Wyeth obviously is not aware of the history of pharmacy and the fact that compounding has provided medications to mankind for about 5,000 years; whereas the pharmaceutical industry has only been around for about 75-100 years (depending upon when you consider that it became mainstream). That looks like to me that we have been serving patients with compounded medications about 50 times as long as the pharmaceutical industry has been providing manufactured products.

Why then, is Wyeth saying that compounding using (1) bioidentical hormones (those that are naturally in the body already), (2) USP monographed hormones (strict quality standards), and (3) hormones that have been commercially available (various brand names by various manufacturers) over the years is now all of a sudden "manufacturing"? They evidently are not aware of the definitions of manufacturing and compounding. This lack of knowledge is unexcusable!

It is quite evident that the uninformed marketing department of Wyeth must be made up of non-pharmacists that are making Wyeth look like a loon, and, that is sad. It is sad because I can remember when Wyeth was an outstanding pharmaceutical company; one that provided many, many different dosage forms for different patients. Take for example, the Phenergan family they market. Phenergan used to be available as tablets, capsules, oral liquids in many different combinations, suppositories, injections, troches, topicals and on and on. I remember their representatives as being interested in pharmacy and what they could do to help us out; it was a good synergistic relationship. However, that is apparently no longer the case.

One reason that Wyeth's actions are irrational is that compounding for bioidentical hormone replacement therapy uses drug substances for which there are standards established in the USP. The USP establishes the official standards for drug substances for the United States (and for much of the world). Bioidentical hormones are already in the body�..what is Wyeth going to do next but tell us that we can't use the hormones that our own bodies produce? Good luck going down that road!

In summary, Wyeth has become a company that is more interested in their own products and profits than they are about quality healthcare for all patients and are behaving irrationally.

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

A series of articles on off-label uses that has been published regularly in Hospital Pharmacy since 2001 were added to CompoundingToday.com's literature search database this week. A total of 45 articles were added and here is a sampling of them:

• Generali J, Cada DJ. Baclofen: Alcohol withdrawal. Hosp Pharm 2003; 38(6): 552-555.
• Generali J, Cada DJ. Clonidine: Postanesthesia shivering. Hosp Pharm 2005; 40(7): 570-581.
• Generali J, Cada DJ. Furosemide (nebulized): Dyspnea in cancer patients. Hosp Pharm 2004; 39(11): 1040-1049.
• Generali J, Cada DJ. Gabapentin: Hyperhidrosis. Hosp Pharm 2003; 38(1): 25-26.
• Generali J, Cada DJ. Mirtazapine: Hot flashes. Hosp Pharm 2006; 41(2): 133-135.

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

Pace Picks Up in 5th Circuit Midland Case
In September 2004, nine pharmacies filed suit in U.S. District Court in Texas against the FDA in a landmark case for pharmacy compounding. In late March 2006, both parties - the pharmacies and FDA - filed Motions for Summary Judgment, asking for the judge to rule in the case instead of conducting trial by jury. On May 4, IACP filed an amicus or "friend of the court" brief in support of the pharmacies. In the amicus brief, IACP presents additional evidence that demonstrates that FDA does not have and has never had jurisdiction over compounding pharmacies. The Midland District Court has scheduled oral argument in the case for Thursday, May 25, 2006. A district court decision should be issued in subsequent months. Get more information on this case and current developments on the IACP website at www.iacprx.org/site/PageServer?pagename=mem_LegalUpdates#Midland

6th Circuit Issues Opinion on BET Motion for Reconsideration
In late March, a Federal District Court in Kentucky issued a revised opinion in the case against BET Pharm, LLC. Both BET Pharm and FDA had filed requests that the court reconsider its previous ruling against BET Pharm due to the original opinion's reliance on FDAMA Section 503(A), a law which was rendered unconstitutional in 2002. The court's revised decision maintained the previous findings against BET Pharm without the reliance on FDAMA Section 503(A). Read more on the BET Pharm case and access briefs at www.iacprx.org/site/PageServer?pagename=mem_LegalUpdates#BET .

As of May 3, 2006, the Wyeth docket had almost 41,000 comments from patients, physicians and pharmacists that oppose the Wyeth petition. FDA has acknowledged that it has a significant backlog of comments that are waiting to be processed. Comments opposing Wyeth's petition are expected to top 50,000.

In addition, on May 3rd, the American Pharmacists Association (APhA) filed comments on the Wyeth Citizen Petition. APhA opposes the Citizen Petition based on its failure to distinguish between compounding and manufacturing, its attempt to apply manufacturing standards to compounding and its request that FDA take enforcement action that is beyond the Agency's authority. APhA's comments are a strong statement in support of compounding practice and state regulation.

Also, several state pharmacy associations have become involved in the Wyeth issue. This week, IACP received copies of filings from the state pharmacy associations in California, Massachusetts, Michigan and North Carolina - bringing total filings by state associations to nine. The filings are excellent and continue to add momentum and credibility to the campaign for patient health and patient choice.

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 payors 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.

Making Capsule Weights More Uniform
In preparing capsules with a capsule device, one cause of non-uniform capsule weights can be attributed to the way the "scraper" or "spatula" is used in spreading out the powder over the opened capsules. If the scraper is moved across the open capsules at an angle, it may "compress" some of the powder tighter in the capsules as compared to areas where the scraper is not held at an angle. If one considers a commercial capsule manufacturing machine, the powder is simply dropped vertically into the empty capsules and any excess is immediately scraped off. In other words, the capsules are filled by the powder simply dropping down into the empty capsule shell and it is not compressed.

To make capsule weights more uniform, adjust the quantity of powder used for a batch of capsules to that quantity that will simply fill the capsules without packing it in. If properly done, the powder mix can then be poured onto the capsule plate and the plastic scraper held vertically at a 90� angle and simply moved back and forth allowing the powder to drop vertically into the empty capsule shells without packing it in. Properly done, the individual capsule weights should be closer with less variability.