Fourth Question of the Day October 23, 2013 How many compounding pharmacies that sell compounds in the state of Washington violate the rule highlighted below? I am guessing a lot. How many doctors, dentists, veterinarians etc. in Washington receive flyers from compounding pharmacies that violate this rule?

Standards for Pharmacist/Pharmacies Compounding Drug Products

• Pharmacists may compound drugs in very limited quantities prior to receiving a valid prescription for an individual based on past routine prescribing patterns.
• The patient and prescriber must authorize the use of a compounded product if substituted for a commercially available product. The prescriber’s authorization is in addition to signing the substitution permitted side of the written prescription, or advising the substitution when a verbal prescription is issued. The prescriber must document the authorization on the prescription or in the patient’s medication record.
• Drugs/substances used for compounding must meet official compendia requirements.
• The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing.
• Pharmacists/Pharmacies shall not offer compounded drug products to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient.
• Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business (e.g., promote, advertise, or use salespersons) to compound specific drug products.
• Records and Reports related to Compounding Procedures or other records required by Chapter 246-878 WAC must be retained for at least two years. This is consistent with all prescription records (WAC 246-869-100).
• All records must be readily available at the pharmacy/establishment for authorized inspection during the retention period. As part of the inspection, the records are subject to photocopying or other means of reproduction.
• Compounding records may be kept either in its original format or as true copies, such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.

See rules in progress page for more information.  Quoted from Washington State Board of Pharmacy

Washington State Board of Pharmacy Considering Compounding Rule Changes--Workshop Scheduled for July 17, 2013 to hear comments

Rules in Progress

Department of Health Rules Page

The Washington State Board of Pharmacy filed notice of possible rule making Preproposal Statement of Inquiry (CR101) with the code reviser’s office on May 20, 2013, (WSR 13-11-096) to announce its intent to evaluate nationally recognized pharmaceutical compounding standards in updating and establishing enforceable practice and quality standards for the compounding of sterile and non-sterile preparation in all pharmacy practice settings.

It's important for pharmacies and pharmacists to ensure compounding preparations are in accordance with good pharmacy practices, and current scientific principles to ensure preparations are of acceptable potency, quality, purity and sterility, with appropriate packaging and labeling.  Updating pharmacy compounding rules will ensure standards are appropriate, clear and enforceable to protect the public.

Rule-making workshops will be held to consider and discuss issues such as: appropriate staff training, proper procedures and techniques, suitable compounding environment and equipment and validation and documentation of critical processes, etc.

The following workshops have been scheduled. Additional dates may be added if deemed necessary. Please note you may also send comments, concerns or other input to the board at WSBOP@doh.wa.gov or by mail to the address below. To sign up as an interested party, join the WSBOP-Rules Listserv. 

Workshop #1 – June 12, 2013, 4-6 p.m.

Department of Health
20425 72^nd Ave S., Suite 310 – Room 309
Kent, WA  98032

with videoconferencing connection to:

Department of Health
River View Corporate Center, Suite 1500 – Room 118
16201 E. Indiana Ave.
Spokane Valley, WA  99216

Workshop #2 – July 17, 2013, 4-6 p.m.

Department of Health
Point Plaza East
310 Israel Road S.E. – Room 153
Tumwater, WA  98501

with videoconferencing connection to Department of Health Kent and Spokane:

Department of Health
20425 72^nd Ave. S., Suite 310 – Room 309
Kent WA  98032

Department of Health
River View Corporate Center, Suite 1500 – Room 118
16201 E. Indiana Ave.
Spokane Valley, WA  99216

Pharmacists in Washington State Encouraged to Review Rules Relating to Compounding

• Hot Topic: Pharmacist/Pharmacy Compounding Standards

During the past few months, we have been following the New England Compounding Center meningitis outbreak and subsequent public health issues related to pharmacy compounding. To date, 34 people have died and 490 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.

Source found here 

Washington State Department of Health Pharmacy Compounding Standards

Pharmacy Compounding Standards

Standards for Pharmacist/Pharmacies Compounding Drug Products

• Pharmacists may compound drugs in very limited quantities prior to receiving a valid prescription for an individual based on past routine prescribing patterns.
• The patient and prescriber must authorize the use of a compounded product if substituted for a commercially available product. The prescriber’s authorization is in addition to signing the substitution permitted side of the written prescription, or advising the substitution when a verbal prescription is issued. The prescriber must document the authorization on the prescription or in the patient’s medication record.
• Drugs/substances used for compounding must meet official compendia requirements.
• The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing.
• Pharmacists/Pharmacies shall not offer compounded drug products to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient.
• Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business (e.g., promote, advertise, or use salespersons) to compound specific drug products.
• Records and Reports related to Compounding Procedures or other records required by Chapter 246-878 WAC must be retained for at least two years. This is consistent with all prescription records (WAC 246-869-100).
• All records must be readily available at the pharmacy/establishment for authorized inspection during the retention period. As part of the inspection, the records are subject to photocopying or other means of reproduction.
• Compounding records may be kept either in its original format or as true copies, such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. 

Source found here

Washington Board of Pharmacy Discussed Compounding during Its November Meeting

On its agenda was the following item:


5.1 Pharmacy Compounding Practice. The board will discuss the scope of pharmacy practice in
compounding pharmaceutical products and consider a response to the Ther-Rx Corporation letter
reviewed at the September meeting. Information/Action

To view entire agenda click here

Washington State Board of Pharmacy To Discuss Compounding Practice Tomorrow

1:50 p.m. DISCUSSION
5.1 Pharmacy Compounding Practice. The board will discuss the scope of pharmacy practice in compounding pharmaceutical products and consider a response to the Ther-Rx Corporation letter reviewed at the September meeting. Information/Action
Source found here

Washington State Board of Pharmacy: Ther-Rx Corp Letter

The Washington State Board of Pharmacy had on its September 27, 2012 agenda to discuss:

3.10 Correspondence. The board may discuss any correspondence received or distributed. Information/Action.
a) Ther-Rx Corp. letter re: Compounding of Hydroxyprogesterone Caproate

Once the minutes to the meeting are posted, I will update you on what position the Washington State Board of Pharmacy has taken.