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USP Chapter 797 on Enforceability, (c) USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, 25 August 2008

In the USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, USP “attempts to clarify the enforceability” of Chapter 797. The guidebook is a compilation of the full text of Chapter 797, public comments with responses from the committee which formulated the document, and five pages addressing enforceability.

Chapter 797 applies to practitioners. Practitioners are regulated by state agencies and in general, the FDA will defer to states with regard to Chapter 797.  The FDA will act with the states in investigating allegations of poor quality compounded drugs, but is willing and able under the Federal Food Drug Cosmetic Act (FFDCA) to act on its own initiative.

Approaches by state to Chapter 797 generally fall into three categories, discussed in detail below in language drawn from the USP publication.

States that require compliance with USP standards

The following states likely fall into this category by having broad legal or regulatory language that requires compliance with the USP-NF generally. Since Chapter 797 is part of USP-NF, “these Boards appear to require compliance with the latest revision of the chapter”:

  • Massachusetts
  • South Dakota
  • South Carolina
  • Virginia
  • West Virginia

States that explicitly reference Chapter 797

The following states have laws or regulations that explicitly require compliance to varying degrees, with some broader assertions:

  • Minnesota
  • Utah: broad assertions that Chapter 797 shall apply
  • Georgia: immediate-use products exempted
  • Indiana
  • Maryland
  • New Mexico

States that include some provisions from Chapter 797 in their regulations

 Some text incorporating portions of 797 has been adopted by the following states:

  • Arizona
  • Arkansas
  • Texas
  • Ohio

Reference:

USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, 2008

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