After failures,Massachusetts DPH seeks 30 new staffers to boost inspection ability

After failures, DPH seeks 30 new staffers to boost inspection ability

California Bill Would Implement Stricter Requirements for Pharmacies Compounding Sterile Drugs

February 27, 2013 5:05 p.m.

Pharmacies compounding sterile drug products for dispensing to patients in California would be required to obtain a license to engage in that practice under a bill (SB 294) introduced to the state’s senate on February 19, 2013. Under the bill, both resident and nonresident pharmacies that compound sterile products for dispensing or shipment into the state must apply to the California State Board of Pharmacy for licensure. An on-site inspection by the Board would be required prior to licensure. Nonresident pharmacies would be responsible for payment of travel expenses of the Board in connection with an inspection. In addition, a list of all sterile drug products compounded by the pharmacy must be provided to the Board, as well as notification of any disciplinary action taken by another state or suspension of any accreditation held by the pharmacy.

Source is NABP

FDA has plenty of ways to cut spending, with or without sequester - Related Stories - FDLI SmartBrief

FDA has plenty of ways to cut spending, with or without sequester - Related Stories - FDLI SmartBrief

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

• 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