The US Food and Drug Administration (FDA) has significant changes in regulation planned throughout the next year, as shared by Alexander Gaffney of RAPS.org. The article highlights six major proposals, five of which fall under the Drug Quality and Security Act (DQSA) of 2013. The following is a brief description of each rule, in order of anticipated or prior proposal release date:
- Proposal granting FDA authority to destroy low-value drugs that are refused admission into the U.S. (May 6, 2014).
- Modification of the list of drug products that may not be compounded as a result of the product’s removal from the market, due to safety and efficacy concerns (May 2014).
- Rules regarding human drug compounding conditions within 503A and 503B facilities (October 2014).
- Rule outlining the minimum requirements for good manufacturing practices (GMP) at outsourcing facilities (November 2014).
- Revision of the current requirements regarding annual reports submitted to investigational new drug applications (INDs) to create consistency with the requirements endorsed by the International Conference on Harmonization (ICH). (March 2015).
- Final rule establishing national standards for licensing prescription drug wholesale distributors and third party logistics providers (November 2015).
To read the full article, click here.