prescriptions?
ANSWER: Schedule 3-5 controlled substances may be transferred once, if the pharmacies do not electronically share them on a real-time basis. The transfer of controlled substance prescriptions must be conducted between two licensed pharmacists, whether shared verbally or electronically on a real-time basis. However, pharmacies that electronically share on a real-time basis may transfer up to the maximum refills permitted by law and the prescriber’s authorization online.
Responsibility of the transferring pharmacist: The pharmacist completing a transfer must write the word “VOID” on the face of the invalidated prescription. On the back of the invalidated prescription, the pharmacist needs to document the name, address and Drug Enforcement Administration (DEA) registration number of the pharmacy to which it was transferred to and the name of the pharmacist receiving the prescription.
Responsibility of the receiving pharmacist: The pharmacist receiving the transfer must write the word “TRANSFER” on the face of the prescription and include all of the controlled substance prescription’s required elements in addition to the original prescription’s date of issuance, the original number of refills authorized, the remaining number of refills and the date of original dispensing. The pharmacist must also document the name of the transferring pharmacy, address, DEA number, the prescription number and the name of the transferring pharmacist. However, pharmacies that electronically share on a real-time basis may transfer up to the maximum refills permitted by law and the prescriber’s authorization online. A schedule 2 controlled substance prescription may not be copied from any pharmacy. Reference: CFR 1306.25
Does the DEA authorize the transfer of unfilled, “profiled” prescriptions?
ANSWER: Yes. According to the NABP clarification statement titled “Clarification on Transfer of Unfilled Controlled Substance Prescriptions,” which address the DEA’s policy, the DEA does authorize the transfer of unfilled, “profiled” prescriptions. The letter states that prescriptions can take the form of paper (including fax), call-in, or electronic prescription for controlled substances (EPCS). The DEA has addressed the forwarding of an EPCS prescription through published information in the preamble of the notice of proposed rulemaking (NPRM) on EPCS, 73 FR 36722, and the preamble of the interim final rule (IFR) on EPCS, 75 FR 16235. Note, because this was in the preamble and not in the EPCS regulations, it represents the DEA’s policy. As posted in the preambles of the NPRM and the IFR, an unfilled original EPCS prescription can be forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy, and this includes Schedule II controlled substances. Forwarded means transferred from one EPCS system to another. Thus, it must be maintained electronically and not verbally, for example.
Note that a pharmacy may have policies or producers in place prohibiting the transfer of unfilled prescriptions.
What information should a pharmacist submit to MAPS as a patient identifier on CS prescriptions?
ANSWER: Patient identifiers include the full name, date of birth and address (including zip code) along with an identification number such as a: a) Driver’s license number, b) State-issued identification number or c) the number zero. Zeros shall be entered if the patient is under 16 years of age. If the patient is an animal, the owner’s identification shall be used. Not that a social security number is no longer an allowable identifier. Reference: MCL 333.7333a; R 338.3102
Can a pharmacist fill a schedule 2 CS prescription prior to the “do not fill until” date?
ANSWER: No, the prescription cannot be filled until the date specified by the physician, not the date on which the prescription was written. Reference: CFR 1360.12
Can a pharmacist fill a faxed-in schedule 2 CS prescription for a long-term care (LTC) patient?
ANSWER: A schedule 2 controlled substance prescription for a resident of a long-term care (LTC) facility may be transmitted by the practitioner or by the practitioner’s agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription. LTC facilities need to have documented “agent of the prescriber” arrangements with each nurse acting as a practitioner’s agent. Facilities should utilize the approved Drug Enforcement Administration “agent of the prescriber” form for each nurse with every prescriber and have these forms updated routinely per facility protocol. Reference: CFR 1306.11
Can a pharmacist fill a schedule 2 CS prescription patients in partial quantities?
ANSWER: Yes. Schedule 2 controlled substance prescriptions can be partially filled and the remaining quantity shall be filled no later than 30 days after the date on which the prescription is written. Note that this new law does replace the partial filling of schedule 2 controlled substance for long-term care and terminally ill patients. The current law recognizes the partial filling of schedule 2 controlled substances, stating that the remaining quantity of a partially filled schedule 2 controlled substance shall be filled no later than 30-days after the date written. The previously referenced 60-day partial filling of schedule 2 controlled substances has been removed from the Public Health Code. Reference: CFR 1306.13(b); MCL 333.7333; 21 USC 829(f)
What are the rules pertaining to the ability for a pharmacist to dispense an emergency supply of a schedule 2 CS prescription for a patient?
ANSWER: A pharmacist may accept an oral prescription authorization from a prescribing practitioner in the case of an emergency situation, provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. Within seven days of authorizing an emergency oral prescription, the prescriber must provide to the dispensing pharmacist a signed written prescription for the schedule 2 medication. The prescription must have written on the front “Authorization for Emergency Dispensing”, and the date of the oral order. This needs to be attached to the oral order, and the prescription must be delivered in person or by mail. If delivered by mail, the postmark must be within the seven-day period. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription, the original authorization and the date of the oral order in order to meet the Drug Enforcement Administration’s (DEA) approved certification standards. If the prescriber fails to deliver the written prescription to the pharmacist within seven days, the DEA office must be notified. Reference: CFR 1306.11(d)
Can a pharmacist provide a partial fill for schedule 3, 4 and 5 CS prescriptions?
ANSWER: Yes, according to the Code of Federal Regulations, providing a partial fill for a schedule 3-5 controlled substance is legal provided that: 1) each partial filling is recorded in the same manner as a refilling. The pharmacist should indicate in the appropriate National Council for Prescription Drug Programs (NCPDP) field the quantity written for and then, in the appropriate NCPDP field, the quantity dispensed, and likewise the appropriate number of refills. If the prescription is billed to a health insurance plan, then the pharmacist should document on the prescription the reason for dispensing less than prescribed (for example, the patient requested less than prescribed) to avoid audit issues; 2) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and 3) no dispensing occurs six months after the date on which the prescription was issued. If a patient requests less medication than the quantity prescribed, or if the insurance limits the quantity that is covered, the pharmacist may dispense fewer than the quantity written for. Dispensing less than the full amount written for does not constitute a refill and, therefore, does not count toward the five refills allowed on schedule 3 and 4 controlled substance prescriptions. Reference: R 338.3168; CFR 1306.22, 1306.23
Are technicians allowed to obtain orders for CS prescriptions, either orally from the prescriber’s office or to give or receive prescription transfers from another pharmacy?
ANSWER: No. A practitioner or the practitioner’s agent may convey a prescription orally to a pharmacist, who promptly reduces to writing all the required information. A pharmacist is defined as anyone licensed by a state to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a state to dispense controlled substances under the supervision of a pharmacist licensed by such state. Michigan Public Health Code defines “dispenser” as a person who dispenses medication and practitioner as a pharmacist permitted to distribute, dispense, etc. medication. Reference: MCL 333.7109, 333.7105; R 338.3162, 338.3153a; CFR 1306.05.