Do you share your home with a pet? Whether feathered or furry, you know they’re an important part of your family and depend on you for love and care.Part of that care is making sure your pet has access to the medicines and healthcare that’s right for them whenever illness strikes. The International Academy of Compounding Pharmacists (IACP) wants you to know that there’s something you can do – TODAY – to help guarantee that.Over the past several months, IACP has worked with Congress to correct a discrepancy in the Food and Drug Administration’s policies on prescriptions for pets. The FDA has declared that preparing compounded medicines from pure pharmaceutical ingredients is inappropriate and even illegal. Why they have that policy is unclear, especially since the Agency recognizes the necessity and appropriateness of pure ingredients for human prescriptions.And that doesn’t make sense. Your pharmacist needs to be able to use bulk products to customize the right dose for your pet. After all, a small kitten has markedly different medicine needs than a large dog, a parakeet has different needs than an iguana.Yet, the FDA thinks the only “right” way to customizes medicines for pets is to make pharmacists use commercially available tablets or capsules that may contain other ingredients, fillers, or dyes that your pet can’t tolerate.What can you do to help fix this problem?Thanks to IACP’s work on your behalf as a pet owner, we have a formal letter from Congress going to the FDA. IACP has worked hard to secure bipartisan support of this inquiry. Congressman Charlie Gonzalez (D-TX) and Congresswoman Marsha Blackburn (R-TN) have agreed to be the lead sponsors and have already begun working with their Congressional colleagues to obtain as many signatures as possible. The more Congressmen that sign the letter, the more powerful it will be.As soon as you can, contact your member of the U.S. House of Representatives and ask them to sign onto the Gonzalez/Blackburn Veterinary Compounding Letter. Tell them to contact either Cara Dalmolin in Congresswoman Marsha Blackburn’s office at (202) 225-2811 or Julie Hart in Congressman Charlie Gonzalez’s office at (202) 225-3236.To make this as easy as possible for you, IACP has also prepared an Action Alert e-mail that will automatically send this request to your Congressman. You and your family can each send an individual e-mail by going to the following link – URL hereIt only takes a few minutes to call or send an e-mail about this important issue. With your support, we will have as many Congressional signatures as possible. That will show the FDA that their unfounded and questionable position on the use of bulk chemicals/APIs in veterinary compounding is under serious legislative scrutiny.Background About This IssueThe FDA has asserted (and in one case issued an injunction against a pharmacy on this issue) that custom preparations of medicine made pursuant to a veterinarian’s prescription cannot use active pharmaceutical ingredients (API), also referred to as bulk ingredients. They insist that compounding for animals must be done from finished (not bulk) product, even if this eliminates treatment options or negatively affects the quality of the medication. This interpretation will have a direct impact on your ability to compound veterinary products from APIs. This position has far-reaching and negative implications for animal health as this would mean that most compounding could not be done or could not be done effectively. For example, converting a medication into a sterile injectable for a dog that is unable to swallow medication cannot be done from a finished pill; making a cream that is rubbed and absorbed into a cat’s ear must be made from API; and preparing medication for tropical fish eliminates the option of using finished product that has fillers that would contaminate their living environment. The letter being developed asks that FDA withdraw their earlier guidance on this issue and allow an open comment period before its provisions are finalized. It is imperative that affected parties (veterinarians, pharmacists, pet owners, etc.) have an opportunity to comment on such a far-reaching guidance document.FDA’s current position on this issue adversely affects pet and animal owners and veterinarians. It also adversely affects compounding pharmacies that make these veterinary medicines per prescription, the vast majority of which are small, family-owned businesses.(reprinted from P2C2 Custom Care Times 11/29/2010)Please feel free to call Steve at 781-893-3870 or e-mail firstname.lastname@example.org if you have any questions.
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