FDA Releases 2015 Schedule for New Rules

By the end of next year, the FDA is expected to release rules on drug shortages, biologic safety testing, compounding pharmacy oversight and OTC monographs on cough and cold medicines.

The FDA highlighted approximately 21 rules expected to be published in 2015 as proposed or final rules, some of which have been in the works for years. They include:

• Finalizing the OTC monograph for any cough/cold products that contain an oral bronchodilator such as ephedrine in combination with any oral nasal decongestant. The rule was originally proposed in 2005 and is expected to be completed by July 2015;
• A proposed rule for minimum good manufacturing practices for large compounding pharmacies that volunteer for agency oversight. The GMPs are expected to be tailored to compounders and are set to be published in a proposed rule in July 2015;
• A rule requiring manufacturers of certain products to report interruptions or discontinuances in manufacturing in case they turn into a shortage. The rule was required under the FDA Safety and Innovation Act of 2012 and is expected to be finalized in January 2015;
• Amending regulations by removing the general safety test requirements for biological products. The agency is taking this action, which is yet to be determined, because the testing requirements are duplicative and obsolete;
• A rule describing the circumstances where a product made or derived from tobacco is subject to regulation as a drug, device or combination product. Recent litigation prompted the proposed rule, which should be published by June 2015; and
• Administrative authority to destroy certain drug imports refused admission into the U.S. The agency issued the proposed rule last year, and the final regulation is expected in September 2015. 

To read a full list of HHS’ updated rules, which include proposed rules for other agencies, visit http://tinyurl.com/pvta7r5. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.