Philippine Pharmacy Laws (PDF)

 A system of laws Science of philosophy of laws  PHARMACY LAWS Define and regulate Pharmacy Profession and delimit its practice  PHARMACEUTICAL JURISPRUDENCE AND ETHICS LEGAL and ETHICAL control governing PHARMACY PROFESSION LAWS GOVERNING PHARM...

 A system of laws Science of philosophy of laws  PHARMACY LAWS Define and regulate Pharmacy Profession and delimit its practice  PHARMACEUTICAL JURISPRUDENCE AND ETHICS LEGAL and ETHICAL control governing PHARMACY PROFESSION LAWS GOVERNING PHARMACY PROFESSION RA 5921, RA 10918 RA 3720 RA 8203 RA 7581 RA 7394 RA 7432 RA 9257 RA 6675 RA 6425 RA 9165 RA 9711 RA 9502  STATUTORY LAWS AFFECTING PHARMACY PROFESSION REPUBLIC ACT TITLE DATE APPROVED RA 5921 PHARMACY LAW JUNE 23, 1969 RA 10918 THE PHILIPPINE JULY 21, 2016 PHARMACY ACT RA 3720 FOOD DRUG DEVICES JUNE 22, 1963 AND COSMETICS ACT RA 8203 SPECIAL LAW ON SEPT 4, 1996 COUNTERFEIT DRUGS RA 9711 FOOD AND DRUG AUG 18, 2009* ADMINISTRATION ACT OF 2009 RA 7581 PRICE ACT MAY 27, 1992 RA 7394 CONSUMERS ACT OF APRIL 13, 1992 THE PHILIPPINES  STATUTORY LAWS REPUBLIC ACTS TITLE DATE APPROVED RA 6425 DANGEROUS DRUG ACT OF MARCH 30, 1972 1972 RA 9165 COMPREHENSIVE DANGEROUS JANUARY 23, 2002 DRUG ACT 2002 RA 7432 SENIOR CITIZENS ACT APRIL 23, 1992 RA 9257 EXPANDED SENIOR CITIZENS FEBRUARY 26, 2004 ACT OF 2003 RA 9994 EXPANDED SENIOR CITIZENS FEBRUARY 15, 2010 ACT OF 2010 RA 6675 GENERICS ACT OF 1988 SEPTEMBER 13,1988 RA 9502 UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY JUNE 6, 2008 MEDICINES ACT 2008  STATUTORY LAWS TITLE DATE APPROVED RA 9184 GOVERNMENT JANUARY 10, 2003 PROCUREMENT REFORM ACT RA 9211 TOBACCO REGULATION JUNE 23, 2003 ACT OF 2003 RA 10354 RESPONSIBLE DECEMBER 21, 2012 PARENTHOOD AND REPRODUCTIVE HEALTH BILL RA 10912 CONTINUING JULY 21, 2016 PROFESSIONAL DEVELOPMENT OF 2016 RA 8432 TAMA DECEMBER 9,1997 RA 8981 PRC MODERNIZATION ACT DECEMBER 5 2000  STATUTORY LAWS REPUBLIC ACT TITLE DATE APPROVE RA 10611 FOOD SAFETY ACT OF 2013 AUGUST 23, 2013 RA 8172 ASIN LAW, SALT W/ IODINE DECEMBER 20, 1995 Eo 51 MILK CODE OF THE PHILIPPINES OCTOBER 28, 1986 ‘An act regulating the practice of pharmacy and setting standards of pharmaceutical education in the Philippines and for other purposes’. JUNE 23, 1969 OBJECTIVES: 1. Standardization and regulation of pharmaceutical education. 2. Examination for registration of graduates of Schools of Pharmacy. 3. Supervision, control, and regulation of the practice of Pharmacy in the Philippines.  IMPLEMENTING AGENCY COUNCIL OF PHARMACEUTICAL EDUCATION BOARD OF PHARMACY  THE COUNCIL OF PHARMACEUTICAL EDUCATION COMPOSITION: Sec. of Ed Undersecretary of Health BOP, Chairman PACOP, Pres.  FUNCTIONS 1. To promulgate rules and regulations relative to pharmaceutical education in the Philippines; 2. To recognize and accredit colleges of pharmacy in the different private colleges and universities; 3. To approve the accreditation of community pharmacies, pharmaceutical manufacturing laboratories, and hospital pharmacies for purposes of pharmacy internship.  The Board of Pharmacy COMPOSITION: Chairman and 2 members three years Shall hold office for Appointed by the President of the Philippines Chairman – most senior member QUALIFICATIONS A natural born citizen of the Philippines A duly registered pharmacist and has been in the practice of pharmacy for at least 10 years. Of good moral character and recognized standing in the pharmaceutical profession. Not a faculty member of any school offering courses in pharmacy A member of good standing of any bonafide national pharmaceutical organization.  REMOVAL OF THE BOARD MEMBERS: May be removed by the president of the Philippines if found guilty of: ü neglect of duty, incompetence, malpractice or unprofessional, unethical, immoral, or dishonorable conduct.  POWERS AND DUTIES OF THE BOARD To examine applicants for the practice of Pharmacy. To issue certificates of registration of pharmacists; To reprimand any pharmacists or to suspend or revoke his certificate of registration (Sec. 13) To promulgate the rules and regulations.  To study the conditions affecting the practice of pharmacy in the Philippines. To check the employment if qualified personnel in drugstores, hospital pharmacies, laboratories and similar establishments for which the board may designate inspectors from the Board of Pharmacy. To encourage the development of botanical gardens and their inspection particularly the propagation of the Philippine medicinal plants.  GROUNDS FOR REPRIMAND, SUSPENSION OR REVOCATION OF REGISTRATION OF CERTIFICATES OF A PHARMACIST Conviction by a court by any violation. Immoral and dishonorable conduct. Fraud or deceit in the acquisition of the certificate of registration. Gross negligence, ignorance or incompetence in the practice of his profession resulting in injury, damage or death of another.  Malpractice, including aiding or abetting the commission of criminal abortion or sex crimes through illegal compounding, dispensing or sale of abortive or sex drugs. Acting as a dummy of an alien or a person who is not qualified to establish and operate a retail drugstore Addiction to alcoholic beverages or any habit forming drug rendering him incompetent to practice his profession  Insanity False or extravagant or unethical advertisements wherein other things such as his name, profession, limitation of his practice and the like are mentioned. Violation of any of the provision of the Code of Ethics.  CANDIDACY FOR BOARD EXAMINATION He shall be a citizen of the Philippines (as amended by P.D. 1363 on May 2, 1978) He shall be of good moral character He shall have completed an internship program (960 hrs.) –Prescription/Community pharmacy –Pharmaceutical laboratory  he shall have graduated with the degree BS Pharmacy or with an equivalent degree from a school. College or university duly accredited by the CPE, completing a standard pharmacy course of not less than 4 academic years (as amended by P.D. 1926 on May 30, 1984)  RATINGS REQUIRED TO PASS Schedule of examination – twice a year during the month of January and July A general average of 75 per cent or over with no rating below 50 per cent in more than 2 subjects PREREQUISITE FOR THE PRACTICE OF PHARMACY Is at least 21 years of age; Has satisfactory passed the corresponding examination given by the board of pharmacy; Is a holder of a valid certificate of registration duly issued to him by the said board.  PRACTICE OF PHARMACY Prepare or manufacture, analyze, assay, preserve, store, distributed, or sell any medicine, drug chemicals, cosmetics pharmaceuticals, devices or contrivances; Render pharmaceutical service in any office or drug and cosmetic establishment where scientific, technological or professional knowledge of pharmacy is applied;  PRACTICE OF PHARMACY Engage in teaching scientific, technological or professional pharmacy subject in college of pharmacy; Conduct or undertake scientific pharmaceutical research for biological and bacteriological testings and examinations. NOTE Persons performing executive managerial or administrative functions & their subordinate personnel employed in the pharmaceutical laboratories shall not be considered, for purposes of this definition, persons in the practice of pharmacy  PRACTICE OF PHARMACY Sale of Medicine, Pharmaceuticals, Drugs, and Device Markings and Inhibition to the Sale of Drug Samples Pharmacist Required and Compensation Display of Certificate Required Responsibility for Safety, Efficacy, Quality, and Purity of Drugs Fillings and Refilling of Prescription Labels of Dispensed Medicine  PRACTICE OF PHARMACY Record Books for Prescription Inhibition Against Use of Cipher or Unusual terms in Rx & Rx Switching Provision Relative to Dispensing of Violent Poisons Provisions relative to Dispensing of Less Violent Poisons Receptacle for Poisonous Drugs Provisions Relative to Dispensing of Anti – Conceptional Substances & Devices Provisions Relative to Dispensing of Potent Drugs VIOLENT POISONS: Arsenical preparations, phosphorous, corrosive sublimate, atropine, strychnine, or any of their salts, hydrocyanic acid or prussic acid, oil of mirbane (nitrobenzene) POISON BOOK: Date of each sale The name and address of the purchaser The name & quantity of the poison sold The purpose of the purchase  ABORTIVES & ANTI-CONCEPTIONAL SUBSTANCES OR DEVICES Number and date of the Rx Name and address of the physician