Policy, purpose, and legal basis
- The regulation implements the Dangerous Drugs Act of 1972 by establishing detailed rules for dealing in dangerous drugs and exempt dangerous drug preparations.
- The regulation ties compliance to the Dangerous Drugs Act provisions (including those on registration/licensing and permit systems).
- The Board controls access to regulated activities by using licenses, permits, and board-issued order forms.
Key definitions and terms
- “Law” refers to Republic Act No. 6425 (approved March 30, 1972), the Dangerous Drugs Act of 1972, as amended.
- “Narcotic Drug” refers to drugs producing insensibility, stupor, melancholy or dullness of mind with delusions, which may be habit-forming, including opium, opium derivatives and synthetic opiates.
- “Dangerous Drug” includes:
- Prohibited Drugs, including opium and its active components and derivatives (e.g., heroin and morphine), coca leaf derivatives (e.g., cocaine), specified hallucinogens (e.g., LSD), indian hemp derivatives, all preparations made from the foregoing, and other drugs/chemical preparations producing narcotic or hallucinogenic physiological effects; and
- Regulated Drugs, including specified self-inducing sedatives (e.g., barbiturals), amphetamine salts/isomers/derivatives (e.g., benzedrine or dexedrine) and similar drugs, and hypnotic drugs (e.g., methaqualone, nitrazepam), and similar compounds.
- “Exempt Dangerous Drug Preparation” means a preparation determined by the Board to be:
- a useful and much-needed medicine required to be easily available to the public for medical need,
- presenting no or negligible risk of abuse, and
- compounded/mixed/prepared so the dangerous drug content is impossible to recover with readily applicable means in quantities liable to abuse, and therefore does not create a public health and social problem.
- “Opium” covers coagulated juice of the opium poppy and all kinds/classes whether crude or prepared; includes ashes/refuse, narcotic preparations, morphine/alkaloids, ingredients containing opium/morphine/alkaloids, opium poppy, seeds, straw, and leaves/wrappings.
- “Cannabis Sativa L.” (marihuana/indian hemp) covers every kind/class/genus/species of cannabis sativa l., including listed varieties, in any form (e.g., reefer, resin, extract, tincture) and parts (including flowering/fruiting tops, seeds).
- “Hallucinogens” are chemical substances that, at pharmacological doses, create gross distortions in perception without significantly blunting/dulling consciousness, with rapid tolerance and development of physical and psychological dependence.
- “Depressants” are dose-dependent central nervous system acting substances causing decreased function with psychological and physical dependence and abstinence symptoms; including sedatives, hypnotics, and anti-anxiety agents.
- “Stimulants” are central nervous system substances producing euphoria, appetite depression, and hyperthemia; chronic use develops tolerance (except for toxic psychosis syndrome) with cross-toleration and withdrawal reactions.
- “Board” means the Dangerous Drugs Board.
- “Exempt Officials” include officials of national/provincial/city/municipal governments and officials of government-owned or government-controlled corporations.
- “Person” includes natural or judicial persons and specified institutions/entities (including drugstores, hospitals, pharmacy colleges, clinics, sanatoria and similar institutions).
- “Physician,” “Dentist,” “Veterinarians,” and “Pharmacists” mean persons duly authorized to practice their professions.
- Words importing singular/plural and masculine/feminine/neuter are construed as applicable, and definitions are not exclusive.
Registration, licensing, fees, and processing
- Applications for registration and license to deal in dangerous drugs and exempt dangerous drug preparations must be filed with the Dangerous Drugs Board, or with the Board’s authorized representatives if outside Metro Manila.
- Persons/entities outside Metro Manila file with Special Processing Officers deputized by the Board.
- The required registration and licensing scheme uses Schedule S classes (license holders) tied to professional status and to the nature of drug activity.
- The regulation sets specific annual fee rates for Schedule S categories, including:
- P30.00 per annum for persons dealing in exempt dangerous drug preparations (Schedule S, Paragraph 1), payable for the year/business period;
- P50.00 per annum for physicians, dentists, veterinarians, and other professionals lawfully entitled to distribute/dispense/give away/administer dangerous drugs (renewable every three (3) calendar years);
- P60.00 per annum for retail dealers;
- P180.00 per annum for wholesale dealers;
- P360.00 per annum for raw materials and P500.00 per annum for finished products for importers (Schedule S, Paragraph 5-I);
- P360.00 per annum for compounders, producers and manufacturers (Schedule S, Paragraph 5-C);
- P30.00 per annum for laboratory use by persons not registered as importer/manufacturer/producer/compounder but lawfully entitled for research, instruction or analysis.
