EXECUTIVE ORDER NO. 175 May 22, 1987
FURTHER AMENDING REPUBLIC ACT NO. 3720, ENTITLED "AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO", AS AMENDED, AND FOR OTHER PURPOSES
WHEREAS, it is State policy, under Article II, Section 15, of the 1987 Constitution to "protect and promote the right to health of the people and instill health consciousness among them";
WHEREAS, the 1987 Constitution also provides, in its Article XIII, Section 12, that: "The State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health manpower development and research, responsive to the country's health needs and problems";
NOW, THEREFORE, I, CORAZON C. AQUINO, President of the Philippines, do hereby order:
Sec. 1. The title of Republic Act No. 3720 is hereby amended to read as follows:
"An Act to Ensure The Safety And Purity of Foods and Cosmetics, And The Purity,...
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Executive Orders
Further Amending Republic Act No. 3720, Entitled "An Act To Ensure the Safety and Purity of Foods, Drugs, and Cosmetics Being Made Available To the Public By Creating the Food and Drug Administration Which Shall Administer and Enforce the Laws Pertaining Thereto", as Amended, and For Other Purposes
Executive Order No. 175
Summary of Executive Order No. 175
Title and Declaration of Policies (Sections 1-3):
- Amends the title of Republic Act No. 3720 to "An Act to Ensure The Safety And Purity of Foods and Cosmetics, And The Purity, Safety, Efficacy and Quality of Drugs and Devices Being Made Available To the Public".
- Reiterates the State policies of protecting public health and establishing an effective food and drug regulatory system.
Definitions (Section 10):
- Defines key terms such as "drugs", "new drugs", "batch", "batch number", "Director", "distribute", "expiry date", "export", "import", "manufacture", and "new veterinary drugs".
Prohibited Acts (Sections 11-12):
- Prohibits the manufacture, importation, exportation, sale, distribution, or transfer of adulterated, misbranded, or unregistered foods, drugs, devices, or cosmetics. (Section 11)
- Prohibits the adulteration or misbranding of foods, drugs, devices, or cosmetics. (Section 11)
- Prohibits the refusal to permit entry or inspection, or to allow sample collection. (Section 11)
- Prohibits false guarantees or undertakings. (Section 11)
- Prohibits forgery, counterfeiting, or unauthorized use of marks, stamps, or labels. (Section 11)
- Prohibits the unauthorized disclosure of trade secrets. (Section 11)
- Prohibits the alteration, mutilation, or removal of labeling that results in adulteration or misbranding. (Section 11)
- Prohibits the unauthorized use of representations or suggestions of effectiveness or compliance. (Section 11)
- Prohibits the unauthorized use of references to reports or analyses. (Section 11)
- Prohibits the manufacture, importation, exportation, sale, distribution, or transfer of unregistered drugs or devices. (Section 11)
- Prohibits the manufacture, importation, exportation, sale, distribution, or transfer of drugs or devices without a license. (Section 11)
- Prohibits the sale or offering for sale of drugs or devices beyond their expiration date. (Section 11)
- Prohibits the release for sale or distribution of a batch of drugs without batch certification when required. (Section 11)
- Violators are subject to imprisonment of not less than one year but not more than five years, or a fine of not less than five thousand pesos but not more than ten thousand pesos, or both. (Section 12)
Adulteration and Misbranding (Sections 18-20):
- Defines when a drug or device is considered adulterated, including filthy or unsanitary conditions, substandard strength or quality, and non-compliance with good manufacturing practices. (Section 18)
- Defines when a drug or device is considered misbranded, including false or misleading labeling, lack of required information, and non-compliance with labeling requirements. (Section 19)
- Provides regulations for exempting drugs and devices from labeling or packaging requirements under certain conditions. (Section 20)
- Regulates the dispensing of habit-forming, toxic, or new drugs, requiring a written or oral prescription from a licensed practitioner. (Section 20)
