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
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