- A per-weight dangerous drug content fee applies where the fee is One Peso and Fifty Centavos (P1.50) per 100 grams (or fractional part) in each package/container, with specific rules:
- It is paid immediately before removal from the place of production (if produced locally) or before release from customs house (if imported);
- The fee is measured by the entire content of a package/container, not by the dangerous drug weight alone;
- The unit subject to fee is the smallest individual package/container (outer packaging does not trigger additional fee on what is already within inner packages);
- For ampules in packages holding not more than twelve (12) units of single-dose hermetically sealed units, the fee may be paid on the joint contents at the P1.50 per 100 grams (or fraction) basis, and a new fee attaches for each new derivative/compound/preparation produced (including cascaded fee effects across processing steps);
- For tablets in a pack of 100 tablets or less, the fee is P1.50 per 100 grams (or fraction);
- For capsules where 100 capsules or less are contained in one pack, the fee is P1.50 per 100 grams (or fraction).
- Business done during January triggers full-year payment, and the fee for S-1 is P30.00 a year or any fraction regardless of commencement.
- Renewal of Schedule S license must be made not later than January 31st of each year.
- Failure to secure the S-license in the prescribed period triggers a surcharge of 10% of the required fee but not less than P10.00, except for S-2 license, where the surcharge is P50.00.
- Persons who paid the retail dealer fee do not become liable as manufacturers/compounders solely for compounding to fill legitimate prescriptions of registered practitioners.
- An S-1 license is issued only to persons who do not possess any other Schedule S license.
- A retail dealer/pharmacist who himself makes medicines containing dangerous drugs for prescriptions must secure an S-3 license, even if the dangerous drug content does not exceed amounts fixed in Section 11.
Special processing officers and records custody
- Department of Health Drug Regulation Officers are deputized as Special Processing Officers of the Board.
- These deputized officers must:
- receive, process, and approve registration/licensing applications submitted by qualified applicants in their region,
- issue S-Licenses, and
- submit monthly reports to the Board listing persons/entities registered and licensed during the month.
- If regional processing problems cannot be resolved, applications and pertinent papers must be forwarded to the Dangerous Drugs Board in Manila.
- If multiple Drug Regulation Officers operate in a region, the higher-ranking officer (as determined by the Department of Health) is deputized.
- Custody of all records for registration and licensing rests with the Dangerous Drugs Board.
- Records in health regional offices must be transferred to the custody of deputized Regional Drug Regulation Officers acting as Special Processing Officers.
Inspection powers and grounds to deny, revoke, suspend
- Inspections are conducted in accordance with Board Regulation No. 1, series of 1980.
- Inspections are undertaken by:
- the Board’s Executive Director,
- the Chief, Control, Regulation and Intelligence Division,
- Drug Regulation Officers, and
- other officers deputized in writing by the Chairman.
- The Board inspects a drug establishment to determine compliance with:
- the record-keeping system and
- security requirements under the regulations.
- Registration may be denied, and a license may be revoked or suspended for grounds including:
- conviction of the applicant/licensee under Republic Act No. 6425 (as amended) or under the regulations or other existing laws/regulations,
- unfitness of the person to hold the license, or
- establishment premises deemed by the Board unfit for the purpose for which the license was granted.
Schedule S license categories and operational limits
- Schedule S, Paragraph 6 covers lab users who obtain and use dangerous drugs for research/instruction/analysis under lawful entitlement at P30.00 per annum.
- Producers (Section 9): Persons who produce dangerous drugs or exempt dangerous drug preparations for sale on order forms by transferring packaged contents without mixing/compounding/method changes are liable to license as producers at P360.00 per annum.
- Wholesale dealers (Section 10):
- Wholesale license is P180.00 per annum.
- Wholesale dealers may sell/offer for sale only in original packages.
- Wholesale dealers are prohibited from importing, manufacturing, producing, compounding, or mixing dangerous drugs/exempt preparations in any manner.
- Wholesale dealers may not open original packages to dispose of only portions without securing an S-3 license.
- Retail dealers (Section 11):
- Retail license is P60.00 per annum.
- Retail dealers may sell dangerous drugs/exempt preparations from original stamped packages with or without compounding, pursuant to prescriptions written by registered physicians/dentists/veterinarians in the course of professional practice only.