Name, quantity, and manufacturer of the drug Name and address of the purchaser Date of filling the Rx Signature of the pharmacist filling the Rx  Requirements for the opening and operations of drugstores and pharmacies “ The minimum requirements necessary for the opening and operation of drugstore and pharmacies shall be in accordance with the rules and regulations prescribed by the BFAD. No application for the opening of a retail drugstore shall be approved unless it is signed by a Filipino registered pharmacist, either as owner or as a supervising pharmacist (as amended by P.D. 1363 on May 2, 1978 )“  R.A. 5921 VIOLATIONS: Sale of medicines outside of Hospital pharmacy (HP) and Drugstores (DS) Sale of Samples Operation without a pharmacist PENALTY: Fine of not less than P 1,000 but not more than P 4,000 or imprisonment of 6 months and I1 day not to exceed 4 years depending on the discretion of the court. VIOLATIONS: Operating without a certificate Filling of Rx without pharmacist Using cipher in dispensing Improper dispensing of abortive, poisonous compounds, etc. Continuing to practice even if the license is already suspended PENALTY: Not less than P 100 but not more than P 500 or imprisonment of 30 days but not more than 4 months  REVIEW QUESTIONS 1. RA 5921 was signed into law on: A. June 23, 1969 C. June 22, 1969 B. June 23, 1963 D. June 22, 1963 2. RA 5921 provides for and shall govern: A. Standard’n & regulation of pharm education B. Examination for registration of graduates of school of pharmacy C. Supervision, control & regulation of the practice of pharmacy in the Phil. D. A and C only E. AOTA 3. For the purpose of implementing RA 5921 these were created:  A. Board of Pharmacy C. PRC B. Council of Pharm’l Educ. D. A & B only E. AOTA 4. For how many years shall the chairman & members of the board hold office? A. 3 C. 5 B. 4 D. 6 5. To be appointed member of the Board has been in the practice of Pharmacy for A. 5 C. 8 B. 7 D. 10 6. Any of the ff shall be a ground for reprimanding, suspending or revoking the cert. of registration.  A. Immoral or dishonorable conduct B. Fraud or deceit in the acquisition of cert. C. Insanity D. A & B only E. AOTA 7. This is a requirement for the opening of d/s A. Filipino registered pharmacist B. 7x5 drugstore space C. Drugstore label D. Record books 8. Age requirement in order to practice pharmacy A. 18 C. 21 B. 25 D. 20 9. This s a proof that a person is a licensed pharmacist:  A. Transcript of record C. Cert. of registration B. Diploma D. Certificate of internship 10.To encourage the development of a botanical garden is one function of: A. Board of Pharmacy C. Council of Pharmaceutical Education B. BFAD D. AOTA LAW NEW PHARMACY 11. Method of secret writing w/c substitutes other letters or transposes the letter after arranging them in blocks A. Cipher C. Secret keys B. Code D. Any of the above 12. Record for the sale of poisons must be kept for: A. 5 years C. 3 years B. 1 year D. 2 years  R.A. 3720 FOODS, DRUGS, DEVICES & COSMETICS ACT “ An act to ensure the safety and purity of foods and cosmetics, and the purity, safety, efficacy and quality of drugs and devices being made available to the public, vesting the BFAD with authority to administer and enforce the laws pertaining thereto, and for other purposes.”  R.A. 3720 June 22, 1963 – approved E.O. 175 (May 22, 1987) – amendment E.O. 851, Sec. 4 (December 2, 1982) – The Food and Drug Administration was abolished and created the BFAD. RA 9711 – Renamed BFAD to FDA “ BUREAU” means the Bureau of Food & Drugs “ SECRETARY” means the Secretary of Health “ DEPARTMENT” means the Department of Health “ DIRECTOR” means Director of the BFAD “ PERSON “ includes individual, partnership, corporation and association “ FOOD” means articles used for food or drinks for man chewing gum articles used for components of such article “DRUG” means Articles recognized in the current official USP-NF, official Homeopathic Drug Formulary, or any supplement to any of them Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal Articles (other then food) intended to affect the structure or any function of the body of man of animals “COSMETICS” means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance articles intended for use as a component of any such articles “DEVICE” means instrument, 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 to affect the structure or any function of the body of man animals  Adulterated Food A food shall be deemed to be adulterated if: ü If it bears or contains any poisonous or deleterious substances: may render it injurious to health other than one w/c is a pesticide chemical in or on a raw agricultural commodity & with an established tolerances in the container used – may affect the contents üIf it has been prepared, packed, or held under unsanitary conditions may have been contaminated may have been injurious to health üIf any substance or valuable constituents has been: omitted or abstracted replaced or substituted by any substance injurious to health added or mixed or packed so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value. ü If it bears or contains a coal-tar color other than one which is permissible under existing regulations Note: any poisonous or deleterious substance added to any food shall be deemed to be unsafe except when such substance is required or cannot be avoided in its production or manufacture. ü If it is a confectionary, and it bears or contains any alcohol or non-nutritive articles or substance ü If it is an oleomargarine or margarine or butter and any of the raw material ü unfit for food if in whole or in part consists of any filthy, putrid or decomposed substance  Misbranded Food A food shall be deemed to be misbranded: ! If its labeling is false or misleading ! If it is offered for sale under the name of another food ! If it is an imitation of another food Note: unless its labels bears in type of uniform size and prominence the word “IMITATION” and immediately thereafter the name of the food imitated. ! If its container is so made, formed, or filled as to be  Misleading ! If it purports to be or is presented for special dietary uses unless its label bears such information concerning its vitamins, mineral and other dietary properties in order to fully inform purchasers as to its value for such uses. ! If is bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact  Adulterated Drugs and Devices - A drug or device shall be deemed to be adulterated ! If it consist in whole or in part of any filthy, or decomposed substance: may affect its safety, efficacy, or good quality ! If it has been prepared, manufactured or held under unsanitary conditions: may have been contaminated with filth or dirt may have been injurious to health ! If its container is composed, in whole or in part, of any poisonous or deleterious substance: may render the contents injurious to health ! If it is a drug and it bears or contains, for purposes of coloring only, any color other than a permissible one taking into consideration standards of safety, efficacy or good quality. ! If the drug which is recognized in the official compendium: !if its strength differs from standards of, safety, efficacy, quality, or purity ! If it is a drug or device & any substance has been mixed or packed or has been substituted wholly or in part may reduce its safety, efficacy, quality, strength or purity ! If in the manufacture of drugs does not conform with the CGMP standard  Adulterated Cosmetics A cosmetics shall be deemed to be adulterated: ! If it bears or contains any poisonous or deleterious substance may render it injurious to users ! If it contains in whole or in part of any filthy, putrid, or decomposed substance ! If it has been prepared, packed, or held under unsanitary conditions may have been contaminated with filth may have been injurious to health ! If it is not a hair dye and it bears or contains a coal-tar color other than one which is permissible  Factory Inspection Officers or employees duly designated by the secretary, upon appropriate credentials to the owner, operator, or agent in charge, are authorized: to inspect, in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished or unfinished materials, containers, and labeling therein  Certificate of Drugs Containing Antibiotics Antibiotic Drug – means any drugs intended for use by man containing any quantity of any chemical