Drug Quality and Security Act – An Act
The Drug Quality and Security Act (DQSA), was signed into law on November 27, 2013. The DQSA amends the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.
The legislation contains important provisions relating to the oversight of compounding of human drugs.
Title I of DQSA: the Compounding Quality Act (CQA)
The CQA 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).
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.
Compounding Pharmacy Will Be Required to Register with the FDA
FDA is getting ready to issue Guidance documents applicable to pharmacy compounding or compounding pharmacy within few weeks of time.
Download the Statute “Drug Quality and Security Act” below.
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- A Bill (downloadable here)
- Drug Quality and Security Act (DQSA)
- [2013-09-25] Senate, House Health Policy Leaders Announce Bipartisan, Bicameral Legislation to Address High-Risk Drug Compounding Practices and Secure the Pharmaceutical Supply Chain (http://www.help.senate.gov/newsroom/press/release/?id=549b94cd-bca0-470d-aa39-3cfe1cea055f&groups=Chair)
Compounding Pharmacy Regulatory Information
- Compounding-Regulatory Policy Information
- Compounding and the FDA-Questions and Answers
- Compounding Quality Act
- FDA Inspection, Recalls and 483s Issued to Compounding
Title II of DQSA: Drug Supply Chain Security Act (DSCSA)
The DSCSA outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will:
- enable verification of the legitimacy of the drug product identifier down to the package level;
- enhance detection and notification of illegitimate products in the drug supply chain; and
- facilitate more efficient recalls of drug products.
Among key provisions implemented over the next 10 years are requirements for:
- Product identification
- Product tracing
- Product verification
- Detection and response
- Wholesaler licensing
- Third-party logistics provider licensing
Download DQSA in PDF
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Last Updated: 2015-08-11
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