Tuesday, January 27, 2015

1,4-Butanediol Now a Drug?

Today the Food and Drug Administration (FDA) published a notice in the Federal Register (80 FR 4283-4288) that the World Health Organization was considering placing 1,4-Butanediol (BDO) on the Schedule 1 list of the Convention on Psychotropic Substances of 1971. If this proposal were adopted it could lead to the regulation of this industrial chemical under the Controlled Substances Act (21 USC Chapter 13).

The basis for this recommendation is the fact that the human body metabolizes BDO into gamma-hydroxybutyric acid (GHB) a well-known drug of abuse frequently known on the streets as ruffies or the ‘date-rape drug’.

In a previous place of employment I was responsible for the manufacture of an industrial coating product that used BDO as one of the primary ingredients. During our safety assessment of this raw material we became aware of this potential use of the chemical. Since voluntary ingestion of industrial chemicals is not a common mode of exposure we decided not to take any specific measures to protect employees from this possible exposure risk. Management did make the decision not to communicate this specific hazard to employees to reduce the risk that employees might start considering this industrial chemical as a potential recreational drug.

I am not currently up to speed on the provisions of the CSA, so I cannot discuss in any detail the requirements that a company would have to go through to register with the Federal Government and to track and protect its inventory of BDO if this proposed listing were to become law. I suspect that they would be onerous and unusual for most industrial chemical manufacturers.

The FDA is seeking public comment on this matter. Comments may be submitted via the Federal eRulemaking Portal (www.Regulations.gov; Docket # FDA-2015-N-0045). Comments must be submitted by February 26th, 2015 so that the FDA can formulate their response to the WHO. Interestingly the WHO has asked for a response by January 30th, 2015; Friday. WHO communicated their request on December 14, 2014.

No comments:

/* Use this with templates/template-twocol.html */