For the twenty-third year, during the early summer months, the International Academy of Compounding Pharmacists (IACP) held its Compounders on Capitol Hill meeting in Washington, D.C. from June 10-13, 2017. Keith S. Hasson, founder of the Hasson Law Group, attended the meeting as the guest of two of his long-time […]
Keith Hasson authored an article published by Law360 on March 28, 2017, discussing the ongoing regulatory updates compounding pharmacies must monitor, including changes in the U.S. Food and Drug Administration (FDA) inspection methods and the proposed rule adding new bulk substances that can be used in compounding.
As the federal trial of the New England Compounding Center (NECC) continues, Keith Hasson was quoted in Pain Medicine News on Feb. 16, 2017, discussing the ongoing crackdown compounding pharmacies face from the Drug Quality and Security Act. A recent report from the FDA stated that the administration has issued […]
Nonsterile drug compounding, which refers to formulating medications that patients drink, swallow or apply to the skin, is the most common kind of drug compounding done in community and hospital pharmacies. Despite the nonsterile designation, preventing contamination is still a key part of compliance with legal and professional standards, such […]
The U.S. Food and Drug Administration has proposed adding a list of bulk drug substances that can be used in compounding to Section 503A of the Federal Food, Drug and Cosmetic Act. The rule proposed on Dec. 15, 2016, includes six bulk drug substances: Coomassie Brilliant Blue G-250, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, […]
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 […]
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 […]
The FDA released guidance that represents the agency’s current thinking on insanitary conditions, which can be defined as “so dirty or ridden with germs as to be a danger to health.” So what conditions are potential pitfalls for compounding pharmacies?
Note: This article was published Nov. 3, 2016, in Specialty Pharmacy Times. Fraud is a leading concern of federal investigators and the compounding pharmacies they oversee. Compounded drugs are covered by Medicare’s Part D program, and they accounted for a 56 percent increase in costs over the last year, according to […]
An amendment to the Georgia Pharmacy Practice Act that went into effect July 1, 2016, authorizes the Board of Pharmacy to create rules for the permitting of outsourcing facilities and third-party logistics providers in Georgia. This change allows the state to recognize and create its own rules for outsourcing facilities […]