Overview / Abstract
This one hour webinar is an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today. Attendees will learn how regulatory initiatives and court decisions have influenced the regulation of compounders, the authority of the Food and Drug Administration (FDA) when inspecting compounding pharmacies, and up-to-date information on the current federal proposed legislation. Are YOU current on your compounding pharmacy law? Never assume. This is one hour you do not want to miss!
At the conclusion of this program, the pharmacist and technician attendee will be able to:
• Explain how compounders are regulated and enforced by the State Boards of Pharmacy, Food and Drug Administration (FDA), and Drug Enforcement Administration (DEA).
• List four different regulatory initiatives and two court cases that have defined FDA’s oversight to compounders.
• State what authority the FDA has when inspecting compounding pharmacies.
• Define “bulk ingredients” and the difference between “FDA-approved” products.
• Define “office use” and describe how compounding for office use differs from wholesaling.
• Describe key components of federal proposed legislation that may change the balance of existing federal and state authorities.
At the conclusion of this program, the pharmacist and technician attendee will be able to:
• Explain how compounders are regulated and enforced by the State Boards of Pharmacy, Food and Drug Administration (FDA), and Drug Enforcement Administration (DEA).
• List four different regulatory initiatives and two court cases that have defined FDA’s oversight to compounders.
• State what authority the FDA has when inspecting compounding pharmacies.
• Define “bulk ingredients” and the difference between “FDA-approved” products.
• Define “office use” and describe how compounding for office use differs from wholesaling.
• Describe key components of federal proposed legislation that may change the balance of existing federal and state authorities.
LIVE Activity Location Details
Online WebinarUnited States of America
Date(s)
11-14-2013 - 11-14-2016
LIVE, Online, Webcast
Credits / Hours
1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians.
Activity Certified By
This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians.
The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is applying for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians.
Is This Activity Certified for "Live" Credit?This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians.
The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is applying for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians.
YES
Activity Cost
$25 - $70
Presenters / Authors / Faculty
David G. Miller, RPh
Executive Vice President/CEO
International Academy of Compounding Pharmacists
David G. Miller, R.Ph. is Executive Vice President and Chief Executive Officer of the International Academy of Compounding Pharmacists. IACP represents more than 3,600 pharmacists, technicians, students, and members of the compounding community and 164,000 consumers who recognize the value of customized medication solutions provided by the art and science of pharmacy – compounding.
After receiving his bachelor of science inpharmacy degree from the University of Maryland School of Pharmacy in 1985, he joined the staff of the National Community Pharmacists Association (formerly NARD) as Director of Professional Affairs. In 1988, he accepted a position as Director of Professional Affairs for the Maryland Pharmacists Association and was promoted to serve as that organization’s Executive Director three years later.
Miller left the pharmacy association world in 1996 to become the Director of Pharmacy Affairs at Merck where he was responsible for corporate relations with the profession at the national and state level as well as with the academic community. During his tenure at Merck, he supported and participated in large scale demonstration projects that documented the value of pharmacists in improving adherence and compliance, developed innovative approaches for continuingeducation programs , and championed the public health role of pharmacists as immunizers and patient educators.
In 2010, he took over as CEO for IACP as it began its twentieth year. A passionate advocate for pharmacy, he has received numerous awards from national and state associations, served on committees and in advisory positions for the American Pharmacists Association (APhA), National Community Pharmacists Association (NCPA), National Association of Chain Drug Stores (NACDS), National Alliance of State Pharmacy Associations (NASPA), and many others. Miller lectures frequently on leadership development, strategic planning for organizations, and on advancing the profession of pharmacy.
Executive Vice President/CEO
International Academy of Compounding Pharmacists
David G. Miller, R.Ph. is Executive Vice President and Chief Executive Officer of the International Academy of Compounding Pharmacists. IACP represents more than 3,600 pharmacists, technicians, students, and members of the compounding community and 164,000 consumers who recognize the value of customized medication solutions provided by the art and science of pharmacy – compounding.
After receiving his bachelor of science in
Miller left the pharmacy association world in 1996 to become the Director of Pharmacy Affairs at Merck where he was responsible for corporate relations with the profession at the national and state level as well as with the academic community. During his tenure at Merck, he supported and participated in large scale demonstration projects that documented the value of pharmacists in improving adherence and compliance, developed innovative approaches for continuing
In 2010, he took over as CEO for IACP as it began its twentieth year. A passionate advocate for pharmacy, he has received numerous awards from national and state associations, served on committees and in advisory positions for the American Pharmacists Association (APhA), National Community Pharmacists Association (NCPA), National Association of Chain Drug Stores (NACDS), National Alliance of State Pharmacy Associations (NASPA), and many others. Miller lectures frequently on leadership development, strategic planning for organizations, and on advancing the profession of pharmacy.
Sponsors / Supporters / Grant Providers
Activity Specialities / Related Topics
This program is made possible through an unrestricted educational grant-in-aid from Freedom Pharmaceuticals, Inc.
Regulatory / Compliance / Risk Mgt, Preceptor & Mentor Development/Training, Pharmacology, Manufacturing, Law / Legal, Government / Regulatory, Education / Teaching, Compounding of Medications
Activity Disciplines
Pharmacy CPE, Law