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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 (FDA) recent determinations that both semaglutide and tirzepatide shortages are officially resolved. Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act prohibit physicians, pharmacies, and outsourcing facilities from compounding essential copies of commercially available approved drugs. However, essential copies of approved drugs may be compounded when such drugs are included on the FDA’s drug shortage list. The FDA will take action against those continuing to compound these medications after the enforcement deadlines. Providers should start transition planning now. For more videos, make sure to subscribe via: https://bit.ly/2rEKFwn Website - https://www.hchlawyers.com/ LinkedIn - https://www.linkedin.com/company/hendershotcowart Facebook - https://www.facebook.com/HendershotCowart/ Instagram - https://www.instagram.com/hendershotcowart/ ABOUT KEITH LEFKOWITZ Keith Lefkowitz is an experienced regulatory and transactional attorney with a dual focus on health law and commercial leases. Keith understands the business of health care and routinely helps clients navigate fraud and abuse laws while ensuring that their company objectives are achieved. Keith is intimately familiar with healthcare laws and regulations, including the Stark Law, Anti-Kickback Statute, and False Claims Act. Keith’s practice primarily focuses on M&A matters for our healthcare clients and reviewing, drafting, and negotiating contracts and agreements, as well as compliance programs. He also represents clients in connection with OIG, False Claims Act, Texas Medical Board, Texas Board of Nursing, and other regulatory body investigations. ABOUT HENDERSHOT COWART P.C. At Hendershot Cowart P.C., we work with business and healthcare clients who are fiercely protecting their livelihoods. From start-up ventures to established institutions, we advise, prepare, and protect your business or medical practice from start to finish. Our law firm is based in Houston, Texas, but we serve clients throughout Texas and the nation. We shoulder the legal burden – so you can get back to business. Contact us today at 713-677-2063. ATTORNEY ADVERTISING This information should not be construed as legal advice or a legal opinion on any specific facts or circumstances. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. The contents are intended for general informational purposes only, and you are urged to consult your attorney concerning any particular situation and any specific legal question you may have.
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