Guidance Documents

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

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”).

This presentation on fireworks provides an overview of the classification of explosive materials and exemptions under Part 555, storage, identifying appropriate Tables of Distances and determining if a variance to deviate from the regulations might be needed.

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.

This presentation details the process for requesting a variance for deviating from the explosives regulations through use of a quantitative risk assessment software tool known as ‘Institute of Makers of Explosives Safety Analysis for Risk.’

This presentation provides an overview of the FELC’s responsibilities for reviewing and processing all new applications for federal explosives licenses and/or permits as well as renewals, the background check process, and ensuring sufficiency of information received.

This ATF procedure is to set forth the recordkeeping and NICS procedures for federal firearms licensees (FFLs) who facilitate the transfer of firearms between private unlicensed individuals. This procedure does not apply to pawn transactions, consignment sales, or repairs. Supersedes ATF Procedure 2017-1.

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 the bulk destruction of controlled substances during the civil unrest.

The Guide addresses, among other things, who and what is covered by the FCPA's anti-bribery and accounting provisions; the definition of a "foreign official"; what constitute proper and improper gifts, travel and entertainment expenses; the nature of facilitating payments; how successor liability applies in the mergers and acquisitions context; and the hallmarks of an effective corporate compliance program.

Question and answer concerning controlled substance prescription transfers during civil unrest.