Frequently Asked Questions
Following are answers to frequently asked questions regarding this data sharing project. Question categories include data/information sharing, board investigations, pharmacy participation, project audits, and Food and Drug Administration’s (FDA’s) memorandum of understanding (MOU). Refer to FDA’s frequently asked questions about the MOU for more information. If you have any additional questions, see the Compounding Pharmacy Information Sharing Project overview page or contact firstname.lastname@example.org.
What information will be provided to FDA through the Information Sharing Network developed by NABP?
Upon approval by a board of pharmacy, the system will provide FDA with:
- Information about compounders for which the number of prescription orders for compounded drug products distributed interstate is greater than 50% of the number of prescription orders for compounded drug products distributed or dispensed both intrastate and interstate by such compounder; and
- Information provided by a board of pharmacy about:
- complaints of serious adverse drug experiences and product quality issues relating to human drug products compounded at a pharmacy and distributed interstate;
- complaints regarding an adverse drug experience or product quality issue relating to human drug products compounded by a physician and distributed interstate; and
- notifications about distribution of any amount of human drug products compounded by a physician and distributed interstate.
What volume of compounded human drug products distributed interstate is considered an inordinate amount?
A pharmacy has distributed an inordinate amount of compounded human drug products interstate if the number of prescription orders for compounded human drug products that the pharmacy distributed interstate during any calendar year is greater than 50% of the sum of:
- the number of prescription orders for compounded human drug products that the pharmacy sent out of (or caused to be sent out of) the facility in which the drug products were compounded during that same calendar year; and
- the number of prescription orders for compounded human drug products that were dispensed (eg, picked up by a patient) at the facility in which they were compounded during that same calendar year.
The distribution of inordinate amounts of compounded human drug products interstate is a threshold for the board of pharmacy to identify and report certain information to FDA, not a limit on the distribution of compounded human drug products interstate. Pharmacies whose data are reported to FDA will not necessarily be subject to inspection by FDA.
Do boards of pharmacy need to report to FDA information about compounding physicians’ offices that have distributed “inordinate amounts”?
No, reporting for compounding physicians’ offices is not limited to inordinate amounts. The board must report to FDA the distribution of any amount of human drug products compounded by a physician and distributed outside a state. The reporting requirement for “inordinate amounts” refers only to compounding pharmacies.
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.”
What compounded drug products are not covered by the MOU?
Such products include:
- drugs intended for veterinary use
- repackaged drug products
- biological products subject to licensure under section 351 of the Public Health Service Act
- drugs compounded by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act
What specific information will boards of pharmacy submit to the Information Sharing Network about compounding pharmacy complaints?
Regarding complaints relating to human drug products compounded by a pharmacy and distributed outside a state, boards of pharmacy will submit the following information:
- 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
- The board’s assessment of whether the complaint was substantiated, if available
- Description of any actions that the board has taken to address the complaint
What specific information will boards of pharmacy submit to the Information Sharing Network about compounding physician complaints and notifications?
Regarding complaints relating to human drug products compounded by a physician, or regarding the distribution of any amount of human drug products compounded by a physician and distributed outside a state, boards of pharmacy will submit the following information, if available:
- Name and contact information of the complainant or notifier
- Name and address of the physician who is the subject of the complaint or notification
- A description of the complaint or notification, including a description of any compounded human drug product that is the subject of the complaint or notification
How quickly must a board of pharmacy submit complaint information to FDA?
The MOU requires boards of pharmacy to submit information about a serious adverse drug experience or serious product quality issue relating to a drug product compounded at a pharmacy and distributed interstate no later than five business days after receiving the complaint.
It may take time for the board to obtain enough information to determine whether the complaint is serious. The five-day time period begins after the board discovers the complaint is serious.
Will NABP provide training on the use of the Information Sharing Network?
Yes. Additional information on training and data entry instructions will be forthcoming. You can also review these resources about the Information Sharing Network:
- Download the information sheet for a breakdown of the process for data entry and data flow through the network
- Watch the recent webinar, Preparing for FDA’s Compounding MOU, to understand how the MOU can better position your board to address patient safety and improve communication between FDA and all boards of pharmacy
What is included in “the number of prescription orders for compounded human drug products that the pharmacy sent out of (or caused to be sent out of) the facility in which the drug products were compounded during that same calendar year?”
This statement refers to the number of prescription orders that were shipped or mailed out of the facility, regardless of whether the products went in state or out of state.
Note that this is added to “the number of prescription orders for compounded human drug products that were dispensed (eg, picked up by a patient) at the facility in which they were compounded during that same calendar year” to calculate the total number of prescription drug orders dispensed/distributed. This total is used as the denominator to determine the inordinate amount percentage.
What is included in “the total number of prescription orders for compounded human drug products distributed interstate during that same calendar year?”
This statement refers to the number of prescription orders that were sent (or caused to be sent) out of the state in which the drug was compounded.
This number is used as the numerator to determine the inordinate amount percentage. Then, the calculation is made. If the result is greater than 50%, the amount is considered inordinate, and the data needs to be sent to FDA. (The calculation is shown at the top of page 6 of the MOU.)
What types of complaints does the MOU obligate the board of pharmacy to investigate?
The board of pharmacy or state agency will investigate complaints of adverse drug experiences and product quality issues relating to human drug products compounded at a pharmacy in that state and distributed outside the state.
- An adverse drug experience is any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action (21 CFR 310.305(b)).
- A product quality issue is information concerning (1) any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article; or (2) any bacteriological contamination; any significant chemical, physical, or other change or deterioration in the distributed drug product; or any failure of one or more distributed batches of the drug product to meet the applicable specifications (21 CFR 314.81(b)(1)). Contamination in general, including but not limited to mold, fungal, bacterial, or particulate contamination, is a product quality issue.
