February 27, 2013 5:05 p.m.
Source is NABP
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, February 28, 2013
California Bill Would Implement Stricter Requirements for Pharmacies Compounding Sterile Drugs
Source is NABP
AVMA Now: Video Update from the Governmental Relations Division on Fairness to Pet Owners Act, Drug Compounding, and Controlled Substance Laws
AVMA NOW: Update from the Governmental Relations Division
ANIMAL HEALTH SMARTBRIEF | FEB 19, 2013
The Fairness to Pet Owners Act, drug compounding and controlled substance laws are among the many issues facing veterinarians today. A new Congress is in place, and with it comes a certain amount of uncertainty about what’s going to happen with these important issues. In this episode of AVMA NOW, Dr. Mark Lutschaunig, director of AVMA’s Governmental Relations Division, discusses the status of these issues and what the AVMA is doing to protect and promote the veterinary profession on Capitol Hill.Watch the episode.
University of Iowa IACUC Guidelines: Use of Drugs and Chemicals in Laboratory Animals With Useful Flow Chart Submitted by kzobeck on Fri, 02/22/2013 - 14:53
These guidelines describe the requirements regarding the use of drugs and other chemicals administered to laboratory animals at the University of Iowa. The use of drugs falls into one of two usage categories: therapeutic purposes or experimental use. These guidelines apply to both categories of administration. Deviation from these guidelines must be described and justified in an IACUC-approved Animal Protocol.
The use of non-pharmaceutical grade compounds in animals may be necessary and appropriate, but must be scientifically justified in an IACUC-approved Animal Protocol.
Definitions
Definitions
- Pharmaceutical grade compound: Drug, biologic, or reagent which is approved by the FDA or for which a chemical purity standard has been established by USP/NF or BP.
- Non-pharmaceutical grade compound: Any substance which does not meet the above definition of pharmaceutical grade, including:
- Analytical grade bulk chemical: ~99% purity chemical, Certificate of Analysis typically available
- Pharmaceutical grade drug compounded with non-pharmaceutical grade vehicle or other substance
- FDA – Food and Drug Administration
- USP/NF – United States Pharmacopeia/National Formulary
- BP – British Pharmacopeia
Drugs Administered for Therapeutic Purposes
- Current standards for the veterinary therapeutic care of research animals state that pharmaceutical grade medications should be used for routine medical treatment
- Examples of therapeutic purposes include:
- Sedation and anesthesia for surgery or other procedures
- Relief or treatment of disease or injury
- Pain control (analgesia)
- Euthanasia
- Drugs used for veterinary care, either as part of an IACUC-approved Animal Protocol or an OAR veterinarian-approved treatment plan, should be obtained from a veterinary supply or from a pharmaceutical supplier licensed by the FDA, if available from such sources
Popular pet ointment nixed
Zoetis, the animal health unit of pharmaceutical giant Pfizer, plans to stop making Panolog, a popular ear-and-skin medication for pets.
“We have made the decision to discontinue production of our Panolog ointment and cream products,” Zoetis spokesman Deron Johnson told Examiner.com in a two-sentence statement Feb. 25. “This decision is based on a regular review of our product portfolio and consideration of future API (active pharmaceutical ingredient) supplies; it is not related to the quality or integrity of the finished product currently available on the market.”
More details about the prescription drug’s demise were not immediately available from Zoetis.
Panolog cream and ointment are used to treat skin infections in cats and dogs. The ointment also is used to treat ear infections in pet.
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FDA Doesn't Plan Furloughs; Eyes Training, Contract Cuts If Sequestration Kicks In
FDA does not currently anticipate having to furlough employees if the cuts mandated by sequestration go into effect Friday (March 1), but will likely reduce travel and training, and curtail contracts and outside collaborations.
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Source HealthPolicyNewstand
Sterile compounding lessons to be learned
FEB 27, 2013
Source found at Drug Topics
The importance of cleanliness and being proactive were the two most important lessons learned following the New England Compounding Center’s practices that led to the nationwide fungal meningitis outbreak, said sterile compounding expert Eric Kastango, MBA, RPh, FASHP.
"This is probably the most catastrophic event that has happened in my lifetime, as it relates to compounding," Kastango said during a web seminar Feb. 20 sponsored by Pharmacy OneSource.
In October 2012, the FDA issued a 483 form to NECC, detailing the filthy conditions of its main clean rooms, gown rooms, prep rooms, and adjacent rooms, as well as observations of vials of methylprednisolone acetate (preservative free) 80 mg/mL from one of the lots known to be contaminated with fungus.
"It's mind-blowing," Kastango said of FDA's findings. "If you have a person in a clean room, you're going to have micro-organisms."
It was noted that the air-conditioning was turned off at 8 pm to 5:30 am in the clean room, according to personnel who were interviewed during the FDA inspections.
Sequester, Hitting HHS Anti-Fraud Efforts, Could Lead To Smaller Returns
02-27-2013
If the budget sequester kicks in March 1, cuts slated for CMS' anti-fraud, waste and abuse activities will have a multiplying effect as funding reductions in those areas could also reduce the amount of money program integrity activities are able to return to the Medicare trust fund, CMS Center for Program Integrity Director Peter Budetti told lawmakers Wednesday (Feb. 27).
Source HealthPolicyNewstand
Drug Companies Start Buying Off Doctors In Med School Carl Lowe | Feb 28, 201
Medical schools say they are trying to keep drug companies away from medical students. But a survey of medical students and residents shows that pharmaceutical sales reps are still sending medical students gifts, buying them meals and generally trying to bribe them with industry-sponsored educational materials.
“In medical school and residency, as trainees are learning the fundamentals of their profession, there is a need to ensure the education they receive is as unbiased as possible,” warns researcher Dr. Aaron Kesselheim of Brigham and Women’s Hospital in Boston. “However, it is well known that promotional information and gifts from pharmaceutical companies can encourage non-evidence-based prescribing. Though many institutions have tried to insulate trainees from these effects, trainees’ exposure to industry promotion is still quite high.”
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The survey shows that one-third of first-year students and more than half of fourth-year students and residents report receiving industry-sponsored gifts.
source found here
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