FDA is working to respond to questions from states regarding the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between state boards of pharmacy or other state agencies and FDA. This web page will be updated as we receive additional questions. Please email questions to email@example.com.
- Will states have an opportunity to negotiate the language of the MOU?
No. FDA has made the standard MOU available for signature. Section 503A of the FD&C Act directs FDA to develop, in consultation with the National Association of Boards of Pharmacy (NABP), a standard MOU for use by states. Developing individualized MOUs would create a patchwork of regulation of distribution of compounded drugs interstate and it would be impractical to have individual MOUs with each state.
The MOU describes, in brackets, the state in the agreement as “State Board of Pharmacy or other appropriate State agency.” The bracketed language appearing in the MOU is intended to be substituted with the appropriate name and contact information of the state.
- Can the state solely rely on pharmacies entering information into an information sharing network to identify pharmacies that distribute inordinate amounts of compounded human drug products interstate under the MOU?
By signing the MOU, the state is agreeing to identify pharmacies that distribute inordinate amounts of compounded drugs interstate. However, the MOU provides flexibility in how the state does this, including use of tools like an information sharing network, such as the one established in cooperation with NABP. If a state that chooses to use an information sharing network is uncertain whether the information it contains is complete, the state may verify information through other means, such as during inspections. FDA will continue to work with states to address questions regarding reporting expectations under the MOU.
- What will FDA do with information submitted by the states under the MOU?
Protecting patients is our top priority. Information submitted by the states will help inform FDA about potential for patient harm, including whether additional federal oversight is warranted. The information submitted by the states also will help inform the agency’s risk-based inspection priorities.
- What happens if a state does not fulfil the agreements under the MOU?
The MOU may be terminated upon a 60-calendar day notice of termination if a state does not adhere to the MOU provisions.
- Can states use their established processes to investigate complaints of adverse drug experiences and drug quality issues?
Yes, states can use their established processes as long as those policies and procedures do not conflict with the terms of the standard MOU. The MOU indicates any state investigation will be performed according to the state agency’s established investigatory policies and procedures, including those related to prioritizing complaints.
For example, using established procedures, a state board of pharmacy or other appropriate state agency may review an incoming complaint describing an adverse drug experience and determine the complaint does not warrant further investigation. In other cases, a state board of pharmacy or other appropriate state agency may determine that an incoming complaint contains insufficient information and investigate further to determine appropriate action.
Can a state that is prohibited by a state law from disclosing a complainant’s name and contact information fulfil the agreed upon data reporting under the MOU?
Yes. Under the MOU, the state is agreeing to report the name and contact information of the complainant, if available, to FDA. If providing this information is prohibited by state law, FDA does not consider it to be “available” for purposes of the MOU.
Does “prescription order” in the MOU include new and refill prescription orders?
As stated in the September 10, 2018, Federal Register Notice proposing this MOU, “For purposes of this MOU, each refill is considered to be a new prescription order.”
Can state agencies that enter the MOU collect and report information on additional activities that the state may define as compounding even if these activities would not be considered compounding under section 503A(e) of the Food, Drug, and Cosmetic Act?
FDA does not intend to object if state agencies collect and report information on activities that the state defines as compounding even if these activities would not be considered compounding under section 503A(e). States should indicate if they are reporting information that would not be considered compounding under 503A(e). Human drug compounding is generally a practice in which a licensed pharmacist or a licensed physician combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Section 503A(e) defines compounding as not including “mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling."