Dispensing Legend Drugs

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The Food and Drug Modernization Act of 1997 Signed into law in November of 1997 and fully enacted in April of 1999, the Act (among many other things) called for: A reduction in the time for the approval of new pharmaceutical drugs. Relaxed medical device regulations. Restricted the advertising of compounded drugs, i.e. mixtures made up by pharmacists. This provision was overturned by the US Supreme Court in 2002 on grounds of freedom of speech.
Obtaining Approval: New Animal Drug Applications Section 512 of the FD&C Act outlines the rules that govern the safety and efficacy of new animal drugs. The Code of Federal Regulations (CFR) details the requirements of submissions demonstrating the safety and efficacy of a drug before approval can be granted. The new animal drug approval (NADA) process is extremely complicated and has so far proved a very effective safeguard.
Page 1 and 2: Laws and Rules Governing Dispensing
Page 3 and 4: Veterinary Prescription Drugs Vete
Page 5 and 6: Veterinarian/Client/Patient Relatio
Page 7 and 8: Section 2 Federal Laws
Page 9 and 10: DEA Registration In order for Flor
Page 11 and 12: DEA Registration Veterinarians who
Page 13 and 14: DEA Registration Modification Prac
Page 15 and 16: DEA Registration Renewal Certifica
Page 17 and 18: DEA Inspections The DEA does not
Page 19 and 20: Controlled Substances Act: Drug Sch
Page 21 and 22: Controlled Substances Act: Drug Sch
Page 23 and 24: Ordering Controlled Substances Due
Page 25 and 26: Source: An Informational Outline of
Page 27 and 28: DEA Records and Prescriptions Vete
Page 29 and 30: DEA Records and Prescriptions In e
Page 31 and 32: DEA: Transfers of Controlled Substa
Page 33 and 34: DEA: Safety Requirements If a move
Page 35 and 36: DEA: Safety Recommendations It is
Page 38 and 39: DEA: Theft And Loss Reporting You
Page 40 and 41: U.S. Food and Drug Administration
Page 44 and 45: Extra-Label Drug Use (ELDU) "Extra
Page 46 and 47: Extra-Label Drug Use In the absenc
Page 48 and 49: Labeling of drugs prescribed for ex
Page 50 and 51: Compounding Under AMDUCA Animal Me
Page 52 and 53: Adulterated Drugs Under Section 30
Page 54 and 55: Compounding However, the FDA is gr
Page 56 and 57: Compounding Neither the Act nor it
Page 58 and 59: Compounding The FDA chooses to en
Page 60 and 61: Compounding in Florida (a) The prep
Page 62 and 63: Chapter 465, F.S. Chapter 465, F.S.
Page 64 and 65: §465.0255, F.S.- Expiration date o
Page 66 and 67: Other Pertinent Chap. 465 Sections:
Page 68 and 69: Chapter 499, F.S.: Drugs, Devices,
Page 70 and 71: Chapter 499, F.S.: Drugs, Devices,
Page 72 and 73: Chapter 828, Florida Statutes Anim
Page 74 and 75: Chapter 893, F.S. Florida Comprehen
Page 76 and 77: §893.02 Definitions "Prescription
Page 78 and 79: §893.07: Records (3) The record of
Page 80 and 81: §893.07: Records (4) Every invento
Page 82 and 83: Other Chapter 893 Provisions §893
Page 84 and 85: Rule 64F-12.006, F.A.C. (1) The de
Page 86 and 87: Rule 64F-12.006, F.A.C. (b) An auth
Page 88 and 89: Rule 64F-12.006, F.A.C. (2) The dep
Page 90 and 91: END OF PRESENTATION Edwin A. Bayó
Page 92 and 93:
The Sources Chapter 474, Florida S
Page 94 and 95:
The Sources Chapter 499, F.S.: Dru
Page 96 and 97:
Common Causes for Disciplinary Acti
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
Important: When an investigation i
Page 104 and 105:
Important: When its investigation
Page 106 and 107:
Final Agency Action § 455.225(6),
Page 108 and 109:
Emergency suspension, restriction,
Page 110:
END OF PRESENTATION Edwin A. Bayó
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