Drug Enforcement Administration September 2020 – Federal Register Recent Federal Regulation Documents

This proposed rulemaking would add provisions requiring a person served with an order to show cause issued pursuant to the Controlled Substances Act to file a request for a hearing no later than 15 days after the date of receipt of the order. The proposed rulemaking would also add provisions requiring that a person who requests a hearing file an answer to the order to show cause no later than 30 days after the date of receipt of the order; it also sets forth criteria for what the answer must contain. The proposed rule would add provisions allowing the entry of a default where a party served with an order to show cause fails to request a hearing, fails to file an answer to the order to show cause, or otherwise fails to defend against the order to show cause. The proposed rule provides that where a party defaults, the factual allegations of the order to show cause would be deemed admitted. The proposed rule would also provide for the dismissal of an order to show cause where the Administration fails to prosecute the proceeding. This proposed rule would also provide that a default may only be excused upon a party establishing good cause to excuse its default and sets forth the procedures a party must follow to seek such relief. Further, the proposed rule would remove the current provisions allowing a recipient of an order to show cause to file a written statement while waiving his/her/its right to an administrative hearing.

Caligor Coghlan Pharma Services has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Novitium Pharma LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug(s) information.

Cerilliant Corporation has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Nanosyn Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substances. Refer to Supplemental Information listed below for further drug information.

Cayman Chemical Company has applied to be registered as a bulk manufacturer of basic class(es) controlled substances. Refer to Supplemental Information listed below for further drug information.

The Drug Enforcement Administration proposes to adjust the 2020 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.