This webinar will cover the legal regulations for dispensing and record keeping of controlled substances. This training will discuss the new changes in food animal antimicrobial drugs from OTC to Rx. Compounding guidelines and legal ramifications of dispensing human drugs to animals will be discussed in detail. It will review new drug dosages forms and extra labels use and further it will review what is legal for technicians and what to do when handling medications.
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:
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
Speaker
Bernadette AlisantosaCourse Provider
Bernadette Alisantosa,
