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USP Initiatives Regarding Veterinary Compounding

USP Initiatives Regarding Veterinary Compounding. Gigi Davidson, BSPh, FSVHP, DICVP Director of Clinical Pharmacy Services North Carolina State University College of Veterinary Medicine AAVPT 14 th Biennial Symposium/SVHP Joint Meeting May 17, 2005, Rockville, MD Pg. 253-266 (Slide#1-14).

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USP Initiatives Regarding Veterinary Compounding

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  1. USP Initiatives Regarding Veterinary Compounding Gigi Davidson, BSPh, FSVHP, DICVP Director of Clinical Pharmacy Services North Carolina State University College of Veterinary Medicine AAVPT 14th Biennial Symposium/SVHP Joint Meeting May 17, 2005, Rockville, MD Pg. 253-266 (Slide#1-14)

  2. Gigi Davidson, BSPh, RPh, DICVP Director of Clinical Pharmacy Services College of Veterinary Medicine North Carolina State University 4700 Hillsborough Street Raleigh, NC 27606 Telephone: (919)513-6575 E-mail: gigi_davidson@ncsu.edu

  3. It started with the stakeholders… • COBTA • FDA • USP COE’s • FDAMA reference to compounding items from official compendia • Human Compounding CPGs reference to compounding from official compendia • Revision of Animal Compounding CPG

  4. Animal Compounding CPG Revision • Synchronized with human compounding CPG • Human CPG item #5 notes regulatory enforcement for items not recognized in official compendia • No longer tolerate use of bulk chemicals except for those in Appendix A Yet some bulk chemicals are medically necessary for veterinary therapy. What if medically necessary bulks had official monographs in USP?

  5. Joint Activities Between 3 Expert Committees • Veterinary Medicine (Information) • Veterinary Drugs (Standards) • Compounding Pharmacy

  6. Veterinary Information/Veterinary Drug EC’s • Surveyed veterinarians and veterinary pharmacists • Prioritized list of most commonly used veterinary compounds • Prioritized list of must-have medically necessary bulk chemicals

  7. Top 10 Medically Necessary Bulk Chemicals Drug # entries Avg score Methimazole 20 2.65 Bromides 18 3.56 Metronidazole’s 17 4.82 Cisapride 16 4.81 Diethylstilbesterol 14 5 Prednisolone/sone 14 5.86 Amitriptyline 11 5.27 Enrofloxacin 8 5 Phenylpropanolamine 7 6.28 Piroxicam 7 8

  8. Pilot List of Most Commonly Compounded Veterinary Medications • Potassium Bromide Oral Solution • Sodium Bromide Injection • Acetazolamide Injection • Acetazolamide Oral Suspension • Amitriptyline Hydrochloride Capsules • Amitriptyline Hydrochloride Oral Suspension • Cisapride Capsules • Diethylstilbesterol Capsules • Methimazole Oral Suspension • Metronidazole Benzoate Oral Suspension

  9. Pilot List USP will develop for each compound: • Peer-reviewed, evidence-based information monograph • USP drug substance monograph for each API • USP Compounding Formulation Monograph

  10. API Substance Monographs To Date • Potassium Bromide – published as proposal in PF31(2) tentatively scheduled to become official with USP28, Second Supplement. • Sodium Bromide – published as proposal in PF31(2) tentatively scheduled to become official with USP28, Second Supplement.

  11. Compounding Formula Monographs To Date • Bromide Oral Solution and Sodium Bromide Injection monographs are under development and are tentatively scheduled to be published in the PF in late 2005-early 2006 as proposals. • Each monograph as they are developed and proposed will undergo testing to validate analytical methodology specified in the monograph and to determine stability to set beyond use date.

  12. Veterinary Drug Information Monographs To Date • BROMIDE Veterinary—Systemic information monograph has been approved by the Expert Committee and this monograph will be available for public comment in May-June 2005. Proposed information monographs can be obtained by visiting USP’s website, www.usp.org, or by sending a request to veterinary@usp.org.

  13. 2005-2010 Veterinary Products Collaborative Group • USP invited to extend international advice and assistance to emerging nations in areas of: • Veterinary drug quality • Veterinary drug information • Proper use of good quality manufactured and compounded veterinary drugs key to preventing epidemics and transmission • Animal reservoirs for human disease • WNV, BSE, Avian flu, SARS

  14. Collaborative Group Goals • Finalize: • Drug substance and dosage form monographs • Compounding formulation monographs • Veterinary drug information monographs • Approximately 500-600 drugs requiring new monographs or revision

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