- Holders of S-3 who compound for keeping medicines in stock for sale/disposition at wholesale must secure S-5 as compounders.
- An S-3 holder is not required to secure S-5 if the business involves manufacturing/sale/distribution/giving away/dispensing/possession of preparations/remedies with amounts not exceeding these per specified measures:
- opium: not more than two grains (0.1296 gram);
- morphine: not more than one-fourth of a grain (0.0162 gram);
- heroin: not more than one-eight of a grain (0.0081 gram);
- codeine: not more than one grain (0.0648 gram);
- and for salts/derivatives of the above “in one fluid ounce (29.57 cubic centimeters)” or “in one avoirdupois ounce (28.3495 grams)” for solid/semisolid preparations;
- Indian Hemp for external use only, if manufactured for retail trade as medicines and not for the purpose of evading law.
- Transfers by the pharmacist in charge of prohibited drugs in a drugstore to a successor on retirement or resignation are not treated as a wholesale dealer transfer.
- Importers, manufacturers, compounders (Section 12):
- S-5-I is issued only to importers; S-5-C is issued only to compounders, manufacturers or producers.
- An importer may not manufacture/produce/compound dangerous drugs/exempt preparations, and a manufacturer/compounder/producer may not import as such.
- An importer with only an importers license may not purchase from local firms for wholesale sale/distribution without securing an S-4 license as a wholesale dealer.
- Those disposing of their imported/manufactured/produced/compounded drugs do not need wholesale privilege licenses for that disposal; retail disposition requires a retail dealer license.
- A retail dealer holding S-3 who fills prescriptions using a portion from original packages is not required to secure an S-5 license as a compounder.
- Laboratory use (Section 13):
- Chemists who are lawfully entitled and occupy independent status (not employees), and other lawfully entitled persons using dangerous drugs in a laboratory for research/instruction/analysis without registering as compounder/importer/manufacturer and without manufacturing/compounding for sale/removal for consumption/sale are liable to license at P30.00 per annum.
- Exclusivity of license types and multiple businesses:
- Persons conducting two or more types of business at the same location must secure a license for each type.
- Persons must secure licenses for each place of business, including separate branches (with the manufacturing/production office exception where only orders are taken for delivery from the production location and no merchandise except samples is kept; retail/wholesale sales from that office require the corresponding dealer license).
- S-3 holders must notify the Board of pharmacist absence/leave and submit written authority authorizing a temporary replacement.
- Dispensing/dealing is permitted only upon orders received or engagements made with respect to or by reason of a fixed address.
- Warehouse (Section 18):
- A license does not attach with respect to a warehouse where dangerous drugs/exempt preparations are stored, provided no sales are made there.
- Partnerships, institutions, principals, employees, nurses, traveling salesmen:
- Partnerships incur the same license liability as individuals, and partners individually engaging incur additional liability.
- Hospitals, colleges, clinics, sanitaria, and other institutions not expressly exempted must carry special license liability.
- Principals, not agents, are liable to the imposed license; employers/principals are responsible for acts of employees/agents within scope of employment.
- Employees do not incur license liability when acting solely within the scope of employment; employees committing unlawful acts within or outside scope are personally liable.
- Nurses are treated as agents of practitioners/institutions; nurses are not permitted to register or possess dangerous drugs/exempt preparations except as agents or as patients.
- Unused dangerous drugs/exempt preparations left by a practitioner with a nurse for administration during the practitioner’s absence must be returned upon nurse discharge, with accounting in practitioner records.
- Dangerous drugs/exempt preparations found in a nurse’s possession outside supervision are forfeited to the government.
- Traveling salesmen who only solicit orders and forward them to principals are not required to register or pay license.
- Display and retirement/termination:
- Licenses and certificates of registration must be kept conspicuously displayed in the office or place of business during the paid period.
- Retirement on or before expiration requires presenting the license to the processing officer for annotation and return to the payer; the processing officer must promptly mail certification of retirement to the Board or regional processing officer.
- Registration terminates upon death, cessation of legal existence, or discontinuance of business/professional practice; registrant must notify the Board promptly when discontinuing.
Reports and operational administration
- After issuance of each Schedule S license, the processing officer must submit an immediate report to the Board’s Executive Director containing:
- name/style of licensee,
- date of issue,
- paragraph and assessment number,
- amount of fee paid,
- period for which paid,
- kind of business/occupation/profession,
- place of business (street/number/municipality/province),
- and the number/date of relevant certificates from Medical, Dental, Veterinary, or Pharmaceutical Examiners (as applicable), stating if no such certificate exists.
