There is comfort in knowing that compounding pharmacists working with physicians and patients in bioidentical hormone replacement therapy are using the exact same hormones as those already in the body. Their value has also been recognized by many pharmaceutical companies, past and present, that commercially market different bioidentical hormones, especially considering the fact that they are introducing new delivery systems, such as the transdermal patches.

However, let's step back and look at the NON-bioidentical hormones that are commercially marketed today, especially the conjugated estrogens manufactured by Wyeth. Let's ask a single question and think about its ramifications.

The question is:

"Is the composition of today's conjugated estrogens identical to when they were originally approved by the FDA?

Obviously, the answer is "No one really knows."

The reason no one really knows is that even today Wyeth has stated that the exact composition of their conjugated estrogens is unknown, and the FDA does not approve something that has an unknown composition. This is the reason Wyeth claims there can be no generic product introduced on the market.

It also causes one to question whether the horses are producing the same hormones they did many, many years ago. Do they eat the same food? Do they exercise the same as they did? Are they still in the same age category? Do they receive any vitamins or supplements today? Did they receive any vitamins or supplements in the past? If so, are they the same? Do they have any illnesses, etc. today that they did not formerly have? Is the urine collected, purified, treated and prepared in exactly the same manner today as it was years ago?

What is the point of all this? Well, it follows that if there is any possibility that the conjugated estrogens today are not exactly identical to the original conjugated estrogens, then Wyeth is marketing an unapproved new drug. However, one does not really know and cannot really determine at this point in time because the marketed conjugated estrogens have still not been adequately characterized, and Wyeth has stated that they do not know the exact composition of their drug.

As previously said, it is gratifying to know that compounding pharmacists have USP quality bioidentical hormones as the starting material for compounding patient specific medications.

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

IACP's 2006 Annual Meeting and Compounders on Capitol Hill is only 2 weeks away! The dates are June 3 through 6, 2006 and the location is the J. W. Marriott on Pennsylvania Avenue in Washington, D.C. REGISTER TODAY! Don't miss this exciting chance to network with colleagues, receive continuing education on important developments affecting the compounding profession, meet with your Members of Congress, and party at the Rx Mixer. Now is a critical time for the compounding profession. Fight to protect your practice.

For more information on the meeting, secure hotel reservations and to register, visit www.iacprx.org/site/PageServer?pagename=Hotels.

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists. For more information, www.iacprx.org.

Federal District Court Rules in Landmark Pharmacy Compounding Case
In a landmark decision for pharmacy compounding, a federal district court judge in Midland, Texas, ruled yesterday that compounded preparations are not new, unapproved drugs. Two other issues in the case - the Food and Drug Administration's broad authority to inspect pharmacies' records and pharmacies' ability to compound from bulk active ingredients for non food-producing animals (e.g., pets, horses, zoo animals) - are still being considered by the judge. The judge ruled from the bench on the first issue and may issue a written opinion. The case (Medical Center Pharmacy, et al v. Gonzalez) was originally filed by nine pharmacies in September 2004.

More information will be available soon at www.iacprx.org

There have been 25 citations on the subjects of pediatrics, intravenous admixtures, enteral feeding tubes and more that have been published in Hospital Pharmacy (not indexed on PubMed), plus over 20 citations about the use of progesterone to preterm delivery added to CompoundingToday.com's literature search database this week. Here is a sampling of them:

• Beckwith MC, Feddema SS, Barton RG et al. A guide to drug therapy in patients with enteral feeding tubes: Dosage form selection and administration methods. Hosp Pharm 2004; 39(3) 225-237.
• MacKay MW, Holley M, Cash J et al. Dose standardization of oral liquid medications in a pediatric hospital. Hosp Pharm 2005; 40(7): 582-587.
• Sanborn M. Core competencies in hospital pharmacy-Intravenous admixtures. Hosp Pharm 2006; 41(4): 377-380.
• Meis PJ; Society for Maternal-Fetal Medicine. 17 hydroxyprogesterone for the prevention of preterm delivery. Obstet Gynecol 2005; 105(5 Pt 1): 1128-1135.
• Spong CY, Meis PJ, Thom EA et al; National Institute of Child Health and Human Development Maternal Fetal Medicine Units Network. Progesterone for prevention of recurrent preterm birth: Impact of gestational age at previous delivery. Am J Obstet Gynecol 2005; 193(3 Pt 2): 1127-1131.