substance which is produced by a microorganism in dilute solution (including the chemically synthesized equivalent of any such substance). The Secretary, shall provide for the certification of batches of drugs composed wholly or partially of any kind of antibiotic. Must meet or conform with the applicable standards of identity, strength, quality and purity  Prohibited Acts the sale or offering for sale of any drug or device beyond its expiration or expiry date. The release for sale or distribution of a batch of drugs without batch certification The manufacture, importation, exportation, sale offering for sale, distribution, or transfer of any drug or device: Ø which is not registered Ø which is considered adulterated or misbranded Ø without the license from the Bureau Ø the refusal to permit entry or inspection or to allow samples to be collected  the adulteration or misbranding of any food, drug, device, or cosmetic forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag, label, or other identification device the alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the label of a food, drug, device or cosmetic, if such act is done while such article is held for sale the using by any person to his own advantage, or revealing, other than to the Secretary of officers & employees of the Department any information concerning any method or process which is a trade secret is entitled to protection  R.A. 3720 Violations: Provisions on Misbranded drugs and devices Penalties: Imprisonment of not less than 1 year and one day but not more than 5 years or a fine of P5000 and not more than P 10,000 or both imprisonment and fine No person will be subject to penalties for having sold, offered for sale, if the drugs were bought in good faith, unless he refuses to furnish BFAD with information relating to the acquisition of the said drug.  Organization of the BFAD Office of the Director Director Drug Information Unit Regulation Division I Inspection & Licensing Section Retail drugstores Hospital pharmacies Retail outlet for non- Rx drugs Drug department – general wholesale – distributor / importer/ exporter of finished products retailer of household hazardous substances Regulation Division II Inspection & Licensing Section drug manufacturer drug assay laboratory drug producer drug department – importer/exporter in bulk – distributor/importer/exporter, w/c at the same time a manufacturer or producer food & food products manufacturer/processor cosmetic manufacturer household hazardous substance manufacturer Product Services Division Food Product Section Drug & Medical Device Product Section Cosmetic Product Section Household Hazardous Substance Section Laboratory Services Division Physico - Chemical Section Microbiology Section Toxicology Section Research Section Experimental Animal Section Legal, Information & Compliance Division Legal, Research and Investigation Section Public Assistance, Information & Compliance Section Advertising & Promotion Section Administrative Division Planning & Budget Section Personnel Section Cash, Collection & Disbursement Section Accounting Section Supply & Properly Section Records & Communication Section Building & Facilities Maintenance Section  The minimum mandatory information that shall be included in the labeling materials are: Labeling Requirements Name of the product Dosage form and strength Pharmacologic category Rx symbol Name & complete address of trader & manufacturer Net content  Indication (s) Formulation C/I, Precautions (s), Warning (s) Mode of administration / Direction for use Batch and lot number Expiry date & date of manufacturer Registration number Storage conditions (For Rx product) Foods, Drugs, Devices & Cosmetics Act prohibits dispensing w/o prescription  REVIEW QUESTIONS 1. The division of BFAD which is in charge in the inspection and licensing of the manufacturer of food, drug and cosmetics: A. Regulation Division I C. Product Service Div B. Legal Division D. Regulation Division II 2. Which Exec. Order abolished the Food & Drug Adm. and created the BFAD? A. EO 137 C. EO 951 B. EO 851 D. EO 147 3. RA 3720 was signed into law on: A. June 22, 1963 C. June 23, 1969 B. June 22, 1969 D. July 22, 1969 4. A food shall be deemed to be adulterated if: A. Prepared, packed, held under unsanitary condition B. Damage or inferiority, concealed in any manner C. Offered for sale under the name of another food D. A & B only E. AOTA 5. If the food is an imitation of another food: A. Fake C. Misleading B. Misbranded D. Adulterated 6. Drugs are considered adulterated if: A. Label is misleading C. Differs from USP Std. B. An imitation of a product D. NOTA 7. RA 3720 was amended by EO: A. 881 C. 175 B. 851 D. 170 8. The Division of BFAD that certifies batches of antibiotics: A. Product ServicesC. Legal Info & Compliance B. Laboratory Services D. Inspection Services 9. Among the prohibited act under RA 3720 are: A. Manufacture for sale, distribute declared as banned B. Adulteration or misbranding of any food, drug C. Manufacture, sale, distribution of any drug not registered with BFAD D. B and C only E. AOTA 10. Shall provide for the certificate of batches of drugs composed wholly or partially any kind of antibiotics A. Secretary of Health C. BFAD Director B. PRC Commissioner D. BFAD Administrator 11. Any person who commits the following shall be penalize for 6mon- 5 yrs imprisonment & fine >1000 A. Sale of any drug beyond its expiration date B. Distribution of batches of drugs w/o batch cert. C. Forging, counterfeiting w/o proper authority D. A & C only E. AOTA 12. In order to manufacture, sell, distribute any drug, a license to operate shld. be first secure from: A. BFAD C. PRC B. DTI D. Dept of Commerce  R.A. 8203 Special Law on Counterfeit Drugs “An act prohibiting counterfeit drugs, providing penalties for violations and appropriating funds therefore” Sept. 4, 1996  Counterfeit Drug / Medicines refers to: Medicinal products with the correct ingredients but not in the amounts as provided Wrong ingredients Without active ingredients With insufficient quantity of active ingredients Reduction of drugs “QEPSS” Deliberately & fraudulently mislabeled With fake packaging Drug product refilled in containers by unauthorized persons if legitimate labels or marks are used An unregistered imported drug product Adulterated drug – reduction or loss of efficacy due to expiration  4S segregate seal search warrant seize Monitoring of Counterfeit Drug The said inspection shall be w/o prior notice FDRO – inventory, segregate, seal, collect samples for examination Owner – sales invoice, delivery receipts or documents FDRO – submit to either LSD or PSD  Administrative Sanctions Permanent closure of the establishment concerned & revocation of its LTO A fine of NLT P 100,000 but NMT P 500,000 Forfeiture, confiscation, & destruction of products and / or equipment found to be counterfeit Filing of an appropriate proceeding against the registered pharmacist involve at the PRC for cancellation of license Permanent disqualification of the person concerned from owning or opening an establishment Minimum Penalty An administrative fine of NLT P 100,000 but NMT P 500,000 Medium Penalty An administrative fine of establishment Permanent closure of establishment Revocation of LTO Maximum Penalty An administrative fine of NLT P 300,000 but NMT P 500,000 Permanent closure of establishment Revocation of LTO  The Following Penalty shall be imposed: Minimum Penalty when the counterfeit drug products are not life-saving drugs when the volume of the said products is worth more than P 100,000 when the number of drug product involved is NMT 3 brands or generic products  Medium Penalty when the counterfeit drug products are not life-saving drugs when the volume of the said product is worth more than P 100,000 but not exceeding 1 million pesos when the number of drug product involved is more than 3 brands or generic products  Maximum Penalty when the counterfeit drug products are life-saving regardless of the volume when the volume of the said product is worth more than P 1,000,000 DRUG ESTABLISMENTS TYPES: Drug manufacturer – engaged in operations Drug trader – registered owner of the drug product – procures the raw materials & packing components – engage in distribution & / or marketing – sub-contractor Drug Distributor – DD/ Importer – DD/Exporter – DD/Wholesaler Renewal of LTO Initial Period (Initial Application) – 1 year Subsequent Period (Renewal Application) – 2 years Grounds for non – renewal of LTO Failure to comply or rampant violation of existing laws, rules and regulations Failure to assures the safety, efficacy & quality of its drug products  Administrative Sanctions Grounds for Revocation of LTO misrepresentation of any material fact for manufacturers & traders – any deficiency in GMP – lack of key technical & professional personnel – lack of key equipment in production or QC – poor or inadequate or improper documentation of the production process for distributors – distribution of: – fake or counterfeit drugs – misbranded or adulterated – unsafe drug products  violations of BFAD standards of “QEPS” of drug products sale or distribution of antibiotic products w/o batch certification failure to take adequate remedial or corrective measures for deficiencies identified failure to keep up-to-date, secure, orderly & inspected record for compliance  Grounds for suspension of LTO Minor deficiencies in GMP : – poor housekeeping – inadequate storage facilities – lack of minor equipment – lack of minor requirement – other minor shortcomings lapses in record-keeping of: – Invoices – receipts of distribution records  RE-APPLICATION AFTER REVOCATION “No establishment whose LTO has been revoked may apply for an LTO within 5 years after revocation of its license.”  DRUG OUTLETS TYPES: Drugstore, Pharmacy or Botica, Hospital Pharmacy, Dispensary – Where registered drug, chemical products, active principles, proprietary medicines, galenical, or veterinary preparations are compounded and/ or dispensed Retail outlet non- Rx drugs including non- traditional outlets such as supermarkets and store – where registered non-Rx or OTC drugs are sold in their original packages, bottle or containers or in small quantities not in their original containers  SPECIFIC REQUIREMENTS FOR OPENING A DRUGSTORE Signboard in front of the place of business bearing the registered name of the drugstore Well – ventilated for compounding prescription A suitable and proper place for the adequate storage of the drugs and biological products A suitable cabinet and adequate water supply Reference books and documents  Philippine National Drug Formulary United States Pharmacopeia National Formulary RA 3720, RA 6675, RA 5921, RA 8203 Remington’s pharmaceutical sciences Goodman and Gilman pharmacological basis of therapeutics Record books duly registered with BFAD Prescription book Dangerous preparation book Exempt preparation book Poisons book  Record book for selected non-prescription drugs subject to abuse as determined by BFAD or DDB A full-time validly registered pharmacist physically present while drugstore is open business Invoices indicating the lot number or batch number of the manufacturer’s stock File or prescriptions filled, consequently numbered Dry seal or rubber stamp containing the name and address of drug outlet Red and white labels indicating the name and address of the drugstore  Administrative Sanctions Temporary Closure: Absence of pharmacist on three inspections by BFAD inspector Suspension of LTO: Failure to produce invoices and receipts together with lot no., expiry dates for the drugs in stock Failure to properly record & keep a file of all Rx filled in the last 2 years Refusal to allow entry of BFAD inspectors Revocation of LTO: sale or offer for sale of drugs that are: – adulterated & misbranded – substandard & unregistered – expired and unsafe – marked “not for sale” failure to properly record dangerous drugs failure to take necessary remedial or corrective measures w/in the prescribed period  REVIEW QUESTIONS 1. Counterfeit drugs refer to medicinal products A. Recognized in USP/NF B. Article intended for use in the diagnosis, cure, treatment of disease C. W/O active ingr. w/c results in reduction of drug safety, efficacy, quality or strength D. A and C only E. AOTA 2. RA 8203 was signed into law on: A. Sept. 4, 1996 C. Oct. 4, 1996 B. Sept. 13, 1988 D. Sept. 4, 1992 3. Counterfeit drug may contain less than how many % of the active ingredient  A. 80% C. 60% B. 75% D. 85% 4. Parties liable under RA 8203 A. Pharmacist C. Manufacturer B. Inspector D. A and C only 5. Co involved in manufacture, distribution of drugs A. Drug establishment C. Drug manufacturer B. Drug outlet D. Drug trader 6. Administrative sanctions for any violation of RA 8203 A. Fine NLT 100,000 pesos & NMT 500,000 pesos B. Permanent closure of establishment & revocation of license to do business C. Confiscation & destruction of counterfeit products D. A and C only E. AOTA 7. Drugs as defined in RA 8203, refers to: A. Any article recognized in the official USP/NF B. Any article use in diagnosis, cure, treatment or prevention of disease in man C. Herbal or traditional drugs used in folk medicine D. A and B only E. AOTA 8. Upon finding that the drugs are counterfeit, the professional license of reg. pharmacist will be: A. Revoke C. Cancel B. Suspend D. A and B 9. Commission of acts prohibited in RA 8203, punished by A. Imprisonment of NLT 6 months & 1day but NMT 1 year B. Imprisonment of 6 years & 1day but NMT 10 years C. Fine of NLT 100,000 pesos but NMT 500,000 pesos D. B and C only E. AOTA  R.A. 7581 Price Act “ An act providing protection to consumers by stabilizing the prices of basic necessities and prime commodities and by prescribing measures against undue price increase during emergency situations and like occasions” Basic Necessities Includes: Rice; corn; bread; dried, & canned fish & other marine products; fresh pork; beef & poultry meat; fresh eggs; fresh & processed milk; fresh vegetables; root crops; coffee; sugar; cooking oil; salt; laundry soap; detergents; firewood; charcoal; candles; & drugs classified as essential by the DOH. Prime Commodities Includes: Fresh fruits; flour; dried processed & canned pork; beef & poultry meat; dairy products not falling under basic necessities; noodles; onions; garlic; vinegar; patis; soy sauce; toilet soap; fertilizer; pesticides; herbicides; poultry; swine & cattle feeds; veterinary products for poultry, swine & cattle; paper; school supplies; nipa shingles; sawali; cement; clinker; GI sheets; hollow blocks; plywood; plyboard; construction nails; batteries; electrical supplies; light bulbs; steel wire; and all drugs not classified as essential drugs by the DOH. Implementing Agency DOA DENR DOH DTI Buffer Fund A contingent fund in the budget of the implementing agency which shall not be used in its normal or regular operations but only for the purposes provided under R.A.7581 Panic Buying Is the phenomenon where consumers buy basic necessities & prime commodities grossly in excess of their normal requirement resulting in undue shortages of such goods to the prejudice of less privileged consumers.  M Disaster area or under state of calamity M State of emergency M Suspension of the privilege of the writ of habeas corpus M State of rebellion M State of war M State of Martial law  HOARDING PROFITEERING CARTEL  HOARDING UNDUE ACCUMULATION OF ANY BASIC OR PRIME COMMODITIES BEYOND ITS NORMAL INVENTORY LEVEL OR REFUSAL TO DISPOSE OR SELL STOCKS TO THE GENERAL PUBLIC. PRIMA FACIE EVIDENCE ü Has 50% stocks higher than usual inventory ü Refuses to sell to the general public  PROFITEERING SELLING OF BASIC AND PRIME COMMODITY AR A PRICE IN EXCESS OF ITS WORTH. PRIMA FACIE EVIDENCE üHas no price tag ü Misinterpreted as to its weight &measure üAdulterated or diluted ü Raises the price by more than 10%  CARTEL AGREEMENT BETWEEN 2 OR MORE PERSONS TO UNREASONABLY INCREASE OR MANIPULATE ITS PRICE. PRIMA FACIE EVIDENCE ü2 or more persons or business enterprise competing for the same market. ü dealing in the same basic/prime commodity ü perform uniform complimentary acts MANDATED PRICE CEILING ØIMPENDING EXISTENCE OR EFFECT OF A CALAMITY ØTHREAT, EXISTENCE OR EFFECT OF AN EMERGENCY ØPREVALENCE OR WIDESPREAD ACTS OF ILLEGAL PRICE MANIPULATION ØEVENT THAT CAUSES ARTIFICIAL & UNREASONABLE PRICE INCREASE ØWHEN PREVAILING PRICE HAS RISEN TO UNREASONABLE LEVELS  DETERMINATION OF PRICE CEILINGS üSUPPLY AVAILABLE IN THE MARKET üAVERAGE PRICE IN THE LAST 3 MONTHS üCOST TO THE PRODUCER, DISTRIBUTOR OR SELLER Ø PESO EXCHANGE RATE Ø CHANGE IN THE AMORTIZATION COST Ø CHANGE IN THE COST OF LABOR Ø INCREASE IN THE COST OF LABOR PRICE COORDINATING COUNCIL SECRETARY OF TRADE AND INDUSTRY SECRETARY OF