News & Analysis as of

FDA Approval Food and Drug Administration (FDA) Pharmacies

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

Hendershot Cowart P.C. on

For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Holland & Knight LLP

Eli Lilly Strikes Back Against Pharmacy Compounders and Telehealth Platforms

Holland & Knight LLP on

Telehealth companies selling compounded drugs are making modest inroads into the market for popular weight loss drugs that Big Pharma spent decades and billions of dollars to develop and bring to market. The compounded...more

Goodwin

Celltrion, Samsung Bioepis, and Organon Receive Interchangeability Designations for Adalimumab Biosimilars

Goodwin on

In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars.  Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without...more

BakerHostetler

FDA Approves Abortion Pill for Sale by Retail Pharmacies

BakerHostetler on

Key Takeaways: ..The FDA has finalized a rule permitting abortion pills to be sold at certified retail pharmacies. ..Mifeprex and its approved generic can now be dispensed by certified pharmacies or by or under the...more

Quarles & Brady LLP

FDA Approval of Pfizer Vaccine – Everything Prescribers, Pharmacies, & Vaccine Administrators Want to Know & Forgot to Ask

Quarles & Brady LLP on

The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more

Shumaker, Loop & Kendrick, LLP

Client Alert: Update on Florida’s Canadian Prescription Drug Importation Program

This year, Florida Governor Ron DeSantis signed into law a bill that creates Florida Statute Section 381.02035, which establishes the Canadian Prescription Drug Importation Program within the Agency for Health Care...more

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