Pharmacy Regulatory Compliance Archives

Pharmacy Compliance with CalRecycle Pharmaceutical and Sharps Stewardship Program

California requires pharmacies, wholesalers, and manufacturers to comply with regulations that facilitate consumer disposal of pharmaceutical and home-generated sharps waste. The program, administered through CalRecycle, requires manufacturers and wholesalers to identify themselves and their products and to engage with approved stewardship organizations to implement disposal programs. Although the bulk of responsibility lies with wholesalers and …

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PBM Enrollment Denials for Common Association Regardless of Acquisition Structure

In the world of Pharmacy Benefit Manager (PBM) enrollment, guilt by association is one of the most common reasons PBM’s deny new pharmacy owners network access. Boesen & Snow often represents new clients who come to the firm with PBM enrollment denials due to alleged common associations with persons or entities with significant audit findings …

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Novo Nordisk Files Lawsuits Against Med-Spas Distributing the Compounded Semaglutide: Highlight the Problematic Nature of Operating Pharmacies and Med-spas

Novo Nordisk filed lawsuits against multiple med-spas that are distributing compounded versions of Semaglutide. Semaglutide is the main ingredient in Ozempic, Wegovy, and Rybelsus—popular weight-loss medications. Their popularity resulted in nationwide shortages and the FDA listing Ozempic and Wegovy on the shortage list. Under certain conditions, compounding facilities can manufacture drugs identical, or near identical, …

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USP General Chapter Revisions for 795 and 797 Published Today (November 1, 2022)

The much anticipated USP General Chapter revisions for non-sterile and sterile compounding were published today. New and Updated Notices | USP-NF (uspnf.com) Please let us know if you need our firm of pharmacists, attorneys, and pharmacist-attorney to help your organization understand not just what the changes are, but more specifically how these will affect your …

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PBM Audits Move Fast. Start Preparing Your Defense Today!

Don’t Wait! Build a relationship with an Experienced Pharmacy Law Team One of the more stressful parts of going through Pharmacy Benefit Manager (PBM) audit is that, by the time the average pharmacy hires experienced pharmacy law attorneys to defend their business, there may only be two weeks or less to formulate a successful response. …

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FTC Reverses Previous Deadlock in Pivotal Vote to Probe Pharmacy Benefit Managers’ Practices

On June 7, 2022, in a unanimous 5-0 vote, The US Federal Trade Commission reversed a previous 2-2 deadlock vote that will result in the commissions probe of pharmacy benefit managers including the top six PBMs; CVS Caremark, Express Scripts, Inc. OptumRx, Inc., Humana Inc., Prime Therapeutics LLC and MedImpact Healthcare Systems, Inc. After the …

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Shared Service Agreements in the Pharmacy Industry

The last decade has seen a rise of so-called “shared service agreements” (“SSA’s”) within the pharmacy industry. These agreements, utilized by pharmacies under common ownership and pursuant to a contract between pharmacies that are not under common ownership, enable pharmacies to work with each other to perform certain prescription dispensing tasks. For example, one pharmacy …

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New York Enacts PBM Licensing and Oversight Laws

On January 2, 2022, New York Governor Kathy Hochul announced the signing of legislation S.3762/A.1396 that seeks to regulate pharmacy benefit managers (“PBM”). PBMs doing business in New York must immediately register with the Superintendent of Insurance, be licensed by the Department of Financial Services by 2022 and renew their licenses every three years. The …

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Boesen & Snow Law Successfully Overturns $1,000,000 in PBM Audit Findings for Specialty Pharmacy Client

Boesen and Snow successfully assisted an independent specialty pharmacy appeal the findings of a major PBMs desktop audit. The preliminary audit consisted of over $1,000,000 in discrepancies, most of which the PBM considered unappealable. Boesen and Snow utilized a multifaceted argument to appeal the “unappealable” claims including a unique presentation of prescription documentation, prescriber statements, …

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Looking to Buy a Pharmacy? Be Sure to Do Your Due Diligence

Purchasing your own pharmacy can be wonderful opportunity to flex your entrepreneurial muscles, while providing the best for your patients. Indeed, the notion of being your own boss, being able to practice pharmacy in the way that you think is best, and increasing your earning potential are all good, sound reasons to consider buying your …

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