Pharmacy Compounding - Food and Drug Administration (FDA)
Compounding Quality Act
The Drug Quality and Security Act of 2013
On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs.
Title I of this new law, the Compounding Quality Act, removes certain provisions from section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) that were found to be unconstitutional by the U.S. Supreme Court in 2002. Section 503A describes the conditions under which certain compounded human drug products are entitled to exemptions from three sections of the FDCA requiring:
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.
In addition, the new law creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.” An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements. Outsourcing facilities:
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
FDA Actions to Implement the Compounding Quality Act
Outsourcing Facility Registration and Reporting
Traditional Compounding
Information for States
Pharmacy Compounding Advisory Committee
Nominations for Lists
Inspections and Enforcement
The Drug Quality and Security Act of 2013
On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs.
Title I of this new law, the Compounding Quality Act, removes certain provisions from section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) that were found to be unconstitutional by the U.S. Supreme Court in 2002. Section 503A describes the conditions under which certain compounded human drug products are entitled to exemptions from three sections of the FDCA requiring:
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.
In addition, the new law creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.” An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements. Outsourcing facilities:
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
FDA Actions to Implement the Compounding Quality Act
Outsourcing Facility Registration and Reporting
Traditional Compounding
Information for States
Pharmacy Compounding Advisory Committee
Nominations for Lists
Inspections and Enforcement
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