Republic Act No. 3720 (RA 3720) Quiz and Flashcards

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Questions and Answers

What is the responsibility of the Licensing and Registration Division within the Center for Device Regulation, Radiation Health, and Research?

Regulating the manufacture of health products

Evaluating health products and establishments for authorization (correct)

Instituting standards for cosmetics and household substances

Conducting research on cosmetics and household substances

Which entities are covered by the activities of the Center for Cosmetic Regulation and Research?

Manufacturers of household hazardous substances (correct)

Importers of cosmetics

Manufacturers of health products

Distributors of health products

What is one of the responsibilities of the Center for Device Regulation, Radiation Health, and Research?

Testing cosmetics for safety

Promoting the use of household hazardous substances

Instituting standards for health products (correct)

Conducting research on health product advertisements

What type of substances are regulated by the Center for Cosmetic Regulation and Research?

Cosmetics and household hazardous substances Signup and view all the answers

What is a specific focus area for the Center for Cosmetic Regulation and Research?

Safety and quality of cosmetics Signup and view all the answers

What is the administrative fine range for a medium penalty?

PHP 100,000.00 - PHP 300,000.00 Signup and view all the answers

When is the maximum administrative penalty imposed?

When the counterfeit drugs are life-saving drugs Signup and view all the answers

What is the minimum administrative fine for the maximum penalty?

PHP 100,000.00 Signup and view all the answers

Under what circumstance is the medium administrative penalty imposed?

For non-life saving drugs with volume more than PHP 100,000.00 but less than PHP 1,000,000.00 Signup and view all the answers

What triggers the permanent closure of an establishment under the medium penalty?

The number of counterfeit drug products exceeding three brands Signup and view all the answers

What constitutes a maximum administrative penalty?

Life-saving drugs regardless of the volume Signup and view all the answers

What is the minimum percentage of the front panel that the health warning should occupy on a tobacco product package?

30% Signup and view all the answers

How should the text of the health warning appear in terms of color and background?

Black text on a white background with a black border Signup and view all the answers

How often should the health warnings on tobacco product packages be rotated?

Within any 24-month period Signup and view all the answers

Where should the health warning not be placed to avoid potential damage or obscuration?

Location where tax stamps are likely to be applied Signup and view all the answers

If a wrapper on a tobacco product package is likely to obscure or obliterate the warning, what must be done?

The warning should be printed on both the wrapper and the package Signup and view all the answers

In addition to the health warning, what statement must be included on one side panel of tobacco product packages?

"No" Signup and view all the answers

What is the primary focus of the section on Unlawful Acts Ban on Sponsorships?

Preventing tobacco companies from sponsoring events or individuals if it involves promoting tobacco products Signup and view all the answers

What is a key restriction mentioned in the section on Unlawful Acts Restrictions on Sampling?

Prohibition on distributing tobacco product samples to individuals under 18 years old Signup and view all the answers

Who chairs the Inter-Agency Committee—Tobacco (IAC-Tobacco) according to the text?

Secretary of the Department of Trade and Industry (DTI) Signup and view all the answers

Which department serves as the Vice Chairperson of the IAC-Tobacco?

Department of Health (DOH) Signup and view all the answers

What is NOT allowed in terms of branding after the passage of this Act?

Registering a tobacco brand name as a company name Signup and view all the answers

What function does the Inter-Agency Committee—Tobacco (IAC-Tobacco) have according to the text?

To administer and implement the provisions regarding tobacco sponsorship restrictions Signup and view all the answers

What is the main purpose of Republic Act No. 3720?

To establish standards and quality measures for foods, drugs, devices, and cosmetics Signup and view all the answers

What is the role of the Bureau of Food and Drugs according to R.A. No. 3720?

Ensuring the safety and purity of foods and cosmetics Signup and view all the answers

What does a batch number printed on the label of a drug or device indicate?

The production history including all stages of manufacture and control Signup and view all the answers

Which of the following is NOT considered a cosmetic according to R.A. No. 3720?

Articles intended for food consumption Signup and view all the answers

What falls under the definition of a 'Device' based on R.A. No. 3720?

Instruments intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals Signup and view all the answers

What does 'Distribute' refer to as defined in R.A. No. 3720?

The delivery or sale of any health product for purposes of distribution in commerce Signup and view all the answers

Study Notes

Center for Device Regulation, Radiation Health and Research

Regulates the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of health products, and institutes standards for the same.

Divisions under each Center

Licensing and Registration Division: evaluates health products and establishments for the purpose of issuance of authorizations and conditions to be observed.
Center for Cosmetic Regulation and Research: regulates the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of cosmetics and household/urban hazardous substances, and conducts research on their safety and quality.

Republic Act No. 3720 (Foods, Drugs, Devices, and Cosmetics Act)

Ensures the safety and purity of foods and cosmetics, and the purity, safety, efficacy, and quality of drugs and devices.
Objectives:
- Establish standards and quality measures for foods, drugs, and devices and cosmetics.
- Ensure pure and safe supply of foods and cosmetics, and pure, safe, efficacious, and good quality drugs and devices.
- Ensure rational use of drugs and devices.

Definitions

Batch number: a designation printed on the label of a drug or device that identifies the batch and permits the production history to be traced and reviewed.
Cosmetic: articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
Device: instruments, apparatus, or contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals.
Distribute: the delivery or sale of any health product for purposes of distribution in commerce, except that it does not include the manufacture or retail of such product.

Health Warning on Tobacco Products

Health warning shall be located on the bottom portion of one front panel of every tobacco product package and occupy not less than 30% of such front panel.
The warning shall appear in clearly legible type in black text on a white background with a black border.
The health warning shall occupy a total area of not less than 50% of the total warning frame.

Ban on Sponsorships

Beginning 1 July 2008, cigarette and tobacco companies are prohibited from sponsoring any sport, concert, cultural or art event, as well as individual and team athletes, artists, or performers where such sponsorship shall require or involve the advertisement or promotion of any cigarette or tobacco company, tobacco product or tobacco use.

Unlawful Acts

Restrictions on Sampling: The distribution of samples of tobacco products to persons below 18 years old is prohibited.
Implementing Agency: An Inter-Agency Committee—Tobacco (IAC-Tobacco) is hereby created to administer and implement the provisions of this Act.

Penalties

Medium Penalty: an administrative fine of not less than PHP 100,000.00 but not more than PHP 300,000.00 and permanent closure of establishment as well as the revocation of its license to do business.
Maximum Penalty: an administrative fine of not less than PHP 300,000.00 but not more than PHP 500,000.00 and permanent closure of establishment concerned as well as the revocation of its license to do business.

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Description

Test your knowledge on the key provisions and objectives of Republic Act No. 3720, also known as the 'Foods, Drugs, Devices and Cosmetics Act'. Explore the regulations aimed at ensuring the safety, purity, and quality of foods, drugs, devices, and cosmetics available to the public.

Republic Act No. 3720 Quiz