During the February 2022 update, the FDA emphasized its intention to implement notice-and-comment rules related to the specific distribution of compounded medications. This is in reference to the FDA's MOU with the state. The published memorandum has been suspended for the time being. As a result, no new agreement with the state will be reached during this period. In addition, states that have previously signed the memorandum are not expected to carry out the activities outlined in the MOU. Once the final decision is made, the updated brief will be available for all states.
An MOU is an agreement designed to handle interstate distributions of large quantities of compounded pharmaceuticals. The agreement also addressed questions about compounded medications delivered outside of the state, which may be subject to investigations.
The FDA established this standard agreement in October 2020 with the goal of providing legal protection for public health. It was also intended to improve communication between the federal and state governments while making use of their resources to monitor compounded pharmaceuticals manufactured by traditional pharmacies.
This MOU was developed with consultation from the National Association of Boards of Pharmacy and is available for states to sign, as described in section 503A of the Federal Food, Drug, and Cosmetic Act. However, following the MOU's issuance, several compounding pharmacies filed a lawsuit against the FDA in the U.S. District Court for the District of Columbia. The plaintiffs in the lawsuit claimed that the FDA did not adhere to proper rule-making procedures when implementing the MOU. The rule-making process involved undertaking the mandated Regulatory Flexibility Analysis to examine the economic impact on states and compounding pharmacies. Following that, in September 2021, the court ordered the FDA to either certify that there will be no significant economic impact on small businesses or to conduct a regulatory flexibility study.
Under section 503A, applicable compounding pharmacies create medications only for home use and does not allow for large batches to be made to reduce costs. Medication compounded specifically for a patient's needs must adhere to U.S. Pharmacopeia and other standards. The 5% limit on interstate distribution is one specific guideline that ties into the standard MOU. Compounders working in states that have not signed the MOU are not permitted to distribute more than 5% of the state's total prescription orders out of state. Prior to this ruling, there was an existing extension in place for the enforcement of the 5% limit. The FDA intends to keep this extension in effect while the rulemaking process is underway.
The FDA and the state both play a part in minimizing risks and ensuring patient safety with compounding. These provisions are a key to aid in public health. The goal is to achieve a communal collaboration amongst states and the federal government to prevent serious problems from occurring. With this collaboration in place, communication between states and the federal government can improve the detection of adverse drug events and drug-quality problems. The FDA continues to encourage the public to report any adverse events or quality concerns associated with compounded medication to the FDA Safety and Adverse Event Reporting Program, MedWatch.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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