Rule Change at FDA would raise compounded drug prices by 300% or more #legalityofpergolide

Barbara Rosensteel

I received this forwarded message from Wedgewood Pharmacy.     The Food and Drug Administration (USA) is proposing changes that would force compounded pharmacies to prepare animal medications with manufactured drugs rather than bulk ingredients from FDA-approved suppliers.   This would raise the price of the pergolide we use for our horses by 300% or more.  Please read below and click on the link near the end to send a message to your Representative and Senators.

Wedgewood Pharmacy
My name is Marcy Bliss and that’s my family’s dog, Ginger. I am the President and CEO of Wedgewood Pharmacy. Like you, I am an animal lover. I need your help to protect our Marcy and Gingerpets. At Wedgewood Pharmacy we compound custom medications for animals, including our beloved family pets. Since mid-March, we have been focused on responding to your needs for compounded medications during the coronavirus pandemic. But we have not lost sight of threats to your access to these life-saving medications. I’m writing to alert you to proposed Guidelines that could have serious and damaging ramifications for pet owners and pets.
The Food and Drug Administration (FDA) is proposing changes that would force us to prepare animal medications with manufactured drugs, rather than bulk ingredients from FDA-registered suppliers. This would dramatically reduce your access to compounded medications, lower their quality, and increase the cost of medications compounded for animals by an average of 300% and up to 3,000% in some cases. A bi-partisan group of Members of the House of Representatives has written a letter asking FDA to withdraw this guidance. I am asking you to act now to encourage your member of the House to co-sign that letter and ask your Senators to request that FDA withdraw these proposed dangerous and unwarranted changes to animal compounding.
Act Now
Veterinarians told us in a recent survey, that if this guidance is adopted, “financial euthanasia” will spike, as pet owners are forced to let their sick pets go because they can’t afford the medicines they need. Shelter veterinarians also reported that others will surrender their pets to already over-crowded shelters and rescue organizations. This will certainly lead to an increase in euthanasia for tens of thousands of animals. People on fixed incomes could be especially affected by huge cost increases and forced to give up their companion animals when they need them most.
As we all know, family pets are precious for many reasons. They are important companions and stress reducers. They spread love and joy especially during these high-anxiety times in which we find ourselves. We make it easy to send a comment to your Representative and Senators. We have even supplied sample messages to get you started. If your Member is already a sponsor of the letter to FDA, you will be sending him or her a thank you.
Please, send your message today.

Barbara Rosensteel

Sept 2007, Cookeville TN














Eleanor Kellon, VMD

Here is the FDA document: . It was published in November of last year.

Several important points: This is a guidance document which means it tells the industry how the FDA thinks they should proceed. It is not a law and is nonbinding.

Secondly, this is nothing new.  It is not a new rule. There is nothing pending in Congress. As the document explains, existing laws can be interpreted to prohibit compounding from bulk drugs when an FDA approved drug already exists. This has come up multiple times on this list [#legalityofpergolide]. Two state level district courts have ruled against the FDA on this issue in the past. Those rulings are only binding within their jurisdictions but it does not bode well for the FDA attempting to enforce their opinion .

At this point it's a matter for the courts to decide unless Congress was to pass a clarifying modification to the existing laws. In the meantime, the best we can hope for is that the FDA will look the other way. There is little to no chance they will ever change their guidance document.
Eleanor in PA 
EC Owner 2001


Signed and sent.
Carol Walters

On Sun, Aug 9, 2020 at 11:43 PM Barbara Rosensteel <brosensteel9@...> wrote:
...  Please read below and click on the link near the end to send a message to your Representative and Senators.