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

Reminder: Alabama State Board of Pharmacy Has New Rules Effective August 27, 2012

To view the new rules, click here.

Alabama State Board of Pharmacy Amended Rules Effective August 27, 2012

 The following rules have been amended:

1.       680-X-2-.08  PHARMACIST CONSULTANTS OF

                       PHARMACEUTICAL SERVICES

2.       680-X-2-.09  TRAINING FOR PRECEPTORS

3.       680-X-2-.16  PRACTICAL TRAINING PROGRAM 

                                STANDARDS

4.       680-X-2-.19  PARENTERAL THERAPY

5.       680-X-2-.20  NUCLEAR PHARMACY

Rule Amendments found here.

New Rules in Texas Relating to Veterinary Compounding

The Texas State Board of Veterinary Medical Examiners have adopted rules impacting veterinarian compounding in Texas.  A complete set of all the new rules adopted in Texas can be found here.  The following rule was adopted in the Spring of 2012 and became effective June 14, 2012.  The rules are intended to limit veterinarians from compounding significant quantities of drugs in advance of diagnosis for business profit reason without having established a veterinarian-client relationship  for the patient and diagnosing a condition or disease in that patient.  The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs.  The new rule 573.44 provides:

 RULE §573.44 COMPOUNDING DRUGS
(a) A veterinarian may only compound drugs for a specific animal or herd with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.
(b) A veterinarian may only prescribe compounded drugs to treat a specific occurrence of a disease or condition, which threatens the health of the animal or will cause suffering or death if left untreated, that the veterinarian has observed and diagnosed in the particular patient for whom the compounded drugs are prescribed. The amount of a drug that a veterinarian compounds or orders compounded must not exceed the established need for specific compounded drugs for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship.
(c) Labeling Requirements.
(1) All compounded drugs must bear the labeling information required under §573.40 of this title (relating to Labeling of Medications Dispensed), as well as the following information:
(A) date on which the drug was compounded;
(B) name and strength of medically active ingredients;
(C) identity of treated animals;
(D) withdrawal/withholding times if needed; and
(E) condition or disease to be treated.
(2) In addition to the information listed in paragraph (1) of this subsection, compounded drugs dispensed to the client must also state a date dispensed and an expiration date, which should not exceed the length of the prescribed treatment.
(d) Limitations on Compounded Products.
(1) A veterinarian shall not compound or order a drug compounded if there is a FDA-approved,
commercially available animal or human drug that, when used as labeled or in an extra-label fashion in its available dosage form and concentration, will appropriately treat the patient.
(2) A veterinarian shall only compound or order compounded products with FDA-approved commercially available animal or human drugs as the active ingredients.
(3) A veterinarian shall not promote and/or distribute compounded drugs that are essentially similar to FDAapproved products.
(4) A veterinarian must ensure the safety and efficacy of a compounded drug, including but not limited to avoiding known drug incompatibilities and inappropriate combinations, and must use a pharmacist to perform drug compounding when the complexity of the compounding exceeds the veterinarian's knowledge, skill, facilities, or available equipment.
(e) Compounding for Food Producing Animals.
(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval for the compounded product sufficient to ensure food safety and may not compound from any drugs prohibited for use in food producing animals. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.
(2) A veterinarian shall not compound or order a drug compounded if the compounded drug results in
violative food residue, or any residue that may present a risk to public health.
(3) Compounding from a human drug for use in food-producing animals is not permitted if an approved animal drug can be used for compounding.
(4) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.
(f) Limitations on Promotion and Sale of Compounded Drugs.
(1) A veterinarian shall not prepare for sale any compounded drugs which employ fanciful names or trade names, colorings or other additives, or that in any way imply that the compounds have some unique effectiveness or composition.
(2) A veterinarian shall not advertise, promote, display, resell, or in any other way market prepared
compounded drugs.
(3) A veterinarian shall not offer compounded drugs to other state licensed veterinarians, pharmacists or other commercial entities for resale.
Source Note: The provisions of this §573.44 adopted to be effective June 14, 2012, 37 TexReg 4229

Here are the boards comments, which can be found here,  on that new rules:

