Dr James Schaller
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FDA "BIG BROTHER" IGNORANCE
ABOUT CUSTOM PHARMACY COMPOUNDING CONTINUES

STOP THE ONE-SIZE FITS ALL
TENT DRESS THINKING!

This week I will call a doctor of pharmacy and he will work with me to design a custom treatment for Mrs. Smith. It could be a nausea medication that passes through the skin or a special suppository to treat her horrible vulva-dynia pain or a six component cream for her father's hand arthritis -- it works to decrease his pain 99%!

But the FDA is routinely like a rabid dog going after this Doctor of pharmacy, apparently because he does not fill out 500 pages of forms for each of these prescriptions and actually tailors the medication to my patient. He engages in REAL MEDICINE.

Compounding pharmacists can be the best thing to a physician or a vet. I want them to stop having to justify their obvious need!

Compounding has always been an important, core component of the practice of pharmacy. Medicinal compounding of ingredients can be traced back thousands of years. In the 17th century, John Winthrop, Jr., son of the first governor of Massachusetts, was one of the first Americans to engage in compounding.

The United States Pharmacopoeia ("USP"), an official compendium of drug information recognized as authoritative in medical pharmacy has included instructions on compounding since 1820.

Congress has intended to control human and veterinary drug company manufacturers, not pharmacists or physicians who were compounding.

There is no indication that the federal government, or anyone else in the past government passed laws intended to ban compounding.

Pharmacy compounding has always been an integral part of the practice of medicine, but drug representatives and the loss of time to learn about medications among physicians have crowded some of their use out.

Pharmacists compound millions of scripts each year. Indeed, in 1938, the year the FDA thinks the government supposedly limited compounding, there were over 250 million prescriptions filled. The federal government recognized the importance of compounding as part of the practice of pharmacy in the armed forces and the civil service. Banning pharmaceutical compounding in 1938 would have had a disastrous impact on American healthcare -- and would have a disastrous effect today -- because of the lack of commercially manufactured alternatives.

The USP and the National Formulary ("NF") both recognized the practice of compounding and have long included instructions for compounding as part of their standards, e.g., instructions on making compounded pills of iron, suppositories, tinctures, ointments and syrups. Inclusion in the USP and NF is simple and OBVIOUS evidence that compounding was widely recognized as legal, because Congress identified both these sources as "official compendia" in pharmacy medicine.

Just this year, USP adopted a general chapter for the compounding of sterile drugs. But according to "Big Brother" FDA, the USP monographs and chapters established standards for an illegal act! Who will reign in these people?

Congresses positions defined "manufacture" in its laws to exclude "preparation, compounding, packaging, or labeling of a drug

Colleges of pharmacy continue to teach compounding to pharmacy students.

Pharmacy texts continued to refer to compounding as a legal, integral part of health care.

Congress has never intended to ban -- and did not give the FDA the authority to ban -- compounding from bulk drugs.

Compounding is Legal in All States. Period. We are sorry this upsets the FDA.

The government has acknowledged that "requiring FDA approval of all drug products compounded by pharmacies for the particular needs of an individual patient would, as a practical matter, eliminate the practice of compounding, and eliminate availability of compounded drugs for those patients who have no alternative treatment." Congress has never passed legislation to outlaw the long-standing, state-sanctioned, medically necessary practice of human or veterinary compounding.

It is unnecessary for FDA to attack veterinary compounding to ensure that FDA maintains the ability to restrict manufacturers or large drug companies from distributing unapproved new drugs. Compounding is different in many critical ways.

For example, unlike drug manufacturers, compounding pharmacies compound and make their products:

  • Only with receipt of a prescription
  • Or verbal prescription order from a licensed veterinarian, MD, DO, or other licensed health care professional.

Rejecting FDA's position on the legality of compounding would not defeat the FDA's ability to regulate manufacturing.

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For the source of most of these ideas please read the excellent legal brief: www.iacprx.org/pdf/BET_amicus_brief.pdf.

Committed to the Very Best Medical Care!

Dr. J



Bank Towers, Tamiami Trail, Naples, FL
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