Classification of Nalbuphine as Prohibited Drug

The Dangerous Drugs Board classifies Nalbuphine and related chemical forms as Prohibited Drugs after evaluation.
The regulation treats the listed substances as having the capacity to produce dependency and as likely to be abused, creating a public health and social problem.
The regulation covers substances that are identified as the specified drug and its chemical variants that have the same or similar psychologic and/or physiologic effects as the parent drug.

The regulation classifies Nalbuphine identified by the INTERNATIONAL NON-PROPRIETARY NAME (INN) as a Prohibited Drug.
The regulation identifies Nalbuphine by its chemical name: 17-Cyclobutylmethyl-7,8- dihydro-14 hydroxy-17-normorphine.
The regulation identifies the brand name Nubain for the covered substance.
The regulation also classifies as Prohibited Drugs:
- The substance’s salts,
- Isomers, and
- Salts of isomers (including optical, position, or geometric isomers),
- When the variants fall within the specific chemical designation by whatever official name, common or usual name, or brand name, and have the same or similar psychologic and/or physiologic effects as the parent drug.

The regulation declares that the above-defined substances are Prohibited Drugs under Section 1.
Classification under Section 1 applies to Nalbuphine together with its salts, isomers, and salts of isomers under the chemical designation and effect criteria.

Importers must secure an import certificate prior to each importation under Section 2.1.
Upon arrival of the importation, importers must comply with other pertinent requirements of the Dangerous Drugs Board under Board Regulation No. 3-A, s. 1983 (on procedure for importers of dangerous drugs and exempt preparations upon arrival in the Philippines).
Importers must record importation, distribution, and sale in the Dangerous Drugs Record Book under Section 2.2.
The Dangerous Drugs Record Book must be registered prior to use.

The regulation prohibits the distribution of the covered substances as samples to physicians under Section 3.
The regulation likewise prohibits distribution as samples to the general public under Section 3.

The regulation allows advertising of the covered substances only in scientific journals under Section 4.
Advertising is limited to prescribing practitioners under Section 4.
Advertising to the general public is prohibited under Section 4.

The regulation provides that any violation is penalized with administrative sanctions under Section 5.
The imposition of administrative sanctions is without prejudice to criminal prosecution.
Criminal prosecution may proceed under Articles II and IV of Republic Act No. 6425, as amended, if warranted.

The regulation is adopted May 20, 1993 by the Chairman signed as JUAN M. FLAVIER, and identified as Chairman / Secretary of Health.
The operative restrictions and requirements take effect only after the publication and 15-day rule stated in Section 6.