Definition of Terms of Board Regulation No. 1 DDB

Administer

Any act of introducing any dangerous drug into the body of any person or animal, with or without his/her knowledge by injection, inhalation, ingestion or other means, or of committing any act of indispensable assistance to a person in administering a dangerous drug to himself/herself unless administered by a duly-licensed practitioner for purposes of medication.

Analogue

Any substance whose chemical structure is substantially similar to any dangerous drug whose psychoactive effects are simulated by the substance.

Article

A manufactured item other than a fluid or particle which is formed into a specific shape, has an end use function dependent on that shape, and does not release more than very small quantities of a hazardous chemical under normal conditions of use.

Board or DDB

Refers to the Dangerous Drugs Board under Section 77, Article IX of RA 9165.

Bulk quantity delivery

Quantities equal to or more than 500 kilograms/liters of a controlled chemical or equal to or more than one kilogram of a dangerous drug or its preparation.

Chemical mixture

A combination of two or more chemical substances, at least one of which is not a controlled chemical, excluding any combination where the controlled chemical is present solely as an impurity.

Commercial Broker or Indentor

One who, for compensation, acts as a middleman in bringing about a purchase and sale of goods between a foreign supplier and a local purchaser.

Completely-formulated paint or coating

Any clear or pigmented liquid, liquefiable or mastic composition designed for application to a substrate in a thin layer that is converted into a solid protective, decorative, or functional adherent film.

Controlled chemical

A substance listed as a controlled precursor and essential chemical as defined by RA 9165 and includes those classified as such by the Dangerous Drugs Board for domestic control.

Controlled Laboratory equipment

The paraphernalia, apparatus, materials or appliances used, intended for use or designed for use in the manufacture of any dangerous drug and/or controlled precursor and essential chemical.

Controlled substance

Either a dangerous drug or a controlled precursor and essential chemical.

Controlled substance trader

An establishment which is a registered owner of a health product that may procure raw materials but subcontracts the manufacture to a licensed manufacturer, and is categorized as a manufacturer under the Regulation.

Customs broker

A person who is a bona fide holder of a valid Certificate of Registration from the PRC, functioning to handle the process of clearing goods through the Bureau of Customs.

Dangerous drugs

Those listed in the Schedules annexed to the 1961 and 1971 Single Conventions on Narcotic and Psychotropic Substances, and include those classified as such by the Dangerous Drugs Board for domestic control.

Dispense

Any act of giving away, selling or distributing medicine or any dangerous drug with the use of a prescription by a PDEA-licensed practitioner.

Diversion of dangerous drugs

The unlawful obtaining and channeling of pharmaceutical dangerous drugs for illegal purposes by methods such as forged prescriptions, theft, or fraudulent import permits.

DOH

Department of Health

Drug

Articles recognized in official pharmacopeias

Drug product

A finished dosage form that contains a drug substance that may or may not be in association with other active or inactive ingredients.

End-user declaration

A signed declaration by both the purchaser and end-user stating the intended use of the chemical product/apparatus and that it will not be used for the manufacture of illicit drugs.

End-user license

Authorizes the holder to acquire controlled chemicals from a licensed entity for legitimate use in commercial or industrial operation, but NOT to resell the chemical in its original form.

Entity

Any person, natural or juridical, including a corporation, partnership, trust, estate, association, or joint venture capable of acquiring rights or entering into obligations.

Export

Any physical departure of dangerous drugs or controlled chemicals or other goods from the customs territory of the country which requires a customs declaration.

FDA

Food and Drug Administration of the Philippines

Foreign State

Any country other than the Philippines and every constituent part of such country, including a territory, dependency or protectorate, which administers its own laws relating to dangerous drugs, analogues, and controlled equipment and chemicals.

Generic Drug

A drug which is the same as a brand named drug or innovator product, having the same active ingredient, dosage form, safety, strength, how it is taken, quality, performance, and intended use as approved by the FDA.

GHS

Acronym for Globally Harmonized System of Classification and Labeling of Chemicals, a system for standardizing and harmonizing the classification and labeling of chemicals.

Hazards

The inherent characteristics of chemical substances and mixtures that exist in the workplace and in the environment that are potentially dangerous or have the capacity to harm.

Hazardous or toxic substances

Chemical substances or mixtures that may be harmful to the environment and/or to human health in a short-term and long-term basis if inhaled, swallowed, or absorbed through the skin.

Hospital

A facility that is licensed, approved or designated by the DOH or Bureau of Animal Industry to provide care or treatment to persons or animals suffering from any form of disease or illness.

Illegal Trading

Transactions involving illegal trafficking of dangerous drugs and/or controlled precursors and essential chemicals using electronic devices such as text messages, e-mail, or the internet.

Import

Any physical introduction of dangerous drugs or controlled chemicals or other goods into the customs territory of the country which requires declaration.

Institution

A licensed hospital, nursing home or other institution used for the accommodation, treatment and care of persons or animals suffering from physical or mental conditions.

International Drug Control Conventions

The 1961 Single Convention on Narcotic Drugs, the 1971 Convention on Psychotropic Substances, the 1988 UN Convention Against Illicit Traffic, and any other related convention to which the Philippines is a Party.

Intractable pain

A pain state in which the cause of pain cannot be removed or otherwise treated and no relief or cure is possible or none has been found after reasonable efforts.

In-vitro diagnostic reagents

Reagents and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health.

Label

An appropriate group of written, printed or graphic information elements that are affixed to, printed on, or attached to the immediate container or outside packaging of a hazardous product.

