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Compounded medicines at center of complex web of federal and state regulations

In Georgia, the compounding of medications is regulated by the eight-member Georgia Board of Pharmacy, and under its rules, pharmacists may prepare compound drugs only for a valid prescription order or as part of routine prescription filling. If they start to produce large amounts of drugs without prescriptions, they are considered manufacturers. In a law […]

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FDA pharmacy committee approves 2 substances for compounded medications, rejects 3 others

Two bulk substances that can treat warts and skin discoloration have been approved for use in compounded medications in a meeting of the U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee. Three other ingredients were kept off the list by the eight-member committee, following the FDA’s recommendation. It also unanimously voted to classify transdermal […]

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5 rules for a compounding pharmacy facing an FDA inspection

The FDA has put greater scrutiny on compounding pharmacies since August 2016, with inspectors making preliminary assessments on compliance for patient-specific prescriptions and other rules under Section 503A of the federal Food, Drug and Cosmetic Act. The change allows investigators to cite deviations from the current good manufacturing practices when it appears the pharmacy does […]

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Why your compounding pharmacy faces greater risk under new federal inspection rules

A change in the methods Food and Drug Administration (FDA) inspectors follow when inspecting compounding pharmacies could result in drastic regulatory outcomes. Since August 1, 2016, FDA investigators have been making preliminary assessments during inspections of non-outsourcing facilities on whether the facility is compounding human drugs in accordance with certain provision of Section 503A of […]

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HLG Wins Prestigious Best Law Firm Ranking

The Hasson Law Group has been selected as one of Metro Atlanta’s Best Law Firms in the areas of Tax Law, Non profits & Charities Tax Law (Both Tier 1) and Business Litigation – Tax (Tier 3) for 2016 in US News & World Report – Best Lawyers ranking. The U.S.News – Best Lawyers “Best Law […]

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Welcome James K. Hasson, Jr.

The Hasson Law Group is thrilled to announce that James K. Hasson, Jr. has joined the firm. If the name is familiar, it’s because Jim is the father of the Keith Hasson, our firm’s founder. Jim has experience in advising both individuals and businesses about a wide variety of business transactions, ranging from business formation to business sales and purchases.

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