Editorial: USP-Part 6: General Questions and Comments

To conclude this series on the U.S. Pharmacopeia, I would like to present some frequently asked questions (FAQs) and their answers.

1. Under what authority does the USP conduct its activities?
The 1906 federal Pure Food and Drug Act named the USP and NF as two of the three official compendia of the U.S. and designated them as establishing legal standards.

2. How does the USP enforce its standards? The USP does not enforce its standards. This is done by other agencies of the federal government (FDA) or the states (state boards of pharmacy). The state boards of pharmacy are autonomous and may or may not elect to incorporate the USP standards in their state laws and regulations, generally by reference.

3. Does the USP-NF contain all the drugs that are allowed to be marketed in the U.S.?
No, there are many drugs that are approved by the FDA that are not in the USP-NF. A pharmaceutical company may not want their drug or drug product to be monographed in the USP-NF while it is under patent protection. A concerted effort is underway by the USP to get as many drugs and drug products monographed as possible.

4. Is the USP a "closed" organization or does it seek input from outside?
The USP is constantly requesting input from all sources. It welcomes input and will act upon it. The USP Board of Trustees and Expert Committee Chairs can serve a maximum of 2 terms. The USP Convention membership is dynamic and constantly striving to be representative of all segments of healthcare and the public. Conscientous effort is made to develop Expert Committees that are diverse and represent all segments of the specific areas of expertise they represent. All standards developed by the committees are published for outside review and comment. Outside guests are welcome to attend the committee meetings, etc., as observers.

5. What process does an Expert Committee use to develop a compounding monograph or General Chapter?
Based upon surveys and requests, formulations are received and reviewed. As appropriate, a monograph will be developed and presented to the committee along with experimentally obtained stability information. Today, the USP has hired additional laboratory personnel to assist in conducting stability studies to assign valid Beyond-Use Dates for compounded preparations. The Expert Committees will review the formulation monograph and revise it as necessary. It is then voted upon by the committee and then proceeds to be published for public comment in the Pharmacopoeial Forum, the publication that is used to communicate the USP activities to the public. As comments are received, any appropriate changes may be made and the monograph proceeds to become official and is published in the U.S.

General Chapters are similar. When a topic is presented that may require a General Chapter, a small subgroup of the Expert Committee will work on it and present it to the entire committee for input, revisions and approval. Then, it is published in the Pharmacopoeial Forum and the general process is followed.

6. If the USP has a monograph for a specific compounded preparation, do I have to compound it that way? Not necessarily. There may be changes that may be needed due to physician or patient requirements where the monograph cannot be followed. However, as long as the USP monograph is used, one can be assured of the Beyond-Use Date that is applied and if the formulation is not followed, then the general, default Beyond-Use Dates should be used, unless stability data shows otherwise. Obviously, if the USP monograph is not used, the "USP" initials cannot be placed after the name of the preparation on the label.

7. If there is a USP monograph for a product that is not a specific compounding monograph but was developed for manufactured products, do I have to meet the potency requirements for that monograph?
Yes. The "general" potency of 90% to 110% applies to compounded preparations; in fact if one looks at most product monographs in the USP, probably most of them use this range. However, if there is a specific product monograph that covers a preparation, those potency requirements should be met; it may be 95-105%, 80-120%, 90-120%, etc. Refer to the current USP-NF monographs for the required standards. This does not mean that all the tests have to be done but that the potency should be within that range. There may be some other standards, such as pH, sterility, endotoxin levels, etc. that need to be considered also.

8. If any of the Expert Committees introduce a standard that is unworkable, can it be changed? Also, if General Chapters seem unworkable, can they be changed?
Yes. The USP-NF is under constant revision. If any standard or General Chapter is introduced that is unworkable or unreasonable, the committee can be contacted and a case presented requesting a change. One must keep in mind, however, that the purpose of standards is to protect the public, not to make it easy on the manufacturer or compounder. The committees attempt to develop high standards that can be reasonably met.

9. How much time does it take to serve on a USP committee and how much do the members get paid?
The time commitment varies from a few hours per month to several hours per week, depending upon the committee and the activities of the committee. There is usually one or two meetings in Rockville, MD each year which requires about 2 days away from work. The expenses of the members are reimbursed but there is no payment or honorarium involved; it is all volunteer work.

