Karla Palmer | Hyman, Phelps & McNamara, P.C.

Prioritize FDA Inspection ReadinessNovember 1st, 2022
A decade ago, questions still lingered among pharmacies concerning whether FDA had a legal right to conduct an inspection of their facility. After all, Section 704 of the Federal Food, Drug, and Cosmetic Act (FDCA) seems to exclude (at least to a degree) a pharmacy …
Distribution and Marketing of Drugs in the United States: An OverviewFebruary 1st, 2020
The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations. To compare answers across multiple jurisdictions, visit the Distribution and Marketing of Drugs Country Q&A …
Article, Compounding Remains an FDA Priority: Agency Announces 2018 ‘Compounding Priorities Plan’ and Several Compounding Guidances, Including Guidance on ‘Essentially Copies’ and RepackagingMarch 27th, 2018
In January, FDA announced the release of its 2018 “Compounding Priorities Plan.”1 FDA also released several guidance documents in the wake of its announcement, such as its final guidance on essentially copies of commercially available drug products for Section 503A and 503B facilities, and guidance …
Book Chapter, Co-Author, “Ch. 25: DEA Regulation of Controlled Substances, ” Food and Drug Law and Regulation (FDLI)January 1st, 2015
Article, The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?February 4th, 2014
After months of Congressional consideration throughout the year, on November 27, 2013, President Obama signed into law the “Drug Quality and Security Act” (DQSA). Title I of the DQSA, titled the Compounding Quality Act, both removes the unconstitutional advertising and promotion provisions that for years plagued …
Article, Court Ruling Casts Doubt On FDA’s Use Of Guidance DocumentsDecember 16th, 2011
In a new Legal Backgrounder published by the Washington Legal Foundation, Jeffrey N. Gibbs and Karla L. Palmer write that a recent Florida federal district court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have implications that extend broadly to …
Article, In the Name of Graduate Medical Education: What Mount Sinai Medical Center’s FICA Tax Victory Means for Today’s Teaching HospitalsFebruary 1st, 2010
After a multi-year battle in federal district and appellate courts, a nonprofit teaching hospital in south Florida was able to walk through a door that the Eighth Circuit and a district court in Minnesota first opened in the cases of Minnesota v. Apfel and United …