In 2012, IACP Launched Veterinary Compounding Fact Sheet

As part of IACP’s continuous efforts to educate others about pharmacy compounding, the Academy has worked to develop a comprehensive Veterinary Compounding Fact Sheet. The objectives of the IACP’s Veterinary Compounding Fact Sheet are to:

1. Raise awareness of how licensed compounding pharmacists work with veterinarians to help provide a wider range of needed medications for animals.
2. Emphasize how pharmacy compounding plays a vital role in helping to improve medication compliance for animal patients which have very specific dosage, flavoring, strength and concentration requirements.
3. Clarify how pharmacy compounding is regulated by State Boards of Pharmacy and the United States Pharmacopeia (USP) standards employed in its operation as there has been considerable misinformation disseminated on this topic. 
4. Clarify the FDA’s role in ensuring that the Active Pharmaceutical Ingredients (API) used in compounding are safe and are manufactured by FDA-registered and inspected facilities, and that they are not “unapproved substances.”  To emphasize that there is no such thing as the often- quoted “FDA-approved pharmacy.”
5. Raise awareness of how pharmacy compounding has been a critical help to veterinarians and their owners/patients during the current medication shortages.
6. Introduce veterinarians to IACP’s Compounding Pharmacy Assessment Questionnaire (CPAQ™) and explain how this tool can help them select a pharmacy compounding practice.
7. Gather information from veterinarians on how compounding pharmacists can better serve their practices and their patients’ medication needs.

IACP shared this Veterinary Compounding Fact Sheet at the American Veterinary Medical Association’s (AVMA) Annual Convention Friday, August 3 – Saturday, August 4, 2012.  

Click here to view the Veterinary Compounding Fact Sheet.

IACP to states: High standards, no loopholes on compounding Share This Page Share on facebookShare on twitterShare on emailShare on print December 11, 2012 Suggested changes to state pharmacy practice acts focus on three key areas

The International Academy of Compounding Pharmacists (IACP) recently recommended changes in state pharmacy practice acts to ensure that states have set in regulation the highest standards—United States Pharmacopeia (USP) <795> and USP <797>—and to eliminate the gray area and loopholes that can be exploited by a compounder seeking to manufacture without a license, according to IACP spokesperson David Ball.

IACP formally announced the state-level recommendations during a national town hall–style teleconference for IACP members, state pharmacy associations, and state boards of pharmacy on December 7. USP <797> is a national standard for any compounded sterile preparations, and USP <795> provides similar guidance for nonsterile preparations compounded in health care settings, according to the FAQs posted on the Just the Facts: Compounding section of pharmacist.com.

The IACP action came in the wake of the fungal meningitis outbreak linked to the New England Compounding Center (NECC) facility that has resulted in 37 deaths and 590 illnesses in 19 states as of December 10, according to CDC. In November 15 testimony before a Senate committee, IACP Executive Vice President and CEO David G. Miller, BSPharm, had indicated that NECC was not a compounding pharmacy but rather was acting as an illegal drug manufacturer.

Developed by the IACP Board of Directors, the principles of the recommendations “focus on assuring inspection authority by and adequate funding of all state Boards of Pharmacy, individual practices' compliance with state laws and regulations, and mandaSortory compliance with quality standards for all practitioners engaged in compounding,” according to a statement on the IACP website.

The practice of pharmacy, and therefore compounding, is regulated at the state level, Rebecca P. Snead, BSPharm, Executive Vice President & CEO, National Alliance of State Pharmacy Associations (NASPA), told pharmacist.com. “It is critical that state regulators are proactive in their review of their rules and regulations to ensure they have addressed any areas that may be improved,” Snead said. “In addition, they must remain diligent in their enforcement of their regulations.
Asked if IACP planned to release federal recommendations related to FDA activity and Congress, Ball told pharmacist.com, “We continue to work closely with Congress and the FDA to ensure that federal law and regulations ensure the safest possible environment for compounding.”
Ball added that feedback from state associations, state boards, and IACP members during the teleconference was “supportive.”
Noting that NASPA had just received the IACP state recommendations, Snead said, “They seem reasonable; however, we have not yet discussed them with the states.”

Diana Yap

Source found here

IACP Law Library-Compounding for Office Use Available for Purchase

As part of our ongoing development of tools, programs and materials that help our members improve their professional and business practice, IACP is launching its IACP Law Library. As conceived, this law library will provide pharmacists with a comprehensive analysis of state pharmacy law and regulation that affect many day-to-day decisions.

Our first installment in the new IACP Law Library—Compounding for Office-Use is now available for purchase! Click here for purchase information.

Overview of Results
The majority of the states (42) allows pharmacies to sell any non-controlled prescription drug and compounded drugs to practitioners for office use. Six states specifically prohibit that activity, and two states appear to be silent. Silent means the statutes and regulations do not specifically say whether it’s allowed. As our phone calls to the states Boards revealed, silent does not necessarily mean it is not allowed. Many of the states Boards confirmed that although the statutes or regulations don't say office use is specifically permitted, the Boards allow by broad interpretation, board policy, or by common practice covered by a pharmacy’s license the provision of office-use prescriptions.
For the most part, those states that do specifically prohibit office-use prescriptions provide for a “sales” process instead and require that in lieu of a prescription, orders from practitioners must be placed via an invoice. Several of these states limit the amount of product that a pharmacy can sell to a practitioner for office use to either 5% of the total annual sales or 5% of the total dosages in a consecutive 12-month period. This five percent figure appears in many of the states controlled substances laws and is being applied by the Boards to sales for office use in general.
The percentage limitation is from the federal DEA Controlled Substances Act and rules. The five percent language was placed into some of the states PDMA laws – which deal with wholesaler licensure -- where the allowing of sales for office use also is found in an exemption provided in the definition of wholesale drug distribution. In these states, sales to practitioners are not wholesale drug distribution and do not require a wholesaler license. Many of the states providing the exemption limit the sales to 5%. If sales exceed 5%, then a pharmacy would be required to obtain a wholesale drug distributor license.
Unanswered Questions
Even the best research has limitations. Three states did not respond to our numerous phone calls and emails for clarifications and additional information. They are: Georgia, Illinois, and New Jersey.

• Based on our review of the statutes and regulations, Georgia allows the sale to practitioners for legend drugs but is not clear as to whether such is allowed for compounded products.
• Illinois and New Jersey allow the sale of compounded products for office use but appear to be silent as to whether legend drugs may be sold to a practitioner for office use.

IACP members doing business in those states should confer with the Board of Pharmacy if they have any questions.

To read entire IACP statement click here