Tuesday, May 25, 2021
(11:00 PT / 12:00 MT / 2:00 ET)
for Technician or Student Members
$55 for Pharmacist Members
$75 for Non-Members
Alliance for Pharmacy Compounding
Credentialing, Pharmacy Practice
A growing number of compounding pharmacies are developing an online business model. This move into the online space is precipitated by advances in technology and has been fast-forwarded by the pandemic. As the move into the online space increases, the challenge for industry stakeholders is to maintain quality control and legally compliant operations. A tool to meet this challenge is accreditation. An important goal of accrediting online pharmacies is to distinguish legitimate online pharmacies (that have invested in technology, qualified personnel and systems) from “fly-by-night” online pharmacies that are only in business to make quick money. There are two organizations that accredit online compounding pharmacies: NABP .Pharmacy and LegitScript. The challenge for online compounding pharmacies is that if they have received an FDA Form 483 and/or an FDA Warning Letter, and if the FDA has not officially closed out the Form 483 and Warning Letter, then it is unlikely that NABP .Pharmacy and LegitScript will accredit the pharmacy. This places an unfair burden on the pharmacy because (i) a Form 483 and Warning Letter do not constitute a citation or violation – but rather – constitute the FDA’s observations and (ii) it is the exception, not the norm, for the FDA to officially close out Form 483s and Warning Letters. This program will discuss (i) the requirements that online compounding pharmacies must meet to obtain accreditation; (ii) the view of NABP .Pharmacy and LegitScript towards Form 483s and Warning Letters; (iii) the actions that NABP .Pharmacy and LegitScript require pharmacies to take that have received Form 483s and Warning Letters; and (iv) the arguments that compounding online pharmacies can make that support their position that closing out of the Form 483s and Warning Letters by the FDA should not be a prerequisite to receive accreditation.
Learning Objectives for Pharmacists:
• Outline the steps to obtain accreditation as an online pharmacy from NABP .Pharmacy and LegitScript.
• Discuss the legal effect of a pharmacy receiving an FDA Form 483 and an FDA Warning Letter.
• Describe the procedure for the FDA to officially close out a Form 483 and Warning Letter.
• Review the arguments to make that support the position that closing out the Form 483 and Warning Letter by the FDA should not be a perquisite to receiving accreditation.
This lesson is a knowledge-based CE activity and is targeted to pharmacists.
The UNC Eshelman School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is approved for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists. UAN #: 0046-9999-21-130-L04-P.
If you are interested in earning credit for this program, please note that you will be asked to enter your NABP e-Profile ID during the credit selection step of the registration process. If you have not yet registered your NABP e-Profile ID, please visit www.nabp.net.
CE credit and certificates of attendance will be provided only to those individuals who registered and logged into the webinar online. If you want CE credit and your certificate of attendance, you must have purchased the program and logged into the web portion under that registration so that we can verify attendance.
If applicable, you may obtain credit in multiple jurisdictions simultaneously for this program (see pending/approved list below). Registrants in jurisdictions not listed below will receive a Certificate of Attendance/Completion that may or may not meet credit requirements in other jurisdictions. Where applicable, credit will be only awarded to a paid registrant attending the live program at their own computer and phone.
How to Attend
Join the live program from your office, home, or hotel room using a computer with high speed internet. You may ask questions, participate in surveys, and post comments from your computer during the program. Please note that credit (if available) is only provided to registered attendees participating at their own computer and phone. Simple instructions with a link to the program will be sent when you register and again the day before the webinar.