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Medical Forum / General / Pharmacy / August 2004

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FDA pressuring "compounding pharmacists"

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John G. - 20 Aug 2004 16:24 GMT
Some of the rules in the USA regarding compounding pharmacists are pretty
outrageous.  This week I found out I'm allergic to two of my allergy medicines
-- one has a dye and the "hypo-allergenic" formula (which shouldn't have to
exist) contains sorbitol.  Yet the FDA bars compounding pharmacists from
purchasing raw, bulk chemicals and compounding them into medicines -- the same
raw ingredients used to make the supposedly safe commercial pharmaceuticals.  
This keeps many of us from taking certain medications altogether or using them
as topicals for local problems.  Compounding pharmacists are forced to buy
commercial drugs and extract the active ingredients.  This is somehow "safer"
-- safer for those extracting rents through political control of the FDA.  For
example, a drug like finasteride might be useful as a topical for balding men,
but less so if it's tainted with dyes and solvent and costs a bundle to extract.

Strangely enough, this rule doesn't apply to veterinary compounders yet this is
who the FDA has targeted:

http://www.nytimes.com/aponline/national/AP-Pharmacy-Raid.html

Ky. Pharmacy Faces Illegal Drug Charges
By THE ASSOCIATED PRESS

Published: August 17, 2004

Filed at 11:05 a.m. ET

LEXINGTON, Ky. (AP) -- The Food and Drug Administration has accused an equine
compounding pharmacy of illegally making and selling animal drugs.

Federal marshals last week raided BET Pharmacy, where they boxed up injectable
doses of drugs that aid horse reproduction and treat hoof diseases. The FDA
said the drugs could pose a health risk to horses.

BET said the seizure was unfounded and that the drugs it blends are safe and
legal under state law.

Compounding pharmacies blend bulk chemicals to fill prescriptions from licensed
veterinarians and physicians.

The federal agency says the pharmacy manufactured drugs from bulk sources that
didn't have FDA approval, made copies of existing approved drugs and sold to
veterinarians who had not prescribed the drugs for specific horses.

The agency sent a warning letter to BET after a November 2003 on-site
inspection, said Gloria Dunnavan, the FDA's director for the division of
compliance in the center for veterinary medicine.

The letter told the pharmacy that several injected forms of pregnancy-aiding
hormones were not approved by the Federal Food, Drug and Cosmetic Act.  The
letter gave BET 15 days to fix the problems.

Last week, the FDA said the pharmacy ``was given an opportunity to correct the
violations but failed to take appropriate actions.''

Steve Atwood, an attorney for BET, said there are no FDA statutes that he could
find stating BET could not compound drugs from bulk sources.

The bulk drugs from which all of BET's drugs are made were approved by the
National Formulary and the U.S. Pharmacopoeia, Atwood said.

After the warning in 2003 and another in April 2004, BET continued compounding
the drugs because the company thought it was obeying state law, Atwood said.

State officials wouldn't address the case directly, other than to say a joint
investigation by state and federal officials was pending.

------

Information from: Lexington Herald-Leader, http://www.kentucky.com
Glenn Gilbreath Jr. - 01 Jan 2002 06:00 GMT
>From: macgyver88@yahoo.com (John G.)
>Subject: FDA pressuring "compounding pharmacists"
>Date: 20 Aug 2004 08:24:05 -0700

>Some of the rules in the USA regarding compounding pharmacists are pretty
>outrageous.  This week I found out I'm allergic to two of my allergy medicines
[quoted text clipped - 9 lines]
>but less so if it's tainted with dyes and solvent and costs a bundle to
>extract.

>Strangely enough, this rule doesn't apply to veterinary compounders yet this
>is
>who the FDA has targeted:

>http://www.nytimes.com/aponline/national/AP-Pharmacy-Raid.html

>Ky. Pharmacy Faces Illegal Drug Charges
>By THE ASSOCIATED PRESS

>Published: August 17, 2004

>Filed at 11:05 a.m. ET

>LEXINGTON, Ky. (AP) -- The Food and Drug Administration has accused an equine
>compounding pharmacy of illegally making and selling animal drugs.