Licensing and Registration (Sections 21, 21-A, 21-B, 21-C):
- Prohibits the manufacture, sale, importation, exportation, distribution, or transfer of any drug or device without an approved application. (Section 21)
- Requires applicants to submit reports, lists of components, composition statements, manufacturing descriptions, samples, labeling specimens, and other requirements to demonstrate safety, efficacy, and quality. (Section 21)
- Provides procedures for the approval, denial, or suspension of applications based on safety, efficacy, and quality evaluations. (Section 21)
- Requires a license to operate for the manufacture, sale, importation, exportation, distribution, or transfer of any drug or device. (Section 21-A)
- Requires the registration of drugs and devices by the manufacturer, importer, or distributor. (Section 21-B)
- Authorizes the Secretary to establish fees for product registration and licensing. (Section 21-C)
Certification of Drugs Containing Antibiotics (Section 22):
- Requires the certification of batches of drugs containing antibiotics to ensure safety, efficacy, and quality. (Section 22)
- Allows the Secretary to exempt certain drugs or classes of drugs from certification requirements when not necessary for safety, efficacy, and quality. (Section 22)
General Administration Provisions, Administrative Sanctions, Regulations, Hearing and Institution of Criminal Action (Sections 26, 29-A):
- Authorizes the Secretary to issue rules and regulations for the effective enforcement of the Act, including banning, recalling, or withdrawing unsafe or ineffective drugs and devices, adopting a National Drug Formulary, and using generic names in drug labeling. (Section 26)
- Authorizes the Secretary to impose administrative fines of not less than one thousand pesos nor more than five thousand pesos for violations of the Act, after notice and hearing. (Section 29-A)
- Provides procedures for hearings, notifications, and the institution of criminal actions for violations. (Section 26)
Publicity and Publication (Section 29):
- Allows the Secretary to disseminate information regarding foods, drugs, devices, or cosmetics in situations involving imminent danger or gross deception. (Section 29)
- Requires the Bureau to publish a Drug Reference Manual and Drug Bulletin for reference by manufacturers, distributors, physicians, consumers, and other groups. (Section 29)
Importation and Exportation (Section 30):
- Requires the Commissioner of Customs to deliver samples from every incoming shipment of foods, drugs, devices, and cosmetics to the Bureau for examination. (Section 30)
- Provides procedures for the refusal, destruction, or export of adulterated, misbranded, or unregistered articles. (Section 30)
- Allows the Secretary to authorize the relabeling or other actions to bring articles into compliance, under supervision and with the execution of a bond. (Section 30)
- Requires the owner or consignee to pay expenses related to the destruction, supervision, storage, and labor for refused articles. (Section 30)
- Exempts articles intended for export from adulteration or misbranding if they conform to the foreign purchaser's specifications, comply with the laws of the destination country, and are labeled as intended for export. (Section 30)
Repealing Clause and Effectivity (Sections 24-25):
- Repeals or modifies all laws, orders, issuances, rules, and regulations inconsistent with the Executive Order. (Section 24)
- Provides that the Executive Order shall take effect fifteen days after publication in the Official Gazette. (Section 25)
Title and Declaration of Policies (Sections 1-3):
- Amends the title of Republic Act No. 3720 to "An Act to Ensure The Safety And Purity of Foods and Cosmetics, And The Purity, Safety, Efficacy and Quality of Drugs and Devices Being Made Available To the Public".
- Reiterates the State policies of protecting public health and establishing an effective food and drug regulatory system.
Definitions (Section 10):
- Defines key terms such as "drugs", "new drugs", "batch", "batch number", "Director", "distribute", "expiry date", "export", "import", "manufacture", and "new veterinary drugs".
