QA Pharmacy Delivery of Buprenorphine Prescription under SUPPORT Act

Drug Enforcement Administration
Diversion Control Division
DATA-Waived Guidance Document
Title: Q&A Pharmacy Delivery of Buprenorphine Products under the SUPPORT Act
Question: May a pharmacy deliver a prescribed buprenorphine product to a practitioner for
direct administration to the patient?
Answer: Yes, but only in limited circumstances. Ordinarily, a prescription only authorizes a
pharmacist to dispense a controlled substance to an ultimate user, which includes a patient or a
member of the patient’s household. 21 U.S.C. 802(10) and (27); 21 CFR 1300.01
(“[p]rescription means an order for medication which is dispensed to or for an ultimate user”).
However, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment
for Patients and Communities Act (SUPPORT Act) permits a pharmacy to deliver a controlled
substance prescribed for maintenance or detoxification treatment to a practitioner’s registered
location for the purpose of direct administration through either injection or implantation to a
narcotic dependent person. 21 U.S.C. 829a(a).
The prescription must be issued by a qualifying practitioner who is authorized to
prescribe controlled substances for maintenance or detoxification purposes under 21 U.S.C.
823(g)(2) and the prescription must meet the requirements of the Controlled Substances Act and
DEA regulations, including the requirement that it may not be used to supply the practitioner
with stock for general dispensing to patients. The pharmacy may deliver the controlled
substance to the registered location of either the prescribing practitioner or the administering
practitioner, and must be administered by injection or implantation only to the patient named on
the prescription within 14 days after the date of receipt of the controlled substance by the
practitioner. 	21 U.S.C. 829a(a)(2)(B) and 829a(a)(5).
Notwithstanding any exceptions under 21 U.S.C. 827, a practitioner administering
controlled substances must maintain complete and accurate records of all controlled substances
delivered, received, administered, or otherwise disposed of under 21 U.S.C. 829a, including the
persons to whom controlled substances were delivered. 21 U.S.C. 829a(a)(6). The pharmacy
must maintain, for a period of at least two years, complete and accurate records of all controlled
substances received, distributed, dispensed, or otherwise disposed of, including either, where
applicable, the original paper prescription or an electronic prescription which is readily
retrievable. See 21 CFR part 1304. The pharmacy must also comply with all other Federal,
State, local and tribal laws in the jurisdiction in which they are licensed. See, e.g., 21 U.S.C.
829a(a)(3). Relatedly, nothing in this guidance document relieves any pharmacy or other entity
that dispenses a buprenorphine product from any obligations that might arise under the Federal
Food, Drug, and Cosmetic Act, such as those relating to an FDA-approved Risk Evaluation and
Mitigation Strategy (REMS).

Guidance documents, like this document, are not binding and lack the force and effect of
law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or
cooperative agreement. Consistent with Executive Order 13891 and the Office of Management
and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance
document that is not accessible through the Department’s guidance portal, or similar guidance
portals for other Executive Branch departments and agencies, except to establish historical
facts. To the extent any guidance document sets out voluntary standards (e.g., recommended
practices), compliance with those standards is voluntary, and noncompliance will not result in
enforcement action. Guidance documents may be rescinded or modified in the Department’s
complete discretion, consistent with applicable laws.
EO-DEA220, September 18, 2020, DEA-DC-045