"Medical Supplies Donated to Volunteer Groups Must Be Managed by Doctors or Pharmacists"
MFDS and Ministry of Health and Welfare Strengthen Management of Pharmaceutical Acquisition and Use
[Asia Economy Reporter Jo In-kyung] When social volunteer organizations receive pharmaceutical donations from pharmaceutical companies, these medicines must be used exclusively for direct volunteer activities. Donating or selling the medicines to other organizations constitutes a violation of the Pharmaceutical Affairs Act.
The Ministry of Food and Drug Safety and the Ministry of Health and Welfare announced on the 1st that they will strengthen the management of pharmaceutical donations by pharmaceutical companies for social volunteer activities and the acquisition and use of donated medicines by social volunteer organizations.
This follows the incident in May when prescription medicines donated by a pharmaceutical company to a social volunteer organization were distributed to daycare centers without a doctor's prescription, highlighting the need to reinforce management of pharmaceutical donations.
The Ministry of Food and Drug Safety clarified that when pharmaceutical companies donate medicines to social volunteer organizations, a doctor or pharmacist must be affiliated with the organization, and the donated medicines must be used directly for social volunteer activities for the donation to be considered lawful.
They also urged the pharmaceutical industry to implement the "Pharmaceutical Donation Management Improvement Plan" independently prepared by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The pharmaceutical company that donated the prescription medicines involved in the May incident was advised to strictly comply with the requirements for pharmaceutical donations.
According to the improvement plan, pharmaceutical companies must submit information about the doctor and pharmacist affiliated with the organization responsible for managing the donated medicines when pre-reporting pharmaceutical donations to the association. Additionally, the organization must submit a pledge stating that the donated medicines will be used directly and not distributed to other organizations.
If a social volunteer organization with affiliated doctors or pharmacists redistributes or sells donated medicines received for social volunteer activities to other organizations, it may violate Article 44 of the Pharmaceutical Affairs Act, which prohibits unauthorized persons from selling medicines.
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The Ministry of Food and Drug Safety and the Ministry of Health and Welfare stated, "We will thoroughly investigate and strictly take action against pharmaceutical donations or the acquisition and use of donated medicines that do not comply with procedures, and closely cooperate to establish a lawful and sincere culture of pharmaceutical donations."
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