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Questions and Answers
What is the main function of the FDA regarding health products?
What is the main function of the FDA regarding health products?
When can the FDA issue cease and desist orders for health products?
When can the FDA issue cease and desist orders for health products?
What is the maximum validity period for a cease and desist order issued by the FDA?
What is the maximum validity period for a cease and desist order issued by the FDA?
What action can the FDA take after due process regarding a health product that caused serious illness?
What action can the FDA take after due process regarding a health product that caused serious illness?
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What is one of the FDA's roles in relation to information and advertising about health products?
What is one of the FDA's roles in relation to information and advertising about health products?
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Who is required to report incidents indicating harm caused by a health product to the FDA?
Who is required to report incidents indicating harm caused by a health product to the FDA?
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What is among the powers of the FDA related to research studies on health products?
What is among the powers of the FDA related to research studies on health products?
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What is one of the FDA's roles in relation to establishing standards for health products?
What is one of the FDA's roles in relation to establishing standards for health products?
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Who can the FDA require to report incidents involving harm caused by health products?
Who can the FDA require to report incidents involving harm caused by health products?
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What action can the FDA take regarding inappropriate marketing activities related to health products?
What action can the FDA take regarding inappropriate marketing activities related to health products?
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Study Notes
Licensing and Registration
- Local manufacturers of vaccines and biologic products must avail of a Compassionate Special Permit (CSP)
- Drug registration is required for herbal and/or traditional products
- Licensing to operate is necessary for establishments
Labeling Requirements
- Minimum mandatory information in labeling materials includes:
- Name of the product (generic name alone or with brand name)
- Dosage form and strength
- Pharmacologic category
- Rx symbol for prescription drugs
- Name and complete address of manufacturer and trader
- Net content
- Formulation
- Indication(s)
- Contraindication(s), precaution(s), warnings(s)
- Mode of administration/directions for use
- Batch and lot number
- Expiry/expiration date of manufacture
- Registration number
- Storage conditions
Drug Establishments and Outlets
- AO No. 56 Series of 1989 revised regulations for licensing of drug establishments and outlets
- Types of drug establishments include:
- Regular or full-time capacity of its consultative designation
- Regulated establishments including related foundations
Qualifications for Deputy Director General
- Field Regulatory Operations:
- Master's degree in pharmaceutical sciences or allied sciences
- Management experience in the field of discipline
- Disclosure of all conflict of interest
- Disclosure of income
- Administrative and Financial Office:
- CPA or Master's degree in accounting, management, economics or equivalent
- Management experience in the field of discipline
- Disclosure of all conflict of interest
- Disclosure of income
Food and Drug Administration (FDA)
- FDA functions, powers, and duties include:
- Conducting tests on health products prior to authorization
- Requiring reporting of incidents related to health products
- Issuing cease and desist orders
- Ordering ban, recall, and/or withdrawal of health products
- Strengthening post-market surveillance
- Developing and issuing standards and authorizations
- Conducting research studies on health and safety issues
- Prescribing standards for information and marketing activities
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Description
This quiz covers important topics related to legal pharmacy and ethics, focusing on key Administrative Orders (AOs) and Executive Orders (EOs) such as licensing, drug registration, labeling requirements, and more. Stay updated with the latest information in the pharmaceutical field.
