Last week, DEA continued the temporary scheduling of a single synthetic cathinone, methylone (3, 4-methylenedioxy-N-methylcathinone) in Schedule I of the Controlled Substances Act (“CSA”). The temporary scheduling will expire on April 20, 2013, or upon completion of rulemaking proceedings, whichever occurs first. 77 Fed. Reg. 64,032 (Oct. 18, 2012). DEA also initiated rulemaking proceedings to permanently schedule methylone on October 17, 2012. 77 Fed. Reg. 63,766 (Oct. 17, 2012). This represents DEA’s latest step in combatting synthetic drug abuse in response to increased reports of abuse of substances contained in products marketed as “bath salts” and “plant food” and incense. See 76 Fed. Reg. 55,616, 55,617 (Oct. 21, 2011). As previously reported, DEA Administrator Leonhart stated DEA is “committed to targeting these new and emerging drugs with every scientific, legislative and investigative tool at [its] disposal.”
As background, methylone was subject to DEA’s October 2011 final order temporarily scheduling it and two other synthetic cathinones in Schedule I on an emergency basis. See 21 U.S.C. § 811(h); 76 Fed. Reg. 65,371 (Oct. 21, 2011). Then, after introduction of the Synthetic Drug Control Act (“SDCA”), Congress permanently scheduled 11 cathinones (including two of the three that DEA had temporarily placed in Schedule I in the October 2011 emergency order) as part of FDASIA. Methylone is the only substance from that order that Congress did not legislatively add to Schedule I when it enacted FDASIA, despite being in earlier drafts of the SDCA. See FDASIA, Pub. L. No. 112-144, § 1152 (2012); 77 Fed. Reg. 64032 (Oct. 18, 2012); H.R. 1254 112th Cong. (2012). See also S. 3189 112th Cong. (2012). DEA continued its synthetic drug war on yet another front through “Operation Log Jam.” On July 26, 2012, the operation seized 167,000 packets of synthetic cathinones (and products to produce an additional 392,000 cathinone products). In additional legislative efforts, in August 2012, a bill was introduced to place 15 cathinones in Schedule I, to include methylone. H.R. 6312, 112th Cong. (2012). The bill was referred to committee but no further action was taken.
It is unclear why methylone was left off of FDASIA’s Schedule I classification, which included other cathinones. It may be because, as lawmakers raised in debates about the SDCA concerning cathinones and other substances generally, it is more difficult to obtain a substance for research purposes (or any purpose) in Schedule I. See 112 Cong. Rec. H8238 (daily ed. Dec. 7, 2011). It appears, based on aggregate quotas that DEA has granted for the substance, that researchers are interested in methylone. See 77 Fed. Reg. 39,737 (July 5, 2012), 77 Fed. Reg. 55,500 (Sept. 10, 2012), 77 Fed. Reg. 59,980 (Oct. 1, 2012). Once scheduled, DEA limits via quotas the aggregate amount of a Schedule I substance that may be manufactured annually, making the product more difficult to obtain. 21 U.S.C. § 826; 21 C.F.R. § 1303.11.
It is significantly more onerous for DEA to pursue a scheduling classification through the rulemaking process than it is for a drug to be scheduled via legislative process. The administrative rulemaking process mandates that the agency procure a scientific and medical report from FDA, conduct a detailed, multifactor analysis, and provide the public an opportunity to comment, unlike the simpler statutory scheduling procedures observed with the passage of FDASIA. See 21 U.S.C. § 811.
The scheduling of methylone is not the only scheduling proceeding that DEA could face in the near future. On October 29 and 30th, the FDA will convene a meeting to take public comment on the potential rescheduling of hydrocodone, likely a much more controversial initiative. 77 Fed. Reg. 34,051 (June 8, 2012).