Order forms and transaction controls
- Written order forms govern transactions:
- Order forms are required for all transactions in dangerous drugs and for the importation/exportation/manufacture of exempt dangerous drug preparations.
- Specific form types include Dangerous Drug Order Forms (DDB Form No. 8-72), Import Certificate Forms (DDB Form No. 10-72), Order Forms for Importation of Exempt Dangerous Drug Preparations (DDB Form No. 9-72), and Order Forms for Exportation of Exempt Dangerous Drug Preparations (DDB Form No. 11-72), available from the Board.
- Restrictions on who may obtain blank order forms:
- Blank order forms may be obtained only by duly qualified persons under Republic Act No. 6425 with legitimate use.
- Dangerous Drug Order Forms are sold only to persons holding a current Schedule S license except S-1.
- Import Certificate Forms (DDB Form No. 10-72) are sold only to persons holding current Schedule S-5-I licenses (importers).
- Order forms are non-transferable except when the booklet has not had any part used and Board authority is secured before transfer.
- Serial number accountability applies:
- Order forms must be used consecutively with serial numbers accounted for.
- Cancelled/spoiled/missing forms require forwarding of all copies to the Board, or (if lost/destroyed) submission of an affidavit describing circumstances.
- A subsequent serial order form must not be acted upon by the Board unless these requirements are complied with.
- Lost or stolen order forms must be immediately reported to the Control, Regulation and Intelligence Division (CRID), with an affidavit and a police blotter copy; Executive Director forwards documents to the Chairman; Board must be notified if later recovered/found.
- Purchase requirements for order forms require, among others:
- current Privilege Tax Receipt (PTR),
- current Schedule S (Narcotic License),
- current PRC registration card,
- duly accomplished application form with blank forms obtainable from CRID,
- an ID-size picture taken not earlier than a month for first purchase,
- three (3) specimen signatures,
- BFAD permit to operate,
- and an authorization letter from the owner authorizing the representative to purchase order forms.
- Disposition and permit requirements:
- It is unlawful to sell, barter, exchange, or give away dangerous drugs/exempt dangerous drug preparations except in pursuance of a dangerous drug order and a permit from the Board.
- The requirement also covers transfers of dangerous drugs from wholesale to retail within the same establishment.
- Manufacturing/compounding preparations is prohibited without a Board-approved permit.
- Permitted exceptions include:
- sales/dispensing/distribution to a consumer under and in pursuance of an original prescription of a registered physician/dentist/veterinarian under these regulations or a government official authorized to prescribe;
- physicians/dentists/veterinarians administering such drugs to patients they personally attend for legitimate medical purposes;
- lawful exportations;
- disposition by duly registered persons with a current Schedule S license on personal written emergency orders in accordance with Section 34.
- Local purchase mechanics:
- The Board compares the signature on the order form with the signature on the registration application; the Board does not honor if not satisfied the order is authentic.
- Order forms must be accomplished in sextuplicate, and extra sheets are not permitted.
- Order forms cover disposition of dangerous drugs to registered persons and must not be used in prescriptions.
- Completed order forms become part of permanent records and must be kept available for inspection for five (5) years.
- Orders should be prepared in a manner that makes subsequent alteration difficult and detection easy; purchasers must protect signed order forms against alteration.
- For dangerous drug order forms, entries should be made using typewriter or ink, and unfilled order forms executed less permanently must be returned.
- The order form records the preparation date, purchaser name/address and current S-license number.
- Only one item per line and not more than six items per single form.
- Items are defined by packaging/bottle/bulk grouping consistent with listed rules.
- Purchasers must specify quantities and dangerous drug contents where applicable.
- Qualification of purchaser:
- Purchaser must be registered and have paid necessary fees up to end of the calendar year at time of presenting the order form; must likewise be qualified for the year within which merchandise is received.
- If not duly registered/fees not paid, the order form will not be issued to that purchaser.
Approval, alterations, and document loss procedures
- Manner of approval:
- Upon receipt of DDB Form No. 8-72 in sextuplicate, approving officers analyze, process, and enter in the record book with consecutive numbering.
- Approved order forms are signed by the Executive Director or duly authorized representative.
- Purchaser or authorized representative signs file copies (copies 5th and 6th) to obtain the first four copies.