License

A written permission or authorization, with S-License for dangerous drugs and P-License for controlled precursors and essential chemicals.

Licensing

The process involving the grant, registration, renewal, denial, revocation, suspension, annulment, withdrawal, limitation, amendment, modification or conditioning of a license.

Mail or postal matters

All matters authorized by the Government to be delivered through the postal service, including letters, parcels, printed materials, and money orders.

Manufacture

The production, preparation, compounding or processing of any dangerous drug and/or controlled precursor and essential chemical, including packaging or repackaging, but excluding actions by a duly-authorized practitioner as an incident to professional practice.

Medical practitioner

Any person who is registered and entitled under the laws of the Philippines to practice the profession of medicine, to include dentistry and veterinary medicine.

Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS)

A document that provides important physical, ecological, health, safety and toxicological information on chemical substances or mixtures used at the workplace or transported.

Operator

Any person who engages in a business of the importation, exportation, manufacture, dispensation, end-use, research, acquisition or sale/supply of a dangerous drug for lawful use or a controlled chemical for lawful use.

Opioid

Any morphine-like synthetic narcotic that produces the same effects as drugs derived from the opium poppy, such as pain relief, sedation, constipation and respiratory depression.

Parcel

An object, article, container, or quantity of a wrapped or packed small package or bundle intended for delivery to an addressee.

Patient

Any human or animal recipient of health care services who is ill or injured and in need of treatment by a health care provider.

Permit

An authorization granted in writing by the PDEA Director General or his authorized representative to a license holder for the importation, exportation and other activities of a controlled substance.

Person

Any entity, natural or juridical, including a corporation, partnership, trust, estate, association, or joint venture capable of acquiring rights or entering into obligations.

Pharmacist

Any person who is registered and entitled under the laws of the Philippines to practice the profession of pharmacy.

PDEA

Refers to the Philippine Drug Enforcement Agency as provided for in Section 83 Article IX of RA 9165.

PDEA-CS

Refers to PDEA Compliance Service as provided for in Paragraph III, Section 83, Article IX of RA 9165.

Place

Includes any land (whether vacant, enclosed, or built upon, or not), and any other premises.

Prescription

A written direction by a medical practitioner that a stated quantity of a dangerous drug or a drug containing a controlled chemical be dispensed for the patient named therein.

Preparation

A solution or mixture, in whatever physical state, containing a dangerous drug or a controlled chemical.

Proceedings

Any administrative or quasi-judicial procedure conducted by a government agency, the Board and PDEA, including an inquiry, investigation, or determination of facts.

Recycler

A commercial enterprise that acquires waste containing controlled chemicals

Regulatory Compliance Officer

Any person appointed and/or designated as such by the PDEA pursuant to Article IV of this Regulation.

Retail distributing

Selling limited almost exclusively for personal use, both in number of sales, directly to walk-in customers or in face-to-face transactions.

Sell

Any act of giving away any dangerous drug and/or controlled precursor and essential chemical whether for money or any other consideration.

Special Prescription Form for dangerous drugs

The prescription form for dangerous drugs that is made of a special kind of paper exclusively issued by and obtainable from DOH.

Supply

Includes sale, shipment, dispatch, transport, delivery, distribution, dispensing, as well as offer to stock.

Here are the Knowt flashcards for the provided definitions, formatted as [answer]

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Table I Controlled Chemical

Chemicals enumerated in Table I of the 1988 UN Convention, which are specific and critical raw materials that become incorporated into the drug molecule of a finished narcotic or psychotropic drug.

Table II Controlled Chemical

Chemicals enumerated in the list of substances in Table II of the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

Table III Controlled Chemical

Chemicals classified as a controlled chemical in accordance with Section 93 Article XI of the Act for domestic control.

Test Kit

A substance that contains reagents to show the presence of a substance, is used for medical, laboratory, industrial, educational or research purposes, and is not intended for administration to humans.

The 1961 UN Convention

The Single Convention on Narcotic Drugs, 1961-United Nations as amended by the 1972 Protocol.

The 1971 UN Convention

The Convention on Psychotropic Substances, 1971-United Nations.

The 1988 UN Convention

The United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.

Transit

Any transport of dangerous drugs or controlled chemicals between third countries through the customs territory of the Philippines and any transshipment in the Philippines.

Therapeutic dose

The quantity which is required to elicit the desired therapeutic response in the individual in the treatment of disease or ailment.

Transcribing

The act of transferring a medication order from the original prescription to the current administration record/prescription sheet.

Ultimate user

A person who has lawfully obtained and possesses a dangerous drug for personal or animal use, or a controlled chemical preparation for their own household consumption.

Uniformed Service

Armed Forces, National Police and Coast Guard of the Philippines and foreign countries.

UN Number

The identification serial number assigned to any chemical or hazardous material by the United Nations (UN) Committee of Experts on the transportation of these materials.

Use

Any act of injecting, consuming, chewing, smoking, sniffing, eating, swallowing, drinking or otherwise introducing any dangerous drug into the physiological system of the body.

Veterinarian

Any person who is registered and entitled under the laws of the Philippines to practice the profession of veterinary medicine.

Volatile substances

Any liquid, solid or mixed substance having the property of releasing toxic vapors that, when introduced into the body, produces intoxication, excitement, stupefaction, or irrational behaviour.

Wasting

An occurrence when a controlled substance removed from the original container has become contaminated or has become unusable.

Wholesale distributing

Activities by any person which stands between the manufacturer and the retail seller in purchases, shipments, or contracts for sale of a controlled substance.