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April 29, 2020
American Society for Pharmacy Law
AMDUCA, FDA, Regulations, Veterinary Compounding
In the United States, veterinary compounding is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). Although pharmacists are compounding and dispensing more veterinary prescriptions than ever before, pharmacists are often unaware of the regulatory issues that are required for veterinary compounding compared to compounding for human use. This session will explore key aspects of AMDUCA that every community pharmacist should know when dispensing prescriptions for veterinary patients.
As compounding for animal use provides expanded practice opportunities for pharmacists, this session will provide a review of extra-label drug use in the veterinary population and under what circumstances it is allowable under AMDUCA. Whereas it is common for pharmacists to use bulk drug substances in compounding for human use, their use is restricted under AMDUCA. Based on a past guidance, the FDA has used regulatory discretion for compounding of bulk substances in specific situations.
Although there have been some alarming anecdotal accounts of adverse outcomes due to incomplete pharmacist knowledge about veterinary dispensing, the session will highlight some of the most common errors and steps pharmacists and pharmacy management can take to limit the occurrences through identification of these gaps and improved communication.
At the conclusion of the session, the learner will understand the key similarities and differences of compounding for human vs animal use and will have the fundamental understanding to know if they are practicing within the guidelines of AMDUCA. Participants will also be equipped with knowledge to implement steps to help ensure patient safety for veterinary patients.
1. Discuss similarities and differences in compounding for human vs animal use.
2. List drugs that are generally prohibited under AMDUCA from being dispensed for animals that may enter the food supply.
3. Explain circumstances by which the FDA may use regulatory discretion, whereby bulk drug substances can be used for compounding for animal use.
4. Identify commonly dispensed drugs that need special consideration for veterinary patients due to the likelihood for error when using human patients as reference.
ACPE Continuing Education Credits Participants may earn up to 1 contact hour (0.1 continuing education units) of Accreditation Council for Pharmacy Education (ACPE)-accredited continuing pharmacy education (CPE) credit. Sessions approved for CPE credit are listed with an ACPE universal activity number and number of continuing education units. Verification of participation will be reported to the CPE tracking service, CPE Monitor, within 4 weeks after the program by Campbell University, and will then be accessible to participants at MyCPEMonitor.net. You will need to include your NABP e-profile ID on the registration page so that it may be reported to CPE Monitor. If you have not yet obtained your NABP e-Profile ID, you may do so by visiting MyCPEMonitor.net, creating an e-Profile, and registering for CPE Monitor. Be sure to register for CPE Monitor to ensure that your e-Profile ID is fully activated. The ACPE accreditation number is 0088-9999-20-059-H07-P for 1-hour ACPE credit.
Campbell University College of Pharmacy & Health Sciences is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. CPE now requires that all pharmacy continuing education (CE) credits must be processed and claimed no later than 60 days from the date of the live activity.
Continuing Legal Education Credits If you intend to apply for continuing legal education credits, please be sure to indicate the state (or states) in which you are licensed and the corresponding license number(s) on the registration form. Quarles & Brady, LLP will process the CLE credits for the webinar. Continuing Legal Education credit is pending and will be applied for based on the attendee list provided by SeminarWeb.
Program Titles and Supporting Materials
This program contains the following components:
If applicable, you may obtain credit in multiple jurisdictions simultaneously for this program (see pending/approved list below). If electing credit for this program, registrants in jurisdictions not listed below will receive a Certificate of Completion that may or may not meet credit requirements in other jurisdictions. Where applicable, credit will be only awarded to a paid registrant completing all the requirements of the program as determined by the selected accreditation authority.
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How to Attend
Join the self-paced program from your office, home, or hotel room using a computer and high speed internet connection. You may start and stop the program at your convenience, continue where you left off, and review supporting materials as often as you like. Please note: Internet Explorer is no longer a supported browser. We recommend using Google Chrome, Mozilla Firefox or Safari for best results.
You may access this course on a computer or mobile device with high speed internet (iPhones require iOS 10 or higher). Recommended browsers are Google Chrome or Mozilla Firefox.