AGRICULTURE SECRETARY OF HEALTH SECRETARY OF ENVIRONMENT & NATURAL RESOURCES SECRETARY OF LOCAL GOVERNMENT SECRETARY OF TRANSPORTATION & COMMUNICATION SECRETARY OF JUSTICE DIRECTOR GENERAL OF NEDA ONE REP FROM THE CONSUMER SECTOR ONE REP FROM THE AGRICULTURAL PRODUCER SECTOR ONE REP FROM THE TRADING SECTOR ONE REP FROM THE MANUFACTURERS SECTOR  PRICE ACTION OFFICER ☻ANY MEMBER OF THE PRICE COORDINATING COUNCIL ☻APPOINTED BY THE PRESIDENT  NATIONAL STATISTICS OFFICE ☻CONDUCT INDEPENDENT PERIODIC SURVEY ☻STUDIES THE SELLING PRICES OF BASIC & PRIME COMMODITIES  PENALTIES ACTS OF ILLEGAL PRICE MANIPULATION Ø Imprisonment for 5 to 15 years Ø Fine of 5 thousand to 2 million VIOLATION FOR PRICE CEILING Ø Imprisonment for 1 to 10 years Ø Fine of 5 thousand to 1 million LAWS AND LETTER OF INSTRUCTIONS REPUBLIC ACT NO. 4164 PRESIDENTIAL DECREE NO. 1674 LETTER OF INSTRUCTION NO. 1305 LETTER OF INSTRUCTION 1342 LETTER OF INSTRUCTION NO. 1359  REVIEW QUESTIONS 1. Directing measures to prevent hoarding, profiteering and price manipulation: A. Letter of Instruction 1305 C. Letter of Instruction1359 B. Letter of Instruction 1342 D. Letter of Instruction1349 2. A prevailing price be placed under automatic price control except: A. State of calamity C. Declare in a State of rebellion B. Declared under an emergency D. Privilege of the writ E. NOTA of habeas Corpus 3. Appoints the Sectoral representative of the Price Coordinating Council: A. Secretary of Trade & Industry C. Secretary of DA B. President of the Philippines D. Secretary of DENR 4. Penalty for acts of illegal price manipulation is: A. Imprisonment for 1 year and NMT 10 years. B. Fine for NLT Php 5,000 and NMT 1 million. C. Imprisonment for NLT 5 years and NMT 15 years. D. Fine of NLT Php 500,000 and NMT 2 million. 5. FF conditions may impose a price ceiling except: A. Existence of calamity C. Widespread illegal price manipulation B. Existence of an emergency D. NOTA 6. Factors in determining reasonable price ceiling: A. Supply available in the market C. Change in the amortization cost B. Peso exchange rate D. AOTA  IT IS THE POLICY OF THE STATE TO PROTECT THE INTEREST OF THE CONSUMER, PROMOTE HIS GENERAL WELFARE AND TO ESTABLISH STANDARDS OF CONDUCT FOR BUSINESS AND INDUSTRY. APPROVED: APRIL 13, 1992  Building Equipment Personnel Components (Raw Materials) Master-formula & batch production records Production and control procedures Product containers Packaging & labeling Laboratory controls Finished-goods warehouse control and distribution records Stability Complaint files “An act to maximize the contribution of senior citizens to nation building, grant benefits, and special privileges and for other purposes” April 23, 1992 Senior citizen – shall mean any resident citizen of the Philippines at least 60 years old, including those who have retired from both government & private enterprises, and has an income of not more than P60,000 per subject to review by the NEDA every 3 years. An act granting additional benefits and privileges to senior citizens amending for the purpose R.A. 7432, otherwise known as “An act to maximize the contribution of senior citizens to nation building, grant benefits, special privileges and for other purposes” APPROVED: February 26, 2004 SENIOR CITIZEN or ELDERLY any resident citizen of the Philippines at least 60 years old BENEFACTOR any person whether related to the senior citizens or not who takes care of him/her as a dependent HEAD of the FAMILY any person so defined in the National Internal Revenue Code, as amended GERIATRICS branch of medical science devoted to the study of the biological and physical changes and the diseases of old age  Senior citizenS What to ask the doctor/pharmacist to avail of the 20% discount in the purchase of medicines for your personal use and according to his personal needs. What are the requirements to purchase the medicine and avail the 20% discount? Present the National Identification Card and his purchase slip booklet duly approved by the OSCA chairman Doctor’s prescription pad should have the following information: 1. Patient name, age, address, and date  2. Generic name of the medicine prescribed 3. Name and address of the doctor, his PTR number and S2 license For those who cannot afford the consultation fee of a private doctor: Consult at their nearest Health Center or Government Hospital and get a prescription free of charge Any single dispensing should not be more than one-week supply  When drugs are for chronic condition requiring continuous use for more than a month, such as but not limited to: anti-hypertensive, anti-diabetic, anti-parkinsonism, anti-arthritis, anti-TB, anti-neoplastic, anti- psychotic, hormonal drugs for prolonged use and dietary supplements, a maximum of one month supply may be dispensed at a time.  The following should be recorded in a special record book for senior citizens discount provided under RA 7432: 1. Name and address 2. National ID number of senior citizen 3. Generic name of the drug / medicine 4. Number of units dispensed For partial filling: The drugstore pharmacist will indicate the quantity partially filled in the special record book and the unfilled balance in the prescription  SAMPLE FORM TO BE STAMPED TO PRESCRIPTIONS THAT ARE PARTIALLY FILLED PRESCRIPTION A prescription is an order for medication issued by a physician, dentist, veterinarian or other properly licensed practitioner. Parts of Prescription 1. Heading 2. Patient’s information 3. Date 4. Superscription – Rx symbol 5. Inscription – medication prescribed 6. Subscription – direction to the pharmacist 7. Transcription – direction to the patient 8. Special labeling and other instructions 9. Prescriber’s signature PRACTICES TO BE OBSERVED TO AVOID DISPENSING ERRORS 1. One should have adequate knowledge about drugs to avoid dispensing errors. 2. Careful examination of prescription. Read accurately what is written on the prescription. 3. Read the label of the bottle/container twice or thrice and should not rely on the familiarity of its location. 4. Always label the products to be dispensed for proper identification. 5. Allow other pharmacy assistants or pharmacist to recheck your work. 6. Do not hesitate to ask the help of the pharmacist-in-charge in case there is any doubt about the prescription  REVIEW QUESTIONS 1. RA 7432 was signed into law on: A. April 23, 1992 C. February 13, 1992 B. February 7, 1992 D. April 13, 1992 2. The Expanded Senior Citizens Act of 2003 is also known as: A. RA 9265 C. RA 9275 B. RA 9165 D. RA 9257 3. The term “senior citizen” shall mean any resident citizen at least ___ years old: A. 50 B. 55 C. 60 D. 65 4. The government agency w/c issues National ID card and purchase slip booklet: A. DSWD B. GSIS C. OSCA D. BFAD 5. The discount privileges of the senior citizen shall be: A. Non transferable B. Transferable but limited for senior citizen C. Limited and exclusive for senior citizen D. Both A and C 6. Any person maybe a relative or not who takes care of senior citizen as dependent: A. Head of the family C. Benefactor B. Relative D. Care giver 7. Supplies of medicine to be given shld not exceed: A. One day supply C. One month supply B. One week supply D. One year supply 8. OSCA refers to: A. Office of Senior Citizen Affiliate D. NOTA B. Office of Senior Citizen Affairs C. Office of Senior Citizen’s Academy 9. Which of the ff shld be presented by senior citizen: A. Purchase slip booklet D. National ID card B. Prescription E. A, B & D C. Birth Certificate F. AOTA 10. Violation of any provision of senior citizen act is punishable by: A. Fine not exceeding 2,000 pesos B. Imprisonment not exceeding 1mon & fine not exceeding 1,000 pesos C. Imprisonment not exceeding 2 months D. Both A and C “An act to promote, require, and ensure the production of an adequate supply, distribution, use, and acceptance of drugs and medicines identified by their generic name” SEPTEMBER 13, 1988 GENERIC NAME – is a simpler term for the scientifically recognized active ingredient of a drug BRAND NAME – proprietary name given by the manufacturer to distinguish its production from those of competitors EDL or NDF – is a list of alternative drugs prepared & periodically updated by DOH on the basis of health conditions obtained in the Philippines, as well as on internationally accepted criteria - consist of a core list and a complementary list CORE LIST – is a list of drugs that meet