PCAB Accepting Applications
Accreditation Gives Compounding Pharmacies Competitive Advantage

WASHINGTON, DC- The Pharmacy Compounding Accreditation Board (PCAB) is now accepting applications for accreditation from all compounding pharmacies. The initial class of nearly sixty pharmacies has begun the documentation process and the first in-pharmacy surveys are complete. Based on the successful inauguration of the accreditation program, PCAB is now inviting all compounding pharmacies to apply at www.pcab.info. PCAB accreditation is a voluntary program for compounding pharmacies which was founded and continues to be lead by the American College of Apothecaries, the American Pharmacists Association, the International Academy of Compounding Pharmacists, the National Association of Boards of Pharmacy, the National Community Pharmacists Association, the National Alliance of State Pharmacy Associations, the National Home Infusion Association, and the United States Pharmacopeia.

As a part of the accreditation process, PCAB will provide accredited pharmacies with advertising and marketing material designed to provide an advantage in a very competitive field.

Ken Baker, PCAB Executive Director, noted several advantages that can be gained by pharmacies that become PCAB Accredited� compounding pharmacies. "Accreditation will not only provide assurance to patients and prescribers that this pharmacy has been tested against very strict quality and safety standards, but it will also identify it as one of the preeminent compounding pharmacies." Baker adds, "A compounding pharmacy now has a way of proving its adherence to high standards, not only patients and physicians, but also to insurance companies and regulators."

With so many sensationalized stories concerning compounding being highlighted in the news, accreditation provides a positive, quality-based message to patients, prescribers and the public. PCAB believes accreditation has other benefits. By answering payers' demands for proof from pharmacies that they are following quality standards, PCAB believes that accreditation will lead to an increase in the number of insurance companies willing to write policies for compounding pharmacies. "Accreditation should also help hold the line on insurance premiums for accredited compounders," says Baker. "Insurers understand that adherence to strict quality standards helps minimize errors and risks which leads to fewer liability claims."

"Compounding is a critical component of the healthcare industry." said PCAB Board President John A. Gans, PharmD., "because ultimately, PCAB accreditation is for the patient." Dr. Gans, who holds the dual role of being APhA Executive Vice President, added that pharmacists must ensure that the process is driven and controlled by the profession. He believes that this will improve pharmacy practices and thereby improve patient care.

EPS® Respiratory Therapy Bottles

EPS , INC. is pleased to announce the addition of 9 new 6-mL screw cap bottles to its growing line of compounding and dispensing accessories. These bottles are ideal for respiratory therapy and nebulizer applications. They are available in white, ultraviolet inhibitant, high-density polyethylene, with an easy-to-use screw cap. The cap is ribbed to allow for easy opening and closing.

They're available either blank or with 8 different imprints of commonly used respiratory therapy solutions in packages of 100 bottles and caps per case. Custom imprints and quantity pricing are also available (blank and imprinted bottles can be combined to achieve quantity pricing).

For more information, please contact: EPS, INC., 70 Industrial Drive, Ivyland, PA 18974, Toll-Free Phone: (800) 523-8966. Toll-Free Fax (800) 323-8966, E-Mail: info@medidose.com, Website: www.medidose.com

Air currents causing a problem?
If you have an air-conditioning duct entering the room that may cause troublesome airflow, it can often be handled by suspending a 2 x 2 foot piece of Plexiglass or other hard plastic or metal about 6 inches below the duct outlet. This diffuses the incoming air outward over the ceiling rather than downward towards the work area.