$100M fund outlined for victims of NECC manufacturing problems

Backlash led to new authority for FDA to regulate large compounding pharmacies

January 2, 2014 | By Eric Palmer

Read more: $100M fund outlined for victims of NECC manufacturing problems - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/100m-fund-outlined-victims-necc-manufacturing-problems/2014-01-02#ixzz2pIOr4jOh
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Pharmacy fills health care niche with customized medications

Patients who get customized prescription medications from Cascade Specialty Pharmacy don’t necessarily get new drugs, but they may get the drugs they need in a different form. Instead of a standard capsule, the medication might be mixed into a salve or cream to be rubbed directly on an affected area and absorbed through the skin.
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Forbes: Matthew Herper Grading Pharma In 2013: 16 Drug Companies Ranked

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Forbes: If you don't market drugs, how do you expect to sell them?

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Eye on FDA blog: A Look Back at 2013 and FDA January 2, 2014 by Mark Senak

     Happy New Year!  It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come.  Here is a little overview of events that shaped the FDA landscape this year:

• Legislation and FDA Authority - Occasionally FDA gets new regulatory authorities as a result of legislation passed by Congress.  Despite the fact that this Congress has not produced as much legislation as others have, the Congress did pass and the President did sign legislation – the Drug Quality and Security Act – that gives the agency new authorities in regulating compounding pharmacies.  The action came after several high-profile recalls during the course of the year that resulted in Congressional hearings, FDA testimony and consequential legislation.  An overview of the compounding issue events can be found at the blog web site tab on Compounding.
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Third Question of the Day January 4, 2014 Recent FDA information states: It’s important to note that Part 530.13 specifically states, “Nothing in this part shall be construed as permitting compounding from bulk drugs.” What is the FDA's position for those in the 5th Circuit regarding compounding from bulk for animals?

FDA Information on Compounding for Animals:

Compounding

Under the FD&C Act, an animal drug that is compounded using an unapproved drug or bulk drugs as the starting material is adulterated. An animal drug that is compounded using an approved human or animal drug as the starting material is not adulterated, and using such a drug is considered a legal extra-label use as long as all other conditions required by law are met. You can find these requirements in Sections 512(a)(4) and (5) of the FD&C Act⁸ and Title 21 of the CFR, Part 530.13⁹. It’s important to note that Part 530.13 specifically states, “Nothing in this part shall be construed as permitting compounding from bulk drugs.”

Drugs Prohibited from Extra-Label Uses in Animals

Under the AMDUCA provisions, FDA has the right to prohibit extra-label uses of certain drugs in animals. The following drugs (both human and animal), families of drugs, and substances are prohibited from extra-label uses in all food-producing animals, including horses intended for human food:

• Chloramphenicol
• Clenbuterol
• Diethylstilbestrol (DES)
• Dimetridazole
• Ipronidazole and other nitroimidazoles
• Furazolidone and nitrofurazone
• Sulfonamide drugs in lactating dairy cattle, except for the approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine
• Fluoroquinolones
• Glycopeptides
• Phenylbutazone in female dairy cattle 20 months of age or older
• Cephalosporins (not including cephapirin) in cattle, swine, chickens, or turkeys:
  • For disease prevention purposes;
  • At unapproved doses, frequencies, durations, or routes of administration; or
  • If the drug is not approved for that species and production class.

The following drugs, or classes of drugs, that are approved for treating or preventing influenza A are prohibited from extra-label uses in chickens, turkeys, and ducks:

• Adamantane
• Neuraminidase inhibitors

The above list can be found at Title 21 of the CFR, Part 530.41¹⁰. Currently, no approved drugs are prohibited from extra-label uses in companion animals.

 

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Resources for You The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians

Resources for You The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians

Second Question of the Day January 2, 2014 Isn't it true that the veterinary compounding industry will be cleaned up only when the FDA and state boards of pharmacy listen to the people who actually have knowledge of this specific industry and what goes on in veterinary compounding on a daily basis?

Question of the Day January 2, 2014 Why do most state boards of pharmacy insist that a complaint be filed against a compounding pharmacy or pharmacists before they will investigate and enforce their own rules? Why are more state boards of pharmacy not willing to enforce their own rules against compounding pharmacies and pharmacists when they learn about violations from the FDA, the news media, etc.? Shouldn't this be changed as suggested by the comment below?

The "complaints driven" component of how enforcement actions work is why it is so easy for pharmacies and physicians can get away with these illegal kickback relationships.

Kenneth Woliner, MD
www.holisticfamilymed.com