QuestionsQuestions (DDB BOARD REGULATION NO. 1 s. 1993)
It acted pursuant to its powers under Section 36(a) of R.A. 6425, as amended.
It classified Nalbuphine (INN) identified by its chemical description and brand name (Nubain), including its salts, isomers, and salts of isomers.
No. The regulation states that although Nalbuphine is not yet under international control, the Board still evaluated it and found it has dependency and abuse potential.
The Board found the substance has capacity to produce dependency and is likely to be abused, constituting a public health and social problem; it also considered that related compounds within the chemical designation have the same or similar psychologic and/or physiologic effects as the parent drug.
It is classified as a Prohibited Drug.
An import certificate shall be secured prior to each importation.
Other pertinent requirements of the Dangerous Drugs Board under Board Regulation No. 3-A, s. 1983 must be complied with.
Importation, distribution, and sale must be recorded in the Dangerous Drugs Record Book, which must be registered prior to use.
No. Section 3 prohibits distributing the substances as samples to physicians or to the general public.
The substances may be advertised only in scientific journals limited to prescribing practitioners, and in no case may they be advertised to the general public.
Any violation is penalized with administrative sanctions, without prejudice to criminal prosecution under Articles II and IV of R.A. 6425, as amended, if warranted.
No. Section 5 expressly states administrative sanctions apply without prejudice to criminal prosecution under specified provisions of R.A. 6425 if warranted.
Fifteen (15) days after completion of its publication in a newspaper of general circulation once a week for two consecutive weeks.
Section 2.1, which requires an import certificate prior to each importation.
Section 2.2, which requires that the Dangerous Drugs Record Book be registered prior to use.