Regulatory Focus™ > News Articles > DHHS Signs Over (a Little Bit of) Compounding Oversight Authority to FDA

DHHS Signs Over (a Little Bit of) Compounding Oversight Authority to FDA

Posted 23 April 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is getting some new, though not unexpected, authority this week by way of its parent organization, the US Department of Health and Human Services (DHHS).

The new authority pertains to a new law passed in 2013 known as the Drug Quality and Security Act (DQSA), which was passed in the wake of a deadly scandal involving pharmaceutical products compounded using deficient practices. Part of the law permitted FDA to more tightly regulate some-but not all-of the compounding pharmacies.

It also called for it to establish more regular communications with state boards of pharmacy, which continue to oversee the bulk of the small-scale compounding operations, such as those found in hospitals.

In particular, Section 105 of the act, Enhanced Communication, calls for 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 Federal Food, Drug, and Cosmetic Act (FD&C Act)."

For example, FDA and state boards of pharmacy might communicate about Warning Letters, sanctions, penalties, violations, revoked licenses, registration violations or other problems.

There was just one minor problem: The law called for the communications to go through the "Secretary"-that is, the secretary of DHHS.

But on 22 April 2014, DHHS transferred this authority to FDA in a "delegation of authorities" notice published in the Federal Register.

Henceforth, FDA has the authority to communicate on its own behalf with state boards of pharmacy under Section 105 of the DQSA, and all prior communications are retroactively made official as well.

The new authority should make it somewhat-though not substantially-easier for FDA to communicate with its state-level regulatory counterparts around the country.


DHHS Federal Register Notice


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