The Compounding Quality Act: What Is It? Who Benefits? What Does It Mean For Compounding Pharmacies?

Thursday, March 5th, 2015
In late 2013, the U.S. Congress passed the Compounding Quality Act (“CQA”). This Act provides for additional FDA oversight of compounding pharmacies. However, this oversight change has brought up new questions for pharmacies and how it affects their compounding operations.

What Is The Compounding Quality Act?

The CQA is Title I of the larger Drug Quality and Security Act. Title I enhances compounding drug oversight in the following five ways:

First, the CQA creates a new entity known as an outsourcing facility. The outsourcing facility is usually much larger than the traditional compounding pharmacy and supplies compounds to hospitals and other healthcare facilities. The facility must report any adverse events and give reports to the FDA on all compounded medications twice a year. The facility is subject to FDA inspections, required to pay an annual fee and pay for any re-inspection fees. The CQA also outlines what labeling each facility must put on compounded medications, including creation dates, expiration dates, and storage instructions.

Second, the CQA reinstates Section 503A of the Food, Drug, and Cosmetic Act (“FDCA”). The Supreme Court deemed parts of this section unconstitutional in 2002. The reinstated version of the 503A exempts compounds from the drug approval provisions of the FDCA. This version also provides guidelines for labeling, and does not require that a compounding facility meet the current Good Manufacturing Practices (cGMPs) mandated by the FDA as long as it complies with the conditions stated in Section 503A.

Third, the CQA puts new penalties in place for various activities related to compounded medications. These activities include selling compounded medications marked “not for resale”, intentionally falsifying a prescription for a compounded medication, failure by an outsourcing facility to report adverse events or compounded medications, and using false advertising on the benefits of these medications.

Fourth, the CQA sets up a mechanism for easier communication between the FDA and state pharmacy boards on drug compounding. The state boards must inform the FDA when they send a warning letter or impose sanctions in regards to compounding medications. The FDA must also be informed when the state boards suspend or revoke the license of a pharmacy for violation of state drug compounding laws, and put a recall in place for a compounded medication on the basis of quality. The FDA must tell the state boards if it finds a compounding pharmacy is violating Section 503A of the FDCA.

Fifth, the CQA prevents compounding pharmacies from making copies of any commercial drugs or any drugs the FDA has removed from the market for safety or efficacy purposes.

Who Benefits From The Compounding Quality Act?

The Act is designed to put safeguards in place to make compounded medications safer for patients. The CQA puts into place clearer labeling requirements to make sure patients understand what they are taking, how to take it, and when it expires.

To enhance compounding pharmacy oversight, the CQA creates better communication between the FDA and state pharmacy boards. The CQA also prevents compounding facilities from creating drugs that have been pulled from the market.

Providing a safe harbor for pharmacists that practice traditional compounding, the CQA creates the new outsourcing facilities that can go beyond the traditional compounding practices.

What Does The Compounding Quality Act Mean For Compounding Pharmacies?

The CQA has brought up many considerations for pharmacies that compound medications. Do these pharmacies need to register with the FDA? Do these pharmacies want to become an outsourcing facility? Does the pharmacy labeling meet the new guidelines?

If you own or manage a compounding pharmacy and have questions about the CQA and its effect on your business, contact us here at Brown & Fortunato Call us at (806) 345-6320, or you can visit our office at 905 S. Fillmore, Suite 400, in Amarillo, Texas. You can also read more about our attorneys and practice areas on our website or drop us an email on our Contact Us page. Our Healthcare Group looks forward to assisting you with any concerns you may have.

This information is subject to change. Please check for updates that are more recent than the published date of this article.