10. Is the USP growing or decreasing in its influence and work here in the US and around the world? The USP is expanding its influence and standards setting activities. As the pharmaceutical marketplace is now global, the USP is becoming more global. The USP-NF is already accepted and used by numerous countries that does not have its own compendium; so, it is used in countries throughout the world. Since most active drug chemicals are now imported into the U.S., the USP standards are used for drug substances or drug products, as appropriate. The USP has opened a new office in India. Additional plans are underway for working on the world-wide market by the USP.

For the first five articles in this series are available at http://compoundingtoday.com/Newsletter/NewsletterArchives.cfm. The series includes:

• USP Pharmacy Compounding Expert Committees 2005-2010
• USP Expert Committee Procedures
• Resolutions of the 2005 USP Convention
• Resolutions of the 2005 USP Convention, Continued
• Resolutions of the 2005 USP Convention, Concluded

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

Approximately 30 citations were added to CT.com this week related to Dermatology. Here is a sample of some of these citations representing articles:

• Alam M, Dover JS. Treatment of photoaging with topical aminolevulinic acid and light. Skin Therapy Lett 2004; 9(10): 7-9.
• Buenger J, Driller H. Ectoin: An effective natural substance to prevent UVA-induced premature photoaging. Skin Pharmacol Physiol 2004; 17(5): 232-237.
• Glaser DA. Anti-aging products and cosmeceuticals. Facial Plast Surg Clin North Am 2004; 12(3): 363-372, vii.
• Grossman R. The role of dimethylaminoethanol in cosmetic dermatology. Am J Clin Dermatol 2005; 6(1): 39-47.
• Stern RS. Clinical practice. Treatment of photoaging. N Engl J Med 2004; 350(15): 1526-1534.

...on the Compounder's Network List this week, pharmacists worldwide talked the following:

• A methylcobalamine injection formula for an autistic patient
• BHRT drops
• Pharmacy technician job descriptions and requirements
• Sourcing noscapine

The International Academy of Compounding Pharmacists provided this regulatory update
States Adopt Pedigree Legislation, Bill Introduced in U.S. Congress
On May 4, Senate Bill 874, legislation that amends Florida's current drug pedigree law, passed in the Florida House and was referred to the governor for final signature. According to the bill, wholesalers must provide pharmacies a pedigree to accompany all drugs distributed in or to the state beginning July 1, 2006. Read more>>

This regulatory update was provided by Hance Scarborough Wright Woodward & Weisbart
Midland Coalition Lawsuit
On Monday, U.S. District Court Judge Junell (Western District of Texas) denied the government's motion to dismiss the Midland Coalition's complaint against the FDA. On September 29, 2004 10 compounding pharmacies (the Coalition), represented by Howard Hoffmann and Rachael Pontikes (Duane Morris - Chicago) and Terry Scarborough and Matt Slimp (Hance & Scarborough - Austin) filed a 9 count complaint against the FDA. The Coalition, 3 of whom were Western States plaintiffs, claim that the FDA is acting outside the scope of its statutory authority and its own regulations by:

• attempting to prohibit compounding pharmacies from compounding from bulk for non-food animals;
• attempting to treat and label all compounds as "New Drugs" and, therefore, subject to complete and unfettered FDA regulation;
• by declaring and treating all pharmacy compounds as illegal and compounding an illegal activity;
• directing trade show sponsors to require compounding pharmacies to certify in writing that they comply with an FDA Compliance Policy Guideline ("CPG") in direct violation of the U.S. Supreme Court's Western States ruling. The requirement imposes an impermissible restriction on the compounding pharmacies' First Amendment Right to advertise, solicit and promote its business;
  • by enforcing CPGs as law; and
  • from inspecting compounding pharmacies, since, under federal law, all pharmacies have been expressly exempted from inspection by the FDA

The United States Pharmacopoeia (USP) has published enforceable requirements, USP Chapter <797>, that addresses the proper preparation of compounded sterile preparations. USP <797> has redefined the practice of sterile product preparation in all practice settings (hospital, retail, institutional, and home infusion). Many states have developed new regulations for sterile product compounding practices and have begun to inspect pharmacies for compliance with USP <797>.

The Aseptic Training Program offered by Clinical IQ, LLC in cooperation with the Contamination Control Institute (C2I) will offer participants the unique opportunity to combine classroom training and hands-on practice to develop and enhance their sterile compounding skills, while learning how to integrate quality into their daily activities. Attendees will have the opportunity to work in cleanrooms, barrier isolators, biological safety cabinets and laminar airflow workbenches and will undergo aseptic media fill qualification, learn how to establish an environmental monitoring program, perform environmental sampling, cleaning and sanitizing, designing and building a cleanroom and understand on how to handle hazardous drugs.

