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Pharmacy Design
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:
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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