The Drug Quality and Security Act: Compounding Guidance

In November 2013, President Obama signed the Drug Quality and Security Act (DQSA), a law that aims to address and improve the safety of the United States pharmaceutical supply and contains updates to the oversight systems for pharmaceutical compounding.

In December 2013, the United States Food and Drug Administration (FDA) released (for public comment) six guidance and regulatory documents for implementing the new law. The documents:

• Implement reinstated FDA authority.
• The DQSA under Section 503A of the Food, Drug and Cosmetic Act, exempts pharmacies engaged in traditional compounding, the practice in which a pharmacist creates or adjusts a medication for a specific patient need, from federal regulations applied to drug manufacturing.
• Define the registration process and interim reporting for outsourcing facilities.
• The DQSA creates a new category of drug compounders called “outsourcing facilities,” who will volunteer to register with the FDA, meet more rigorous standards, and submit to FDA inspections that are scheduled to mitigate risks. FDA guidance will also provide technical instructions regarding facility registration and compounding reporting.
• Call for “do not compound” suggestions.
• The FDA has asked for suggestions regarding drug products that ‘present demonstrable difficulties for compounding’ where compounding such drugs could result in an unsafe or ineffective product. Upon review, the FDA will develop a list of drugs that cannot be compounded.
• Request nomination for bulk substances.
• If drugs are in shortage or on a list approved by the FDA, registered outsourcing facilities would be able to compound drugs from bulk substances or active ingredients.

Public responses are now closed. Stay tuned for detailed information regarding each topic.