The cost of the program (tuition) is $1,495 per person. ACPE credits (30 hours) are pending in cooperation with Lab Safety Corporation. Attendees will also receive a policy and procedure manual that will meet or exceed USP <797> requirements.

The faculty will include:

• Eric S. Kastango, RPh, MBA, FASHP, President, Clinical IQ, LLC
• Lawrence A. Trissel, RPh, FASHP, Director, Clinical Pharmaceutics Research, Division of Pharmacy, University of Texas, M. D. Anderson Cancer Center, Houston, TX
• Holly Simmons, RPh, President, Impact Solutions Group, LLC
• James T. Wagner, President, Controlled Environment Consulting

The first class is June 20-22, 2005, conducted at a state-of-the-art training facility located in Bethlehem, PA, located within minutes of the Lehigh International Airport. For more information, call 973.765.9393 or download a C2I Registration Form.

MINNEAPOLIS / ST. PAUL (May 23, 2005) - Minneapolis-based Paddock Laboratories donated $2 million to the University of Minnesota College of Pharmacy to renovate teaching and research facilities on the Duluth campus and further the college's efforts in Greater Minnesota.

Paddock Laboratories made the gift to support the college's 2003 expansion to the Duluth campus. The money will be used to pay for a portion of renovation of classrooms and laboratories for faculty and students at the College of Pharmacy, Duluth. The donation will also enhance the college's commitment to expanding pharmacy services for Greater Minnesota. Bruce Paddock, president of Paddock Laboratories, is a Duluth Native.

"Paddock Laboratories' gift will transform our Duluth program," said Dean Marilyn K. Speedie, Ph.D. "The generosity accelerates our growth, propelling us years ahead of where we otherwise would be."

The 2005 bonding bill provided state funding to renovate the Life Sciences Building on the University of Minnesota Duluth campus. The College of Pharmacy, Duluth, will occupy two floors in the building. The College of Pharmacy, Duluth, area of the building will be named the "Paddock Laboratories Pharmacy Education Center."

The Paddock gift will pay for the college's obligation of the cost of renovation and will provide additional funds to purchase equipment, provide scholarships, and otherwise enhance the program.

The gift will enable the College of Pharmacy, Duluth, to assume a leadership role in alleviating the critical shortage of pharmacists in Greater Minnesota. Minnesota has one of the highest demands for pharmacists in the country.

"The University of Minnesota College of Pharmacy has afforded me the opportunity to pursue a career that has been rewarding both professionally and financially," Paddock said. "It gives me great pleasure to support the College of Pharmacy, Duluth, initiative."

Paddock Laboratories is a privately held, niche-based pharmaceutical company founded in 1977. The company has more than 250 employees and has committed itself to bringing new branded generics to market.

Paddock, a 1970 alumnus of the College of Pharmacy, received the University of Minnesota Pharmacy Alumni Society Distinguished Pharmacist Award in 2000. He also established the Paddock Laboratories Scholarship that provides annual support to pharmacy students.

"Paddock Laboratories shares our vision for the Duluth expansion," Speedie said. "Bruce has been an enthusiastic supporter of the project from its inception."

The College of Pharmacy expanded its program to the Duluth campus in 2003 to help address the severe shortage of pharmacists in Greater Minnesota.

While the college has increased its capacity by 50 percent, the number of students from Greater Minnesota has more than doubled, and in some cases tripled, compared with before the expansion. In 2002, the college had 21 first-year students from Greater Minnesota. In 2003, 41 first-year students were from Greater Minnesota. And in 2004, 47 first-year students called Greater Minnesota home. The number of first-year students from the Arrowhead region increased from two in 2002 to 11 in 2004.

The College of Pharmacy, the only school of pharmacy in Minnesota, offers its program on the Twin Cities and Duluth campuses. Founded in 1892, the College of Pharmacy educates pharmacists and scientists and engages in research and practice to improve the health of the people of Minnesota and society. The college is part of the Academic Health Center, which is home to the University of Minnesota's six health professional schools and colleges as well as several health-related centers and institutes.

Contact: Rebecca Lentz, College of Pharmacy, 612.624.7654
Sara E. Buss, Academic Health Center, 612.624.2449

The EPS® INC. Nultraviolet® amber cover bag is an ideal accessory to protect IV infusions from the harmful effects of ultraviolet light.

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