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Pharmacies Regulatory Requirements

Foley & Lardner LLP

GLP-1 Drugs: Ohio Board of Pharmacy Issues FAQs for Compounders

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Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more

Jackson Lewis P.C.

City of Long Beach to Require Staffing for Self-Check Out

Jackson Lewis P.C. on

The City of Long Beach introduced a new ordinance aimed at curbing retail theft and improving safety in grocery and drug stores that use self-service checkout stations. The ordinance applies to “drug retail establishments”...more

Hogan Lovells

Turnaround of Medical Cannabis in Germany? – Draft bill by new German Government to address alleged missteps

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On June 18, 2025, the Federal Ministry of Health (Bundesministerium für Gesundheit - BMG) published a draft bill proposing severe amendments to the German Medical Cannabis Act (Medizinal-Cannabis Gesetz - MedCanG) – just a...more

Hogan Lovells

Pharmacy compounding under the EU pharma law package

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Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more

McGuireWoods LLP

Pharmacist Has Key Role in Assessing “Legitimate Medical Purpose” of Controlled Substance Prescriptions

McGuireWoods LLP on

Federal Controlled Substance Act regulations require that prescriptions for controlled substances be issued only for legitimate medical purposes by individual practitioners acting in their usual course of professional...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - June 2025 #1

News Briefs - Healthcare M&A Expected to Rebound, Post-Acute Care to See Most - Economic uncertainties may have put a damper on healthcare M&A during the first quarter of the year, but many still expect a rebound as 2025...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

Dinsmore & Shohl LLP

Mixing Medicine and Risk: Ohio’s Joint Regulatory Statement Targets Retail IV Therapy Clinics

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On May 15, 2025, the State Medical Board of Ohio, the Ohio Board of Pharmacy and the Ohio Board of Nursing (collectively, the “Boards”) jointly issued a significant regulatory statement (the “Statement”) clarifying the legal...more

Bradley Arant Boult Cummings LLP

DEA Proposed Rule for Special Registrations for Telemedicine and Limited State Telemedicine Registrations

On January 17, 2025, the Drug Enforcement Administration (DEA) released the proposed rule, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations.” The proposed rule marks a significant first...more

Quarles & Brady LLP

Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits

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On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

Bass, Berry & Sims PLC on

The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...more

Quarles & Brady LLP

Alabama Bill Rewriting Pharmacy Practice Act Clears Senate Hurdle

Quarles & Brady LLP on

As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more

McDermott Will & Schulte

This Week in 340B: March 25 – 31, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Maynard Nexsen

The Alabama Community Pharmacy Relief Act: Key Provisions and Legislative Journey

Maynard Nexsen on

Introduction The Alabama Community Pharmacy Relief Act, Senate Bill 252, has successfully passed the Alabama Senate and is now advancing to the House for consideration. This legislation aims to regulate pharmacy benefits...more

Bass, Berry & Sims PLC

Illinois Board of Pharmacy Adopts New Licensure Requirement for Out-of-State Pharmacists-in-Charge

Beginning January 1, 2026, the Illinois Board of Pharmacy will require “out-of-state” (non-resident) pharmacies licensed or seeking licensure in Illinois to have a pharmacist-in-charge (PIC) who is licensed in Illinois....more

McDermott Will & Schulte

This Week in 340B: March 18 – 24, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

Hendershot Cowart P.C. on

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

McDermott Will & Schulte

This Week in 340B: March 11 – 17, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

Trending in Telehealth: February 2025

Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

McDermott Will & Schulte

California Introduces Bill to Protect 340B Contract Pharmacy Arrangements

California legislators recently introduced AB 1460, which would prohibit prescription drug manufacturers from engaging in discriminatory practices aimed at providers participating in the 340B drug pricing program (covered...more

McDermott Will & Schulte

This Week in 340B: March 4 – 10, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Foley & Lardner LLP

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is...

Foley & Lardner LLP on

On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more

Hogan Lovells

Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing

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The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more

McDermott Will & Schulte

Semaglutide Shortage Resolved

On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

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