Any investigations will be performed pursuant to the board of pharmacy or state agency’s established investigatory policies and procedures, including those related to prioritizing complaints, provided they are not in conflict with the terms of the MOU.
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.
Any investigations performed by the board of pharmacy or state agency under the MOU will include taking steps to assess (1) whether there is a public health risk associated with the compounded drug product; and (2) whether any public health risk associated with the product is adequately contained.
There is no obligation for the board of pharmacy to investigate complaints regarding compounding physicians.
The MOU requires the board to report a variety of information within a certain number of business days after receipt. When does that timeline begin in a situation where the umbrella agency, rather than the board, receives the information initially?
The timeline begins when the agency that signs the MOU, be it the umbrella agency or the board, receives the information.
Why would a pharmacy voluntarily enter the requested information?
The information requested in the MOU will be incorporated into the application for many NABP accreditation and inspection programs, including Verified Pharmacy Program (VPP). As a result, all applicants seeking accreditation or a VPP inspection will voluntarily submit the requested information – regardless of whether their primary intent is to participate in the pilot project. Compounding pharmacies also will be able to enter the requested information, outside of the VPP application process, for a chance to receive a VPP inspection at no cost to them. The VPP inspection in this scenario will be adapted to serve the dual purpose of a traditional blueprint inspection and an audit for the pilot project. If pharmacies that submit the requested information through the NABP program application are chosen for an audit, they will receive either a refund or a future VPP inspection at no cost to them.
Some pharmacies already have a profile in NABP’s e-Profile Connect system and would only need to provide the additional information related to compounding. Others would need to create a new profile. All entities providing the requested data would be entered into the pool of possible compounding pharmacies to be audited through a VPP inspection.
Under the pilot project, what will NABP do with the information that the pharmacies provide?
NABP will consult with FDA to select 150 eligible pharmacies to be audited for the project. The pharmacies will be prioritized based on factors including the volume of compounded drug products distributed interstate and other considerations. Those selected to be audited will receive a VPP inspection developed for entities engaged in sterile compounding. These VPP inspections will be modified to gather the additional information needed for the project. NABP will engage its team of seasoned and knowledgeable surveyors to conduct the audits, after providing them with the appropriate training to gather the necessary information.
How do compounding pharmacies submit the requested data?
Pharmacies that already have a business e-Profile can log into their account and add the information in the Compounding Details tab. If you do not yet have an e-Profile for your business, you will need to create one before you can enter the requested data. For more details, review the Instructions for Entering Pharmacy Compounding Data.
How many pharmacies are expected to voluntarily submit their information?
Participation by compounding pharmacies is voluntary; therefore, a specific number of pharmacies submitting information has not been determined. NABP plans to conduct 150 pharmacy audits over the course of the pilot program to evaluate the system and assess the information it produces.
Will the free VPP inspection still be available after the pilot project is over?
The funding from FDA includes the cost of these inspections. Thus, once the funding has been exhausted, VPP will no longer be available free of charge.
What will the audits entail?
The audits will, among other things, assess the accuracy of the information provided, including the total number of prescription orders for compounded drug products distributed interstate and distributed or dispensed intrastate, and whether the pharmacy distributes compounded drugs without patient-specific prescriptions, such as for office stock. Audits also will evaluate the compounding facility for issues such as those related to production quality.
What will NABP do with the audit findings?
NABP will conduct research to analyze the information that the pharmacies self-reported in the data system, as compared with the audit findings. The analysis will assess the quality and reliability of the data collected in the system. This research will provide the following information:
- an assessment of the extent of interstate distribution of compounded drugs;
- a descriptive analysis of the characteristics of compounders engaging in interstate distribution, including the number of states into which they distribute compounded drugs, scale of production, distribution of office stock, and production quality factors;
- an assessment of the prevalence of data inaccuracies;
- an assessment of remaining data gaps and other factors that may inform risk-based oversight; and
- an analysis of complaints submitted to the Information Sharing Network.
How will NABP determine which pharmacies to audit?
NABP will select pharmacies for audits in consultation with FDA, prioritizing pharmacies based on several factors, including the volume of compounded drug products distributed interstate.
Can states now sign the MOU and, if so, have any states done so?
The final MOU was released in October 2020; therefore, states can now sign. See the MOU participation map for the latest updates.
What should a state do if it would like to sign the MOU?
States with interest in entering the MOU should email email@example.com.
After signing the MOU, when are boards of pharmacy expected to start sharing inordinate amount data with FDA?
The expected start date for sharing inordinate amount data may vary based on when the state signs the MOU. The calculation of inordinate amounts is based on data from a calendar year. and states may be signing the MOU at different times in the middle of a calendar year.
States are invited to communicate with FDA regarding their individual circumstances and start date for sharing data. FDA intends to work with the states that sign the MOU as they phase in the annual identification and calendar-year-based calculations of inordinate amounts.
Can the state solely rely on pharmacies entering information into the 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 NABP’s Information Sharing Network. If a state that chooses to use the 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.
When will FDA be enforcing the 5% rule?
FDA announced on August 6, 2021 that enforcement of the 5% rule will begin two years after the release date of the MOU, in October 2022. At that time, FDA will begin enforcing the 5% limitation on interstate distribution of compounded human drugs by pharmacies in states that have not signed the MOU.
What if a board that signs the MOU does not or cannot comply with the MOU?
There are no penalties associated with non compliance; however, FDA may move forward with terminating the MOU following a 60-calendar-day notice, which will result in enforcement of the 5% limitation on interstate distribution of compounded human drugs by pharmacies.
Will boards 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 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.
Can a state that is prohibited by a state law from disclosing a complainant’s name and contact information fulfill 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. In addition, NABP’s Information Sharing Network will allow boards to select whether to make this information accessible to other boards.