Compounders Urge FDA to Revise MOU
Drug compounding groups are urging the FDA to revise a draft memorandum of understanding that outlines how states should regulate small compounders, saying a proposed cap on interstate shipments of compounded products would hinder patient access and unduly burden state enforcement agencies.
The International Academy of Compounding Pharmacists and Professional Compounding Centers of America both take issue with the 30 percent-a-month limit on prescription units that states could send to other states, saying in comments to the FDA that the number is arbitrary and not backed by evidence. PCCA notes that Section 503A of the FD&C Act contains no requirement for capping a percentage of medicines that travel across state lines.
The National Associations of Boards of Pharmacy wants the FDA to reconsider the word “unit” — which is difficult to define — and replace it with the more understandable “prescriptions.”
All three groups say the MOU puts too much responsibility on states to investigate complaints, conduct investigations and collect data to determine whether compounders violated the out-of-state limits.
State boards of pharmacy should have the flexibility to use enforcement discretion as needed, and not be required to perform such as actions, as the MOU would have them do, NABP says.
IACP agrees, saying the MOU puts states in a lose-lose position to either take on a tremendous burden regulating compounders according to FDA guidelines, or have their pharmacies barred from shipping more than 5 percent of their total patient-specific prescriptions to other states.
This would make it impossible for states to agree to the MOU, thereby allowing the FDA to regulate all compounding within interstate commerce, a broad authority never given to the agency by Congress, the group adds.
PCAA and NABP also claim that the 72-hour window to report complaints to the FDA doesn’t allow time for a thorough investigation.
Last month, IACP urged Congress to require the FDA to revise the MOU. — Kellen Owings