Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, January 31, 2014
Draft Minutes for Virginia Board of Pharmacy January 21 and 27, 2014 Meeting
| Tuesday | January 21, 2014 9:30 a.m. | Special Conference Committee & Informal Conference Committee Board Room 2 | Draft Minutes | |
| Monday | January 27, 2014 9:00 a.m. | Telephone Conference Call | Draft Minutes |
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
Second Question of the Day January 31, 2014 What percentage of compounding pharmacies where complying with state laws relating to compounding pharmacies prior to the DQSA? What percentage are now in compliance with state laws relating to compounding pharmacies? What percentage aren't sure if they are in compliance are not?
California Board of Pharmacy Disciplinary Action Against Jay Scott Drugs and North Highlands Pharmacy
Jay Scott Drugs, PHY 40912, Administrative Case AC 3482
Burbank, CA
Through a disciplinary action of the board, the license is revoked.
Decision effective 1/27/2014.
View the decision
North Highlands Pharmacy, PHY 39917, Administrative Case AC 3428
North Highlands, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 1/13/2014.
View the decision
Burbank, CA
Through a disciplinary action of the board, the license is revoked.
Decision effective 1/27/2014.
View the decision
North Highlands Pharmacy, PHY 39917, Administrative Case AC 3428
North Highlands, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 1/13/2014.
View the decision
California Board of Pharmacy Webcast of Meeting January 29-30, 2014
| January 29-30, 2014 Webcast | Department of Consumer Affairs 1625 N. Market Blvd. 1st Floor Hearing Room Sacramento, CA 95834 | Agenda | Meeting Materials |
Arkansas Board of Pharmacy Public Hearing on Proposed Regulation Changes set for February 12, 2014
| Public Hearing on Proposed Regulation Changes | |
| Date | 02/12/2014 |
| Time | 8:30 AM - 04:30 PM |
| Address | 322 South Main Street Suite 600 Little Rock, AR 72201 |
| Location | Suite 600 |
| Event Contact | John Kirtley |
| Event Phone | 501-682-9010 |
| Event Email | asbp@arkansas.gov |
| Description | PUBLIC NOTICE <br>On February 12, 2014 at 8:30 AM, the
Arkansas State Board of Pharmacy will hold a public hearing at the Arkansas
State Board of Pharmacy, 322 South Main, Suite 600, Little Rock, AR
72201. The following regulation changes will be considered: <br>
<br>Regulation 01 – General Operations: <br> <br>Proposed
changes will update the physical address of the Arkansas State Board of Pharmacy
to, 322 South Main Street, Suite 600, Little Rock, AR. 72201. <br>
<br>Regulation 02 – Pharmacists <br> <br>Proposed changes will
clarify that the intern training requirements for pharmacist licensure by
examination in Arkansas may be obtained as part of the school curriculum for the
colleges of pharmacy under Board approved conditions. <br>
<br>Regulation 04 – Pharmacy <br> <br>Proposed changes will
update language regarding the electronic recording of legend or schedule III,
IV, or V controlled substance prescriptions transferred from a retail pharmacy
to a Central Fill pharmacy. Changes will also expand the protocol for methadone
clinics to utilize additional drugs in research, clean up language regarding
electronic prescribing and make technical corrections within the regulation.
<br> <br>Regulation 05 – Long Term Care Facilities <br>
<br>Proposed changes will add language to allow licensed in-patient
hospice facilities to have emergency kits with a limited supply of prescription
medications for use in emergencies. <br> <br>Regulation 07 – Drug
Products/Prescriptions <br> <br>Proposed changes will allow
pharmacists to electronically receive and document prescriptions in accordance
with Arkansas Act 1331 of 2013 and as allowed by federal regulations.
Proposed changes will also update language according to Arkansas Act 176 of 2013
to allow a pharmacist to manually enter information into the electronic tracking
database when utilizing a Military ID to purchase Schedule V ephedrine,
pseudoephedrine or phenylpropranolamine products and update language to clarify
the option for a pharmacist to either enter verbal orders directly into the
pharmacy’s electronic prescription system or promptly reduce the verbal order to
writing. <br> <br> <br>Public comments will be
accepted until the conclusion of the public hearing. A copy of the
proposed regulation changes can be obtained through our website, <br>by
calling (501) 682-0190, writing: <br>Arkansas State Board of Pharmacy
<br>322 South Main Street, Suite 600 <br>Little Rock, AR 72201,
<br>or by emailing the Board of Pharmacy at <a
href="mailto:asbp@arkansas.gov">asbp@arkansas.gov</a>
<br> quoted from here (sorry about the way it is typed but it is straight from website this way) |
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