Cutting the red tape: the FDA responds with exclusive interview - Pharmaceutical Technology

Cutting the red tape: the FDA responds with exclusive interview - Pharmaceutical Technology

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

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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US FDA pulls 27 ANDAs for drugs made at banned Ranbaxy plants

US FDA pulls 27 ANDAs for drugs made at banned Ranbaxy plants

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