Review of the Multistate Inspection Blueprint Program (Resolution 122-3-26)
RESOLUTION NO: 122-3-26
TITLE: Review of the Multistate Inspection Blueprint Program
ACTION: PASS
WHEREAS, the most recent version of United States Pharmacopeia (USP) Chapter <797> Pharmaceutical Compounding – Sterile Preparations became official on November 1, 2023; and
WHEREAS, some boards of pharmacy adopted, by reference, this most recent version of USP sterile compounding standards, thus requiring compounding pharmacies to comply with these standards; and
WHEREAS, some boards of pharmacy have not adopted or delayed enforcement of this most recent version of USP sterile compounding standards for various reasons; and
WHEREAS, due to this inconsistency, sterile compounding standards across the states are not uniform, which may result in pharmacy noncompliance with current sterile compounding standards when shipping compounded products across state lines and may place patients at risk of harm; and
WHEREAS, NABP created the Multistate Inspection Blueprint Program in 2013 to create agreed upon expectations for states inspecting compounding pharmacies, as defined in Section 503A of the Federal Food, Drug, and Cosmetic Act1, to ensure uniformity and compliance with current sterile compounding standards and enhance patient safety; and
WHEREAS, the states that participate in the Multistate Inspection Blueprint Program (Blueprint states) have the choice to use either the jointly developed NABP Universal Pharmacy Inspection Form for Sterile Compounding or their own sterile compounding inspection form that has been reviewed by NABP and updated to ensure uniformity with current standards found in the Pharmacy Inspection Blueprint for Sterile Compounding; and
WHEREAS, some Blueprint states may be unknowingly utilizing an outdated version of the NABP Universal Pharmacy Inspection Form for Sterile Compounding, or the inspection forms of some Blueprint states have not been updated to ensure uniformity with the current version of the NABP Universal Pharmacy Inspection Form for Sterile Compounding;
THEREFORE, BE IT RESOLVED that NABP convene a work group to review:
- the Multistate Inspection Blueprint Program Memorandum of Understanding that states sign when joining the Multistate Inspection Blueprint Program;
- the process by which NABP assists states to ensure compliance with the Multistate Inspection Blueprint Program; and
- the NABP Universal Pharmacy Inspection Form for Sterile Compounding to ensure that it:
- fully aligns with current USP sterile compounding standards; and
- can be completed by state inspectors within a reasonable amount of time;
BE IT FURTHER RESOLVED that NABP evaluate participating Blueprint states to determine compliance with the Multistate Inspection Blueprint Program, including ensuring that participating Blueprint states are fully inspecting for compliance with current USP sterile compounding standards.
(Resolution passed at the 122nd Annual Meeting in Boston, MA.)