Washington Pharmacy Quality Assurance Commission is requesting public input on second draft of sterile compounding rules through September 30, 2015

Progress

Draft Pharmaceutical Compounding Practices

Department of Health Rules Page

Draft Pharmaceutical Compounding Practices Comment Period

The Pharmacy Quality Assurance Commission is requesting public input on the second draft of sterile compounding rules (PDF). Changes between the first and second draft are documented in a memo (PDF). 

The commission will accept comments through Wednesday, September 30, 2015. Please submit comments toSterileCompoundingRules@doh.wa.gov or by mail to Chris Humberson at the following address:

Chris Humberson
Department of Health
Pharmacy Quality Assurance Commission
P.O. Box 47852
Olympia, WA  98504

When submitting comments, please identify the specific section and subsection for which you're commenting.  

Stakeholder Workshop Meeting Notes    

In order to prepare the first draft language, commission staff members reviewed what five other states established regarding compounding rules. Staff members studied United States Pharmacopeia 797 and 795, and used language from those documents to complete the draft. Using these various sources, commission staff members and specially trained pharmacy investigators wrote draft language that commission members of the compounding sub-committee then reviewed and edited for content.

As a result of establishing new rules for pharmacy compounding, Chapter 246-903 WAC Nuclear Pharmacies and Pharmacists and Chapter 246-871 WAC Pharmaceutical – Parenteral Products for Nonhospitalized Patients will be repealed. Chapter 246-873 Pharmacy-Hospital Standards will be amended to require that hospital pharmacies comply with Chapter 246-878 WAC Compounding Practices when it's finalized.

After receiving comments on the first draft, commission staff members reviewed the comments and made changes to the draft as needed and as appropriate. The commission will hold a stakeholder meeting during this second comment period. The commission will send a meeting notice through the Listserv and add it to the commission’s meeting calendar.  After the commission reviews the comments, additional changes will be made as need. The commission will consider the draft for approval at a future business meeting and filing with the code reviser’s office (CR-102) to schedule a public rules hearing.

quoted from http://www.doh.wa.gov/LicensesPermitsandCertificates/ProfessionsNewReneworUpdate/PharmacyCommission/RulesinProgress/PharmaceuticalCompoundingPractices