the health care needs of the majority of the population COMPLEMENTARY LIST – is a list of alternative drugs used when there is no response to the core essential drug, when there is hypersensitivity reaction or if it cannot be given GENERIC DRUGS – are drugs not covered by patent protection and which are labeled solely by their INN or generic name 1. GENERIC NAMES SHALL BE USED IN ALL PRESCRIPTIONS 1.1. For drugs with a single active ingredient, the generic name of that active ingredient shall be used in prescribing 1.2. For drugs with two or more active ingredients, the generic name as determined by BFAD shall be used in prescribing 2. THE GENERIC NAME MUST BE WRITTEN IN FULL BUT THE SALT OR CHEMICAL FORM MAY BE ABBREVIATED 3. THE GENERIC NAME OF THE DRUG ORDERED MUST BE CLEARLY WRITTEN ON THE PRESCRIPTION IMMEDIATELY AFTER THE Rx SYMBOL, OR ON THE ORDER CHART 3.1. In addition to the generic name, a brand name may also be indicated. In such cases, the following shall be observed: 3.1.1. If written on a prescription pad, the brand name enclosed in parenthesis shall be written below the generic name 3.1.2. If written on a patient’s chart, the brand name enclosed in parenthesis shall be written after the generic name 4. ONLY ONE DRUG SHALL BE PRESCRIBED ON ONE PRESCRIPTION FORM THINGS TO REMEMBER WHEN BUYING MEDICINES TO CHECK IF IT IS REGISTERED WITH BFAD-DOH AND IF IT COMPLIES WITH “GENERIC LABELING” Bottle/Box (Syrup, Tablet, Capsule, Injectable, ointment) - Generic name / Brand name - Dosage strength / form - Pharmacologic category - Company logo - Name / Address of company - Rx symbol if prescription drugs - Net content - Formulation - Indication / Dosage - Warning / contraindication / precaution - DR number - Expiry date - Batch number / Lot number - Manufacturing date - Storage condition Foil/blister (Tablet, capsule) - Generic name - Brand name - Dosage from / strength - Company logo or name of company - Rx symbol if prescription drugs - Expiry date / Lot number Ø WHAT is the drug’s name (e.g. Paracetamol, Amoxicillin) Ø WHEN does the patient take the medicine (e.g. in the morning, twice a day) Ø HOW MUCH dosage does the patient take (e.g. 1 Tbsp, 1 capsule) Ø FOR HOW LONG does the patient take the medicine (e.g. 4 days, 1 week) Ø HOW should the medicine be taken (e.g. with food, empty stomach, with water) I. ERRONEOUS Rx Ø Prescriptions are considered erroneous if: § The brand name precedes the generic name § The generic name is the one in the parenthesis § The brand name is not in the parenthesis II. VIOLATIVE Rx Ø Prescriptions are considered violative if: § The generic name is not written § The generic name is not legible and a brand that is legible is written § The brand name is indicated and instructions § (such as the phrase “NO SUBSTITUTION”) § that tend to obstruct, hinder, or prevent generic § dispensing III. IMPOSSIBLE Rx Ø Prescriptions are considered impossible if: § Only the generic name is written but is not legible § The generic name does not correspond to the brand name § Both generic name and the brand name are not legible I. VIOLATIVE AND IMPOSSIBLE Rx Ø Shall not be filled Ø Shall be kept & reported by the pharmacist to the nearest DOH office Ø Pharmacist shall advise the prescriber of the problem Ø Instruct the customer to get proper Rx II. ERRONEOUS Rx Ø Shall be filled Ø Shall be kept & reported to the nearest DOH office vDISPENSING – is the act by validly registered Pharmacist of filling a prescription or doctor’s order on the patient’s chart. vGENERIC DISPENSING – means dispensing the patients’/ buyers’ choice among the generic equivalents, i.e. finished pharmaceutical products having the same active ingredient(s) same dosage form and same strength as the prescribed drug. vPARTIAL FILLING OF PRESCRIPTION – means dispensing less than the total number of units prescribed. I. All drug outlets are required to practice generic dispensing. II. Dispensing: products not in their original containers: § Small bottles; Tin cans; Boxes; Plastic or paper envelopes Information required on drug outlet’s labels: 1. Name of the patient 2. Generic name of the drug 3. Brand name, if any 4. Manufacturer 5. Dosage strength 6. Expiry Date 7. Directions for use 8. Name of the Pharmacist III. In partial filling of the Rx. Information required to be written on the Rx: 1. Date of partial filling 2. Quantity served & balance of the Rx 3. Name & address of the drugstore Additional requirements: 1. The prescriber must have an S-2 license 2. The special DDB Rx form must be used 3. A recording system following pertinent DDB regulation must be covered. IV.In dispensing drugs in List A and List B: 1. Dispensing must be done by the pharmacist 2. Follow the order & instructions of the doctor on the Rx 3. Partial filling of Rx for drugs in List A: 3.1 Rx must be retained by the pharmacist 3.2 The patient must asked the prescriber for another Rx to complete the total dose of the medication 4. After the Rx is filled the original copy of the Rx shall be retained & kept for a period of 1 year by the pharmacist for inspection.  DRUGSTORES, BOTICAS, AND OTHER DRUG OUTLETS In order to ensure the informed choice and use of drugs by the patient/ buyer, the outlets are required to: Ø Inform the patient/ buyer of all the available drug products generically equivalent to the one prescribed with their corresponding prices. Ø Shall not favor or suggest any particular product so that the patient/ buyer may fully and adequately exercise his option to choose  Ø Post in a conspicuous place in their establishment a list of drug products using generic names with their corresponding brand names, if any, and their corresponding current prices. Ø Provide a handbook or directory containing the above-required information readily accessible to the patient/ buyer. NOTE: The partially filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore that completes the filling of the prescription shall keep the prescription on file 1. Imposing a particular brand or product on the buyer 2. Inaccurate dispensing 3. Failure to post or make accessible the required up-to-date information on drug product 4. Failure to adequately inform buyer on available product that meet the Rx 5. Failure to indicate the generic name/ official name designated by the BFAD & other required information on the drug outlet’s label of the dispensing drug. 6. Failure to record and keep Rx filled 7. Failure to report to the nearest DOH office incorrect Rx within 3 months after receipt of such Rx. ØSuspension, or revocation of the LTO of the drug outlet by the Secretary of Health ØProfessionals directly involved in the violation shall be recommended by the Secretary for appropriate administrative sanctions by the PRC VIOLATIONS: Provisions related to the Practice of Pharmacy PENALTIES: Ø Fine of Php 5,000 to Php 10,000 and or suspension or revocation of license to operate such business establishment. Ø Officers responsible for the violation shall suffer a penalty of fine and suspension or revocation of license to practice & if applicable, imprisonment of not less than 6 months but not to exceed 1 year or both penalty and fine  REVIEW QUESTIONS 1. RA 6675 was signed into law on: A. Sept. 23,1998 C. Sept. 4, 1988 B. Sept. 13, 1988 D. Sept. 30, 1988 2. When the drug product prescribed is not registered w/ BFAD, this is a case of: A. Violative Rx C. Erroneous Rx B. Impossible Rx D. Coded Rx 3. If the brand name precedes the generic name, the Rx A. Violative C. Erroneous B. Impossible D. Coded 4. Under the generics law, w/c of this Rx shall be filled. A. Violative C. Erroneous B. Impossible D. NOTA 5. Rules & regulations to implement dispensing requirement under the Generics Act of 1988: A. AO 63 C. AO 65 B. AO 64 D. AO 66 6. FF are the violations on the part of dispensers & outlet A. Failure to record & keep Rx filled B. Imposing a particular brand or product C. Failure to report to the nearest DOH office D. Both A and B E. AOTA 7. Generic prescribing is also known as: A. AO 61 C. AO 63 B. AO 62 D. AO 64 8. What is to be done with violative prescription: A. Shall be filled & kept C. Shall be mark w/ red ink B. Not be filled & report to nearest DOH D. torn 9. Which if the ff is an erroneous Rx. A. Generic name is not legible & brand name is legible B. Brand name is not in parenthesis C. Only generic name is written but not legible D. AOTA 10. Corelist