Buprenorphine is a schedule III controlled substance. According to 21 CFR 1306.05 (a), controlled substance prescriptions must bear the name, address, and registration number of the prescriber. When buprenorphine is prescribed for the treatment of opioid dependence, the DEA requires both the prescriber’s regular DEA registration number as well as the DATA 2000 waiver number to be included on the prescription. See the link: https://www.samhsa.gov/medication-assisted-treatment/buprenorphine-waiver-management/qualify-for-physician-waiver as well as 21 CFR 1306.05 (a) and (b) for more information.
For special circumstances where buprenorphine can be provided without a waiver:
To verify a prescriber’s DATA waiver:
For the purposes of reporting to the MN PMP, only the prescriber DEA field (PRE02) is required. The DATA 2000 waiver number MUST NOT be reported in the prescriber DEA field (PRE02) when reporting to the MN PMP. Only the prescriber’s regular DEA registration number should be reported. If the pharmacy needs to include the DATA 2000 waiver number for the purposes of processing the prescription claim to a third party payer, the whereabouts of entering this number should be determined with the pharmacy’s software vendor so long as it does not get carried forward in the prescriber’s DEA field (PRE02) to the MN PMP.
In 2012 the Governor signed into law legislation that allows controlled substances to be electronically prescribed for Schedule II, III, IV or V prescriptions in accordance with applicablefederal rules. MN Board of Pharmacy Statute 152.11 was revised to address electronic controlled substance prescriptions.
Subdivision 1.General prescription requirements for controlled substances.
(a) A written prescription or an oral prescription reduced to writing, when issued for a controlled substance in Schedule II, III, IV, or V, is void unless (1) it is written in ink and contains the name and address of the person for whose use it is intended; (2) it states the amount of the controlled substance to be compounded or dispensed, with directions for its use; (3) if a written prescription, it contains the handwritten signature, address, and federal registry number of the prescriber and a designation of the branch of the healing art pursued by the prescriber; and if an oral prescription, the name and address of the prescriber and a designation of the prescriber's branch of the healing art; and (4) it shows the date when signed by the prescriber, or the date of acceptance in the pharmacy if an oral prescription.
(b) An electronic prescription for a controlled substance in Schedule II, III, IV, or V is void unless it complies with the standards established pursuant to section 62J.497 and with those portions of Code of Federal Regulations, title 21, parts 1300, 1304, 1306, and 1311, that pertain to electronic prescriptions.
(c) A prescription for a controlled substance in Schedule II, III, IV, or V that is transmitted by facsimile, either computer to facsimile machine or facsimile machine to facsimile machine, is void unless it complies with the applicable requirements of Code of Federal Regulations, title 21, part 1306.
(d) Every licensed pharmacy that dispenses a controlled substance prescription shall retain the original prescription in a file for a period of not less than two years, open to inspection by any officer of the state, county, or municipal government whose duty it is to aid and assist with the enforcement of this chapter. An original electronic or facsimile prescription may be stored in an electronic database, provided that the database provides a means by which original prescriptions can be retrieved, as transmitted to the pharmacy, for a period of not less than two years.
(e) Every licensed pharmacy shall distinctly label the container in which a controlled substance is dispensed with the directions contained in the prescription for the use of that controlled substance.
Subd. 1a.Prescription requirements for Schedule II controlled substances.
No person may dispense a controlled substance included in Schedule II of section 152.02 without a prescription issued by a doctor of medicine, a doctor of osteopathy licensed to practice medicine, a doctor of dental surgery, a doctor of dental medicine, a doctor of podiatry, or a doctor of veterinary medicine, lawfully licensed to prescribe in this state or by a practitioner licensed to prescribe controlled substances by the state in which the prescription is issued, and having a current federal Drug Enforcement Administration registration number. The prescription must either be printed or written in ink and contain the handwritten signature of the prescriber or be transmitted electronically or by facsimile as permitted under subdivision 1. Provided that in emergency situations, as authorized by federal law, such drug may be dispensed upon oral prescription reduced promptly to writing and filed by the pharmacist. Such prescriptions shall be retained in conformity with section 152.101. No prescription for a Schedule II substance may be refilled.
Subd. 2. Prescription requirements for Schedule III or IV controlled substances.
No person may dispense a controlled substance included in Schedule III or IV of section 152.02 without a prescription issued, as permitted under subdivision 1, by a doctor of medicine, a doctor of osteopathy licensed to practice medicine, a doctor of dental surgery, a doctor of dental medicine, a doctor of podiatry, a doctor of optometry limited to Schedule IV, or a doctor of veterinary medicine, lawfully licensed to prescribe in this state or from a practitioner licensed to prescribe controlled substances by the state in which the prescription is issued, and having a current federal drug enforcement administration registration number. Such prescription may not be dispensed or refilled except with the documented consent of the prescriber, and in no event more than six months after the date on which such prescription was issued and no such prescription may be refilled more than five times.
Link to Code of Federal Regulations, Title 21, parts 1300 1321 is: http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFRandsearchPath=Title+21%2FChapter+IIandoldPath=Title+21andisCollapsed=trueandselectedYearFrom=2014andycord=801
Yes, a prescription for a Schedule II drug can now be partially filled.
On July 22, 2016, in an effort to address the prescription opioid abuse crisis the Comprehensive Addiction and Recovery Act of 2016 (Act), was signed into law. The Act amended the Controlled Substances Act to allow a pharmacist to partially fill a prescription for a Schedule II controlled substance (CS). Previously, according to 21 Code of Federal Regulations §1306.13(a), partially filling a Schedule II CS was only permissible if the pharmacist was unable to supply the full quantity as issued on the prescription and required that the remaining portion be filled within 72 hours.
The Act specifically amends 21 United States Code §829 by adding subsection (f), which allows for the partial filling of a Schedule II CS prescriptions if the following conditions are met:
• it is not prohibited by state law (Minnesota law does not prohibit partial filling of Schedule II drugs);
• the prescription is written and filled in accordance with federal and state law;
• the partial fill is requested by the patient or the practitioner who wrote the prescription; and
• the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
The Act also provides that the remaining portion of a partially filled Schedule II CS prescription may be filled not later than 30 days after the date on which the prescription was written. However, if the partial filling of a Schedule II CS is the result of an emergency situation oral prescription, the pre-existing partial fill time frame of 72 hours after the prescription was issued remains.
The Minnesota Board of Pharmacy has been fielding many calls about the use of medical cannabis in the hospital setting, however, the Board is not involved in the regulation or distribution of medical cannabis. For more information please visit the Minnesota Medical Cannabis website or contact the Office of Medical Cannabis, which is part of the Department of Health.