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

Q&A (BFAD BUREAU CIRCULAR NO. 03, S. 2004)

The circular provides guidelines for the registration and performance validation of methamphetamine (MET) and tetrahydrocannabinol (THC) drug screening test kits.

Drug screening test kits are regulated under the Comprehensive Dangerous Drugs Act of 2002 and Republic Act No. 3720 as amended.

The Bureau of Food and Drugs (BFAD) is responsible for licensing and regulating drug screening test kits.

EAMC is designated as the National Reference Laboratory (NRL) to conduct performance evaluation of drug screening test kits and reagents.

EAMC initially evaluates drug screening test kits containing methamphetamine (MET) and tetrahydrocannabinol (THC) using non-instrumental analysis only.

Yes, certificates for drug screening test kits for Opiates, Cocaine, and Barbiturates are indefinitely extended until further notice.

Violations of the guidelines shall be subject to appropriate sanctions by the Bureau of Food and Drugs (BFAD).

It was adopted on 26 March 2004.

Prof. Leticia-Barbara B. Gutierrez, M.S., the Director, signed the circular.


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