means: A. List of drugs that meet health care needs B. List of drugs that meet the requirements established by Pharmaceutical Assn C. List of drugs with corresponding brand names. D. AOTA  An act instituting the Comprehensive Dangerous Drugs Act of 2002, repealing Republic Act No. 6425, otherwise known as the Dangerous Drugs Act of 1972, as amended, providing funds therefore, and for other purposes. COMPOSITION: Ø 17 members (3 of which are permanent members) Ø 12 members in ex-officio capacity (2 shall be regular members) PERMANENT CONSULTANTS: Ø Director of the NBI Ø Chief of the PNP Ø Implementing arm of the Board Ø Shall be headed by a Director General (with the rank of Undersecretary) Ø Shall be appointed by the President of the Philippines Ø Created on July 30, 2002 Ø Sec. 4 : Importation of DD &/or Controlled Precursors & Essential chemicals Ø Sec. 5 : Sale, trading, administration, dispensation, delivery, distribution & transportation Ø Sec. 6 : Maintenance of a den, dive or resort Ø Sec. 7 : Employee & visitors of a den, dive, resort Ø Sec. 8 : Manufacture DD &/or CD & EC Ø Sec. 9 : Illegal chemical diversion of CP & EC Ø Sec. 10 : Manufacture or delivery of equipment instrument, apparatus & other paraphernalia for DD &/or CP & EC. Ø Sec. 11 : Possession of DD Ø Sec. 12 : Possession of equipment, instrument, apparatus, & other paraphernalia for DD Ø Sec. 13 : Possession of DD during parties, social gatherings or meetings Ø Sec. 14 : Possession of equipment, instrument, apparatus & other paraphernalia for DD during parties, etc. Ø Sec. 15 : Use of DD Ø Sec. 16 : Cultivation or culture of plants classified as DD Ø Sec. 17 : Maintenance & keeping of original records of transaction on DD &/or CP & EC Ø Sec. 18 : Unnecessary prescription of DD Ø Sec. 19 : Unlawful prescription of DD PENALTY: Ø DANGEROUS DRUGS Life imprisonment to death & a fine ranging from Php 500,000 to Php 10M (regardless of quantity & purity) including any & all species of opium, poppy or any part/substance even for floral, decorative & culinary use. Ø CONTROLLED PRECURSORS AND ESSENTIAL CHEMICALS Imprisonment ranging from 12 years & 1 day to 20 years and a fine of Php 100,000 PENALTY: Ø DANGEROUS DRUGS Life imprisonment to death & a fine ranging from Php 500,000 to Php 10M Ø CONTROLLED PRECURSORS AND ESSENTIAL CHEMICALS Imprisonment ranging from 12 years & 1 day to 20 years and a fine of Php 100,000 PENALTY: Ø DANGEROUS DRUG: Life imprisonment to death & a fine ranging from Php 500,000 to Php 10M (NOTE: Regardless of degree of purity) 10 grams or more of: § Opium § Morphine § Cocaine or Cocaine HCL § Marijuana Resin or Marijuana Resin Oil - 50 grams or more of Methamphetamine HCL or “Shabu” - 500 grams or more of Marijuana 10 grams or more of other dangerous drugs such as, but not limited § MDMA – methylenedioxymethamphetamine or “Ecstacy” § PMA – paramethoxyamphetamine § TMA – trimethoxyamphetamine § LSD – lysergic acid diethylamide § GHB – gama hydroxybutyrate I. PHARMACIST Ø Shall maintain and keep an original records of sales, purchases, acquisitions and deliveries of dangerous drugs: 1. License no. & address of pharmacist 2. Name, address & license of the manufacturer, importer or wholesale. 3. Quantity and name of the dangerous drugs purchase or acquired 4. Date of acquisition or purchase  5. Name, address & community tax certificate number of the buyer 6. Serial number of the Rx & name of the practitioner 7. Quantity & name of the dangerous drugs sold or delivered 8. Date of sale or delivery II. PHYSICIAN, DENTIST, VETERINARIAN OR PRACTITIONER: Ø Rx must be issued in triplicate copies Ø One original & 2 duplicate copies I. Processed Foods (Ready to Eat) II. Drugs: § Prescription/ ethical § Over-the-counter drugs § Vaccine & biologicals § Herbal medicines § Veterinary III. Medical Devices (Invasive) IV. In-vitro Diagnostic Reagents (e.g. for AIDS, HEPA, etc…) V. Cosmetics VI. Household Hazardous Substances I. Manufacturer II. Trader III. Distributor Importer Exporter Wholesaler SAMPLE TESTED: 1. Government deliveries 2. Collected samples for routine monitoring 3. Complained products from consumers 4. Products for registration 5. Donated products I. MARKET MONITORING OR PRODUCTS: § COUNTERFEIT DRUGS/ PRODUCTS § MISLAbELED PRODUCTS § ADULTERATED PRODUCTS § ExPIRED PRODUCTS § UNREGISTERED PRODUCTS II. PRICE MONITORING Ø S-1: for persons dealing in exempt Dangerous Drugs Preparation Ø S-2: for physicians, dentist, and veterinarians, lawfully entitled to distribute, dispense or administer any dangerous drugs. Ø S-3: for retail dealers Ø S-4: for wholesale dealers Ø S-5-1: for importers of raw materials & finished products Ø S-5-C: for compounders, producers and manufacturers Ø S-6: for persons not registered as importer, manufacturer, producer or compounders but lawfully entitled to obtain and use in a laboratory dangerous drugs for the purpose of research, instruction or analysis. Ø S-7: for importer, manufacturer, producers or compounder of dangerous drugs in any form, their salts, isomers, any material, compound, mixture or preparation which contains any quantity of dangerous drugs, and exempt preparation imported into or produced in the Philippines  REVIEW QUESTIONS 1 Dangerous Drug Act of 1972 is: A. RA 9165 C. RA 6675 B. RA 6425 D. RA 9465 2. Regular member of DDB: A. Secretary of Health C. Director of NBI B. Secretary of Justice D. Pres. of IBP 3. Head of PDEA: A. Secretary of Health C. NBI Chief B. Director General D. PNP Chief 4. Permanent consultant of DDB: A. Sec of Health & Director of BFAD B. NBI Director & PNP Chief C. NBI Chief & BFAD Director D. NOTA 5. Substances covered by RA. 9165 A. Prescription drugs C. Controlled precursors B. Dangerous drugs D. B & C only 6. Methylenedioxymethampethamine (MDMA) is: A. Shabu C. Ecstacy B. Marijuana D. Opium poppy E. NOTA 7. Cannabis is also known as: A. Shabu C. Ecstacy B. Marijuana D. Indian hemp E. B & D only 8. Metamphetamine HCL is: A. Shabu C. Ecstacy B. Marijuana D. Opium poppy E. LSD 9. Has the power to reclassify, add or remove from the list of dangerous drugs A. DDB C. NBI B. PDEA D. BFAD E.DOH 10. Set guidelines & ensure proper implementation of RA 9165 is a function of: A. Congressional oversight committee C. BFAD B. PDEA D. DDB E.NBI 11. Responsible for efficient & effective law enforcement on any dangerous drug & controlled precursor A. DDB C. NBI B. PDEA D. BFAD E. DOH 12. PDEA was created on A. July 30,2002 C. July 25,2002 B. July 30,1998 D. July 25,1998  RA 9711 FOOD AND DRUG ADMINISTRATION ACT OF 2009 BUREAU OF FOOD AND DRUGS (BFAD) RENAMED THE FOOD AND DRUG ADMINISTRATION (FDA) JUNE 3, 2009  RA 9502 UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF 2008 Ø AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES AMENDING FOR THE PURPOSE REPUBLIC ACT NO 8293 OR THE INTELLECTUAL PROPERTY CODE, RA NO 6675 OR THE GENERICS ACT OF 1988 AND REPUBLIC ACT 5921 OR PHARMACY LAW. Ø JUNE 6, 2008 An act creating the Philippine Institute of Traditional and Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the Philippines, providing for a traditional and alternative health care development fund and for other purposes. APPROVED: December 9, 1997 CLINICAL PHARMACOLOGY: PHASE I – TOLERANCE AND SAFETY PHASE II – SAFETY AND EFFICACY PHASE III – CONTROLLED CLINICAL TRIALS (for foreign and local) PHASE IV – Provisional Monitored Release/Post Marketing Surveillance DRUG CLASSIFICATION: a. Number of Active Ingredients - single ingredient - fixed-dose combination of 2 or more ingredients b. Available Scientific Evidence & Experience on the Drug’s Use - Investigational Drug – refers to a new chemical or structural modification of a tried & tested or established drug proposed to be used for a specific therapeutic indication (needs phases I, II, or III) - New Drug – needs phase IV - Tried & Tested Drug – is a drug which has been used for at least 5 years & involving at least 5,000 patients - Established Drug – found in current official USP- NF - Pharmaceutical or Therapeutic Innovation of a Tried & Tested or Established Drug: An Innovation involving: b.1. use for new indication(s) b.2. a new mode of administration b.3. a new dosage form b.4. a new fixed dose combination of 2 or more active ingredients c. Pharmacologic/Therapeutic Category as specified in the PNDF d. Source or Circumstances of Drug Production - Imported as finished - Locally manufactured