PHAR100-0415: Pharmaceutical Regulatory Review 2015
(Accepted for Florida State Veterinary Board Pharmacy CE requirement)
(Accepted for New York State Controlled Pharmacy requirement)
The lecture for this course will be presented in a predominantly text format.
Sections of the lecture and responses to questions will be handled using audio.

Enrollment is closed.

Instructor(s): Doug Kemp, PharmD, DICVP
Course Open: April 23-May 10, 2015
Real Time Sessions (RTS): Thursday, April 30; 8:30-10:30 pm ET (US)
Course RTS Times in Your Area: World Clock Converter

Practice Sessions: In order to prepare you for a successful experience in your CE course, we request you attend a Practice Session prior to the first Real Time Session. Please arrive promptly at the start time; each Practice Session is up to 1 hour in length. For more information, please visit the CE Practice Area.

*The instructors for this course will be using audio which will require you to have a headset or speakers to listen. If you have any concerns regarding your computer's audio capabilities, please be sure to attend one of the Practice Sessions.

Level and Prerequisites: This basic course will be open to veterinarians and veterinary support staff actively interested in learning how to evaluate their practice to reduce the risk of theft, diversion or prosecution for failure to maintain an adequate system of security and accountability for controlled substances.
VIN CE Course: Open to veterinarians and veterinary support staff. This course has been submitted for RACE approval for veterinarians and veterinary technicians. The Veterinary Information Network (VIN) is RACE Provider #22.

Course Description:
Participants will learn the federal requirements that apply to the security and accountability for controlled substances in veterinary practices, including:

• Why it is important to develop a good system for your practice
• Structure of applicable federal laws and how to find them
• Schedules of controlled substances
• Laws pertaining to ephedrine and other list 1 substances
• Registration requirements
• Use of agents
• Employee screening and criminal background checks
• Components of a distribution system
• Receiving and ordering records
• Storage requirements and disposal
• Disposition & dispensing records
• Audit requirements and recommendations
• Medical record documentation including computerized medical records
• Duty to report loss or theft
• Retention of records
• Inspections and inspectors
• Distribution to other practitioners and filling of prescriptions written by other practitioners
• Penalties

The second portion of the course addresses Food and Drug issues relating to veterinary practice, including:

• Structure of federal laws and regulations, and where to find them
• FDA friend or foe?
• Compliance policy guides
• How to respond to proposed regulations or compliance policy guides
• AMDUCA and when extra label use is allowed
• Compounding vs. manufacturing issues

This course consists of one (1) 2-hour Real Time Session, supplemental library materials, interactive message board discussions, and a mandatory end-of-course test. Successful completion (scoring 80% or better) on the end-of-course test is required to earn a certificate of completion for the course.

To learn more about the requirements for earning a CE certificate, please refer to Receiving Your CE Credit and Course Completion Certificate.

Upon completion of this course, the participant should be able to

• evaluate their current practices, and if needed, implement improvements that reduce the risk of theft, diversion or prosecution for failure to maintain an adequate system of security and accountability for controlled substances.
• better comprehend the actions of the FDA and will know how to express their opinions to the FDA representatives.
• recognize when they can use drugs in an extra-label manner and when they are engaging in activities that are of enforcement priority by FDA.
• recognize when he/she can use compounded drugs in veterinary practice.

Course Materials: Course materials will be available in the course library prior to each Real Time Session.

Required Textbook(s): There is no required textbook for this course.

About the Instructors:
Douglas Kemp is board certified in Veterinary Pharmacy the International College of Veterinary Pharmacists (ICVP), 2000. He earned a Doctor of Pharmacy (Pharm. D) from Mercer University in 1975. He worked as the Clinical Pharmacy Associate and Director of Pharmaceutical Services at the University of Georgia college of Veterinary Medicine for 25 years. Following retirement from UGA in 2004 Dr. Kemp worked in independent community pharmacies and in a 300 bed human hospital pharmacy until re-retirement in May of 2014. Douglas was a member of the Veterinary Medicine (Information Division) Expert Committee, USP, served on FDA committees and served on the Pharmaceutical Administration Board, Department of Administrative Services, State of Georgia for many years.

Course Outline:
Week 1 (Real Time Session April 30, 2015)
Required Reading (prior to April 30th Real Time Session): Daily postings on the course message boards.
Content: Controlled Substances

CE Credits: 3

Tuition: Member $63 ($57 early bird special if enrolled by April 9, 2015)
Non-Member $130 ($117 early bird special if enrolled by April 9, 2015)

*To ensure participants are ready and prepared for classes, enrollment will close on April 30, 2015 at 5 pm ET (USA) or when the maximum number of participants is reached.
*For more information on how online CE works, see the Participant Resource Center.

To Enroll:
Enrollment is closed.

1. Enrollment qualifications: VIN CE courses are open to VIN member and non-member veterinarians. Veterinarians enrolling in a VSPN CE course must be a VIN member. Veterinary support staff must be a VSPN member to enroll in a VSPN CE or a VIN CE course open to VSPN member enrollment.
2. Each enrollee must be able to receive emails from @vspn.org and @vin.com addresses. Email is our major form of communication with participants; personal emails are highly recommended rather than clinic/hospital email addresses.
3. Each person is individually responsible for his/her own registration. To ensure that all information received is secure and correct, please do not enroll for a course on behalf of another individual.
4. For further assistance call 800-846-0028 ext. 797 or email CEonVIN@vin.com. Please include the course title, your full name, and contact information in your correspondence.

*Note: "This course is approved for 3 continuing education credits in jurisdictions which recognize AAVSB RACE approval; however participants should be aware that some boards have limitations on the number of hours accepted in certain categories and/or restrictions on certain methods of delivery of continuing education." Call VIN CE at 800-846-0028 ext. 797 for further information. (Attendees are encouraged to check with their licensing jurisdiction(s) for information regarding recognition by their board).

Course withdrawal and refund policy: A complete refund of the paid course price will be issued when your withdrawal request is received prior to the listed start date of the course. If you wish to withdraw after the start date please contact the VIN office 800-846-0028 ext. 797 to discuss eligibility for a pro-rated refund.
* Note: To ensure rapid handling of your request for withdrawal, we recommend that you call the VIN office at 800-846-0028 ext. 797.

*For more information on VIN's upcoming CE courses, check the VIN Course Catalog.

Katherine James, DVM, PhD, DACVIM (SAIM)
VIN Education Coordinator

VIN CE Services: CEonVIN@vin.com
800-846-0028 or 530-756-4881; ext. 797
or direct line to VIN/VSPN from the United Kingdom: 01452 226154
or direct line to VIN/VSPN from Australia: 02 6145 2357

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800.700.4636  |  CEonVIN@vin.com  |  530.756.4881  |  Fax: 530.756.6035 777 West Covell Blvd, Davis, CA 95616 Copyright 2002, Veterinary Information Network, Inc.