M5-SUMMARY

• Important Statutes Summarized (Must know)

  • RA No. 5921 - Pharmacy Law (June 23, 1969, EO 174)

  RA 3720 - Food, Drugs and Cosmetics Act (June 22, 1963, EO 175, AO 55, AO 56)

  RA 6675 - Generics Act of 1988 (September 13, 1988, AO 62, AO 63)

  RA 8203 - Special Law on Counterfeit Drugs (July 22, 1996)

  RA 6425 - The Dangerous Drugs Act of 1972 (April 4, 1972, RA 9165)

  RA 9165 - Comprehensive Dangerous Drugs Act of 2002 (June 7, 2002)

  RA 7432 - Senior Citizen Act of 1992 (April 23, 1992, RA 9257, RA 9994)

  RA 7394 - Consumer Act of the Philippines (April 13 1994)

  RA 7581 - Price Act (May 7, 1992)

  RA 9502 - Universally Accessible Cheaper and Quality Medicines Act of 2008 (June 6, 2008)

  RA 9711 - Food and Drug Administration (FDA) Act of 2009 (August 18, 2009)

  RA 8423 - Traditional and Alternative Medicine Act (TAMA) of 1997 (December 9, 1997)
• Administrative Orders

  • OO no. 1, s. 1988 - Implementation of Executive Order No. 119, Reorganizing the Bureau of Food and Drugs (January 26, 1988)

  AO no. 153, s. 2004 - Revised Guidelines in cGMP in manufacturing, packing, repacking or holding food (May 07, 2004)

  AO no. 43, s. 1999 - Current Good Manufacturing Practice Guidelines For Drugs (September 29, 1999)

  AO no. 90, s. 2002 - Current Good Manufacturing Practice Guidelines For Cosmetic Products (March 18, 2002)

  AO no. 42, s. 1982 - Drug Registration of Herbal and/or Traditional Drugs, Both Local And Imported (August 19, 1992)

  EO no. 302 - Declaring and Adopting the Philippine Pharmacopoiea as The Official Book of Standards and Reference for Pharmaceutical Products and Crude Plant Drugs in the Philippines (March 29, 2004)

  AO no. 55, s. 1988 - Requirements for Labelling Materials of Pharmaceutical Products (December 07, 1988)

  AO no. 64, s. 1989 - Amendment of AO no. 55, s. 1988 (March 13, 1989)

  AO no. 107, s. 1991 - Guidelines on Dispensing Multiactive-Ingredient Fixed-Dose Combination of Drug Products (May 16, 1991)

  AO no. 56, s. 1989 - Revised Regulations For The Licensing of Drug Establishment and Outlets (January 03, 1989)

  AO no. 67, s. 1989 - Revised Rules and Regulations on Registration of Pharmaceutical Products (March 15, 1989)

  AO no. 4, s. 1992 - Policy and Requirements for Availing of Compassionate Special Permit (CSP) for Restricted Use of Unregistered Drug and Device Product/Preparation (November 03, 1992)

  AO no. 27, s. 2001 - Rules and Regulations for Licensing Local Manufacturers of Vaccines and Biological Products (June 19, 2001)

  AO no. 47-A, s. 2001 - Rules and Regulations on the Registration, including Approval and Conduct of Clinical Trials and Lot or Batch Release Certification of Vaccines and Biologic Products (August 30, 2001)

  AO no. 62, s. 1989 - Rules and Regulations to Implement Prescribing Requirements under the Generics Act of 1988 (March 15, 1989)

  AO no. 90, s. 1990 - Amendment to AO no. 62, s.1989 (April 23, 1990)

  AO no. 63, s. 1989 - Rules and Regulations to Implement Dispensing Requirements under the Generics Act of 1988 (March 13, 1989)
• Ethical Principles Summarized


  • Non-maleficence - To do no harm

  Beneficence - Duty to promote good

  Respect for autonomy - Respect for the individual's right to decide on issues that affect self

  Confidentiality - Right to give or refuse consent relative to release of privileged information

  Veracity - Obligation to tell the truth, or honesty

  Role fidelity - Obligation
• Container


  device that holds a drug and is or may be in direct contact with the drug
• Well-Closed Container


  protects against extraneous solids and liquids, loss of drug under ordinary conditions of handling, shipment, storage and distribution
• Hermetic Container


  impervious to air or any other gases under ordinary conditions of handling, shipment, storage and distribution

  generally sterile
• Light Resistant Container


  protects the contents from photochemical deterioration amber, opaque, blue