- Each copy bears specific prescribed dispositions (e.g., file copies, endorsement upon completion, returned to Board, etc.).
- Alterations:
- No alteration/erasure/change in any description may be made after approval by the Board unless first approved by the Board.
- If a dealer cannot fill an approved order form, both copies must be returned to the Board within thirty (30) days from approval, with a statement of the reason.
- If the order was presented personally by the purchaser or via representative, the obligation devolves upon the purchaser.
- If the dealer cannot supply the full quantity, the dealer must notify the office in writing of the amount available (which must not exceed the original approved quantity), and return both copies for corrections; changes must be noted in all six copies.
- Loss, theft, robbery, breakage, accidents—dangerous drugs:
- The person in possession/responsibility must inform the Board within twenty-four (24) hours by telephone or other possible means.
- The person must execute an affidavit in quadruplicate stating kinds and quantities lost/destroyed and circumstances, and forward it with an invoice copy to the Board within seventy-two (72) hours from occurrence/discovery.
- Documentary evidence of police notification must accompany theft/robbery losses.
- Board drug regulation officers conduct immediate ocular inspection/investigation to verify circumstances.
- Results plus affidavit and documents are referred to the National Bureau of Investigation for investigation and recommendations regarding veracity and liability, if any.
- Outside Metro Manila, reports go directly to the deputized Regional Drug Regulation Officer; NBI referral is made by that officer to the nearest NBI branch, which then submits recommendations to the Board.
- Copies of affidavit and documentary evidence are retained in Board records for the person/establishment/agency/institution involved.
- Loss/theft—order forms:
- Stolen or lost order forms must be immediately reported to the Board upon discovery stating serial numbers.
- If an entire booklet/order forms is stolen/lost and serial numbers cannot be stated, report licensee name/address and approximate purchase date.
- If unused order forms later recovered, the Board must be notified.
- Loss of prescription forms for dangerous drugs (DDB Form No. 1-72):
- Physicians/veterinarians/dentists/other practitioners must report loss within twenty-four (24) hours from discovery, indicating circumstances.
- The Board publishes the loss in a newspaper of general circulation upon receipt.
- The Board refers each loss for investigation to any police/investigative agency it determines; authorities may take possession of remaining forms if needed.
- If findings show negligence, the negligent practitioner reimburses the Board for publication costs and may be barred from further purchasing prescription forms.
Emergency orders, emergency categories, and certification
- A purchaser may send an emergency order in any form duly signed by the purchaser to a dealer to supply the kind and quantity ordered.
- After filling, the dealer must prepare a signed statement explaining circumstances and submit it, together with a regular dangerous drugs order (DDB Form No. 8-72) properly accomplished by purchaser, immediately after receiving drugs and no later than:
- the business day following filling if within Metro Manila, or
- a reasonable time if in provinces.
- Disposition of copies follows the regular order form structure, except that one copy goes to the purchaser and another to the dealer.
- If explanation is unsatisfactory or abuse is indicated, Board action is taken.
- Emergency cases include:
- when prescriptions must be issued urgently due to effects of natural/other calamities (e.g., typhoons, earthquakes, conflagrations) so magnitude precludes prompt access to official prescription forms;
- when prescribing arises from a serious accident requiring administration at the scene/nearby and prescription forms are not readily available;
- when urgent need exists and ready availability in the physician’s opinion is the difference between life and death, and required prescription forms are not accessible for unavoidable and justifiable reasons.
- When the emergency exemption under Section 25(B) of Republic Act No. 6425 is availed of:
- the prescribing physician must certify at the back of the ordinary prescription form the nature, time, and place of emergency conditions and patient name/address;
- the physician’s printed full name and address must appear beneath the signature;
- the physician must inform the Board in writing within three (3) days from issuing such prescription.
Returned goods rule
- Registered persons in any class may return dangerous drugs to the person from whom they obtained, using an order form from the latter addressed to the former.
- The return is allowed only if approved by the Board and the order form contains a notation that the drugs are merely returned goods.
Importation: permits, procedures, quotas, and effects
- Dangerous drugs and exempt dangerous drug preparations may only be imported under a Board-issued permit pursuant to an application and after the Board determines the quantity is necessary for medical and legitimate uses only.
- An emergency exception exists when the Board judges that the welfare of all or a large proportion of the population justifies extraordinary action.
- No importation by mail is permitted.
- The Board