vol1 - Page 36

 21 § 355 good AND D_UCS
 y_ _t_ _c of,_stc_._em _'ghis Az_ [SeNt. 2_, Law R_ev|ew Commentaries
 19_.]. A s_wey _ law _gsg_.i_ 8 hie lia_fi_ _ mamt.
 _) D_rL_g _ l_,od _¢gm_ia_ sixty dlyi fact_c_s _g _,¢II¢t,_ of d_g products _ _ed/cal
 _ _I_ ds_ o¢ the e_aclm_n_ of this Act [S¢l_t. devil. Bl_'_ £ Ms_ _ Sheree Lynn
 pr_lllal_ under subsectio_ (_) take eff_., _ OMIt ivvixh_im_ hi _DA ,_g reguh_/on_:
 lxe_vial_¢l _ clr_11 alVlic_ti¢_li rosy be iubmili_
 lt.e_lati.g ¢.t¢ relltflalor_. Comment, 311 Catho_
 hi lt¢oo_llinc_ with _he p_vv_lsiom of i¢_i¢_t _l&_ U.LRt_. 175 (Dill).
 lie _ st laitabt¢ for ray _p_ which _llh_ of pci_y in ch,o_iedn11 radical tr_li._l_:
 _ lpprovt_tl f_ _ _ ¢tTo_iivcn_i$ Shouhl let_i_mtlly ill _ have _ to dru_
 _mdl¢ _ _c) _ the F_ilrt_! FootL Drut_ _ _,_t sllgr_oit I:_ the F,_:l_l _d D_$ _c!m_
 _ A_ [_. (c) of _ section| _rs_io,a? 20 _oh_ M_tlh_fl LgeVo 696 (I911').
 24_ 19_. _f _y luch _ _ /nco_s_ii_ R_l_on .4,ci of |9g4. Jam_ L Wh_Itollh 35
 _ h_ r_qgir_m of s,_ic_ _I0_) 04 _ Clsthdk U.LRev. 4_ (19t6).
 F_,'tJ Fcg_d, Dnll,_ _ Colmeti¢ Ace [subset.
 _') _ this sect/on], the _ _hall _onsi_,r
 •l_pli¢_ _a:ieg _t_ s_;ic_hl¢ roq_r¢_ of Noil_ll of D_|s|ons
 such scclk_,t_. _ ,_l"_lary of Hets|th _ _-
 tag_ ,_ _ _ sFI_ such _t _bbrcvi_i- CC_i.eilly $_
 i_¢w drug appl_c. Amend- Def_ 7b
 _e_n_ by Pub,L 92-35'_ eJY_fi_e o_t ehe fi_t diay Di_,_ll|o_ of _ I_
 _he _/xth/nonth b¢_/nning at3_r Aug 16, 197L Drugs sd_liaisl_.rl_l by _,_khs_s 31
 s_,_on $ of '!hib. L. 92-31t7, _I, out _s s fso_e Exchlslve _lill_illlll _ 91t
 _m_ _tioa 360 _ff _is _itl_ g_emet_o_ 7s
 oi S|g_|ft_tty Res_'k_e_ Sub_t_ga_g. _or p_o. Ins_g_ l_tt
 v_sion._ _hi_11 _o _he applic_tb_ly of _he _etrn J_Hs_ct_o_ 17_
 "lattmed or _igtlific.azlt_y r_ricted subst_n_", a_ No¢_ o_ _,n_ _
 d!efia,_tL l_l the F_e_'a.I pc_l_cy r_ing lhe exo O'ffan_ _hL_ _
 _ _ b_u_ed _ sillnif_aa'_y re_tnele_l s_b_ 0_I_o_ le_e_ 3_
 I_mter t_k_ 2463 _f Thl_ _, App_m:ti_ W_ Re_umlt M
 Nst_oliil _ f_e_. Re_
 Legtg_seve Hlst_ For l_sh_five h_s_o_ _ lt_;ro_t'ltvt _ li
 of lh_b.L. 92-387, s_ ]972 U.$. Code l_e_ew 2II
 9g-_.17, lgbt U.$. Code C,o¢15. and Adm, Ncw_. $_mm_r_ jsalllmltl
 p. 2647.
 " l_ of Tille 1_0 Patna _ g'_lic_y n_y _ _ _ c-onstirutionllly per=
 _t_ pr_ls. W_nlie_er v. l_yn._on, W_tzoc,t
 ll_¢w oi" rscl_nisl,nii/v¢ d_¢_si_l i_ c_url..s _ U.& 609_ 37 1._.26 207.
 I _ Will.hi, l_i_, _ & Gr_nmll: This _ rwluiria | new dug _pprov_
 .hx._dii:liol_l _ 39_l. liot detiy _ Im_t_ to _ suffennlt from
 Dt_n_'_ Sy_xh'_a_ lit lhe/r l_t'_tt trod cu_otfio
 W_t'_ Fed_l Practice _an_uel 39.
 mit intrcdu,_k_ _o inner,late _lrnmer_ of s_h
 Code of Fe_ter_ R¢luhlt|olis new _r_g _a_ ao_ ¢ Foo_ a_cl Drag A_b
 evb:llm_hll_ _M_ l_'inifb _ 2 ! C_R min_trs_m io _ or _s_ppr_ve any
 |2.1 et IsStto clog _ ll_.- of _ppli_iio_l _ is i_astitutiol_.
 bt# laL,nil _hl_,qlit_ si_ II _ _!0.3. al _ e_erei_ of Cxmllr_t'$ 9own" :o set
 _ew tni_ foed dl_l_ tee 21 _. 5_I._I. i,l_ ordc_ to prolec_ publ_ IPeo_ u_fe d_gs,
 l_lew lli_ll f_ h_usl,i g l_e 21 CFR 310. I00 thoulli _lru11 applicli_oe rely involve coats which
 _3