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.
If a compounder chooses not to register as an outsourcing facility and qualify for the exemptions under section 503B, the compounder could qualify for the exemptions under section 503A of the FDCA. Otherwise, it would be subject to all of the requirements in the FDCA applicable to conventional manufacturers. FDA anticipates that state boards of pharmacy will continue their oversight and regulation of the practice of pharmacy, including traditional pharmacy compounding. The Agency also intends to continue to cooperate with State authorities to address pharmacy compounding activities that may be violative of the FDCA.
FDA has initiated actions to implement the new law.
- Outsourcing Facility Registration and Reporting
- Traditional Compounding
- FDA Communication with States
- Pharmacy Compounding Advisory Committee
- Nominations for Lists
- Inspections and Enforcement