ORA “Authorization of Pharmacy Compounding Information Disclosure” SOP

FDA has provided Article 3 notice to NTEU that ORA will revise the “Authorization of Pharmacy Compounding Information Disclosure” SOP.

Pharmacy compoundingThe FDA has provided Article 3 notice to NTEU that the Office of Regulatory Affairs (ORA) will revise its Standard Operating Procedure (SOP) for “Authorization of Pharmacy Compounding Information Disclosure.” According to the notice, the revised SOP outlines procedures related to authorizing testimony and sharing non-public information involving pharmacy compounding and non-public information related to implementation of the Drug Supply Chain Security Act (DSCSA) with state government officials.

NTEU has requested a briefing and to bargain this change.

If you have any comments or questions, please contact your chapter president.