Part B -- Authority to Control; Standards and Schedules As of Oct 2007
by Erowid
From 21 USD 811 as of Oct 2007
21 USC 811 Part B -- Authority to Control; Standards and Schedules a) AG (DEA) must follow these rules 1) AG (DEA) has power to add to or transfer substances between schedules. a) if it has potential for abuse, and b) AG (DEA) must hold hearings 2) AG (DEA) can remove substances that don't meet requirements b) Before transferring, adding, or removing a substance, the AG (DEA) shall "gather necessary data" and request from HHS (FDA) a "scientific and medical evaluation" and HHS (FDA) recommendations about whether to proceed. Process must follow (c) below. c) Lists the 8 factors the AG (DEA) and HHS (FDA) must consider. d) International Treaty Exception Allows different process for scheduling that are made in order to comply with treaties. 1) For drugs listed in original 1970 UN treaties/conventions/protocols AG (DEA) can just add these to U.S. Schedules at his discretion. 2) a) When data is received that may justify adding, transfering, or removing a scheduled substance, HHS (FDA) must publish this information in federal register, with opportunity to comment, and HHS (FDA) must provide relevant data about the substance back to WHO. b) When new proposal is received from UN for adding, transferring, or removing a scheduled substance, HHS (FDA) shall publish a summary in the Federal Register, provide opportunity to comment, and evaluate the proposal and make a binding recommendation to the HHS who negotiates with the UN. 3) When US receives notification of a scheduling decision by the UN and the US control doesn't meet the UN requirements, the HHS (FDA) and AG (DEA) must decide whether U.S. law is sufficient as is. Both must follow the rest of (3). a) If U.S. control already meets UN requirements, but HHS (FDA) wants stricter controls, HHS (FDA) shall recommend to the AG (DEA) that he increase controls according to 811 (a) and (b). b) If U.S. control doesn't meet UN requirements and HHS (FDA) agrees with the UN requirements, then HHS (DEA) shall recommend to AG (DEA) to change controls according to 811 (a) and (b). c) If U.S. control doesn't meet UN requirements and HHS (FDA) does not agree with UN requirements, then i) HHS (DEA) can recommend higher scheduling to AG (DEA) following 811 (a) and (b). ii) HHS may request that Secretary of State transmit "notice of qualified acceptance" according to Convention P7 Art 2 iii) HHS may request (ii) and ask UN to re-review iv) HHS may request UN to unschedule drug. 4) A) If HHS (FDA) can't meet time requirements in cases of (3)(b) or (3)(c)(i), the AG (DEA) after consultation with HHS and after opportunity for public comment can issue a "temporary" control order under schedule IV or V. AG shall (after consultation with HHS) Don't have to follow the 8-factor anaysis. If (3)(b), the AG should gives UN "qualified acceptance". "Temporary" scheduling expires when permanent controls are put into effect. B) Issuing a "qualified acceptance" notice under (3)(c)(ii), (iii), or (iv-notice given), the AG after consultation with HHS and comment period, sticks substance in IV or V. Don't have to follow the 8-factor anaysis. If: i) the UN reversed decision based on US request and ii) no scheduling is then required by UN of US, Then temporary scheduling (IV or V) expires in the US. C) Decisions made under (D)(4)(A) or (D)(4)(B), they don't have to follow the normal scheduling proceedures 811 (a) and (b) and don't have to follow 812 (b) 5) US can request UN review of any substance or schedule at any time regardless of all of the above. e) Without going through 811 (a)(b) or 812 (b), the AG can place "immediate precursors" of any scheduled substance in the same or lesser schedule. The "immedate precursor" rule can only go one level deep (not applicable to precursors of precursors). f) HHS (FDA), must notify AG (DEA) of new-drug applications for drugs that have abuse potential. g) DXM Exception. h) Rules for emergency scheduling (schedule I only)