BioCentury
ARTICLE | Politics & Policy

FDA releases three guidances on compounding

December 3, 2013 1:45 AM UTC

FDA's Center for Drug Evaluation and Research (CDER) released three draft guidances on compounding less than a week after President Obama signed into law the Drug Quality and Security Act, which allows voluntary oversight of compounding pharmacies by FDA and creates an electronic, unit-level system for tracking and tracing pharmaceutical products. The first guidance describes the requirements for a compounded drug to be exempt from cGMP practices as well as labeling and approval requirements. The guidance does note that traditional compounding pharmacies can compound "limited quantities" of a drug prior to a prescription and remain exempt from FDA regulation if the pharmacy has historically received valid prescription orders for the drug. FDA said it also will create a list of drugs that pharmacies are prohibited from compounding due to "demonstrable difficulties" that show an adverse effect on safety or efficacy of the drug.

The second and third guidances outline the requirements for compounding pharmacies that choose to register with FDA as outsourcing facilities. These pharmacies must comply with cGMP requirements and are required to report information to FDA about the drugs compounded at the pharmacy, but the compounded drugs are exempt from labeling and approval requirements. Comments on the guidances are due 60 days from publication in the Federal Register, which is expected Wednesday. ...