Guidance Documents

This document informs DEA registrants impacted by the flexibilities DEA granted during the COVID-19 PHE, which flexibilities will automatically terminate at the conclusion of the COVID-19 PHE on May 11, 2023, and which flexibilities will remain in effect after May 11, 2023 under the Opioid Crisis PHE. The document also informs DEA registrants of newly published proposed rules intended to make some exceptions related to the COVID-19 PHE permanent.

This manual prepared by the Drug Enforcement Administration (DEA), Diversion Control Division, to assist those persons who handle scheduled listed chemical products and List I and II chemicals in understanding the Federal Controlled Substances Act and its implementing regulations as they pertain to regulated chemicals.

Question and Answer addressing if a Researcher registrant should complete a DEA Form 222 when participating in double-blind studies in the exact quantity of schedule I or II controlled substances received is unknown.

Pharmacist Manual

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Q&A answering whether a physician transport controlled substances and administer controlled substances at the patient’s home residence (the so-called “black bag exception”).

Q&A asking if a pharmacy may deliver a prescribed buprenorphine product to a practitioner for direct administration to the patient. This Q&A further explains that a pharmacy may deliver buprenorphine to the registered location of either the prescribing 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 CS by the practitioner.

Question and answer concerning DEA allowing certified health care providers to administer REMS-designated controlled substances to patients in parking lots at the health care providers DEA registered location.

Question and answer concerning off-site dosing of narcotic treatment program patients during civil unrest.

During the Covid19 Public Health Emergency, DEA will temporarily permit registered practitioners such as hospitals, pharmacies, and physicians to distribute controlled substances (CS) in excess of five percent of their total number of dosage units of CS distributed to other registered dispensers during this calendar year, without registering as a distributor. All DEA security, recordkeeping and other applicable regulations, including state requirements, remain in effect.

During the Covid-19 Public Health Emergency, DEA will permit distributors to deliver narcotic substances to Narcotic Treatment Programs without requiring immediate signature by the NTP’s authorized individual accepting delivery. Distributors must confirm physical possession by the NTP and complete additional recordkeeping requirements in a timely manner.