Pages

Friday, January 31, 2014

Update on Washington State Pharmacy Quality Assurance Commission (formerly Washington State Board of Pharmacy)New Rules--including compounding

No. 1161 Update on Pharmacy

Compounding Rule Development
House Bill 1800, which passed during the 2013 legislative

session, addresses resident and nonresident pharmacy compounding.

The new law also requires that compounded medicinal

products meet minimum compendia standards to protect the

health and safety of the public.

In May 2013, the process to develop drug compounding

administrative rules was started. Since then there have been

three public meetings held so that pharmacists, representatives

from pharmacies, and others could provide their thoughts and

recommendations on how the new rules should be shaped. Following

the public meetings, staff has looked at administrative

rules from other states and has begun to draft the compounding

rules. Given the complexity of drug compounding, work on the

draft rules will continue through winter with an opportunity for

public review anticipated during spring or early summer 2014.

When a draft is ready for review, comments and suggestions will

be accepted and encouraged. Interested parties may sign up for

updates at http://listserv.wa.gov/cgi-bin/wa?A0=PQAC-RULES.





No. 1162 Frequently Asked Questions

Question: Can a compounding pharmacy distribute compounded

controlled substance (CS) preparations in Schedules



II through V on an invoice to a prescriber for office use within

the confines of the facility?

Answer: No. Compounding a CS is, by definition, the act of

manufacturing (21 U.S.C. 802(15)). Manufacturing is an activity

that requires a separate Drug Enforcement Administration



(DEA) registration (21 822(a) (1)). A DEA-registered pharmacy

is exempted from having to register as a manufacturer only

when it compounds a CS pursuant to a valid patient specific

prescription, and then dispenses this compounded CS directly



to the ultimate user or a member of his or her household (21

U.S.C. §§ 802(10) and (27)).

Question: Is it within the scope of practice for naturopathic

physicians to prescribe for Vicodin®, Norco®, and other CS?

Answer: While naturopathic physicians can write prescriptions

for all legend drugs except Botox®, their authority to write



prescriptions for CS is limited. Authorized CS include Schedule

III through V codeine and testosterone. Naturopathic physicians

may not prescribe any other CS.

Question: Have Washington State laws changed regarding



the expiration dates of Schedule II prescriptions?

Answer: Yes. The 2013 Washington State Legislature passed



a law, effective July 29, 2013, that states all Schedule II prescriptions

expire six months from the date the prescription

is written. The same law eliminated the ability for patients to



purchase Schedule V codeine-containing cough preparations

without a prescription. Except when dispensed directly by a

practitioner, substances included in Schedule III through V must

be dispensed by prescription only.

Question: What are ancillary utilization plans?

Answer: An ancillary utilization plan is a document that



details the duties and responsibilities of pharmacy assistants and

pharmacy technicians specific to the practice of pharmacy in

the location where they work. Ancillary staff must work within

the scope of their credential. Duties are considered nondiscretionary

and must be under the direct supervision of a licensed

pharmacist.

All ancillary utilization plans must be approved by the Commission

and a copy of the approved plan must be accessible to

all pharmacy staff and made available for inspection by the

Commission. Ancillary utilization plans are reviewed as part of

an inspection for their relevancy, accuracy, and completeness.

Changes in the operation of a pharmacy that revises the functions

of the ancillary staff must be submitted to the Commission.

All ancillary staff must be duly credentialed and the pharmacy

must comply with the 3:1 pharmacy technician to pharmacist

ratios or seek an exception by the Commission. The standard

ratio includes certified technicians and technicians-in-training.
quoted from here

No comments:

Post a Comment