Prohibited Acts (Sections 11-12):
- Prohibits the manufacture, importation, exportation, sale, distribution, or transfer of adulterated, misbranded, or unregistered foods, drugs, devices, or cosmetics. (Section 11)
- Prohibits the adulteration or misbranding of foods, drugs, devices, or cosmetics. (Section 11)
- Prohibits the refusal to permit entry or inspection, or to allow sample collection. (Section 11)
- Prohibits false guarantees or undertakings. (Section 11)
- Prohibits forgery, counterfeiting, or unauthorized use of marks, stamps, or labels. (Section 11)
- Prohibits the unauthorized disclosure of trade secrets. (Section 11)
- Prohibits the alteration, mutilation, or removal of labeling that results in adulteration or misbranding. (Section 11)
- Prohibits the unauthorized use of representations or suggestions of effectiveness or compliance. (Section 11)
- Prohibits the unauthorized use of references to reports or analyses. (Section 11)
- Prohibits the manufacture, importation, exportation, sale, distribution, or transfer of unregistered drugs or devices. (Section 11)
- Prohibits the manufacture, importation, exportation, sale, distribution, or transfer of drugs or devices without a license. (Section 11)
- Prohibits the sale or offering for sale of drugs or devices beyond their expiration date. (Section 11)
- Prohibits the release for sale or distribution of a batch of drugs without batch certification when required. (Section 11)
- Violators are subject to imprisonment of not less than one year but not more than five years, or a fine of not less than five thousand pesos but not more than ten thousand pesos, or both. (Section 12)
Adulteration and Misbranding (Sections 18-20):
- Defines when a drug or device is considered adulterated, including filthy or unsanitary conditions, substandard strength or quality, and non-compliance with good manufacturing practices. (Section 18)
- Defines when a drug or device is considered misbranded, including false or misleading labeling, lack of required information, and non-compliance with labeling requirements. (Section 19)
- Provides regulations for exempting drugs and devices from labeling or packaging requirements under certain conditions. (Section 20)
- Regulates the dispensing of habit-forming, toxic, or new drugs, requiring a written or oral prescription from a licensed practitioner. (Section 20)
Licensing and Registration (Sections 21, 21-A, 21-B, 21-C):
- Prohibits the manufacture, sale, importation, exportation, distribution, or transfer of any drug or device without an approved application. (Section 21)
- Requires applicants to submit reports, lists of components, composition statements, manufacturing descriptions, samples, labeling specimens, and other requirements to demonstrate safety, efficacy, and quality. (Section 21)
- Provides procedures for the approval, denial, or suspension of applications based on safety, efficacy, and quality evaluations. (Section 21)
- Requires a license to operate for the manufacture, sale, importation, exportation, distribution, or transfer of any drug or device. (Section 21-A)
- Requires the registration of drugs and devices by the manufacturer, importer, or distributor. (Section 21-B)
- Authorizes the Secretary to establish fees for product registration and licensing. (Section 21-C)
Certification of Drugs Containing Antibiotics (Section 22):
- Requires the certification of batches of drugs containing antibiotics to ensure safety, efficacy, and quality. (Section 22)
- Allows the Secretary to exempt certain drugs or classes of drugs from certification requirements when not necessary for safety, efficacy, and quality. (Section 22)
General Administration Provisions, Administrative Sanctions, Regulations, Hearing and Institution of Criminal Action (Sections 26, 29-A):
- Authorizes the Secretary to issue rules and regulations for the effective enforcement of the Act, including banning, recalling, or withdrawing unsafe or ineffective drugs and devices, adopting a National Drug Formulary, and using generic names in drug labeling. (Section 26)
- Authorizes the Secretary to impose administrative fines of not less than one thousand pesos nor more than five thousand pesos for violations of the Act, after notice and hearing. (Section 29-A)
- Provides procedures for hearings, notifications, and the institution of criminal actions for violations. (Section 26)
Publicity and Publication (Section 29):
- Allows the Secretary to disseminate information regarding foods, drugs, devices, or cosmetics in situations involving imminent danger or gross deception. (Section 29)
- Requires the Bureau to publish a Drug Reference Manual and Drug Bulletin for reference by manufacturers, distributors, physicians, consumers, and other groups. (Section 29)
Importation and Exportation (Section 30):
- Requires the Commissioner of Customs to deliver samples from every incoming shipment of foods, drugs, devices, and cosmetics to the Bureau for examination. (Section 30)
- Provides procedures for the refusal, destruction, or export of adulterated, misbranded, or unregistered articles. (Section 30)
- Allows the Secretary to authorize the relabeling or other actions to bring articles into compliance, under supervision and with the execution of a bond. (Section 30)
- Requires the owner or consignee to pay expenses related to the destruction, supervision, storage, and labor for refused articles. (Section 30)
- Exempts articles intended for export from adulteration or misbranding if they conform to the foreign purchaser's specifications, comply with the laws of the destination country, and are labeled as intended for export. (Section 30)
Repealing Clause and Effectivity (Sections 24-25):
- Repeals or modifies all laws, orders, issuances, rules, and regulations inconsistent with the Executive Order. (Section 24)
- Provides that the Executive Order shall take effect fifteen days after publication in the Official Gazette. (Section 25)