[ DDB BOARD REGULATION NO. 1 s. 1993, May 20, 1993 ]
CLASSIFYING NALBUPHINE AND ITS SALTS, ISOMERS AND SALTS OF ISOMERS AS PROHIBITED DRUGS
Pursuant to its powers under Section 36 (a) of R.A. 6425, as amended, the Dangerous Drugs Board, having found after evaluation that although not yet under international control, the substance identified as follows:
as well as its salts, isomers, and salts of isomers (whether optical, position, or geometric) which
a. exist within the specific chemical designation by whatever official name, common or usual name, or brand name, and
b. have the same or similar psychologic and/or physiologic effects as the parent drug
have the capacity to produce dependency and is likely to be so abused as to constitute a public health and social problem, hereby prescribes the following:
SECTION 1. Classification - The above-defined substances are classified as Prohibited Drugs.
SECTION 2. Requirements - The above substances shall be subject to the following requirements:
2.1 Import Certificate. An import certificate shall be secured prior to each importation. Upon arrival of the importation, other pertinent requirements of the Dangerous Drugs Board under Board Regulation No. 3-A, S. 1983 (SUBJECT: Procedure to be followed by Importers of Dangerous Drugs and Exempt Preparations upon arrival of the Importation in the Philippines) shall be complied with.
2.2 Records. Importation, distribution and sale thereof shall be recorded in the Dangerous Drugs Record Book, which book shall be registered prior to use.
SECTION 3. Prohibition Against sample distribution - The above identified chemical substances shall not be distributed as samples to physicians or to the general public.
SECTION 4. Limitations as to Advertising - The subject substances may be advertised only in scientific journals limited to prescribing practitioners. In no case shall the chemical substances be advertised to the general public.
SECTION 5. Sanctions - Any violation of this Regulation shall be penalized with administrative sanctions without prejudice to criminal prosecution under Articles II and IV of R.A. 6425, as amended if warranted.
SECTION 6. Date of Effectivity - This Regulation shall take effect fifteen (15) days after completion of its publication in a newspaper of general circulation once a week for two consecutive weeks.
Adopted: 20 May 1993
(Sgd.) JUAN M. FLAVIER
Chairman
Secretary of Health
INTERNATIONAL NON-PROPRIETARY NAME (INN) |
CHEMICAL NAME |
BRAND NAME |
||
Nalbuphine |
17-Cyclobutylmethyl-7,8- dihydro-14 hydroxy-17-normorphine |
Nubain |
||
(-)-(5R,6S,14S)-9a-Cyclo-butylmethyl-4,5-epoxymor-phinan-3,6,14-triol |
as well as its salts, isomers, and salts of isomers (whether optical, position, or geometric) which
a. exist within the specific chemical designation by whatever official name, common or usual name, or brand name, and
b. have the same or similar psychologic and/or physiologic effects as the parent drug
have the capacity to produce dependency and is likely to be so abused as to constitute a public health and social problem, hereby prescribes the following:
SECTION 1. Classification - The above-defined substances are classified as Prohibited Drugs.
SECTION 2. Requirements - The above substances shall be subject to the following requirements:
2.1 Import Certificate. An import certificate shall be secured prior to each importation. Upon arrival of the importation, other pertinent requirements of the Dangerous Drugs Board under Board Regulation No. 3-A, S. 1983 (SUBJECT: Procedure to be followed by Importers of Dangerous Drugs and Exempt Preparations upon arrival of the Importation in the Philippines) shall be complied with.
2.2 Records. Importation, distribution and sale thereof shall be recorded in the Dangerous Drugs Record Book, which book shall be registered prior to use.
SECTION 3. Prohibition Against sample distribution - The above identified chemical substances shall not be distributed as samples to physicians or to the general public.
SECTION 4. Limitations as to Advertising - The subject substances may be advertised only in scientific journals limited to prescribing practitioners. In no case shall the chemical substances be advertised to the general public.
SECTION 5. Sanctions - Any violation of this Regulation shall be penalized with administrative sanctions without prejudice to criminal prosecution under Articles II and IV of R.A. 6425, as amended if warranted.
SECTION 6. Date of Effectivity - This Regulation shall take effect fifteen (15) days after completion of its publication in a newspaper of general circulation once a week for two consecutive weeks.
Adopted: 20 May 1993
Chairman
Secretary of Health