Legal control of drugs

• Food and Drug Administration

  FDA stands for
• Bureau of Animal Industry

  BAI stands for
• Permits for drugs for humans and animals; All drugs, whether for humans or animals, are being scrutinized EXCEPT feeds and water drugs

  What is the role of FDA
• Permit for drugs for animals; All drugs for animals for feed and water drugs until 2026 (After 2026, all drugs of animals will be handled by BAI)


  What is the role of BAI
• Licensed To Operate

  LTO stands for
• Certificate of Product Registration

  CPR stands for
• LTO - company for manufacturing

  CPR - manufactured products


  Differentiate LTO and CPR
• Manufacturing


  Studies on efficacy, adverse effects, contraindications, interactions, and withdrawal period.​
• GMP (Good Manufacturing Practices)

  This certificate will be given once the criteria are met: Clean/Good Equipment, Raw Materials, & Procedure - Local
• International Organization for Standardization

  ISO stands for
• Primary Packaging


  Shall mean any material, including printed material, employed in the packaging of the product, excluding any outer packaging used for transportation or shipment, that is in direct contact with the electronic cigarette refill solution
• Secondary Packaging


  Shall mean any material, including printed material, employed in the packaging of product, excluding any outer packaging used for transportation or shipment, that is not in direct contact with the electronic cigarette refill solution (e.g. product inserts, tags, etc.)
• Over the Counter


  OTC stands for
• OTC (over-the-counter) drug


  The drug, when dispensed without a prescription
• Prescription drug (Rx drug)


  The drug, when dispensed with a prescription
• Controlled Substances


  The drug, when dispensed with a licensed to prescribe (commonly in narcotics) a prescription
• S2​/Yellow prescription


  Used for drugs that contain anesthetics or narcotics
• Pharmacist


  S3 is for
• Drug Supplier


  S4 is for
• Class 1


  These drugs have high potential for abuse (leading to severe addictive properties).
• Class 1


  These drugs have no medical uses for treatment. Never to use in any practice situation
• Ecstasy, Heroin, LSD, Marijuana (pure), PCP, Pure morphine


  Give examples for Class 1
• Class 2


  High potential for abuse. Highly addictive. But it has accepted medical use for treatment.
• Class 2


  Used in severe pain.
• Class 2


  High psychological and high physical dependency.
• Morphine (Synthetic or Pure but Low Concentration), Oxycodone, Methamphetamine (Shabu)

  Give examples for Class 2
• Class 3


  Less abuse potential than C-II drugs. Accepted medical use.
• Class 3


  High psychological but low physical dependency.
• Anabolic Steroids, Hydrocodone


  Give examples for Class 3
• Class 4


  Low psychological and low physical dependency.
• Class 4


  Less abuse potential than C-III drugs. Accepted medical use.
• Valium (Anti- depressant or Anti-anxiety), Xanex, Darvon, Phentermine

  Give examples for Class 4
• Class 5


  Less abuse potential than C-IV drugs. Accepted medical use.
• Class 5


  Exempted narcotics.
• Class 5


  Narcotics due to excessive usage.
• Cough medicines with Codeine, Carbocisteine

  (Drowsy or

  Non-drowsy)

  Give examples for Class 5
• Particular species of animal,

  Different or other route,

  Drug mixing,

  Compounding cocktail (drugs),

  Human drug,

  Give the factors for ELUD
• Extra Label Use of Drugs

  ELUD stands for
• Product Name

  Dosage Form

  Name of Active Ingredients)

  Strength of Active Ingredients)

  Batch Number

  Manufacturing Date

  Expiration Date

  Route of Administration

  Storage Condition

  Registration Number

  Name and Address of Marketing Authorization Holder and/or Product Owner

  Name and Address of Manufacturer

  Special Labelling (if applicable)

  Recommended Daily Allowance

  Warning (if applicable)

  Pack sizes (Unit/Volume)

  Give the informations needed for labelling the packaging (both primary and secondary)
• Generic Act of 1988 (Republic Act No. 6675)

  What law must be followed by veterinarians when writing prescriptions, which states that the generic name should always appear first and be enclosed in a box?