Enhancing FDA Communications: DQSA Update

The Food and Drug Administration (FDA) was granted some new authority this week by the Department of Health and Human Services (DHHS), its parent organization. The new authority, though not unexpected or substantial, pertains to the Drug Quality and Security Act (DQSA) which was passed in late 2013 in response to the deadly New England Compounding tragedy.

As discussed previously on the Baer Law Blog, the DQSA permits the FDA to closely regulate compounding pharmacies that voluntarily register as outsourcing facilities.  The DQSA also calls for more regular communications with the state boards of pharmacy, who continue to monitor and oversee the much smaller, patient-specific compounding operations.

Section 105 of the DQSA, Enhanced Communication, calls for the FDA to receive submissions from state boards of pharmacy “describing actions taken against compounding pharmacies” or “expressing concerns that a compounding pharmacy may be acting contrary to Section 503A of the Food, Drug and Cosmetic Act.”

However, the problem was that the DQSA called for communications to go through the “Secretary” of the DHHS. To clarify and likely simply the communication process, earlier this week the DHHS transferred authority to the FDA. Now, the FDA has authority to communicate on its own behalf with the state boards of pharmacy under Section 105. Additionally, all prior communications are retroactively made official as well.

The new grant of authority will hopefully streamline the communication process and make it easier for the FDA to communicate with each state board of pharmacy.