22 TAC §573.44

The Board adopts new §573.44, regarding Compounding Drugs, which sets out the limited circumstances in which a veterinarian can compound a drug.  The adopted new rule parallels current state and federal regulations on the compounding of drugs by veterinarians while emphasizing issues that are of particular significance for veterinarians, such as the importance of the veterinary-client-patient relationship and the limitations on drugs compounded for foodproducing animals. The adopted rule is structured by subject-area, to clarify the limitations that apply to all compounded products, the limitations on compounding for food producing animals, and the limitations on promotion and sale  of compounded drugs. The new adopted rule strengthens the requirement that a veterinarian must establish and maintain a veterinarian-client
-patient relationship with any animal for which the veterinarian compounds drugs. The Board intends the adopted rule to limit drug compounding by veterinarians only  to treat a specific occurrence of a disease or condition that the veterinarian has diagnosed in a specific patient, and to prohibit veterinarians from compounding on any other basis or in quantities greater than those needed for the treatment of the particular disease occurrence in the specific diagnosed patient.   The Board's concern is that some  veterinarians compound significant quantities of drugs in advance of diagnosis for business profit reasons without first diagnosing the condition or disease the compounded drug is designed to treat in a particular patient with whom the veterinarian has established and maintained a  veterinarian-client-patient relationship. Compounding drugs for
office use is allowed under the rule, but only in amounts that do not exceed the established historical need for specific compounded drugs  for patients with which the veterinarian has established and maintained a valid veterinarian-client-patient relationship. The adopted rule includes more detailed provisions requiring that a veterinarian only compound products made with FDA-approved drugs as active ingredients, and not promote or distribute compounds that are essentially the same as other FDA-approved drugs. The subsection of the adopted rule regarding compounding for food-producing animals parallels existing federal and state law on the subject by requiring that the veterinarian set withdrawal times that are based on scientific
information and note the method used to determine the withdrawal period in the patient records, and ensure that procedures are in place to maintain the identity of any food-producing animal that receives a compounded drug. With regard to labeling requirements for compounded drugs, the new adopted rule eliminates redundancies in the labeling information required for all drugs under §573.44, and requires that the label for  compounded drugs include both name and strength of medically active ingredients. 

RULE §573.45 EXTRA-LABEL OR OFF-LABEL USE OF DRUGS provides:

(a) Extra-label or off-label use is the actual or intended use of a drug in an animal that is not in accordance with the approved labeling, and includes, but is not limited to:
(1) compounded drugs;
(2) use in species not listed in the labeling;
(3) use for diseases or other conditions not listed in the labeling;
(4) use at dosage levels, frequencies, or routes of administration other than those stated in the labeling; and
(5) deviation from the labeled withdrawal time based on these different uses.
(b) A veterinarian must use his or her discretion in the off-label use of drugs for animals. In exercising such discretion, a veterinarian shall consider, to the extent possible:
(1) whether the off-label use of a drug meets the community standard of humane care and treatment set out in §573.22 of this title (relating to Professional Standard of Care);
(2) the established safety of the off-label usage;
(3) the inclusion of a drug in a standard veterinary formulary;
(4) analyses of off-label usage in the veterinary medical literature and in articles and commentaries written by the veterinarian's peers in the veterinary medical profession;
(5) information provided by the drug's manufacturer, vendor or the FDA as to whether off-label usage of a drug may present a risk to public health; and
(6) any other sources of pertinent information

(c) If anticipated off-label use of a drug is not commonly accepted or used by average veterinarians in the community in which the veterinarian practices or if the off-label usage does not have an established safety record, the veterinarian shall orally or in writing inform the client that the off-label usage is not commonly accepted or used in the veterinary community and that such usage could pose a risk to the e health of the animal.

Any oral notification shall be recorded in the patient records.

(d) Extra-Label Drug Use in Food Producing Animals.
(1) For animals intended for human consumption, a veterinarian must establish an extended withdrawal interval sufficient to ensure food safety. The withdrawal period must be supported by scientific information, and the veterinarian shall note the method used to determine the withdrawal interval in the patient records.
(2) A veterinarian shall not prescribe an extra-label drug in a manner that will result in violative food residue, or any residue that may present a risk to public health.
(3) Veterinarians shall ensure that procedures are in place to maintain the identity of treated animals, and shall note those procedures in the patient records.
Source Note: The provisions of this §573.45 adopted to be effective June 14, 2012,

The board's comments about rule 573.45 are as follows.

22 TAC §573.45
The Board adopts new §573.45, regarding Extra-Label or Off-Label Use of Drugs, which sets out the conditions under which a veterinarian may prescribe a drug for an off-label use. The adopted new rule includes compounded drugs explicitly among the list of extra-label or offlabel uses for drugs. Although compounding is commonly considered an off-label use, some licensees have expressed confusion over whether the limitations on extra-label use applied to compounded drugs as well as approved drugs. The adopted rule includes limitations on extralabel drug use in food-producing animals, based on federal regulations and is intended to parallel the requirements for compounded drugs set out in adopted new §573.44.