Pharmacists Talking

How Can Your Organization Save Time on Compliance?   

January 21, 2019

 Pharmaceutical Waste Facts:

  • Hospitals throw away 250 million pounds of unused drugs every year, costing them $30 billion.
  • Pharmaceutical waste was detected in 80% of the streams sampled by the USGS in a 2002 study.
  • Only3.5 to 4% of all manufactured pharmaceutical products are returned through reverse distribution.

With the upcoming Drug Supply Chain Security Act (DSCSA) entering law after Nov. 2019, the Healthcare Distribution Alliance (HDA) and others are rushing to ensure pharmaceutical compliance. The new law will mandate that returned pharmaceutical products first be verified by wholesalers, adding another layer of compliance to reverse distribution—and another consideration to make when selecting a reverse distribution vendor. Under this regulatory pressure, how can your organization save time while still remaining in compliance?

There are many regulatory bodies overseeing reverse distribution including the FDA, DEA, and EPA along with various state boards and departments. Most independent pharmacies and many hospitalsrely on a third-party vendor to handle their pharmaceutical reverse distribution process and to issue their return credits. This allows healthcare organizations to recoup some of the value of their expired drugs and medications while also disposing of unreturnable products according to federal regulations.

Given the many regulations governing reverse distribution, many hospitals and pharmacies opt to save time by partnering with a third-party vendor to handle compliance. This is also an effective way for your organization to ensure a reliable revenue stream to boost your operational budget.

Services include different levels of regulatory compliance including inventory, packaging, transfer, and disposal of controlled substances in your custody. For example, your facility might arrange for a DEA-registered vendor to arrive onsite and perform disposal of your controlled substances.  Similarly, a separate service may also be available to dispose of hazardous waste. As always, your organization is responsible for every transfer, for accurate inventory, and for records pertaining to each transfer.

Note that while all vendors require licensing to operate, compliance standards vary among providers. Be sure that your prospective vendor provides visibility into the return process; expected return value (ERV), turnaround times, and the fine details surrounding compliance.

For more on these and other compliance considerations, download our Compliance Handbook.