FDA Seeks Industry Input on Compounding Regulations

The FDA has established a public docket so that compounding pharmacies and others can share their experiences and views regarding the agency’s drug compounding regulations.

The docket, FDA-2015-N-0300, will be open for the foreseeable future and should be used for comments that are not specific to guidance or issues addressed in other dockets, according to the March 9 Federal Register notice.

Commenting on specific documents in the general docket could prevent the comments being considered as the guidance is finalized, the agency emphasizes.

The FDA rolled out its regulations overseeing compounding pharmacies in late 2013, following enactment of the Drug Quality & Safety Act, which was passed by Congress in response to an outbreak of fungal meningitis linked to a New England compounder.

Read the notice at www.fdanews.com/03-09-15-compounding.pdf. — Lena Freund