Rules and Regulations: Fine Print of Running a Point-of-Care Pharmacy

Around the world, point-of-care pharmacies have been in existence as long as physicians have been practicing medicine. In the United States, physician dispensing in its present form began in 1982, with the introduction by the Food & Drug Administration (FDA) of regulations that gave approval for re-packaging of drugs. In 1985, The United States Congress passed legislation to secure a physician’s right to dispense FDA-approved medications to their own patients. As a result, point of care pharmacy solutions have been in development since the 1990s. 

In the 2000s, declining reimbursements not only drove providers to see more patients for less time, but also seek additional sources of practice revenue; point of care dispensaries were an attractive option. Not only could providers increase revenue for the practice with these dispensaries, but also improve therapy adherence and increase patient satisfaction through a cost-effective solution that fit nearly seamlessly into the clinic workflow. 

Despite having been around for more than 30 years in its present form, the number one question asked by dermatologists interested in implementing a point-of-care pharmacy is, “Is it legal?”  Under the Stark Law, in-office dispensing is acceptable when dispensing is limited to the physician’s own patients within the practice environment, and the medications meet FDA guidelines for repackaging and labeling. 

Requirements by state can vary. Some key facts:

  • All 50 states have regulations governing point of care pharmacies.
  • 46 states allow physicians to participate in the profit from their practices’ in-office dispensaries. 
  • Five states have more restrictive laws that allow physician dispensing but with limitations- Massachusetts, Montana, New York, Texas and Utah.
  • Most states do not require anything beyond the physician’s existing DEA and state license to dispense medications.

In short- yes, in-office dispensaries are not only legal, but highly encouraged. This lucrative addition to many practices is successful and fairly easy to implement. If you are looking to introduce a point-of-care pharmacy into your practice, UniteRx is ready to help.

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