Yes. United States Pharmacopeia (“USP”) has determined adding a component such as flavoring not stipulated in the labeling to a conventionally manufactured nonsterile product is compounding and has been within the scope of USP <795> since 2004. USP has reemphasized this in its November 1, 2022 guidance document entitled “<795>: Adding Flavor to Conventionally Manufactured Nonsterile Products.”
Additionally, Minnesota Rule 6800.3300, subpart 1 sets forth the standards for nonsterile compounding. The rule states that if pharmacies engage in nonsterile compounding, they must follow USP <795> standards.
The Minnesota Board of Pharmacy (“Board”) recognizes the importance of this service, particularly in the pediatric population. Furthermore, the Board is aware the majority of states, including those states who border with Minnesota and whose resident pharmacies may directly serve Minnesota patients, have either enacted rules or statutes creating exceptions for flavoring, or have indicated they may use enforcement discretion when applying USP <795> standards to its licensees who add flavoring.
Accordingly, at this time, if a licensed Minnesota pharmacy elects to add flavoring to a conventionally manufactured product for the purpose of improving palatability, the Board may exercise its enforcement discretion regarding the applicable USP <795> requirements with the exception of the following USP <795> requirements:
Flavoring agents must still consist of inactive ingredients and must not exceed 10% variance from the labeled strength.
If a pharmacy adds flavoring to a manufactured product it must still take into account the manufacturer’s Beyond Use Date (“BUD”) and the effect on stability caused by adding flavoring.
The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must still be documented in the patient record notes for the prescription. This includes any relevant calculations and quantities/volumes of additives (e.g., water, flavoring agent(s), etc.). Such documentation must still be made available for inspection and copying upon the request of the Board or an agent of the Board.
The Board also expects its licensees to follow and adhere to all other applicable state and federal rules and laws while conducting pharmacy operations.