from imported materials - Locally manufactured from local materials e. Brand Identification and Patent Protection of the drug - Branded and Patented - Branded and off patent - Unbranded and off patent (generic drugs) f. Prescribing and Dispensing Regulations applicable - OTC or non-Rx - Ethical of Rx drugs - DD (list A drugs) - Drugs requiring strict precaution in prescribing & dispensing (list B drugs) DRUG FOR GENERAL USE – is a drug approved or sale to the general public without restriction other than usual DRUG FOR RESTRICTED USE – is a drug approved for sale to the general public under certain conditions REGISTRATION – means the process of approval for the manufacture, importation, exportation, sale, offer for sale, distribution or transfer of pharmaceutical products containing active ingredient(s) of known chemical structure & properties to be safe, efficacious, and of good quality according to standards of BFAD  PRC LAW IMPLEMENTING RULES AND REGULATIONS  FORFEITING THE EXAMINATION FEES PAID BY EXAMINEE WHO FAILED TO REPORT AND TAKE THE SCHEDULE EXAMINATION > it hereby RESOLVED to forfeit the examination fee or fees paid by ABSENT examinees for such examination and to required them to pay anew the examination fees when they re-apply for future examinations. NON-ADMISSION OF EXAMINEES ARRIVING LATE DURING THE CONDUCT OF LICENSURE EXAMINATIONS 1. Under normal conditions, examinees arriving late after the start of the examinations shall NOT be allowed to take the examinations anymore. 2. In special cases such as high floods, typhoons, transport strike, threats to the peace and order situation like mass rally, mutiny, or coup de-tat, the start of the examinations shall be delayed and the time to finish or end shall be adjusted accordingly. The adjusted time to start and finish the examinations shall be the same in all test centers. Examinees arriving after the adjusted schedule shall no longer be allowed to take the examinations. > FURTHER resolved that schools, colleges and universities who do not have the equipment for scanning of pictures shall attach an original certification on the transcript of records stating the non-availability of equipment for scanning to be signed by the president or registrar.  R.A. No. 8981 “ PRC Modernization Act of 2000”  COMPOSITION: The Commission shall be headed by: 1. Full-time Chairperson and 2. Two (2) full- time Commissioners All are appointed by the President 7-year term without reappointment REQUIREMENTS: At least 40 years of age Holding a valid certificate of registration/professional license and a Valid identification card or Valid certificate of competency issued by the Commission or Valid professional license issued by any government agency Has at least 5 years of executive or management experience EXERCISE OF POWERS AND FUNCTIONS OF COMMISSION Exercise general administrative, executive and policy-making functions Establish and maintain high standard of admission to practice all professions Ensure and safeguard the integrity of all licensure exams CHAIRPERSON: Act as the presiding and chief executive officer of the Commission Preside over the meetings of the meetings of the Commission Responsible for the implementation of policies and programs POWERS, FUNCTIONS AND RESPONSIBILITIES OF COMMISSION Administer, implement and enforce regulatory policies with respect to regulations and licensing of different professions Make rules and regulations and issue orders necessary for the implementation of its functions and improvement of services Review, revise and approve resolutions promulgated by the PRC.  Administer and conduct licensure examinations Determine place and date of examinations Conduct more than 1 licensure examination Require the completion of a refresher course if examiner failed to pass 3x. Appoint supervisors and room watchers for the examinations Publish list of successful examinees  Implement the full computerization of all licensure examinations including registration of professionals by year 2003 Investigate upon filing of verified complaint against any member of the Professional Regulator Boards. Recommend to the President the revoke or suspension of certificates of registration of PRB if found guilty  Provide copies of sample test questions/ syllabi or terms of specifications of subjects for licensure examinations Impose penalty of suspension or prohibition form taking licensure examinations to any examinee Responsible for entry names on its registry book and computerized database of successful examinees.  Issue certificate of registration/ professional license Issue PRC ID. Custody of all records of the various Boards (examination papers, record of administrative cases and investigations, examination results) Determine amount of fees to be charged and collected Submit and recommend to the President names of the licensed/ registered professionals for appointment as members of various Regulatory Boards.  Initiate investigation unauthorized practice of profession of any individual (private or professional; local or foreign) Forward the records of the case to authorities if the evidence so warrants. Prepare an annual report of accomplishments of the programs, projects and activities of the Commission Make appropriate recommendations on issues/ problems affecting the Commission.  Initiate investigation unauthorized practice of profession of any individual (private or professional; local or foreign) Forward the records of the case to authorities if the evidence so warrants. Prepare an annual report of accomplishments of the programs, projects and activities of the Commission Make appropriate recommendations on issues/ problems affecting the Commission. POWERS, FUNCTIONS AND RESPONSIBILITIES OF VARIOUS PROFESSIONAL REGULATORY BOARDS Regulate the practice of the professions in accordance of their respective laws Monitor the conditions affecting the practice of profession or occupation Adopt measures to enhance/ maintain high professional standards May be authorized by the Commission to conduct inspection  Hear, investigate cases arising from violations of their respective laws. Decision of the PRB, unless appealed to the Commission becomes final and executory after 15 days. Recommend registration without examination, issuance of certificate of registration and PRC card upon approval by Commission After due process, suspend or revoke certificate or license.  Prepare, adopt and issue the syllabi or tables of specifications of the subjects for examinations Determine and prepare questions for the licensure examination. Score and rate the examination papers within 10 days from the last day of examination Determine appropriate passing general average rating PERSON TO TEACH SUBJECTS FOR LICENSURE EXAMINATION ON ALL PROFESSIONS Holders of valid certificates of registration and Valid professional licenses of the profession Comply with the other requirements of CHED AUTHORITY TO USE INCOME Annual Appropriations of the Commission Not exceeding 45M pesos a year for 5 years after effectivity of this Act. PENALTIES FOR MANIPULATION AND OTHER CORRUPT PRACTICES IN THE CONDUCT OF PROFESSIONAL EXAMINATIONS Manipulation of licensure exam results Secretly informs content of of licensure examination questions Tampering of grades  PENALTIES: – Imprisonment of nlt 6years and 1 day to not more than 12 years or – Fine of nlt 50,000php to nmt 100,000php or – BOTH  IF THE OFFENDER IS AN OFFICER OR EMPLOYEE OF THE COMMISSION OR MEMBER OF THE REGULATORY BOARD: - Removed from the office and disqualification form public office - Serve penalty  FOR ACCOMPLICES: - Imprisonment of 4 years and 1 day to 6 years or - Fine of 20,000php to nmt 49,000 or - BOTH  FOR ACCESSORIES - Imprisonment ranging from 2 years and 1 day to 4 years or - Fine of 5,000php to nmt 19,000php or - BOTH PENALTY FOR VIOLATION/ ABUSE OF POWER, FUNCTIONS AND RESPONSIBILITIES OF THE COMMISION Imprisonment of nlt 6months and 1 day to nmt 6 years or Fine of nlt 50,000php to nmt 500,000php or BOTH  Implementing Rules and Regulations: - Within 90 days after the approval - Shall be promulgated by PRC, together with representatives of the various Professional Regulatory Boards, accredited organizations, CHED  EFFECTIVITY - Shall take effect after 15 days following its publication in the Official Gazette or in 2 newspapers of general circulation, whichever is earlier APPROVED: -December 5, 2000