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| What's Happening on the Veterinary Compounding Front! |
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The following documents have been posted by the FDA regarding veterinary compounding. Please obtain copies using the links provided below and read them thoroughly.
May 19, 2015 FDA Proposed Guidance Document
Compounding Animal Drugs from Bulk Substances
http://www.fda.gov/downloads/AnimalVeterinary/Guidance ComplianceEnforcement/GuidanceforIndustry/UCM446862.pdf
The FDA has formally withdrawn the CPG entitled "Section 608.400 Compounding of Drugs for Use in Animals," that was issued in July 2003 because it is no longer consistent with the FDA's current thinking on the issues it addresses. For a copy of the document, go to:
http://federalregister.gov/a/2015-11982
The new conditions divide veterinary compounding into three categories of facilities:
1. Compounding in a state-licensed pharmacy.
2. Compounding by a licensed veterinarian.
3. Compounding by an outsourcing facility.
A brief summary of the new requirements include:
- All compounds must be for a specific, identified animal.
- No provisions for office-use.
- Anticipatory compounding is limited to 14 days.
- The FDA is permitting 503B outsourcing facilities to produce veterinary products.
- Mandatory adverse-event reporting.
- Additional, specific labeling requirements (non-food species).
- Mandatory language on prescription requiring that no FDA alternative exists.
- 503B facilities will be limited in number of bulk ingredients that may be used (See Appendix "A" of the document).
All should know and appreciate that IACP has responded to these in detail. If you are not a member, this is a great example of why all compounders should belong and support IACP. Hope to see you at CCH!
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
$50 Million Infusion to PillPack to Grow Its Online Pharmacy
$50 million in venture funding has been raised for PillPack to expand its e-commerce pharmacy business across the U.S., and also to turn it into a brick-and-mortar business. PillPack is distinct in part because of the way it packages its orders; every two weeks, PillPack's customers receive drugs that have been presorted into individual packets, the packets of which are shipped on a tape-dispenser-like roll.
http://blogs.wsj.com/venturecapital/2015/06/03/pillpack-raises-50-million -to-grow-its-online-pharmacy/?KEYWORDS=PillPack
West Virginia Ruling: People with Addictions Can Sue Pharmacists
A West Virginia Supreme Court of Appeals decision now allows people with drug addictions to sue pharmacists, physicians, and other dispensers and prescribers of pain medications for contributing to their addiction and criminal activity. The suit involved 29 people with admitted drug addictions and involved eight separate lawsuits in Mingo County against three West Virginia pharmacies, as well as Mountain Medical Center and four of its physicians, for causing their addiction and subsequent criminal activity.
http://www.pharmacist.com/west-virginia-ruling-people-addictions-can-sue-pharmacists
Supreme Court Says Big Pharma Must Pay for Rx Drug Disposal
In Alameda County, a groundbreaking law that forces the pharmaceutical industry to pay for collection and disposal of unused drugs passed its final court test. The U.S. Supreme Court refused to consider the industry's challenge of Alameda County's law, which is intended to keep drugs out of the bay, the groundwater basin, and the hands of abusers.
http://www.mercurynews.com/news/ci_28191242/supreme-court:-big-pharma-must-pay-for-prescription-drug-disposal-in-alameda-county
Older Namenda Must Remain on the Market
A federal appeals court ruled that Actavis cannot pull an older Alzheimer's drug from the market in order to switch patients to a newer, more expensive version before generic competition emerges. Actavis hoped to convince doctors and patients that its new formulation, Namenda XR, was more convenient and, therefore, boost prescriptions before generic versions of the former Namenda tablets became available. This decision prevents Actavis from coercing Alzheimer's patients into taking drugs they do not want in order to charge them monopoly prices. This decision sends a message that drug companies cannot illegally prioritize profits over patients.
http://blogs.wsj.com/pharmalot/2015/05/22/actavis-must-keep-its-older-alzheimers-pill-on-the-market/
The FDA Bans Czech Company for Shipping Contaminated Active Pharmaceutical Ingredients to the U.S.
The FDA has just issued an import alert banning all human and veterinary antibiotics and other drugs being shipped from a plant in the Czech Republic. The problems were found during an inspection at the company's plant in Roztoky near Prague a year ago but just sent the warning letter last week. The company, Vuab, had a customer that complained it had discovered that one of the APIs it bought from Vuab was contaminated by Clostridium sphenoides. Vuab checked returned samples but didn't find any bacteria; however, according to the FDA, the test Vuab used was "inadequate to detect" the C. sphenoides.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ ucm448433.htm
Deloitte Survey finds Poor Compliance is an Issue with Indian Drug Firms
Deloitte found that poor compliance management, internal controls, secured data and quality systems, and lack of skilled resources are big concerns for India's fast-growing life-sciences sector. The survey found about 30% of respondents said they had experienced non-compliance with GxP guidelines in the last two years. Also, about 55% indicated that their compliance teams were not adequately trained to address regulatory requirements; around 48% felt that compliance strategy was not a key area earmarked for investment in their organizations. India has about 546 facilities approved by the FDA. In the last two years, the FDA and Canada's Health Canada have banned or warned over 25 Indian drug firms for non-compliance with the standards, including drug companies like Sun Pharma, Ranbaxy, and Wockhardt.
http://businesstoday.intoday.in/story/deloitte-survey-compliance-an-issue-with-indian-drug-firms/1/220125.html
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IJPC Now on Facebook and Youtube
Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding
Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.
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Did You Know ...
�that demands from PBMs, requiring "Provide one study supported by compendial listing of IIb, B or higher that supports the stability, safety, and efficacy for each compound ingredient in each compound of your pharmacy's top 10 compounded products, as well as any compounds for which you provide prescribers with pre-printed prescription pads, or promote via sales efforts to patients and/or physicians," are unintelligible gibberish unless they explain what is meant by a "�compendial listing of IIb, B, or higher�"? Surely these over-paid executives can do better than that!!!!
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Tip of the Week
It is difficult to deal with the "uninformed and uneducated." The only recourse in situations like this is to request "clarification" and documentation for the requests! Also, ALL pharmacy organizations must stand up to this intrusion into patient care!
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Looking Back
Shaving brush,
All wet and hairy!
I've passed you up,
For sanitary!
Burma Shave
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Classifieds
Business Opportunity:
FDA Registered Sterile Drug Manufacturer / 503B Outsourcing Facility seeks Sterile Compounding Company for joint 503B venture. Ten years' experience, Sterile manufacturing Blow Fill Seal, single and multi-use vials for injectables, ophthalmic containers, inhalation containers and syringe line.
Contact: Gary Hanley, CEO SterRX/AseptPak, tel. 518 353 3210 admin@aseptpak.com
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