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United States Pharmacopoeia (USP) and PA State Board of Pharmacy

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.


The Board hopes that this information is of help to you.  It may be viewed on the welcome page at www.dos.pa.gov/pharm.  


Keep in mind that the compounding guidelines were approved and finalized June 2019 and follow the current version of USP governing compounding. 


Additionally click here for clarification around USP <800>



New PBM Requirements for MCOs

  • The Pennsylvania Department of Human Services (DHS) has amended their contractual requirements for Managed Care Organizations which specify certain responsibilities for PBMs, including sharing their payment methdology and establishing an appeals process.  To read the full document, click here.


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The Philadelphia Department of Public Health (PDPH) offers a standing protocol for immunizations including flu, shingles, pneumococcal and HepA. In order to be covered under this protocol, pharmacies need to complete the three basic modules that PPA offers for CE credit and submit appropriate documentation (immunization protocol and MOU, PhilaVax Confidentiality form). PDPH will perform license checks.

To find out more, contact: Nichole Dantzler, MBA, Adult Grant Coordinator, Philadelphia Department of Public Health
Phone: 215-685-4440


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Nondiscrimination in Health Programs and Activities

  • The United States Department of Health & Human Services released the Nondiscrimination in Health Programs and Activities Final Rule in May 2016, which took effect on July 18, 2016. Key requirements affecting pharmacies include:
    • Designation of responsible employees
    • Adoption of grievance procedures
    • File assurance of compliance form when applying for federal funding
    • Training
    • Notices of nondiscrimination and taglines
    • Meaningful access for individuals with limited English proficiency
    • Meaningful access for individuals with disability
    • Accessible electronic and information technology programs or activities for individuals with disabilities
    • Reasonable modifications to avoid discrimination on the basis of disability
  • For more information and tips on how to comply, please see this resource from the American Pharmacists Association. Click here for this resource. 



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