Key Issue: Standards for Veterinary Drugs
- Monographs: Morgan Puderbaugh (email@example.com or 301-998-6833)
- General Chapters: Margareth Marques (firstname.lastname@example.org or 301-816-8106)
- Media: Claudia Costabile (email@example.com or 301-816-8264)
Consistent with its commitment to provide public standards for the quality, consistency, purity, identity, and strength of all medicines, USP is advancing its standards for drugs for veterinary use. These standards include monographs and general chapters (including those devoted to veterinary drug topics) applicable to any articles recognized in the United States Pharmacopeia–National Formulary (USP–NF), whether in the form of a manufactured product or a compounded preparation. USP has been active in setting standards for veterinary drugs for many years, and recently has expanded its mission statement to acknowledge this.
Solubility Criteria for Veterinary Drugs
A summary of the discussions during the Workshop on Solubility Criteria for Veterinary Products that took place at USP–U.S. in Rockville, MD on November 7–8, 2012 was published in Pharmacopeial Forum 39(4), together with Stimuli articles that will provide explanations for the approaches to be included in a new USP General Chapter <1236>, provisionally titled Determination of Thermodynamic Solubility of Active Pharmaceutical Ingredients for Veterinary Species.
- Determination of Thermodynamic Solubility of Active Pharmaceutical Ingredients for Veterinary Species: A New USP General Chapter. Pharmacopeial Forum, Vol. 41, No. 3 [May–Jun. 2015] (posted 27–Mar–2015)
- Solubility Criteria for Veterinary Drugs—Workshop Report. Pharmacopeial Forum, Vol. 39, No. 4 [Jul.–Aug. 2013] (31–May–2013)
- Solubility Criteria for Veterinary Drugs. Pharmacopeial Forum, Vol. 38, No. 4 [Jul.–Aug. 2012] (31–May–2013)
- Veterinary Application of In Vitro Dissolution Data and the Biopharmaceuticals Classification System. Pharmacopeial Forum, Vol. 30, No. 6 [Nov.–Dec. 2004] (31–May–2013)
For additional information, contact Margareth Marques, Ph.D., Senior Scientific Liaison (firstname.lastname@example.org or 301-816-8106).
Animal Drugs for Use in Animal Feeds
A new General Chapter, <1152> Animal Drugs for Use in Animal Feeds, will be proposed in Pharmacopeial Forum 40(1) [Jan.–Feb. 2014]. This General Chapter is proposed to replace the Veterinary Drugs and Drug Products Delivered in Animal Feeds section that now appears in the informational General Chapter <1151> Pharmaceutical Dosage Forms. Proposed General Chapter <1152> includes information on naming conventions, labeling and packaging, and the preparation of Type A medicated articles and Type B and Type C medicated feeds. In the Glossary of the existing General Chapter <1151>, Dosage Form is defined as, “A formulation that typically contains the API(s) and excipients in quantities and physical form designed to allow the accurate and efficient administration of the API to the human or animal patient.” This definition does not apply to animal drug products intended for use in animal feeds. This mismatch is most notable in the case of “free-choice” application (21 CFR 510.455), in which animals consume the product without control on dosing. The information provided in the proposed General Chapter <1152> draws on 21 CFR sections 558.3 and 510.455. An early posting of the new General Chapter <1152> can be found below.
For additional information, contact William Brown, Senior Scientific Liaison (email@example.com or 301-816-8380).
- Drugs for Use in Animal Feeds <1152>. Pharmacopeial Forum, Vol. 40, No. 1 [Jan.–Feb. 2014] (posted 22–Nov–2013)
Veterinary Drugs Stakeholder Forum
The USP–NF includes standards of identity, strength quality, purity, packaging, and labeling for drug substances and products used in veterinary compounding. Additionally, USP takes an active role in supporting the public’s access to customized drug therapy by developing compounding preparation monographs for animal patients.
Manufactured Drugs and Drug Products Monographs
USP–NF includes more than190 veterinary-specific monographs for FDA approved drug substances and drug products, and is actively engaged in developing additional monographs through both external industry sponsors and internal development (USP laboratories). Additionally, USP has identified more than 150 related monographs in need of modernization. Modernization opportunities include replacing titration assays, adding and updating procedures for impurities, and incorporating additional tests for Identification.
Parties interested in participating in USP’s monograph development or modernization initiatives are encouraged to contact USP at firstname.lastname@example.org.
Resources for the USP Monograph Development Process
Questions and comments, interpretation, applications, and proposed revisions for specific monographs: email@example.com.