Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, August 23, 2012
FDA investigators, state inspectors, compliance officers attend training on animal compounding
Reminder (as previously posted on blog) that training was taking place this week (ends today at noon) by FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in inspections of animal drug compounding pharmacies and veterinarians’ extra label drug use in food producing animals or review or take compliance action on these inspection reports.
COURSE DESCRIPTION / OBJECTIVES:
This course is intended to instruct field investigators on the laws, regulations and policies pertaining to compounding of animal drugs and the Animal Drug Use Clarification Act related to the extra-label drug use in animals. Compounding of animal drugs has increased exponentially in the last few years. Certain compounding practices undermine the animal drug approval process, and present unknown and potentially hazardous risk to animal and human health. Animal drug compounding is addressed in various laws, regulations, and policies. In order to adequately assess violations of concern, investigators need to understand the laws, regulations and policy that distinguish animal from human drug compounding. Extralabel drug use practices may especially result in violative food animal tissue residues. Investigators need to understand under what circumstances extra-label drug use can or cannot be utilized in veterinary medicine.
For Source see here.
SC company guilty of wholesaling $55 million in stolen drugs
August 21, 2012 | By Eric Palmer
Read more: SC company guilty of wholesaling $55 million in stolen drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/sc-firm-guilty-wholesaling-55-million-stolen-drugs/2012-08-21#ixzz24NXn4hmu
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Federal authorities have caught up with a drug wholesaler who bought more than $55 million worth of stolen drugs, put them back into the legitimate supply chain, then falsified "drug pedigrees," to try and hide the scheme. The case is another in a series of arrests or convictions as it continues to press on cargo theft and warehouse crimes.
Altec Medical has been sentenced to pay a $2 million fine and forfeit $1 million after it was found buying the illegally obtained drugs, the FDA reports. Federal authorities say when the Easley, SC-based company bought the prescription medications from William D. Rodriguez, it knew he was fencing them from parties that obtained them illegally. Altec has also been placed on a year's probation.
Read more: SC company guilty of wholesaling $55 million in stolen drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/sc-firm-guilty-wholesaling-55-million-stolen-drugs/2012-08-21#ixzz24NXn4hmu
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Indian court puts off Novartis patent hearing to Sept. 11 Read more: Indian court puts off Novartis patent hearing to Sept. 11 - FiercePharma http://www.fiercepharma.com/story/indian-court-puts-novartis-patent-hearing-sept-11/2012-08-22?utm_source=rss&utm_medium=rss#ixzz24NU62Afy Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma
August 22, 2012 | By Tracy Staton
India's top court won't start the big Novartis ($NVS) patent argument today as scheduled. In just the latest delay in the closely watched case, the hearing was postponed to Sept. 11.
Read more: Indian court puts off Novartis patent hearing to Sept. 11 - FiercePharma http://www.fiercepharma.com/story/indian-court-puts-novartis-patent-hearing-sept-11/2012-08-22?utm_source=rss&utm_medium=rss#ixzz24NULbaV8
India's top court won't start the big Novartis ($NVS) patent argument today as scheduled. In just the latest delay in the closely watched case, the hearing was postponed to Sept. 11.
Read more: Indian court puts off Novartis patent hearing to Sept. 11 - FiercePharma http://www.fiercepharma.com/story/indian-court-puts-novartis-patent-hearing-sept-11/2012-08-22?utm_source=rss&utm_medium=rss#ixzz24NULbaV8
Expert: Manufacturers in Two Indian States More Likely to Produce Substandard Drugs
Drug manufacturers in the Indian states of Haryana and Uttar Pradesh are more likely to produce substandard or falsified drugs than those in more regulated Indian states, an expert says. . . .
To read the remainder of this article, click here (note you must be a member PharmaSupplyChain.com)
To read the remainder of this article, click here (note you must be a member PharmaSupplyChain.com)
Wednesday, August 22, 2012
FDA Enforcement Report - Week of August 22, 2012
This report contains an overwhelming number of drug recalls from Franck's Pharmacy, which has closed its door (see previous post). All recall drugs contain the following reason for the recall:
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.To view the report with the list of drugs, click here.
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