Coming Into Compliance With the Drug Supply Chain Security Act (DSCSA)

(148 Ratings)

Produced on: April 10, 2018

Course Format On Demand Audio

Taught by

Categories:

Course Description

Time 62 minutes
Difficulty Intermediate

In 2013, Congress enacted the Drug Supply Chain Security Act (DSCSA). The DSCSA applies to pharmaceutical manufacturers, distributors, repackagers and dispensers. Several of its requirements become mandatory in 2019 through 2023; however, it has become clear that many dispensers are currently not in compliance with the Act, and are not prepared to be compliant with the requirements that are soon-to-come. The FDA is currently working with the industry to determine exactly what the methods of compliance should be.

This course , presented by healthcare attorneys Melanie Bork Graham and Christopher Ezold, will address the requirements of the DSCSA, methods for compliance, the FDA’s guidance, and a discussion of how the FDA and the industry are working together to determine standards of compliance.


Learning Objectives:

  1. Discuss the DSCSA and the requirements going into effect next year and beyond

  2. Examine potential methods of compliance for the DSCSA

  3. Explore the FDA’s guidance, and how the agency is working with the industry to determine compliance standards

Faculty

Christopher Ezold

The Ezold Law Firm, P.C.

Christopher Ezold focuses his practice in three areas: representing businesses as outside general counsel; providing wrap-around legal services to health care practitioners and practices; and representing executives with regard to their contracts and equity rights.  In his practice, Mr. Ezold has negotiated, drafted and litigated corporate merger and acquisition documents, commercial contracts, real estate contracts, employment and restrictive covenant agreements, equity and buy-sell agreements, settlement agreements and a variety of other contracts.  

Mr. Ezold has been a member of the Board of Directors of the Main Line Chamber of Commerce, as well as its General Counsel, and is the current Chair of the Health Law Section of the Delaware State Bar Association.  Mr. Ezold is licensed to practice law in the Commonwealth of Pennsylvania and the States of Delaware and New Jersey; he graduated from the Villanova University School of Law in 1995, and obtained an LL.M. in taxation in 2009.

Melanie Graham

The Ezold Law Firm, P.C.

Melanie Bork Graham, Esquire, is the Healthcare Practice Lead at The Ezold Law Firm, P.C.  Melanie concentrates her practice on counseling health care providers and business associates.  Melanie is currently a candidate for a Masters of Public Health at Thomas Jefferson University, writing her thesis on the exchange of super protected data in Pennsylvania, and is certified as a CIPP/US with the International Association of Privacy Professionals (“IAPP”).  

Melanie serves as Co-Chair to the Philadelphia Chapter of the International Association of Privacy Professionals, a board director for White Horse Village, an accredited continuing care retirement community, on the Education committee the Pennsylvania Medical Management Association and formerly served on the Super Protected Data Committee of the Pennsylvania eHealth Partnership Authority.

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