Veterinary Pharmacy Law: New Regulatory Update

Why Should You Attend:

FDA is concerned about the use of animal drugs compounded from bulk drug substances, especially when approved alternatives exist that can be used as labeled or in an extra label manner consistent with the requirements of FDA’s extra label provisions.

Compounded drugs have not undergone premarket FDA review of safety, effectiveness, or manufacturing quality. The unrestricted compounding of animal drugs from bulk drug substances has the potential to compromise food safety, place animals or humans at undue risk from unsafe or ineffective treatment, and undermine the incentives to develop and submit new animal drug applications to FDA containing data and information to demonstrate that the product is safe, effective, properly manufactured, and accurately labeled.

This webinar will discuss FDA’s decision not to take enforcement action depends on its ability to evaluate whether the compounding of animal drugs is in accordance with each of the following conditions:

• If the animal drug is compounded in a state-licensed pharmacy.
• If the animal drug is compounded by a licensed veterinarian
• If the animal drug is compounded by an outsourcing facility

Learning Objectives:

• Legal regulations for dispensing and record keeping of controlled substances.
• The new changes in food animal antimicrobial drugs from OTC to Rx.
• Audit your current practices for inspections of your drug inventory.
• Understand the legal ramifications of compounding.
• Review new drug dosages forms and extra labels use.
• Review what is legal for technicians and what to do when handling medications.

Areas Covered in the Webinar:

• Laws, Regulations, and Litigation with the Drug Enforcement Administration
• How to document record keeping of controlled drugs?
• References needed for pharmacist to practice in a pharmacy dispensing veterinary medications
• Handling extra-labels prescriptions
• Review species differences in drugs

Who Will Benefit:

• Pharmacists
• Veterinary and Pharmacy technicians
• Veterinarians
• Sales Representatives of Veterinary Compounding Pharmacies
• Animal Producers

Bernadette Alisantosa
Attending Veterinarian, George Mason University

Dr. Bernadette Alisantosa completed her MPVM degree from University of CA, Davis, School of Veterinary Medicine in 1996. She is ACLAM Diplomate since 2009. Currently she is working as the Attending Veterinarian for George Mason University in Fairfax, VA.

Her interests are focused on food producing animals and their health related to human health and zoonoses impact in public health. She is the first and co authors on several papers on scientific journals on Pathogenicity of environmental origin salmonella in specific pathogen free and broiler chicks.

Dr. Alisantosa has been serving as a Veterinary reviewer for JoVE Scientific Video journal since 2010.

Topic Background:

Numerous drugs are approved or indexed for use in animals. However, there are many different species of animals with different diseases and conditions for which there are no approved or indexed animal drugs. In some cases, approved human drugs can be used to treat an animal under the extra label use provisions of the FD&C Act and FDA regulations.

For example, various chemotherapeutic drugs approved for humans are used to treat cancer in dogs and cats. FDA recognizes that there are circumstances where there is no drug available to treat a particular animal with a particular condition, because either no drug is approved for a specific animal species or no drug is available under the extra label drug use provisions. In those limited circumstances, an animal drug compounded from bulk drug substances may be an appropriate treatment option.

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