BFAD MEMO CIRCULAR NO. 1

: Section 12.1 states that any product not labeled according to the requirements of the Regulation shall be deemed misbranded.
: The manufacture, sale, offer for sale, or distribution of misbranded drugs is prohibited under RA 3720, as amended.
: Republic Act No. 6675, or the Generics Act of 1988, penalizes violations related to generic labeling.
: Violations are punishable by a fine, suspension or revocation of license to practice profession if applicable, imprisonment of not less than six months nor more than one year, or both fine and imprisonment at the discretion of the court, and/or suspension or revocation of License To Operate.
: Food and Drugs Inspectors are directed to certify facts of violation for appropriate legal sanctions.
: If a drug product is misbranded, its manufacture, sale, offer for sale, or distribution is prohibited by law.
: Generic Labelling refers to the labeling of drugs that includes the generic name of the drug pursuant to the requirements set forth in DOH Administrative Order No. 55 s.1989.
: It enforces compliance with DOH Administrative Order No. 55 s. 1989 on Generic Labelling and warns drugstores and distributors against violations, outlining sanctions and directing inspectors to certify violations.