Title
Drug Test Kit Standards and Validation Rules
Law
Bfad Bureau Circular No. 03, S. 2004
Decision Date
Mar 26, 2004
The Bureau of Food and Drugs (BFAD) establishes guidelines for the registration and performance validation of methamphetamine (MET) and tetrahydrocannabinol (THC) drug screening test kits, designating the East Avenue Medical Center as the National Reference Laboratory for evaluations, while extending the validity of existing certificates for certain drug tests.
A

Designation of National Reference Laboratory

  • The East Avenue Medical Center (EAMC) is designated as the National Reference Laboratory (NRL).
  • EAMC is responsible for conducting performance evaluations of drug screening test kits and reagents.
  • Initially, EAMC will evaluate MET and THC test kits by non-instrumental methods only.

Transitional Provisions for Validation Certificates

  • Certificates of validated MET/THC drug screening test kits issued by the Dangerous Drugs Board are extended until April 15, 2004.
  • Certificates of validated drug screening kits for other substances such as Opiates, Cocaine, and Barbiturates, among others, are indefinitely extended until further notice.

Compliance and Sanctions

  • All concerned parties must comply with these guidelines.
  • Any violations of the guidelines will result in sanctions imposed by BFAD.
  • Sanctions ensure adherence to the regulatory framework for public safety and health.

Administrative Details

  • Issued through Bureau Circular No. 03, Series of 2004, dated March 26, 2004.
  • Authored and signed by Prof. Leticia-Barbara B. Gutierrez, M.S., Director of BFAD.
  • The circular informs and guides industry stakeholders on regulatory compliance related to drug screening test kits containing MET and THC.

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