Showing posts with label State of Washington. Show all posts
Showing posts with label State of Washington. Show all posts

Sunday, March 24, 2013

Washington State Board of Pharmacy Compounding State of Feb. 25, 2013 Re: Office Use and Patient Specific


Compounding Statement of February 25, 2013
Washington State Board of Pharmacy
Chris Humberson, R.Ph.
Executive Director



The Washington State Board of Pharmacy recently discussed pharmacy compounding and specifically WAC 246-878-020(4) at their Feb 21, 2013 meeting.  The board has always read (4) in conjunction with other subsections which specifically require a prescription for a compounded drug.  However, they agreed that (4), read independently, could allow a pharmacy to provide compounded products for a practitioner to administer to individual patients without a prescription for a specific patient.  Because this has clearly been the belief of some compounding pharmacies in Washington, the board decided it will honor this interpretation of the rule

The Board will continue the rule making process on compounding practices as voted on during their January 10, 2013 meeting to make sure pharmacy compounding is done under the appropriate standards to protect the health and safety of the people of Washington. They will involve all stakeholders in this process.

________________
Doreen E. Beebe
Program Manager
Washington State Board of Pharmacy
PO Box 47852
Olympia WA  98504-7852                                                           
Phone 360/236-4834
Fax 360/236-2901
Public Health – Always Working for a Safer and Healthier Washington.


State of Washington Board of Pharmacy: Hot Topic is Compounding Standards


  • Hot Topic: Pharmacist/Pharmacy Compounding Standards
During the past few months, we've been following the New England Compounding Center meningitis outbreak and subsequent public health issues related to pharmacy compounding. To date, 48 people have died and 712 injured nationwide. NECC surrendered its license in several states, including its home state of Massachusetts.
We strongly encourage Washington State pharmacies and pharmacists that engage in the practice of compounding to review Chapter 246-878 WAC. The rule defines compounding as the act of combining two or more ingredients in the preparation of a prescription. The rules go on to establish the conditions by which a pharmacist can compound drug products. More pharmacist/pharmacy compounding standards information.

Wednesday, February 20, 2013

Washington State House of Representatives HB 1800 summary Relating to Compounding

Washington State

House of Representatives
Office of Program Research
BILL
ANALYSIS
Health Care & Wellness Committee
HB 1800
Brief Description: Concerning the compounding of medications for physician offices or
ambulatory surgical centers or facilities to be used by a physician for ophthalmic purposes
for nonspecific patients.
Sponsors: Representatives Cody, Morrell and Schmick.
Brief Summary of Bill
Ÿ Requires the Board of Pharmacy to adopt rules to authorize the compounding of
ophthalmic medications for use by a physician for nonspecific patients.
Hearing Date: 2/19/13
Staff: Chris Blake (786-7392).
Background:
Compounding is a practice in which a pharmacist prepares a prescription by combining two or
more ingredients. Compounding is authorized in specific situations and in limited quantities.
The compounding of an inordinate amount of drugs, relative to the practice site in anticipation of
receiving prescriptions without any historical basis, is considered "manufacturing."
Manufacturers must obtain a license and meet additional state and federal regulatory
requirements.
The Board of Pharmacy allows pharmacists to conduct compounding in limited situations.
Pharmacists may compound drugs for individual patients when there is a pharmacist/patient/
prescriber relationship and the patient presents a prescription. Pharmacists may also compound
drug products that are commercially available for individual patients when it is based upon
anticipated orders based upon routine, regularly observed prescribing patterns. In addition,
pharmacists may compound drugs in very limited quantities prior to receiving a prescription
based upon a history of receiving prescriptions from a certain pharmacist/patient/prescriber
relationship.
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This analysis was prepared by non-partisan legislative staff for the use of legislative
members in their deliberations. This analysis is not a part of the legislation nor does it
constitute a statement of legislative intent.
House Bill Analysis - 1 - HB 1800
Pharmacists are prohibited from offering compounded drug products to others for resale, except
to a practitioner to administer to an individual patient.
Summary of Bill:
The Board of Pharmacy must adopt rules to authorize the compounding of ophthalmic
medications for use by a physician for nonspecific patients in physician offices, ambulatory
surgical centers, and ambulatory surgical facilities. The rules must establish limits on the
quantities that may be made available and requirements to record the dispensing of the
compounded medication, including the identity of the patients and the amounts dispensed.
The term "manufacture," as it relates to legend drugs, excludes the compounding of ophthalmic
medications for use by a physician for nonspecific patients in physician offices, ambulatory
surgical centers, and ambulatory surgical facilities.
Appropriation: None.
Fiscal Note: Available.
Effective Date: The bill contains an emergency clause and takes effect immediately.
House