FDA addresses interstate distribution of compounded drugs in new MOU

Regulatory NewsRegulatory News | 18 May 2020 |  By 

The US Food and Drug Administration (FDA) has developed a standard memorandum of understanding (MOU) with the states that addresses interstate distribution of compounded drugs.
Under the MOU, expected to be signed by 45 states, pharmacy compounders that distribute more than 50% of their compounded drug products interstate will be identified by the states. States will be required to report certain information about these compounders to the FDA.
The 50% threshold merely triggers the information-sharing requirements; it does not limit the quantity of compounded drugs that an individual compounding pharmacy may distribute outside its home state.
“States play a vital role in reducing the risks associated with compounded drugs, while ensuring appropriate patient access,” said Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, in a blog post announcing the availability of the MOU.
When the distribution chain of compounded drugs crosses state lines, many challenges can stand in the way of achieving a coordinated investigation and action plan in the case of serious adverse events, noted Woodcock. She cited the events of 2012, when a compounded injectable drug meant to be sterile carried a fungal infection to more than 750 people, causing a fungal meningitis that resulted in 64 deaths.
States who enter into the MOU with the FDA agree to let the FDA know about reports of serious adverse events or product quality issues involving compounded drugs produced within their state and distributed outside of the state.
If a state does not enter into the MOU with FDA, a pharmacist, pharmacy, or physician in that state cannot sell more than 5% of its total prescription orders across state lines. The 5% limit will not be enforced until 365 days after the final MOU is made available for signature. “This extended timeframe should correspond to a full legislative cycle for most states, giving sufficient time for states to modify their laws and regulations, if necessary,” wrote Woodcock.
The National Association of Boards of Pharmacy has entered into an agreement with FDA to develop an information-sharing network, where states can report information to be transmitted to the FDA and shared with other states. 
All the provisions in the MOU apply only to drugs compounded for human use, and they do not apply to outsourcing facilities, which are governed by section 503B of the FD&C Act.
“Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product, but they can also pose unique risks,” noted Woodcock. “The FDA’s compounding program is a priority for the agency and aims to develop policies that ensure appropriate access to lawfully-marketed compounded drugs for patients who have a medical need for them, while also protecting public health.”


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