USP-Part 1: USP Compounding Pharmacy Expert Committees 2005-2010

As the USP Pharmacy Compounding Expert Committees are in the process of being selected and the work scheduled to begin this summer, let me explain a little about the processes involved.

At the USP Quinquennial Convention 2005 (March 10-13) the Council of Experts was elected. The Council of Experts consists of chairs of 40 different USP Expert Committees representing the areas of expertise required for the proper functioning of the USP for the next five years. These expert committees include the following:

• Aerosols
• Biologics and Biotechnology (4 committees)
• Biopharmaceutics
• Compounding Pharmacy
• Dietary Supplements (5 committees)
• Excipients (3 committees)
• General Chapters
• General Toxicology and Medical Device Compatibility
• International Health
• Microbiology and Sterility Assurance
• Monograph Development (8 committees)
• Nomenclature
• Packaging and Storage
• Parenteral Products-Industrial
• Pharmaceutical Dosage Forms
• Pharmaceutical Waters
• Radiopharmaceuticals (2 committees)
• Reference Standards
• Safe Medication Use
• Statistics
• Sterile Compounding
• Veterinary Drugs (2 committees)

As is evident, the committees cover a wide range of topics that are necessary to establish and maintain standards for drug products for the U.S., and much of the entire world. Each committee is responsible for their associated monographs and general chapters.

After the Chairs were elected at the convention, another meeting was held April 10-12 where the Chairs met for the first time with one goal (among many) of populating their respective committees for the 2005-2010 cycle. This is a very serious activity as the work of the committees results in standards that are enforceable in either the pharmaceutical manufacturing industry or in pharmacy practice, including pharmacy compounding. The chairs must compose a committee that is representative of as many facets of their individual subject areas as possible to obtain the necessary expertise and also be representative of academia, industry/practice, governmental/nongovernmental organizations, etc. The committees must be approved by the Council of Experts (all the chairs) and by the USP Board of Trustees.

Following this, each committee will meet at which time the members will be introduced to the USP, its activities, requirements, etc. and a general workplan for the cycle will be presented and discussed. Then, the work begins. On average, many committees will meet at the USP offices in Rockville, MD once or twice each year and may have a number of teleconferences in between meetings. The time commitment for committee members will vary from less than an hour to a few hours per week, depending upon the level of activity of the committee. Chairs put in significantly more time in the committee activities in working with the USP staff liaison and the committee members on the various projects, etc. All the activities of the committee members and chairs are voluntary and no remuneration is received. The USP does cover the meeting expenses involved, including travel, hotel, meals, etc. Consequently, it is important that all involved be able to be absent from their jobs when required for meetings, teleconferences, and other activities as required and be able to devote the necessary time for the work. The Expert Committees are supported by a USP staff of scientists and office personnel that number over 350 employees. Each Expert Committee has a specific staff liaison (for the two compounding committees it is Dr. Claudia Okeke) that is charged with assisting the committee in its work and other staff to provide support as required. It must be remembered that all the activities have widespread implications so all work is reviewed many times prior to completion.

Over the next few issues, I will try to explain more about the processes and procedures that are used to develop the standards for both the pharmaceutical industry and pharmacy practice.

Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

How many times did you wonder how could a drug taste so metallic? How many times you tried to fix that extreme salty taste to an electrolyte preparation but you just didn't know where to start? CT.com upgraded your Flavoring Tool and now you may find even more resources to help you formulate your oral preparations.

One of the most useful additions is the "General Recommendations Based on Primary Tastes and Odors of Drugs" function. Visiting this feature, you may find that a mix of coffee and chocolate flavor is a good choice to mask a bitter tasting drug. Also, by cross-reference, you may find additional information on "Ancillary Agents in Masking Tastes" which brings you suggestions on how to use menthol as a masking agent and its chemical monograph.

Because all chemical additions to compounded preparations may interfere in their stability, "Sweetening Agents" button will take you to the most used list of sweetening substances in compounding. By choosing an agent, you will find information on its solubility, brief chemical monograph, usual concentration and its sweetness based on sucrose.

CT.com is always updating tools and references so you may compound with more confidence! Be sure to check our newer, upgraded "Flavoring Tool".

