SECTION 12.1 of DOH - Administrative Order No. 55 s. 1989 provides that "any product that is not labelled in accordance with the requirement of this Regulation shall be deemed misbranded"; and the manufacture, sale, offer for sale, or distribution of misbranded drugs is prohibited by Republic Act No. 3720, as amended.

Further, violations of Republic Act No. 6675 or the Generics Act of 1988 are punishable by "fine and suspension or revocation of license to practice profession, if applicable, imprisonment of not less than six (6) months nor more than one (1) year or both fine and imprisonment at the discretion of the court," and/or suspension or revocation of License To Operate.

In view thereof, all drugstores or drug outlets and drug distributors are hereby warned that the sale, offer for sale, and distribution of drugs not complying with the requirements of Generic Labelling or misbranded drugs shall be dealt with in accordance with the aforecited laws and regulation.

All Food and Drugs Inspectors are directed to certify facts of violation for appropriate legal sanctions.

Adopted: 12 Feb. 1990

(SGD.) CECILE P. GONZALEZ

Director