Legal Prohibition on Misbranded Drugs
- The manufacture, sale, offer for sale, or distribution of misbranded drugs is strictly prohibited under Republic Act No. 3720, as amended.
- Such activities involving misbranded drugs violate established food and drug laws designed to protect public health.
Penalties for Violations under Republic Act No. 6675 (Generics Act of 1988)
- Violations can attract the following penalties:
- A fine as determined by the court.
- Imprisonment for a period of not less than six months and not exceeding one year.
- Both fine and imprisonment, at the court's discretion.
- Suspension or revocation of professional license, if applicable.
- Suspension or revocation of the License To Operate (LTO) for drugstores, distributors, or manufacturers.
Enforcement and Compliance Measures
- Drugstores, drug outlets, and drug distributors are formally warned against engaging in the sale, offer for sale, or distribution of drugs that do not comply with generic labeling requirements or are misbranded.
- Food and Drugs Inspectors are tasked with certifying factual violations to ensure appropriate legal sanctions are pursued.
Regulatory Authority and Official Directive
- The directive is issued pursuant to the authority of the Department of Health and enforced through the Bureau of Food and Drugs (BFAD).
- The circular was adopted on February 12, 1990, by the Director, underscoring official commitment to regulatory compliance and public safety.