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HHS Advisory Opinion Rejects Drug Manufacturers' Attempts to Limit Contract Pharmacy Use by 340B Covered Entities | King & Spalding


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On December 30, 2020, the HHS Office of General Counsel (OGC) issued Advisory Opinion No. 20-06 finding the 340B Federal Drug Pricing Program requires drug manufacturers to extend 340B pricing to covered outpatient drugs dispensed through contract pharmacies.
Recently, certain drug manufacturers have declined to distribute covered outpatient drugs through contract pharmacies at 340B pricing. The OGC concluded that this practice is impermissible and that drug manufacturers must offer covered drugs at no more than the 340B ceiling price, even if covered entities use contract pharmacies for distribution.
Many covered entities enter into written agreements with pharmacies (Contract Pharmacies) to distribute their covered outpatient drugs to the entities’ patients. Under those agreements, the covered entity orders and pays for the 340B drugs, which are then shipped from the manufacturer to the Contract Pharmacy. ....

Health Headlines , Public Health Service , B Drug Pricing Program , B Federal Drug Pricing Program , B Program , General Counsel , Advisory Opinion , Federal Drug Pricing Program , Contract Pharmacies , Drug Pricing Program , Public Health Service Act , Contract Pharmacy , Administrative Dispute Resolution , ஆரோக்கியம் தலைப்புச் செய்திகள் , பொது ஆரோக்கியம் சேவை , ஜநரல் ஆலோசனை , கூட்டாட்சியின் மருந்து ப்ரைஸிஂக் ப்ரோக்ர்யாம் , ஒப்பந்த மருந்தகங்கள் , மருந்து ப்ரைஸிஂக் ப்ரோக்ர்யாம் , பொது ஆரோக்கியம் சேவை நாடகம் , ஒப்பந்த மருந்தகம் ,