Tuesday, December 31, 2013

Major Changes in State of Washington Regarding Compounding Rules in 2013

The Washington State Legislature has passed a law stating that all compounding done within the state must comply with United States Pharmacopeia (USP) standards for compounding.  The Washington State Pharmacy Quality Assurance Commission (previously known as the Board of Pharmacy), is currently writing rules based on the standards.  Rumor has it state pharmacy inspectors are already beginning to use USP standards in surveying compounding pharmacies.  William E. Fassett, PhD, RPh, FAPha, Professor of Pharmacy Law and Ethics at Washington State University-Spokane has a great summary of some of the changes effecting pharmacies in his Law Matters June 2013 Newsletter found here.  He explains that the Board of Pharmacy is now the Pharmacy Quality Assurance Commission (HB 1609) and that commission typically have a larger number of members and in this case the increase is from 7 to 15 members.  The commission will have 10 pharmacists, 1 pharmacy technician and 4 public members. Dr. Fassett summaries the new law regarding compounding as follows:



Compounding of drugs for office use, incorporation of USP <795> and <797> (HB 1800) – Effective

May 7, 2013
 
This statute amends the definition of “manufacture” in the Legend Drug Act to include distribution of products compounded by a licensed pharmacy to other state licensed persons for subsequent resale, “unless a specific product item has approval of the board.” However, “manufacture” does not include: (1) compounding by a licensed pharmacy pursuant to an order of a licensed practitioner for use in the practitioner’s practice by
administration to his or her patients; (2) repackaging of a commerciallyavailable medication by a pharmacy in
“small, reasonable quantities” for a practitioner’s office use; (3) distribution of products compounded by a licensed pharmacy to “other appropriately licensed entities under common ownership or control of the facility in which the compounding takes place;” or (4) delivery of finished and appropriately labeled products compounded pursuant to a prescription to “alternate delivery locations, other than the patient’s residence, when requested by the patient, or the prescriber to administer to the patient, or to another licensed pharmacy to dispense to the patient.”

The statute also incorporates USP chapters on compounding into state law, by amending RCW 18.64.270 to read “Any medicinal products that are compounded for patient administration or distribution to a licensed practitioner for patient use or administration shall, at a minimum, meet the standards of the official United States pharmacopeia as it applies to nonsterile products and sterile administered products.”
 



 

















1 comment:


  1. unfortunately, section (4) is a LOOPHOLE that compounding pharmacies such as Auro Pharmacy d/b/a Centra Drugs Compounding Pharmacy (La Habra, CA) use to distribute compounded drugs through physician offices in violation of rules that say that physicians cannot dispense compounded drugs. The way the scam works is:

    - The prescriber does NOT give the patient a choice of pharmacy but faxes the compounded script to the pharmacy they have the kickback relationship with;

    - They note that the patient "prefers to pick the prescription up AT THE PHYSICIAN'S OFFICE";

    - The prescription is paid for by the patient to the physician (where they are picking up their drugs), but the physician pays the pharmacy a lower "wholesale price", making a big markup.

    All of this is illegal violating laws on Patient-brokering, fee-splitting, illegal kickbacks, and dispensing of compounded drugs (a.k.a. "unapproved new drugs") through physician offices.

    Kenneth Woliner, M.D.
    www.holisticfamilymed.com

    ---
    or (4) delivery of finished and appropriately labeled products compounded pursuant to a prescription to “alternate delivery locations, other than the patient’s residence, when requested by the patient, or the prescriber to administer to the patient, or to another licensed pharmacy to dispense to the patient.”

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