By Amy Shank, PCCA Director of Government Relations

To see our recommendation for what to do about the FDA’s final standard MOU, please read our more recent blog post “What the FDA’s Final MOU Means for Your Practice.” 

Earlier this year, the FDA moved forward with implementing its memorandum of understanding (MOU) with the states by transmitting its “final standard MOU” to the White House Office of Management and Budget. This is the last step toward implementation of the MOU, which could become available for states to consider signing at any time. Once fully implemented, States will have 365 days from that date to consider the MOU.

The purpose of the MOU is to provide a framework for the FDA to address inordinate amounts of human compounded medications sent across state lines so that complaints relating to adverse events and quality issues can be investigated by state boards of pharmacy, or the appropriate state agency in the case of prescribers who compound. If a state opts not to enter into an MOU with the FDA, pharmacies in that state can send no more than 5% of compounded human medications to patients in other states. Congress included this provision in the Drug Quality and Security Act, which became law in 2013.

To help explain how the final standard MOU works, here are some frequently asked questions and answers about it.

What does the final standard MOU do?

States that sign the MOU would be required to collect information about pharmacies or prescribers that send more than 50% of their human compounded prescriptions over state lines. The states must report that information to the FDA. According to the FDA, states would collect:

• Name and address of the pharmacy that distributed inordinate amounts of compounded human drug products interstate
• The number of prescriptions for compounded human drug products that the pharmacy sent out of the facility in which the drug products were compounded during that calendar year
• The number of prescriptions for compounded human drug products that were dispensed (e.g., picked up by a patient) at the facility in which they were compounded during that calendar year
• The total number of prescriptions for compounded human drug products distributed interstate during that calendar year
• The total number of prescriptions for sterile compounded human drug products distributed interstate during that calendar year
• The names of states in which the pharmacy is licensed, and the names of states into which the pharmacy distributed compounded human drug products during that calendar year
• Whether the appropriate state agency inspected for and found during its most recent inspection that the pharmacy distributed compounded human drug products without valid prescriptions for individual patients during that calendar year

Said differently, states entering into the MOU must agree to inform the FDA of compounders who exceed the 50% threshold, and report the pieces of information listed above.

The FDA is anticipated to use this information to conduct risk-based inspections. Specifically, it is expected to prioritize inspection of pharmacies or prescribers that ship sterile compounds out of state, and instances when there are reports about lack of patient-specific prescription orders. Remember that in states that do not sign an MOU with the FDA, pharmacies can send no more than 5% of compounded medications to patients in other states.

States that sign the MOU will also have to provide the FDA with information about complaints involving a serious adverse drug experience or serious product quality issue relating to a drug product compounded at a pharmacy and distributed outside the state. Within five business days after receiving the complaint, the state must provide:

• Name and contact information of the complainant, if available
• Name and address of the pharmacy that is the subject of the complaint
• Description of the complaint, including a description of any compounded human drug product that is the subject of the complaint

After the state completes its investigation of a complaint, it must also provide the FDA with:

• Its assessment of whether the complaint was substantiated, if available
• Description and date of any actions the state has taken to address the complaint

How does the final standard MOU interpret the definitions of “distribution” and “dispensing”?

The FDA is not relenting on including patient-specific human compounded medications in the MOU’s meaning of “distribution” when they are “sent out of (or caused to be sent out of) the state” by the pharmacy. Patient-specific human compounded medications “dispensed at the facility,” both those picked up at the pharmacy or shipped to human patients within the state, are considered to be “dispensed.” The FDA’s position that “distribution” continues to include patient-specific human compounds solely because they were shipped to a patient in another state is not aligned with any other known definition of “distribution” in pharmacy practice across multiple federal and state agencies.

What changes did the FDA make to the final standard MOU from the draft released in 2018?

According to the FDA, the following changes to the MOU were made:

• “We have increased the time period, from 3 days to 5 business days, to communicate information about complaints that involve serious adverse drug experiences or serious product quality issues relating to a human drug product compounded at a pharmacy and complaints that involve adverse drug experiences or product quality issues relating to a human drug product compounded by a physician;
• We have increased the amount of time after the final standard MOU is available for signature from 180 days to 365 days before FDA intends to enforce the 5 percent limit in States that have not signed the final standard MOU; and
• We have coordinated with NABP to develop an information-sharing network to help reduce the information collection and sharing burden on the State BOPs or other appropriate State agencies.”¹

How many states are expected to sign the final standard MOU?

The FDA is maintaining its assumption that 45 states will sign the MOU. If you send compounded medications to patients outside your state, we encourage you to reach out to colleagues on your state board to determine if your state will enter into the agreement.

When will the 5% limit be enforced?

Depending on when the final standard MOU is approved by the White House Office of Management and Budget, states could consider whether or not to sign at any time and will have 365 days to make their decision from the time the FDA finalizes the MOU.

Learn More

PCCA members can find links to the FDA’s announcement of the final standard MOU on our Public Affairs webpage. If they still have questions, they can email us at publicaffairs@pccarx.com.

Amy Shank, PCCA’s Director of Government Relations, previously served as Vice President of Capitol Hill Consulting Group (CHCG), where she advised pharmacy, pharmaceutical and university clients on federal legislative priorities. Amy also has over 10 years of experience in the United States Senate. She was the Director of Oversight and Investigations for the Senate Health, Education, Labor and Pensions Committee. She was also a senior policy advisor to the Senate HELP Committee. Amy was a senior analyst for the Chairman of the Senate Budget Committee, former Senator Don Nickles, R-OK, and began her legislative career in his Republican Whip Office as a policy advisor.

Reference

1. Schiller, L. J. (2020). Agency information collection activities; submission for Office of Management and Budget review; comment request; human drug compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act . Food and Drug Administration. https://www.federalregister.gov/documents/2020/05/14/2020-10336/agency-information-collection-activities-submission-for-office-of-management-and-budget-review