Sources of Funding: This study was supported by a grant from the American College of Veterinary Dermatology and by the Department of Clinical Sciences, Auburn University, College of Veterinary Medicine.
Accuracy and precision of compounded ciclosporin capsules and solution
Version of Record online: 13 SEP 2012
© 2012 The Authors. Veterinary Dermatology © 2012 ESVD and ACVD
Volume 23, Issue 5, pages 431–e82, October 2012
How to Cite
Umstead, M. E., Boothe, D. M., Cruz-Espindola, C., MacDonald, J. M., Kennis, R. and Angarano, D. (2012), Accuracy and precision of compounded ciclosporin capsules and solution. Veterinary Dermatology, 23: 431–e82. doi: 10.1111/j.1365-3164.2012.01078.x
Conflict of Interest: No conflicts of interest have been declared.
Editors note The journal has a standard disclaimer which is printed on the inside cover of each issue: “The Publisher, the Society, ESVD & ACVD and Editors cannot be held responsible for errors or any consequences arising from the use of information contained in this journal; the views and opinions expressed do not necessarily reflect those of the Publisher, the Society, ESVD & ACVD and Editors, neither does the publication of advertisements constitute any endorsement by the Publisher, the Society, ESVD & ACVD and Editors of the products advertised.”
In view of the ethical issues raised about the prescription of the compounded drugs described in this article on this occasion I would extend this disclaimer and state: Readers are reminded of their obligation to adhere to the national regulations pertaining to the use of veterinary drugs.
In view of the ethical issues raised in the review of this manuscript the authors provided the following note of clarification:
a The Compliance Policy Guidelines for Compounding in Animals promulgated by the Federal Drug Administration in the USA (CPG Sec. 608.400 Compounding of Drugs for Use in Animals:
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074656.htm) provide guidance and instructions to FDA staff, industry, and the public for obtaining information to help fulfill the Agency’s plans regarding the compounding of drugs for use in animals. Among the 13 conditions under which the FDA has determined that it will seriously consider enforcement action is the following:
“4. Compounding finished drugs from human or animal drugs that are not the subject of an approved application, or from bulk drug substances, other than those specifically addressed for regulatory discretion by the FDA, Center for Veterinary Medicine, e.g., antidotes.” This guideline indicates that compounding should be based on approved dosing forms.
“7. Compounding drugs for third parties who resell to individual patients, or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale.” This guideline specifically discourages the purchase of a compounded product which is subsequently dispensed by a hospital as a prescription.
“9. Compounding of drugs for use in animals where an approved new animal drug or approved new human drug used as labeled or in conformity with 21 CFR Part 530 will, in the available dosage form and concentration, appropriately treat the condition diagnosed”. This guideline specifically discourages the compounding of products for which the sole purpose is cost.
- Issue online: 13 SEP 2012
- Version of Record online: 13 SEP 2012
- Accepted 24 May 2012
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