Regulatory Convergence:Food and Drug Administration, Professional Regulation Commission, and the Professional Regulatory Board of Pharmacy

Regulatory Convergence:
Food and Drug Administration, Professional Regulation Commission, and the Professional Regulatory Board of Pharmacy
21 June 2016, Professional Regulation Commission, Manila

The Food and Drug Administration (FDA) is mandated to ensure the safety, efficacy, and quality of drug products pursuant to Republic Act No. 3720, otherwise known as the Food, Drugs and Devices, and Cosmetics Act, as amended. FDA is also mandated to regulate drug establishments engaged in the different activities such as retailing in drugstores/pharmacies/boticas, including hospital pharmacies and institutional pharmacies, through inspection of their compliance to good practices.

The Professional Regulation Commission (PRC) and Professional Regulatory Board of Pharmacy (PRBOP) are mandated to ensure that licensed pharmacists meet the highest standards of practice pursuant to Republic Act No. 8981, otherwise known as the PRC Modernization Act of 2000, and Republic Act No. 5921, otherwise known as the Pharmacy Act. The said Offices have the regulatory authority to monitor the practice of professional pharmacists and pharmacy support workforce through inspection of drug establishments.

Act. The said Offices have the regulatory authority to monitor the practice of professional pharmacists and pharmacy support workforce through inspection of drug establishments.

Throughout the years, FDA, PRC and PRBOP have faced several reports of non-compliance to regulatory requirements such as the following:

  • “ghost pharmacist(s)”, wherein the pharmacist responsible for supervising the drugstores/pharmacies/boticas and other similar outlets is not present during its operating hours
  • A pharmacist supervising multiple drug establishments
  • Sale and distribution of prescription drugs without prescription
  • Non-compliance to prescribed storage conditions, including cold chain management
  • Other problems and violations following the provisions of R.A. 9711, R.A. 9502, and R.A. 5921

With the continued persistence of such reports, FDA, PRC, and the PRBOP have taken the initiative for regulatory convergence in the monitoring and inspection of drug establishments and the pharmacists’ practice. Both regulatory offices are concerned over the proliferation of the aforementioned unlawful activities and intend to address these concerns through collaboration.

After series of meetings and discussions, in the 1st Regulatory Alignment meeting held last 7-8 April 2015 in Vivere Hotel, Alabang Muntinlupa City it was agreed that a formal Memorandum of Agreement (MOA) shall be made to (1) further strengthen mutual collaboration between these offices, (2) ensure coherence in the formulation and implementation of regulatory policies, and (3) further strengthen the enforcement of relevant laws, rules and regulations.

The MOA has been signed on 21 June 2016 at the Professional Regulation Commission Conference Room. With this MOA, the FDA, PRC, and PRBOP will look forward to a strengthened and rationalize approach in regulating drug establishments, drug products, and pharmacy practice.

Attachments:
Download this file (PRC MOA.pdf)PRC MOA.pdf

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