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Information on USP

Thursday, October 31, 2019  
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The Pennsylvania State Board of Pharmacy (Board) published on its web site today the following information:

United States Pharmacopoeia (USP) 

At the October 22, 2019 Pennsylvania State Board of Pharmacy (Board) Meeting, the Board discussed issues related to USP’s decision to delay implementation of the revisions to chapters 795 and 797 pending resolution of appeals. The following decisions were approved by the Board and placed on record:

  1. The Board is enforcing USP 795 and 797 as currently written. Board Regulation Section 27.601 was finalized on June 22, 2019 and requires compliance with section 503a of the federal Food, Drug and Cosmetic Act, federal regulations promulgated thereunder and the current version of the USP chapters governing compounding.
  2. The Board is delaying the enforcement of USP 800 until the appeals of certain provisions of the revised USP 795 and 797 are resolved. While enforcement of USP 800 is being delayed, pharmacies should do their best to comply with the requirements of USP 800, including the sections related to the handling of hazardous medications, as these requirements will be enforced at some time in the future, dependent on resolution of the appeals of the revised USP 795 and 797.
  3. The Board voted to adopt the following position and will be amending its regulations to reflect this information:
    • The definition of "compounding" does not include the unencumbered flavoring of conventionally manufactured medications provided that the flavors used are inert, tested and do not alter a medication’s concentration beyond USP’s accepted level of variance.

This information may be viewed on the welcome page at www.dos.pa.gov/pharm.


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