Law Against Counterfeit Drugs in PH

"Drugs" includes chemical or biological substances used for disease treatment, prevention, diagnosis in humans or animals, listed in recognized pharmacopoeias, including herbal and traditional medicines.
"Counterfeit drugs" are products with incorrect, insufficient, or no active ingredients, or fraudulently mislabeled products including fake packaging.
Covers drugs with unauthorized use of trademarks, repackaged products without authority, unregistered imports (except justified personal imports).
Defines "brokering," "Bureau," "Department," "business establishment," "owner," and "residence" for regulatory purposes.

Manufacturing, selling, offering, donating, distributing, brokering, exporting, importing, or possessing counterfeit drugs is unlawful.
Presence of counterfeit drugs in business premises or vehicles is prima facie evidence of violation.
Exceptions for legitimate owners possessing counterfeit drugs when properly documented and promptly reported.
Forgery and unauthorized use of official marks and labels is prohibited.
Unauthorized production or use of any device to reproduce trademarks or trade names is prohibited.

Manufacturers, exporters, importers, sellers, distributors, traffickers, brokers, possessors of counterfeit drugs liable upon proof of knowledge.
Managers, operators, lessees of laboratories used in manufacture are liable.
Owners and managers of establishments found with counterfeit drugs are liable if they cause or allow violation.
Pharmacists selling or dispensing counterfeit drugs with knowledge are liable.
Juridical persons held accountable through responsible officers or agents.

The Bureau authorized to segregate, seal, and seize suspected counterfeit drugs with a court warrant.
Search warrant required for private residences or unlicensed premises.
Upon confirmation that drugs are counterfeit, business establishments may be ordered closed for up to 30 days.
Parties liable given opportunity to be heard; Bureau may seek law enforcement assistance.

Possible sanctions include permanent closure and revocation of business licenses.
Fines ranging from P100,000 to P500,000 may be imposed.
Forfeiture and destruction of counterfeit products and related equipment under court order.
Registered pharmacists may face professional disciplinary actions including license cancellation.
Criminal charges filed independently from administrative cases; dismissal in criminal does not automatically lift closure.
Permanent disqualification from operating under the Bureau's supervision is possible.

Possession of counterfeit drugs: imprisonment from six months and one day to six years.
Manufacture, sale, trafficking, brokering of counterfeit drugs: imprisonment from six years and one day to ten years, and/or fines from P100,000 to P500,000.
Counterfeit drugs intended for animals: lesser penalty from six months and one day to two years and four months imprisonment.
Tampering or destroying Bureau seals: severe penalties up to ten years imprisonment.
Aggravation of illness due to counterfeit drugs: imprisonment from twelve to fifteen years plus fines.
Death caused by counterfeit drugs: life imprisonment and fines from P500,000 to P5,000,000.
Higher penalties under other laws prevail if applicable.

Necessary funds to implement the Act shall be included in the annual General Appropriations Act.

The Bureau of Food and Drugs (BFAD) is tasked to administer and supervise the law's implementation.
BFAD to promulgate implementing rules and regulations within 90 days of enactment, effective 30 days after publication.

Invalidity of any clause does not affect the whole Act (Separability Clause).
Previous inconsistent laws and regulations are repealed or modified accordingly.

The Act takes effect 15 days following its publication in two national newspapers of general circulation.