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Author Topic: FDA Wants to Stop Pharmacy Compounding for Pet Meds  (Read 2994 times)
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menusux
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« on: February 12, 2011, 05:44:45 PM »

http://billingsgazette.com/news/local/article_af21e76a-c386-55ad-97e4-be89ce416cae.html

Billings Gazette February 12, 2011

Proposed new policy for pet drugs under fire

"When Fluffy, your feline who just shredded a new curtain gets her next dose of Fluoxetine or kitty Prozac, you may have to give her a pill, rather than rubbing a gel in her ear.

"That will be the outcome if the U.S. Food and Drug Administration formalizes a policy prohibiting pharmacists from mixing or compounding pet medications from pure chemicals. Instead, they would have to buy commercially available drugs and grind up the pills.

""In the eyes of the FDA, the only thing you can use on Fluffy is the capsule manufactured and sold at a drug store. The FDA said it is an unapproved drug if you're turning that capsule into a gel to rub inside Fluffy's ear," said David Miller, a pharmacist and chief executive of the International Academy of Compounding Pharmacists. He's also a pet owner who works in Washington, D.C.

"This policy reaches down to local veterinarians and pharmacists, telling them what ingredients to use, in which dose and whether the drug should be a pill, liquid or gel.

"Strangely, the FDA allows pharmacists to use pure chemicals to mix human medicine.

""It's OK for Pete, the kid, but not Petey, the parakeet," Miller said. "I honestly believe the FDA has backed itself into a corner."

"A call Friday to the FDA for comment reached a recorded message that said responses take two business days."

Note: this proposal was posted by FDA at Regulations.gov shortly after Christmas.  There was little to no information about the fact that this would have an effect on compounded drugs for animals.  The deadline for making public comments is Friday, February 18, 2001.  Many respected organizations, such as AVMA, have posted public comments asking for an extension of the comment period but there has been no consent regarding that from FDA.  The docket folder is here:

http://www.regulations.gov/#!docketDetail;rpp=10;so=DESC;sb=postedDate;po=10;D=FDA-2010-N-0528

To make a comment, click any of the already posted comments.  At the upper right corner of the page you will see an orange box saying "Make A Comment".  Click that and you will be able to write a comment.  The comments are not posted immediately, as they are on a message board, but you will be given a number for your comment which you can use to search for it in the docket folder later.  If you have ever needed the services of a compounding pharmacy, please tell the FDA that you don't want constraints placed on the way they are able to provide needed medications for animals.

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JJ
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« Reply #1 on: February 12, 2011, 07:19:14 PM »

Make more work for a pharmacy to make up the dose by using pills that have to be ground up first - what? That makes no sense whatsoever. Is this so they can charge more for the procedure or what? The greedy picking on the needy syndrome..............
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menusux
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« Reply #2 on: February 18, 2011, 01:30:02 PM »

The comment period for this proposed rule has been extended until April 19, 2011, so if you have something you'd like to say about the issue, please do.

http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0528-0144

Clicking the orange "Submit A Comment" box on the upper right side of this page will allow you to make your comments electronically.
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