Limited, Inordinate, and Extended Can Kicking?

On 8/6/2021, a Federal Register Notice (here) was issued announcing an extension of the period before FDA intends to begin enforcing the statutory 5 percent limit on out of state distribution of compounded human drug products. FDA is extending the period for states to decide whether to sign the final MOU, (“Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between a State Board of Pharmacy or Other Appropriate State Agency and the FDA”) before the Agency intends to begin enforcing the statutory 5% limit on distribution of compounded human drug products out of the state in which they are compounded in states that do not sign the final MOU. The period was scheduled to end on 10/27/2021 and now is extended until 10/27/2022.

Is FDA kicking the can down the road for another year?

Hasn’t industry had enough time to have Boards of Pharmacy (or other appropriate State Agencies) interact with their State Governments to create regulations and laws, determine resources and the expertise needs to meet what is required in the final MOU? Did they have to wait for the final MOU to create those laws and regulations or was the content of the MOU apparent and available during the six-year development period?

In a 10/27/2020 Federal Register notice (here), FDA stated that it was providing a 365-day period for States to decide whether to sign the final standard MOU before FDA intended to begin enforcing the statutory 5 percent limit in States that do not sign the final standard MOU. Following this, FDA received requests to extend the period to allow State governments to evaluate the MOU and modify their laws and regulations, because many State governments were focused on addressing concerns raised by the COVID-19 pandemic. FDA considered the requests and is extending the above period until 10/27/2022.

DQSA has been law since 2013 (almost 8 years now) and Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that must be satisfied for drug products compounded by traditional compounders (pharmacists and physicians) to be exempt from (1) current good manufacturing practice (cGMP), (2) certain requirements for labeling of drugs with adequate directions for use, and the (3) approval of drugs under NDAs or ANDAs.

Section 503A of the FD&C Act limits distribution of compounded drugs outside the state by a pharmacist, pharmacy, or physician located in a state that has not entered into the MOU to 5 percent of its total prescription orders dispensed or distributed.

Also, DQSA required the Secretary (in consultation with the National Association of Boards of Pharmacy) to develop a standard Memorandum of Understanding for use by the States in complying with subparagraph (B)(i) in Section 503A. Finally, FDA announced in October 2020 (almost 7 years after DQSA became law) the standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products became available for signature by the States. This MOU is an agreement between state Boards of Pharmacy or other state agencies and FDA.

Did industry and Boards of Pharmacy have a chance to discuss the content of the MOU with FDA?

On 10/10-11/2019, FDA convened its eighth (in the last 6 years) inter-governmental working meeting of state government officials (here). Attendees included officials from State Boards of Pharmacy and State health departments and representatives from the National Association of Boards of Pharmacy (NABP).

The meeting attendees discussed oversight of compounding, including implementation of the Title I of the Drug Quality and Security Act (DQSA) including the MOU, and to identify opportunities to better protect the public health by strengthening oversight of compounders through improved federal-state collaboration.

The MOU also addresses for States that have signed the MOU, the distribution of inordinate amounts (generally greater than 50%) of compounded drug products interstate and provides for appropriate investigation and response by a State agency of complaints relating to compounded drug products distributed outside such State and for reporting requirements to FDA.

Are some compounding pharmacies taking the attitude that “we’ll keep going as we have in the past, until we get blasted by our Board of Pharmacy or FDA” and do they assume that relief is on the way through additional congressional actions?

As of August 2021, FDA has only two MOUs signed by Colorado and New Hampshire posted on their website (here). FDA assumes 45 States will sign the MOU.

The final MOU and the statutory 5 percent limit do not apply to drugs compounded by outsourcing facilities under section 503B of the FD&C Act and they do not apply to drugs that are compounded for animals.