Frequently Asked Questions
Following are answers to frequently asked questions regarding this data sharing project. Question categories include data/information sharing, pharmacy participation, project audits, and the FDA MOU. If you have any additional questions, please contact email@example.com.
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; plus
- 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 in inspection by FDA.
What information will be collected about compounding pharmacy complaints?
Regarding complaints relating to human drug products compounded by a pharmacy and distributed outside a state, the system will collect the following information from the board of pharmacy:
- name and contact information of the complainant, if available;
- name and address of the pharmacy that is the subject of the complaint;
- a description of the complaint, including a description of any compounded human drug product that is the subject of the complaint;
- the board or state agency’s assessment of whether the complaint was substantiated, if available; and
- a description and the date of any actions that the board or state agency has taken to address the complaint.
What information will be collected about compounding physician complaints?
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, the system will collect the following information from the board of pharmacy:
- name and contact information of the complainant or notifier;
- name and address of the physician who is the subject of the complaint or notification; and
- a description of the complaint or notification, including a description of any compounded human drug product that is the subject of the complaint.
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.
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.
What information will be provided to FDA?
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; and
- complaints relating to an adverse drug experience or product quality issue relating to human drug products compounded by a physician and distributed interstate.
Will NABP provide training on the use of the information-sharing network?
Yes. Information on training will be forthcoming.
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.)
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 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 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.
Does the board of pharmacy have an obligation under the MOU to input compounding pharmacy data to the information-sharing network?
No. Per the memorandum of understanding (MOU), the board is obligated to identify for FDA those pharmacies that are compounding human drug products and distributing inordinate amounts of such products interstate. The board will identify the pharmacies using surveys or reviews of records during inspections or an information-sharing network (NABP’s system) or other available mechanisms. The MOU does not obligate the board to input the data into the information-sharing network. It does, however, allow the board to meet its obligation solely through the use of the information-sharing network. So, if a board does not input any pharmacy compounding data, it is not in breach. It can exclusively rely on the data that has been reported to the system. With this in mind, NABP will put forth great effort to encourage pharmacies to voluntarily self-report the data and will incorporate the requirement to input this data into the Association’s VPP program application and certain other accreditation program applications. Note that the obligation to identify this information for FDA is an annual one, but NABP intends for the system to allow for boards to report information on an ongoing, year-round basis, not just once a year.
If a board is able to and would like to input the information, NABP will work with the board to do that in a way that expends as few resources as possible in an automated fashion.
Have any states signed the MOU?
The final MOU was released in October 2020. States can now begin signing the MOU. One year after the release date, FDA will begin enforcing the 5% limitation on interstate distribution.