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Maintaining Compliance in Pharmacy Compounding: Regulatory & Enforcement Updates

(80 reviews)

Produced on December 14, 2020

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$ 89 Health Care, Administrative, and Life Sciences In Stock
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Course Information

Time 1h
Difficulty Intermediate

Course Description

There have been significant changes in pharmacy compounding regulations since 2013. This program will address these changes and help attorneys keep their pharmacy clients compliant with Section 503A of the Federal Food Drug, and Cosmetic Act, as well as the various federal and state statutes, regulations, and guidance addressing compounding. Taught by Karla Palmer, Director at Hyman, Phelps & McNamara, P.C., the program will also address enforcement activities concerning compounding.

This program will benefit lawyers that advise pharmacy compounders, pharmacies, pharmacists, and owners of outsourcing facilities.



Learning Objectives:

  1. Review exactly what pharmacy compounding is and how it is regulated by states and the federal government
  2. Analyze the current regulatory environment for compounders and how to effectively represent pharmacies that engage in this highly regulated area
  3. Discuss guidance documents and regulations, and what is forthcoming in 2021
  4. Anticipate what compounders can expect when facing regulatory activity, including pharmacy inspections

Credit Information

After completing this course, Lawline will report your attendance information to {{ accredMasterState.state.name }}. Please ensure your license number is filled out in your profile to ensure timely reporting. For more information, see our {{ accredMasterState.state.name }} CLE Requirements page . After completing this course, {{ accredMasterState.state.name }} attorneys self-report their attendance and CLE compliance. For more information on how to report your CLE courses, see our {{ accredMasterState.state.name }} CLE Requirements FAQ .

Faculty

Karla Palmer

Hyman, Phelps & McNamara, P.C.

Karla L. Palmer focuses on DEA and FDA enforcement and litigation matters, with particular emphasis on Controlled Substances Act (CSA) issues. Ms. Palmer advises clients throughout the supply chain, from manufacturers and distributors to pharmacies and doctors on a range of issues including government inspections and investigations, warning letters, consent decrees, and administrative and federal proceedings. 


Ms. Palmer also advises compounding pharmacies and outsourcing facilities on all aspects of the Drug Quality and Security Act, and has closely followed developments in the law prior to and since its enactment in late 2013. 


Over the course of her career, Ms. Palmer has been involved in all aspects of commercial litigation. She has served as trial counsel in federal, state, and administrative courts in the District of Columbia, Florida, Illinois, Maryland, New York, Nevada, Pennsylvania, Kansas, Virginia, and before the Court of Federal Claims, the U.S. Tax Court, and Federal Energy Regulatory Commission (FERC). She also has significant arbitration and mediation experience. 


Before joining Hyman, Phelps & McNamara in 2010, Ms. Palmer was a partner at a large international law firm where she was head of the Washington, D.C. trial department and co-partner-in-charge of its national recruiting program. Following law school, Ms. Palmer clerked for the Honorable Claude M. Hilton, former Chief Judge of the U.S. District Court for the Eastern District of Virginia, Alexandria Division. She has served as both lead and local counsel in the Eastern District of Virginia. 


While in law school, Ms. Palmer was an associate editor of The University of Richmond Law Review, a member of the McNeill Law Honor Society, and a legal writing teaching assistant. 


Ms. Palmer is an immediate past member of the Board of Directors of the Law School Alumni Association at the University of Richmond, and is a former board member of Chattering Children, a nonprofit that provides speech and language education, therapy, and services to hearing impaired children throughout the Washington, D.C. area. 



Reviews

HJ
Hilary J.

Great speaker. She really knew her subject and kept it moving

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