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Rep. Markey Asks Department of Justice to Investigate New England Compounding Center, and to Probe into DEA’s Past Oversight of Pharmaceutical Compounding
…“end user” of the product) compounded pharmaceuticals that contain controlled substances pursuant to a patient-specific prescription from a DEA-registered practitioner. If the pharmacy compounds controlled substances and distributes the formulations…
Another Holiday Surprise: FDA Releases Four Draft Guidances and a Draft Memorandum of Understanding Related to Drug Compounding
…must be repackaged by a pharmacy, federal facility or outsourcing facility, and under the direct supervision of a pharmacist. If repackaged by a pharmacy or federal facility (but not an…
Maryland Bill Would Place Wholesale Distributors in Catch-22 with DEA Suspicious Order Requirements
By John A. Gilbert, Jr. & Larry K. Houck – A bill introduced in the Maryland House of Delegates, HB 0596, would require wholesale distributors to notify their pharmacy customers…
Criminal Convictions for Compounding Activities Overturned for “Legal Impossibility”
…drug manufacturers, while traditional pharmacy compounders were regulated by the state boards of pharmacy. Both pre-, during, and post-trial, defendants argued that there was no discernible federal law defining any…
CMS and OIG Propose Changes to the Stark Law, Anti-Kickback Statute and Civil Monetary Penalty Rule
…whether to exclude pharmaceutical manufacturers, manufacturers and distributors of durable medical equipment (DME), pharmacy benefit managers, wholesalers, and distributors from the definition of “VBE participant,” or, alternatively, to impose a…
Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals
…exemption for injectable opiates distributed to a hospital or hospital pharmacy, then the Board of Pharmacy would refund the fee to the manufacturer. The companion bill was already passed by…
The Wait is — Almost — Over: The Long-Anticipated Proposed Rule for Drug Wholesale Distributors and 3PLs is Out: Comments Due in 120 Days
…2013 report prepared by the National Association of Board of Pharmacy (“NABP”) titled Wholesale Drug Distribution: Protecting the Integrity of the Nation’s Prescription Drug Supply as well as NABP’s Model…
Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs
…individual to present at the pharmacy. The pharmacy bills all or most of the individual’s copayment or coinsurance—which the patient would otherwise pay the pharmacy directly—to the manufacturer. Insurance companies…
The PEW Charitable Trusts Releases Report on the State of Human Drug Compounding by Traditional Pharmacies and Outsourcing Facilities
Today the PEW Charitable Trusts released a detailed report on the general state of pharmacy compounding of human drug products in the United States. The Report focuses on compounding pharmacies,…
The End of the Road: Franck’s Compounding Case is Moot
By Kurt R. Karst & Jeffrey N. Gibbs – We’ve been following litigation involving the Florida veterinary compounding pharmacy Franck’s Lab, Inc. (“Franck’s”) for a couple of years. We won’t…
Biosimilar Substitution: Battles are Brewing at the State Level
…certain conditions are met by both the prescribing physician and pharmacy. Among other things, House Bill 5581 would permit a pharmacy to substitute a prescription biosimilar product for a prescribed…
Surprise! FDA Quickly Issues Compounding Draft Guidances
…oversight and regulation of the practice of pharmacy.” The guidance states, however, that FDA intends to continue to cooperate with State authorities to “address pharmacy activities that may be violative”…
FDA Calls for Comments Addressing Compounding Animal Drugs; Interested Persons Should Weigh In on Specific Topics Identified by the Agency
…pharmacy, state boards of veterinary medicine)? If so, how many reports on average does each state-licensed pharmacy and veterinarian submit to these state agencies each year? For purposes of the…
FDA Issues Final Guidance Addressing Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
…or 30 days after the shortage ends (which is a new guidance provision)). The drug must be repackaged by a state-licensed pharmacy, federal facility or outsourcing facility, and under the…
FDA Will Approve Plan B Without a Prescription for 17-Year Olds
…morning after pill, is an emergency contraceptive that can be used to reduce the risk of unwanted pregnancy if taken within 72 hours of unprotected sex or the failure of…