Just a few comments, but not an in-depth analysis of AMA Resolution #521.

After the five "Whereas" statements, AMA Resolution #521 reads:

Resolved, that our American Medical Association request that the Centers for Medicare and Medicaid Services reconsider the policy of reimbursing for non-Food and Drug Administration-approved compounded medications; and be it further

Resolved, that our AMA ask the FDA to take enforcement action against the manufacturers of these nationally distributed compounded medications; and be it further

Resolved, that our AMA initiate a program of educating physicians to the potential liability exposure to physicians in their approval of these non-FDA approved compounded medications.

This is an interesting resolution for several reasons:

1. If the AMA is looking at non-FDA approved medications, how about prescribing for non-FDA approved indications? I have heard that the majority of prescriptions are for non-FDA approved indications�should they also not be covered? How about the physician's liability here?

2. Physicians routinely write for non-FDA approved medications, but they may not be aware of it, as ANY alteration of an FDA-approved medication (according to the labeling) results in a non-FDA-approved medication (according to the FDA). Think of all the combinations of drugs that are prescribed and even prepared in a physician's office or hospital:
   1. Mixtures of injectables in a single syringe, such as for anesthetics in surgery and chemotherapy anti-nausea regimens
   2. Intravenous (IV) admixtures (chemotherapy, antibiotics, total parenteral feedings)
   3. Mixtures of oral liquids from bulk chemicals, solid tablets, capsules or injectables for administration to patients prior to procedures, babies and children who cannot take adult dosage forms, and elderly patients, etc.
   4. Mixtures of ointments, creams, gels (combination anesthetics for cuts in children needing sutures), etc.
   5. Mixtures of medications for patients who have allergies to ingredients in commercial products
   6. Mixtures in suppository form for children, pregnant women to sustain a pregnancy, and hospice and palliative care patients
   7. Mixtures of topical and bladder irrigating solutions for surgery and routine procedures and refractory infection
   8. Concentrated antibiotics for ophthalmic surgeries and post-treatments
   9. Mixtures of anesthetic and antifungal nasal sprays and irrigations for routine treatment also used in surgical procedures
   10. Mixtures of antibiotic and antiseptic powders instilled in the ear by physicians for ear infections
   11. Concentrated aminoglycides pumped into the inner ear for Meinere's disease
   12. Orally inhaled aminoglycides and hypertonic saline solutions for cystic fibrosis patients

3. Many compounded nebulizer medications are popular and widely used because they are not commercially available. Why should a patient be required to undergo extended administration times when compounded combinations and different concentrations can be prepared for individual patients and enhance their quality of life?

4. Unless I am mistaken, it is the PHYSICIAN that must originate the prescription for these patients, NOT the pharmacist. The physician should be aware of what is commercially available and what is compounded. If a patient needs a compounded prescription, it should be paid for the same as a manufactured prescription.

5. I am not aware that patients in hospitals know that their IV admixtures, and other specially prepared medications, are "compounded" for them; it is simply understood that they are receiving needed therapy.

I hope we never see the day when the only medications that can be used are those that are commercially manufactured. A similar situation already exists in some countries I have visited, and it is a tragedy, as patients go untreated because of the lack of an appropriate strength or dosage form for a drug they need. Meanwhile, the pharmaceutical companies are satisfied and happy because they are the "only game in town." It makes you wonder if the PHARMA companies are behind this AMA Resolution #521 and if they really do have the patient's best interest in mind!

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

FDA Withdraws Seven CMC and Stability Guidance Documents
The US Food and Drug Administration (Rockville, MD, www.fda.gov) is withdrawing seven guidance documents "because some of the principles in the guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative)." The withdrawal was announced in a June 1 Federal Register announcement. For more information go to http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-8417.htm and www.fda.gov/cder/guidance/index.htm.

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