💊AstraZeneca's FTZ Production Notification for Pharmaceuticals
AstraZeneca Pharmaceuticals LP has submitted a notification for proposed production activities related to zibotentan/dapagliflozin tablets in Foreign-Trade Zone (FTZ) 177 in Indiana. The notification aligns with FTZ regulations, detailing duty-free benefits for specified foreign-status materials and products while inviting public comment on the proposal.
Learn More⚖️DEA Revokes Prescript Pharmaceuticals' Registration for Violations
The Drug Enforcement Administration issued an Order of Revocation against Prescript Pharmaceuticals after it violated federal regulations pertaining to the procurement of controlled substances. The order highlights the importance of compliance with the Controlled Substances Act, especially concerning the requirement for obtaining procurement quotas for manufacturing activities, and could set a precedent affecting other registrants.
Learn More💊NIH Notice of Closed Meeting for Drug Development Contract Proposals
The National Center for Advancing Translational Sciences announces a closed meeting for evaluating contract proposals related to drug substance development. This meeting is a key opportunity for stakeholders in the health and pharmaceutical sectors to engage with the NIH as they assess various proposals.
Learn More💊Patheon API Services’ Application for Controlled Substances Import
Patheon API Services, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More🌱DEA Notice of Application for Bulk Manufacturing of Marihuana
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Learn More⚖️Restek Corporation's Import Application for Controlled Substances Notice
Restek Corporation has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More🚫Revocation of DEA Registration for Physician in Georgia
The Drug Enforcement Administration has revoked Dr. Harvey Leslie's DEA registration due to his inability to prescribe controlled substances after the revocation of his Georgia medical license. The document outlines the regulatory process leading to this decision and the implications of default by the registrant.
Learn More💊Notice of Application for Bulk Manufacturing by Promega Corporation
Promega Corporation has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Notice of Pharmaron's Application for Controlled Substances Manufacturing
Pharmaron Manufacturing Services (US), LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊Authorization of Production Activity for PCI Pharma in FTZ 35
The Department of Commerce's Foreign-Trade Zones Board has authorized production activity for PCI Pharma Services in FTZ 35, covering facilities in Croydon and Philadelphia, Pennsylvania. This authorization allows for specific production activities under established regulations, promoting operational efficiency and potential cost benefits for the pharmacy sector.
Learn More