Dispensing Legend Drugs

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Compounding The FDA chooses to enforce its “regulatory discretion” and “ordinarily” will not take regulatory action when: 1. A legitimate need is identified. 2. There is a need for an appropriate dosage regimen for the particular species, size, age, or medical condition, and 3. There is no marketed approved animal drug which, when used in conformity with the regulations as set forth AMDUCA, may treat the condition diagnosed in the available dosage form, or there is some other rare extenuating circumstance. The FDA places its highest priority on compounding products for use in food animals.
Compounding in Florida Rule 64B16-27.700, F.A.C.- Definition of Compounding: “Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. (1) Compounding includes:
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Laws and Rules Governing Dispensing
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Veterinary Prescription Drugs Vete
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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 42 and 43: The Food and Drug Modernization Act
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 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 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),
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Emergency suspension, restriction,
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END OF PRESENTATION Edwin A. Bayó
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Dispensing Legend Drugs

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