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Donating Prescription Drugs in a Time of Crisis

By Sharon Roberts, PharmD, RPh, JD

We are all inherently concerned with the wellbeing of our fellow man and during a time of crisis the generosity of the people comes out. Since the earthquake disaster in Haiti, I have received numerous calls from various types of entities involved in the drug distribution chain who want to donate drug products but are concerned with violating the laws and rules that govern this practice.

There are two ways to donate prescription drugs from the State of Florida (varies with other states):

  1. As a licensed wholesaler/distributor you can distribute the drugs to an entity licensed to receive those drugs at the location of the crisis or to a local licensed entity that will itself ensure the drugs reach the area of crisis. Oftentimes in this situation the entity you are distributing to will be a licensed physician. All pedigree rules apply even if the drugs are leaving the country.
  2. Practitioners may donate drugs to bona fide charitable organizations if they meet the following conditions:
    • The charitable organization must be properly permitted to receive and possess prescription drugs. (oftentimes this is a physician’s license).
    • The prescription drug must not be expired, misbranded or adulterated and must be in its original, unopened package with its labeling intact.
    • A complete donation record must be maintained by both the practitioner and the charitable organization. The record must include: the practitioner's name, address, telephone number, state license number; the manufacturer; brand name, strength, and dosage for the product; the quantity donated; and the expiration date(s) of the product; the date of the donation; the name, address, and state license number of the charitable organization; the signature of the donor; a signature of the recipient; and if controlled substances are being donated, additional DEA requirements must be followed.

Article written by Sharon Roberts, RPh, PharmD, JD., Ms. Roberts is a former State of Florida, Department of Health Inspector, and is now a practicing as healthcare law attorney and pharmacist.

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Sharon Roberts
R.Ph., Pharm.D., J.D.
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Compliance is my business
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