read entire handouts from 2015 FDLI Annual Conference here
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
Monday, April 20, 2015
Important Read for Those interested in Veterinary Drugs: CVM at FDA CVM is concerned about unapproved animal drugs, including drugs compounded from bulk drug substances, being marketed in the USA. • These drugs have 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. • Unapproved animal drugs (including animal drugs compounded from bulk drug substances) are considered adulterated under the FD&C Act. • Although Congress passed The Drug Quality & Security Act (11-2013) applicable to the compounding of human drugs, this legislation does not apply to the compounding of drugs intended for use in animals. • CVM is working on a revised compliance policy guideline for animal drug compounding. • CVM is developing enforcement strategies for unapproved drugs to further support the approval process and to protect human and animal health.
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