October 7, 2022
New Model Act incorporates APC-recommended compounding questionnaire
Among the changes to NABP’s new Model Act are several recommended by APC, including a requirement that licensed compounding pharmacies provide to the state board of pharmacy basic information about their compounding operations.
“In 2021, the APC Board of Directors adopted a policy statement that, among other things, recognized that it was not unreasonable for state boards of pharmacy to need to know some basic info about who was compounding in their state,” said APC CEO Scott Brunner. “That coincided with an announcement that NABP was reviewing its Model Act, so we asked NABP if we could recommend amendments and enhancements to the compounding provisions in the Act.”
An APC work group submitted its recommendations to NAPB in August 2021, and the new Model Act was released last month.
“Though they did not accept all of our suggestions, they did incorporate several, including a series of five general questions about a licensee’s compounding operations,” said Brunner.
The exact language, in the form of two footnotes in Article 4, is:
- Applicants who engage or intend to engage in Compounding shall submit concurrently with their application for licensure responses to a questionnaire regarding the applicant’s Compounding operations.
- The questionnaire contemplated in 502(c) shall request, at a minimum, the following information: 1) The name and address of the location at which Compounding occurs or will occur; 2) Whether nonsterile Compounding occurs or will occur; 3) Whether sterile Compounding occurs or will occur; 4) Whether the applicant Compounds or will Compound with hazardous drugs; and 5) Whether the applicant ships or will ship compounded preparations across state lines.
“States are not compelled to adopt any or all of the Model Act,” said Brunner, “but we believe providing this basic information to state boards of pharmacy only enhances the credibility of the compounding profession.”