PHARMACY

NACDS, NCPA offer suggestions to DEA on drug take-back programs

BY Alaric DeArment

ARLINGTON, Va. — Lobbying groups for the retail pharmacy industry have a few suggestions for the Drug Enforcement Administration for drug take-back programs.

The National Association of Chain Drug Stores expressed support for a rule the DEA proposed in December to govern the secure disposal of controlled substances by DEA registrants – including pharmacies – and patients, as well as people acting on their behalf.

At the same time, the NACDS cited concerns about the manner in which disposal of drugs can be carried out, specifically regarding what it called an undue burden on community pharmacies to track the unique identification numbers on packages used in mail-back programs.

"We share DEA’s goal of working towards a safe and appropriate lawful means for consumers to return their unused medications to authorized entities for destruction," an NACDS statement read.

The group also stressed the importance of ensuring that the requirements for maintaining collection receptacles in community pharmacies are easy for the pharmacy to administer and aligned with other laws and regulations.

Meanwhile, the National Community Pharmacists Association, which lobbies on behalf of independent pharmacies, recommended allowing independents to include controlled substances in medication take-back programs, noting that about 1,600 independent community pharmacies voluntarily participate in the Dispose My Meds program, but are legally prohibited from accepting controlled substances, such as opioid painkillers.

"Controlled substances represent a missing link in efforts to adopt a unified approach to the safe disposal of unwanted, unused or expired medications," NCPA CEO B. Douglas Hoey said. "While the occasional medication collection events sponsored by law enforcement are valuable, consumers need broader access to disposal options for controlled substances throughout the year."

The NCPA also suggested that the DEA clarify that retail pharmacies can use their contracted reverse distributors to collect controlled substances for disposal from long-term care centers; reconsider proposed requirements for collection receptacles and pharmacy employees that are impractical and may negatively affect pharmacy workflow; and work with long-term care centers to develop disposal standards to accommodate them.


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Reports: Florida House subcommittee approves biosimilar-substitution bill

BY Alaric DeArment

NEW YORK — A new bill in Florida’s state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports.

The Sarasota Herald-Tribune reported that the Health Quality Subcommittee of the Florida House of Representatives approved a bill that would allow for substitution while requiring pharmacists to notify prescribing physicians within five days and require the doctor and pharmacist to maintain a record for at least four years.

The Patient Protection and Affordable Care Act included a regulatory approval pathway for biosimilars, though the Food and Drug Administration has yet to finalize regulations for them.


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Mylan, Biocon enter deal on generic analog insulins

BY Alaric DeArment

PITTSBURGH — Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.

Under the deal, Mylan will have the rights to develop and market Biocon’s Glargine, Lispro and Aspart, respectively generic versions of Sanofi’s Lantus, Eli Lilly’s Humalog and Novo Nordisk’s NovoLog.

"This collaboration builds off our existing successful partnership for generic biologics with Biocon and brings Mylan a portfolio of high-value insulin analog products," Mylan CEO Heather Bresch said. "This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential."


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