More than 30 articles related to pain management and compounding were added to CT.com this week. Here is a sampling:

• Carr DB. Goudas LC, Denman WT et al. Safety and efficacy of intranasal ketamine for the treatment of breakthrough pain in patients with chronic pain: A randomized, double-blind, placebo-controlled, crossover study. Pain 2004; 108(1-2): 17-27.
• Kennedy RM, Luhmann JD. Pharmacological management of pain and anxiety during emergency procedures in children. Paediatr Drugs 2001; 3(5): 337-354.
• Moryl N, Santiago-Palma J, Kornick C et al. Pitfalls of opioid rotation: substituting another opioid for methadone in patients with cancer pain. Pain 2002; 96(3): 325-328.
• Roelofse JA, Sipton EA, de la Harpe CJ et al. Intranasal sufentanil/midazolam versus ketamine/midazolam for analgesia/sedation in the pediatric population prior to undergoing multiple dental extractions under general anesthesia: A prospective, double-blind, randomized comparison. Anesth Prog 2004; 51(4): 114-121.
• Zeppetella G, Paul J, Ribeiro MD. Analgesic efficacy of morphine applied topically to painful ulcers. J Pain Symptom Manage 2003; 25(6): 555-558.

The International Academy of Compounding Pharmacists provided this regulatory update

NAPRA Develops Compounding Guidelines
In January 2005, the National Association of Pharmacy Regulatory Authorities (NAPRA), Canada's equivalent of NABP, commissioned a task force to draft guidelines for compounding. Last week NAPRA shared a draft of the guidelines with interested stakeholders and requested feedback. IACP is in the process of seeking input from Canadian members and will send comments to NAPRA as appropriate. Contact IACP for a copy of the draft regulations.

FDA Appoints New Chief Counsel
FDA recently appointed Sheldon Bradshaw as chief counsel, effective April 1st. Bradshaw will replace former chief counsel, Daniel Troy, who left the agency in November 2004. Bradshaw was formerly the deputy assistant attorney general in the Justice Department.

FDA Warning Letter Issued to WY Pharmacy
On March 25, a FDA warning letter was issued to Palace Pharmacy in Lander, Wyoming regarding the compounding of domperidone. In the warning letter FDA states, "Domperidone is not an active ingredient contained in any FDA-approved drug product. FDA does not sanction its use in pharmacy compounding and will not exercise its enforcement discretion for compounded products containing domperidone."

HIPAA Security Rule Effective April 21
The new HIPAA security rules, finalized in February 2003, will take effect on April 21, 2005. The HIPAA security rules differ from HIPAA's privacy regulations and electronic transaction regulations. The security rule outlines a series of administrative, technical, and physical security procedures for healthcare providers to use to assure the confidentiality of electronic protected health information. Requirements include conducting risk assessments, updating policies and procedures, training staff and reviewing agreements with business partners to ensure they meet the new standards. Click here to access a copy of the final security rule (see pages 42-29). NCPA and APhA have resources available to pharmacists to assist with compliance.

EPS^®, Inc. is pleased to announce another addition to its line of IV disposable accessories...our sterile TampAlerT^® Tamper-Evident Syringe Cap. The caps are ideal for use with controlled substances, chemo-therapeutics or meds requiring special handing. They're designed for luer lock syringes larger than 1 cc.

Each cap contains a clear luer lock closure protected by a colored tamper-evident "break-away" sleeve. Once attached to the syringe, the closure can only be removed when the outer sleeve is broken.

The caps are packaged in a highly engineered, convenient 10-pack. The tray has been formed with a special integral wrench construction. This allows the practitioner to attach the sterile cap directly to the syringe...while the cap is still sitting in its tray. Just fully twist the syringe onto the cap and remove both from the tray. This helps minimize "touch" contamination.

EPS TampAlerT Tamper-Evident Syringe Caps are available in 3 colors...red, white and blue...for quick visual identification of your meds and are packaged 100 caps (10 trays of 10) per case. Quantity pricing is available on as few as 5 cases.

The EPS TampAlerT Tamper-Evident Syringe Cap by
EPS, Inc.
70 Industrial Drive, Ivyland, PA 18974
Toll Free: (800) 523-8966; Toll Free Fax: (800) 323-8966
E-Mail: info@medidose.com Web Site: http://www.medi-dose.com.