Title I of the Drug Quality and Security Act of 2013
- Compliance with current good manufacturing practices (CGMP) (section 501(a)(2)(B));
- Labeling with adequate directions for use (section 502(f)(1)); and
- FDA approval prior to marketing (section 505).
By removing the unconstitutional provisions, the new law removes uncertainty regarding the validity of section 503A, which will be applicable to compounders nationwide.
- Must comply with CGMP requirements,
- Will be inspected by FDA according to a risk-based schedule, and
- Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers can provide their patients with drugs that were compounded in outsourcing facilities that are subject to CGMP requirements and federal oversight.
- Outsourcing Facility Registration and Reporting
- Traditional Compounding
- Enhanced Communication with States
- Creation of Advisory Committee
- Nominations for Lists
- Inspections and Enforcement
For More Information
FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas Inter-governmental Working Meeting on Pharmacy Compounding, March 20-21, 2014 Registered Outsourcing Facilities
- Compounding and FDA: Questions and Answers
FDA Video - FDA and Pharmacy Compounding