South Florida Hospital News
Monday August 10, 2020
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January 2010 - Volume 6 - Issue 7
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Does Your Hospital Borrow and Loan Prescription Drugs?

Stay compliant by assuring you have the proper permits

The Florida Department of Health (DOH), directs a program under its Medical Quality Assurance Division called the Drugs, Devices and Cosmetics (DDC) Program. This Programís role is to enforce the provisions of Florida Statutes Chapter 499 and the corresponding regulations of the Florida Administrative Code, 64F-12. Chapter 499, F.S. essentially regulates the movement of prescription drugs into and within Florida, therefore, the transfer of prescription drugs from one licensed health care entity to another may require a permit as well as specific recordkeeping in order to maintain compliance.

Within a hospital, the inpatient pharmacy is the entity that holds the license with DOH that allows the hospital to buy and hold prescription drugs. Typically when a hospital patient needs a drug, the hospital provider contacts the inpatient hospital pharmacy. What if an entity outside of the hospital (local pharmacy, another hospital or clinic, etc.) needs a prescription drug and they call the hospital requesting to borrow a drug?

In the absence of an "emergency", Florida requires that the hospital pharmacy have a license called a Restricted Prescription Drug Distributor Ė Health Care Entity Permit or 2350 permit. This permit allows the hospital pharmacy to borrow and loan prescription drugs to other members of the hospitalís GPO and/or other locations under common control. It is not permissible to borrow or loan prescription drugs to and from entities that do not fall into these two categories.

In addition, there are numerous record keeping requirements codified in F.A.C. 64F-12 including, maintaining a borrow and loan log book, no transfers of partial bottles or compounded products, climate control, written policies and procedures, etc.

So the next time the drug store or unrelated health care facility down the street wants to borrow a prescription drug, think twice. You could be violating the rules of DOH and potentially subjecting the hospital to monetary fines and disciplinary action.

Sharon Roberts is a former State of Florida, DOH Inspector, and is now a practicing healthcare law attorney and pharmacist in Palm Beach County, FL, who specializes in healthcare and regulatory law practice with the law firm of Strawn & Monaghan, P.A. She can be reached at (561) 278-9400 or visit www.healthandregulatorylaw.com.

Guelsys Lopez-Vieira is a pharmacist and former DOH Inspector who consults for GLV Consultants, Inc., a business partner with the Firm.

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