miércoles, 4 de febrero de 2015

FDA Law Blog: WHO’s Recommendations to Schedule GBL and 1, 4 Butanediol under International Drug Control Treaty Would Impose Significant Regulatory Requirements on Precursor Chemicals in the United States

FDA Law Blog: WHO’s Recommendations to Schedule GBL and 1, 4 Butanediol under International Drug Control Treaty Would Impose Significant Regulatory Requirements on Precursor Chemicals in the United States

Posted: 03 Feb 2015 11:07 AM PST
By John A. Gilbert –

On January 27, 2014, FDA published a request for comments (80 Fed. Reg. 4283 (Jan 27, 2015)) on the notification from the UN Commission on Narcotic Drugs (“CND”) that the World Health Organization (“WHO”) had submitted recommendations regarding international scheduling of a number of substances.  The CND will meet in March 2015 and consider whether to adopt or reject the WHO recommendations.  Comments to FDA’s notice are due February 16, 2015 and a request for a public hearing must be filed no later than February 6, 2015.

Of significant note, WHO has recommended that the CND schedule gamma-butyrolactone (“GBL”) and 1, 4 butanediol (“BDO”) in Schedule I of the 1971 Convention on Psychotropic Substances (“1971 Convention”).  GBL is currently regulated in the US as a List I chemical, and BDO, while regulated in some states, is not controlled under federal law.  Both substances are precursor chemicals used in a number of industrial applications.  These substances can also be used in the manufacture of gamma-hydroxybutyric acid (“GHB”).  As a signatory to the international drug control treaties, the US is obligated to take action consistent with any international scheduling action.  Thus, if the CND adopts the WHO’s recommendations, the US would have to schedule both substances under the federal Controlled Substances Act (“CSA”), significantly increasing the regulatory requirements on importing, exporting, manufacturing and distribution of these precursor chemicals in the Untied States.

The WHO recommendations were derived from the WHO’s 36th Expert Committee on Drug Dependence (“ECDD”) issued in December 2014.   The ECDD determined that GBL should be placed in Schedule I, stating that the abuse liability was “especially serious.”  The ECDD recognized that GBL has widespread and important industrial uses but determined that it had not defined therapeutic usefulness.  This latter finding fails to acknowledge that GBL is a precursor to GHB, which is approved for medical use in the United States in the form of Xyrem®.  The ECDD made similar findings regarding BDO, acknowledging its important and widespread industrial use but claiming a serious degree of risk of abuse.  In 2013, the CND voted to reschedule GHB from Schedule IV to Schedule II of the 1971 Convention.

Substances placed in Schedule I of the 1971 Convention are subject to the strictest export, import, registration, recordkeeping, reporting and security requirements.  In addition, such substances are subject to UN reporting requirements.  Given these requirements, the US will likely be required to place these chemicals in either Schedule I or Schedule II under the federal CSA.  Significantly, these substances would also be subject to manufacturing quotas and import and export permits.  Almost certainly, such action would adversely affect the current manufacturing and distribution of GBL and BDO in the United States.

Also, of note, the CND will consider whether to schedule ketamine in Schedule I of the 1971 Convention.  Interestingly, the WHO ECDD did not recommend international scheduling of ketamine.  The proposal to schedule ketamine was submitted by the Government of China.  The scheduling of ketamine continues to be controversial given the need to balance concerns with abuse potential against a competing concern that scheduling would affect availability of this essential medicine in a number of developing countries.

In summary, the WHO recommendations, if adopted by the CND, would impose strict regulatory requirements on two precursor chemicals and subject them to restrictions normally reserved for substances with the most serious abuse potential.  This also raises serious concerns on expanding the regulation of industrial chemicals under the international drug control treaties.  The WHO recommendations also do not adequately consider the potential use of these precursors in manufacture of GHB for legitimate medical use.

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