PH 131: Legal Pharmacy & Ethics - Must Know AOs

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

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.