Through the expansion of our e-Profile system, NABP will soon accommodate the collection, management, and sharing of information related to compounding pharmacies in the United States.
In June 2020, development of a means to gather and share compounding pharmacy information began as part of a three-year pilot project with Food and Drug Administration (FDA). Funded by FDA, the project builds upon our existing NABP e-Profile with the addition of data fields and functionality specific to compounding activities. This new network will increase the amount of compounding data available to member state boards of pharmacy and FDA. With more compounding data available, regulators are better positioned to help reduce the risk of injury to patients from improperly compounded drug products.
This project provides a mechanism for the data collection and reporting outlined in the revised draft “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products” (MOU).” The MOU was developed in accordance with Section 503A(b)(3) of the Food, Drug and Cosmetic Act, which directs FDA to work with us to develop a standard MOU for use by states in complying with section 503A(b)(3)(B)(i).
Over the next year and a half, we will evaluate the usability of the system and the accuracy of the information collected during the pilot and present a final analysis to the FDA.
This pilot project focuses on three goals:
Expand e-Profile to collect, manage, and exchange data pertaining to state-licensed pharmacies engaged in human drug compounding.
Improve and increase information available to the state boards of pharmacy and FDA about compounding pharmacies that distribute across state lines.
Foster better and more targeted regulation and oversight of compounding pharmacies to reduce risk for patients.
Benefits for the Boards
Our expanded information sharing network delivers a tool to report interstate compounding information to the other state boards of pharmacy and FDA. The tool will organize and make available information and data needed to make informed oversight determinations and provide the following benefits for the boards:
- Reduced administrative burden – enables the boards to prioritize their already limited resources to address the compounding pharmacies that pose the greatest risks to patients.
- Real-time data – improves upon the information currently available to the boards and FDA about compounding pharmacies, allowing the boards and FDA to gain a better understanding of the interstate distribution of compounded drugs.
- Uniform tracking – enables the boards to uniformly track pharmacies that ship inordinate amounts of compounded drug products out of state and the kinds of compounded drug products that they are shipping and flag these pharmacies for FDA.
- Seamless information sharing – allows the boards to collect and share information about complaints concerning compounded drugs and compounding pharmacies and physicians on an ongoing, year-round basis.
The MOU does not require boards to enter data into the information sharing network, but boards may do so if they have the data and resources. In addition, the MOU does allow boards to rely exclusively on the data that has been reported to the system by their licensees. Using that data, boards will be able to meet the requirement to identify for FDA, on an annual basis, pharmacies that distribute inordinate amounts of compounded human drug products interstate. State boards that do not sign the FDA MOU will still have access to the information sharing network. The information will be part of each pharmacy’s business e-Profile, which boards can currently access.
In addition to information provided by the boards, we will capture compounding pharmacy data through our VPP and accreditation applications. Pharmacies that do not participate in these programs will be encouraged to self-report this data in NABP e-Profile. Boards who prefer to input pharmacy data into the system can work with us to streamline and automate the process.
For more information about NABP’s compounding data sharing project or the MOU, email NABP Professional Affairs at firstname.lastname@example.org.
The following information will be collected from participating pharmacies that distribute or dispense compounded human drug products:
- Whether the pharmacy engages in the following activities during an identified calendar year:
- Human drug compounding – sterile and/or nonsterile
- Patient-specific compounding
- Non-patient-specific compounding
- If a pharmacy is compounding sterile or nonsterile human drug products, the following information will also be collected or calculated. (Note: The “total number of prescription orders for compounded human drug products that were sent out of or dispensed from the facility in which the drug products were compounded” and “the percentage of compounded human drug products distributed interstate” will be calculated by the system.) All information will be collected per calendar year:
- 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
- The number of prescription orders for compounded human drug products that were dispensed (eg, picked up by a patient) at the facility in which the drug products were compounded
- The total number of prescription orders for compounded human drug products that were sent out of or dispensed from the facility in which the drug products were compounded (this number will be calculated by the system)
- The total number of prescription orders for compounded human drug products distributed interstate
- The percentage of compounded human drug products distributed interstate (this number will be calculated by the system) (Note: this percentage will provide a benchmark for determining “inordinate amounts.”)
- The number of prescription orders for sterile compounded human drug products distributed interstate
- Names of states in which the pharmacy is licensed
- Names of states into which the pharmacy distributed compounded human drug products during the identified calendar year
- Whether or not compounded human drug products are being distributed without patient-specific prescriptions
It is expected that the system will be ready for licensees and the boards of pharmacy to begin entering information in early 2021.