Client Alert

Pharmacy Drug Take-Back Programs Get Green Light in California

27 Oct 2016

On October 26, 2016, the California Board of Pharmacy adopted regulations largely tracking the federal Drug Enforcement Administration’s program encouraging pharmacies to voluntarily collect and dispose of unwanted, unused or outdated drugs. Under the new regulations, pharmacies and hospitals with pharmacies may offer collection receptacles and/or mail-back envelopes to the public, but are not required to do so. Some California counties have adopted ordinances making such programs mandatory; the fate of these ordinances remains unclear.

The new regulations respond to growing concerns about diversion of unwanted drugs. According to the Substance Abuse and Mental Health Administration, over 71 percent of prescription pain medications are obtained from family and friends, and 5 percent took the medication from a friend or relative without asking. The new regulations also address disposal that could have adverse environmental impacts, such as by flushing the drugs down the drain or toilet, or putting them in ordinary trash, by requiring disposal by licensed facilities. Although such disposal is harmless for many drugs, for others there is a risk of groundwater contamination.

Take-back receptacles must be secure, locked units into which the public may directly deposit the unwanted drugs but from which they are not able to remove drugs (much like a mailbox). The pharmacy staff must be able to visually monitor the receptacle but may not deposit drugs in the receptacle and are not allowed to review, count, sort or handle the drugs returned by consumers. Pharmacies electing to establish take-back programs are not allowed to use the receptacles or the envelopes for disposing of their own outdated or unwanted inventory.

Pharmacies must remove drugs collected in the receptacle when it is full. The receptacle’s inner liner must be sealed by two employees, whose names must be recorded in a log book for each such removal. The employees must then place the liner in a rigid shipping container for ultimate disposal by authorized third parties.

These procedures, which specifically apply to drug waste generated by California’s households, could greatly streamline storage, transportation and disposal requirements that might otherwise apply to drug waste.

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