"Legal Issues Facing Physicians in the Compounding Pharmacy Industry" - Sponsoredby Supportedby This program is being funded by an educational ...

“Legal Issues Facing Physicians in the
   Compounding Pharmacy Industry”

  Sponsored by                                        Supported by

This program is being funded by an educational grant from Brown & Fortunato, P.C.

Faculty
Elizabeth J. Jepson, Esq

Bradley Howard, Esq

Lisa Smith, Esq

COURSE DESCRIPTION
Compounding pharmacies have made headlines several times in the last year as a result of the
bad practice of a few pharmacies. The New England Compounding Center meningitis outbreak in
October 2012 is probably the most highly publicized event and it continues to have a devastating
impact on individuals who received injections of contaminated medication compounded by New
England Compounding Center. There has been an exponential increase in the number of onsite
inspections conducted by the Food and Drug Administration (“FDA”) in the last few months, in
attempt to further regulate the industry and prevent catastrophic events like the meningitis
outbreak.

With all the attention given to compounding pharmacies, it is vital that physicians know and
understand the appropriate role of pharmacy compounding, as well as legal considerations that
can impact compounding pharmacies and the physicians that prescribe compounded
medications.

This CME online activity is designed to familiarize physicians with this process, as well as to
understand current and pending federal laws and regulations governing compounding
pharmacies. Federal and state laws and regulations regarding physicians relationships with
compounding pharmacies will be discussed. Special emphasis will be given to the current status
of the Anti-Kickback Statute and the Stark Law. This activity will be vital to all healthcare
providers utilizing the services of compounding pharmacies.
Please join Elizabeth J. Jepson, Esq, Lisa Smith,Esq and Bradley Howard, Esq, attorneys at Brown
& Fortunato, P.C., a leading healthcare law firm, for this important presentation.

COURSE OBJECTIVES

Understanding current and pending federal laws and regulations
governing compounding pharmacies

Improving familiarity with federal laws concerning the health
care industry, including the Anti-Kickback Statute and Stark Law

Identifying suspect arrangements involving compounding
pharmacies, including physician investment in compounding
pharmacies, waiver of copayments, and sampling practices

Faculty Disclosure
As an organization accredited by the IMQ/CMA, The Institute for Medical Education requires everyone who is in a position
to control the content of an education activity to disclose all financial relationships with any commercial interest. The
ACCME defines “financial relationships" as financial relationships in any amount, occurring within the past 12 months,
including financial relationships of a spouse or life partner that could create a conflict of interest.
The Institute for Medical Education encourages speakers to identify investigational products or off‐label uses of products
regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.

Faculty Member:

Elizabeth J. Jepson, Esq
Affiliation/Financial Interest                                              Name of Organization
No financial relationships

Lisa Smith, Esq
Affiliation/Financial Interest                                              Name of Organization
No financial relationships

Bradley Howard, Esq
Affiliation/Financial Interest                                              Name of Organization
No financial relationships

Reviewer Disclosures
To ensure fair balance, and avoid bias, the content for this
activity has been reviewed by an independent medical/legal
expert with no relevant financial relationships for scientific
content and lack of commercial bias. The activity has been
approved by The Institute for Medical Educationsm

                    Staff Disclosures
In compliance with the ACCME's Standards for Commercial
Support, employees of The Institute for Medical Education, who
have control over content of an activity, are required to disclose
their financial relationships. No employee has a financial
relationship regarding this activity

PLANNING COMMITTEE

Edwin J. Jacobson, MD, PhD
Medical Director-IME
Clinical Professor of Medicine, David Geffen School of Medicine at UCLA
Affiliation/Financial Interest                                   Name of Organization
Nothing to disclose

Claudine Hanna, MPH
Program Manager-IME
Affiliation/Financial Interest                                 Name of Organization
Nothing to disclose

Anisa Flores, B.A.
Program Planner-IME
Affiliation/Financial Interest                                 Name of Organization
Nothing to disclose

Robert Mengels, Esq.
Reviewer and Peer Reviewer
Affiliation/Financial Interest                                 Name of Organization
Nothing to disclose

Accreditation Statement:
The Institute for Medical EducationSM is accredited by the Institute for Medical Quality/California
Medical Association (IMQ/CMA) to provide continuing medical education for physicians. The
Institute for Medical Education SM takes responsibility for the content, quality and scientific
integrity of this CME activity.

 Credit Designation Statement:
The Institute for Medical Education S M designates this educational activity for a maximum of 1
AMA PRA Category 1 Credit (s) ™. Physicians should only claim credit commensurate with the
extent of their participation in the activity. This credit may also be applied to the CMA Certification
in Continuing Medical Education. In accordance with the ACCME’s revised Standards of
Commercial Support, potential conflicts of interest are thoroughly vetted by the Executive
Committee of IME. All conflicts are resolved prior to the beginning of the activity by the IME peer
review process. The opinions expressed in this activity are those of the faculty and do not
necessarily reflect those of IME.

Provider approved by the California Board of Registered Nursing, provider number 10672 for a
maximum of 1 contact hour(s).

Approved for Medical Ethics/Professional responsibility by the Texas Medical Board, for
1 ethics hour credit.

CULTURAL AND LINGUISTIC COMPETENCY:
California Assembly Bill 1195 requires continuing medical education activities with patient
care components to include curriculum in the subjects of cultural and linguistic
competency. The planners and speakers of this CME activity have been encouraged to
address cultural issues relevant to their topic area. The Institute for Medical Education
sm, Resources for Physicians also contains many useful cultural and linguistic competency
tools including culture guides, language access information and pertinent state and
federal laws. You are encouraged to visit the portal:
http://www.ime‐cme.com/forms/Cultural_Linguistic_Competency_Resources.pdf

              Hardware/Software Requirements
To view this activity you will need Internet Explorer 7.0+ or Firefox 3.0+ with Windows
Media Player 9+, RealPlayer 12+, or Adobe Flash Player 9+.
Be sure to disable your pop-up blocking software.

Method of Participation/How to obtain
               CME Credit:
There are no fees for participating in and receiving CME credit for this activity.
In order to obtain CME credit for any of the accredited online activities,
participants must:

         1) read the learning objectives and all disclosures
         2) study the educational activity
         3) please return to the home page for this activity, then print out and
complete the registration form and post-test (score of 70% or better required
for passage).

Please return the registration form and post-test to IME by email or fax as
shown on the forms. Please be sure to print or type legibly so that there will
be no delay in receiving your credit and certificate. You will receive your CME
attendance and credit certificate by email within 4-6 weeks.

     Thank you for participating in these important educational activities.