On October 26, 2020, the Food and Drug Administration (FDA) issued its long awaited final MOU which describes the conditions under which certain compounded drugs by a pharmacist in a state-licensed pharmacy, or by a licensed physician, are exempt from current good manufacturing practice, labeling with adequate directions from use, and from approval of drugs under a new/abbreviated drug application.[1] One day later, on October 27, 2020, a group of pharmacies sued the FDA, accusing it of exceeding its authority, failing to consider the Administrative burden of the MOU under the Paperwork Reduction Act, and failing to obtain input from state boards of pharmacy throughout the U.S.[2] The specific contentious issue lies in FDA’s definition of the term “distribution” to include “dispensing”, thus de facto providing FDA its long sought goal of regulatory authority over the act of pharmacy dispensing.
FDA’s definition of distribution contradicts state laws, the NABP model Pharmacy Act, the FDC Act and every other appertaining federal law. Despite numerous comments from many organizations, pharmacy groups, as well as a Citizen’s Petition, FDA has taken the position that dispensing and distribution are not distinct acts, and that Congress established the inclusion of dispensing to a patient and distribution to healthcare practitioners, hospitals, or other entities as a single act in the Drug Quality Security Act (DQSA).[3] FDA’s decision will affect compounding pharmacies throughout the country and the issue will be tied up in litigation for a long time.
States that sign the MOU (365 days to decide) commit to investigating, documenting and reporting to FDA any time a pharmacy ships more than 50% of its compounding drugs to out-of-state patients. If a compounding pharmacy is doing business in a state that has signed the MOU, the pharmacy will have increased regulatory burdens and requirements to share information. Pharmacies in the states that have indicated they will not sign the MOU, will be limited to a 5% limit on interstate distribution of compounded drug products, the “5% rule.” This will have a chilling effect on patient access to compounded medications, some of which are life-sustaining. Many patients do not have access to a local source for their treatment, or else they would not be using an out-of-state pharmacy. Additionally, pharmacies located close to state lines may be particularly impacted.
Some significant changes in this “final” iteration which differ from the May 2020 draft include:
- Details of complaint investigation left to the individual State Boards of Pharmacy
- State Board of Pharmacy (BOP) notification to FDA within 5 business days following receipt of a complaint related to a serious adverse drug experience or product quality issue for a compounded drug
- Physician compounding has been removed from the inordinate amount calculation (presumably because BOPs have no regulatory jurisdiction over this). However, should BOP become aware of “inordinate amounts” they will notify FDA/appropriate state agencies).
- The time period for inordinate amounts has been changed from any calendar month to 1 year (recognizing the possibility of significant monthly variations)
- The 50% threshold does not serve as a limit but rather a “trigger” for information gathering about pharmacy distribution
How Frier Levitt Can Help
Frier Levitt’s FDA regulatory attorneys will continue to work with our pharmacy compounding client stakeholders and organizations to effect policy outcomes to amend FDA’s authorities and ensure patient access to compounded medications. Contact Frier Levitt to speak to an attorney.
[1] Section 503A(b)(3)(B)(ii) of the DQSA.
[2] Wellness Pharmacy Inc., et al v. Azar, et al. 1:20-cv-03082 (U.S. Dist. Ct. 2020).
[3] P.L. 113-54.