>Federal marshals last week raided BET Pharmacy, where they boxed up injectable
>doses of drugs that aid horse reproduction and treat hoof diseases. The FDA
>said the drugs could pose a health risk to horses.

>BET said the seizure was unfounded and that the drugs it blends are safe and
>legal under state law.

>Compounding pharmacies blend bulk chemicals to fill prescriptions from
>licensed
>veterinarians and physicians.

>The federal agency says the pharmacy manufactured drugs from bulk sources that
>didn't have FDA approval, made copies of existing approved drugs and sold to
>veterinarians who had not prescribed the drugs for specific horses.

>The agency sent a warning letter to BET after a November 2003 on-site
>inspection, said Gloria Dunnavan, the FDA's director for the division of
>compliance in the center for veterinary medicine.

>The letter told the pharmacy that several injected forms of pregnancy-aiding
>hormones were not approved by the Federal Food, Drug and Cosmetic Act.  The
>letter gave BET 15 days to fix the problems.

>Last week, the FDA said the pharmacy ``was given an opportunity to correct the
>violations but failed to take appropriate actions.''

>Steve Atwood, an attorney for BET, said there are no FDA statutes that he
>could
>find stating BET could not compound drugs from bulk sources.

>The bulk drugs from which all of BET's drugs are made were approved by the
>National Formulary and the U.S. Pharmacopoeia, Atwood said.

>After the warning in 2003 and another in April 2004, BET continued compounding
>the drugs because the company thought it was obeying state law, Atwood said.

>State officials wouldn't address the case directly, other than to say a joint
>investigation by state and federal officials was pending.

>------

>Information from: Lexington Herald-Leader, http://www.kentucky.com

John,

While the FDA has passed "guidelines" for pharmacist compounding,
the ultimate authority for regulating compounding pharmacies is
still left in the hands of state governments, not federal.  It is
very probable that we currently have 50 differing legislations
dealing with compounding.  What the FDA has attempted to do is
"draw a line" between compounding for an individual patient ( such
as would be the case for your allergies ) and actual "manufacturing"
an exact copy of an approved drug without having proper licenses.  
Compounding for an individual prescription is not the same as
making 1,000,000 lot batches of dosage units, irregardless of what
some of these "compounding pharmacies" claim!

C U L8R!
Wiz  <{;-)
Wizard57M
Glenn Gilbreath Jr.
Registered Pharmacist
http://members.surfbest.net/wizard57m@surfbest.net/index.htm
-- DOS Internet, Close Windows and Keep the Internet Open! --
John G. - 29 Aug 2004 19:41 GMT
> While the FDA has passed "guidelines" for pharmacist compounding, the
> ultimate authority for regulating compounding pharmacies is still left in the
[quoted text clipped - 4 lines]
> actual "manufacturing" an exact copy of an approved drug without having
> proper licenses.

They may make this distinction, but the law does not....

> Compounding for an individual prescription is not the same as making
> 1,000,000 lot batches of dosage units, regardless of what some of these
> "compounding pharmacies" claim!

Actually, compounding this way gives a better product.  Arguably, the real
issue is that big pharm does not want the competition....

> I know it's hard to believe, but the FDA is not evil.

Not intentially anyway.  But political considerations often force them into bad
policy... Also, they can't pay enough to keep good help...
Pumbaa - 21 Aug 2004 14:01 GMT
Its hard to impossible to make logical drug regulations where an agency is
"in bed" with the companies that it is supposed to be regulating.
nobody special - 22 Aug 2004 22:29 GMT
> Its hard to impossible to make logical drug regulations where an agency is
> "in bed" with the companies that it is supposed to be regulating.

A situation which does not exist in the US.  Which nation were you referring
to?
 
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