QuestionsQuestions (DDB BOARD REGULATION NO. 4)
Under the Regulation’s definitions, “Prohibited Drug” refers to substances such as opium and its derivatives, heroin and morphine, coca leaf/cocaine and related compounds, hallucinogens like LSD and similar substances, Indian hemp (cannabis) and preparations from them, plus other drugs/preparations with narcotic or hallucinogenic physiological effects. “Regulated Drug” refers to self-inducing sedatives (certain barbiturates), amphetamine-type stimulants (e.g., benzedrine/dexedrine or similar action), and hypnotic drugs (e.g., methaqualone, nitrazepam or similar compounds).
It must (a) be a useful and much-needed medicine required to be easily available to the public for medical need; (b) present no or negligible risk of abuse; and (c) be compounded/mixed/prepared so that the dangerous drug content is impossible to recover with readily applicable means in a quantity liable to abuse, such that it does not give rise to a public health and social problem.
Applicants outside Metro Manila file applications with the Special Processing Officers deputized by the Board; the text provides that applications are processed/approved by regional special processing officers designated from the Department of Health drug regulation officers.
Drug Regulation Officers of the Department of Health are deputized as Special Processing Officers of the Board. They receive/process/approve applications for registration and licensing in their regions, issue S-Licenses, and submit monthly reports to the DDB. If issues cannot be resolved, applications are forwarded to the DDB in Manila.
Grounds include: (1) conviction of the applicant/licensee for an offense under R.A. 6425 (as amended) or these regulations or other existing laws/regulations; (2) unfitness of the person to hold the license; or (3) the premises being deemed unfit for the licensed purpose.
A wholesale dealer sells/“offers for sale” dangerous drugs in original packages/containers and may not open packages or dispose of portions without an S-3 license. A wholesale dealer cannot import/manufacture/produce/compound/mix. A retail dealer sells dangerous drugs from original stamped packages (with or without compounding) pursuant only to prescriptions by registered physicians/dentists/veterinarians in professional practice.
As stated in Section 12, an importer licensed only as an importer cannot manufacture/produce/compound dangerous drugs and exempt preparations, and similarly a manufacturer/compounder/producer cannot import as such.
Repacking is treated as “production” within the intent of the law and therefore must have prior authority of the Board.
Any person conducting two or more types of business at the same location must secure from the Board a license for each type of business.
No. Under Section 18, the license does not attach with respect to a warehouse where dangerous drugs/exempt preparations are stored, provided no sales are made at such place.
Except as otherwise provided, order forms are required for all transactions involving dangerous drugs and for the importation/exportation and manufacture of exempt dangerous drug preparations. The Regulation specifies types of order forms and that they may be secured from the Board.
Blank dangerous drug order forms may be obtained only by persons duly qualified under R.A. 6425 and holding a current Schedule S license except S-1. Import certificate forms (DDB Form No. 10-72) may be obtained only by persons holding a current Schedule S-5-I license as importers.
Order forms must be used consecutively and all serial numbers accounted for. If an order is cancelled/spoiled/lost/destroyed, copies must be forwarded to the Board or an affidavit submitted (including circumstances). The next serial order must not be acted upon unless requirements are complied with. No alteration/erasure/change in description may be made after approval by the Board; any corrections require return of copies to the Board within prescribed periods.
The possessor/responsible person must inform the Board within 24 hours (by telephone or other means), execute an affidavit in quadruplicate stating kinds/quantities and circumstances, and forward affidavit plus a copy of the invoice within 72 hours. Documentary evidence that police authorities were notified must accompany theft/robbery losses. Board officers conduct initial ocular inspection/investigation and refer for further investigation to the NBI.
Emergency orders may be used where life/health is endangered and official prescription forms cannot be accessed promptly (e.g., disasters, serious accident requiring immediate administration, or urgency where availability may mean life or death). In every case where an exempting provision is availed, the prescribing physician must certify the nature/time/place of emergency on the back of the ordinary prescription, include patient details, ensure printed full name/address, and inform the Board in writing within three (3) days.
No person may export/take out dangerous drugs or exempt preparations without an export permit from the Board. Exports by mail are prohibited. Exportation of heroin is prohibited. The exporter must present documentation to show the goods are consigned to an authorized permittee, for exclusive medical/legitimate uses in the destination, will not be re-exported, and that there is shortage/demand in the destination, including (where required) foreign license permits and consular verification of signatures if in doubt.