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 oh. s rooD, vRu , AND COSMETIC An 21 § 355
 tio_$ for potentially harmful dr_g with- d_et_ t, _o_ ntee_se_ry. Dti_an Drr_g
 o_t _thorlz_t_o_ by 9rescr_bl_g physician flto_ l_c, v. U. fl°° C.A,T_AM4. _ F.
 § 354,  peaz . Pub. L  tle I, j lOS(a) auly
 12, 1960, 74 St_o $|)8
 _tiosL Act Sure _=5, 19_8, co _ _ _, _ff_etl_v Dete_ ef _pe_t|. Be_e,[ _f
 _tat. 1_I_2_ _'_t_'_i _he _ecreta_y to s_c_ie_ effec_tve. _ub_'t _o the prov_s_ot_s
 promu[g_te regeiat_on_ for the |_st_£ _f of _et_o_ _ of Pul_.L. _1& on $u_y i
 by eect]o_ 878 of th_ *_t_, _et out _ _ Da_ tsl_d_r _fto_ 378 e_f
 _h_ _tt to.
 § 3_. New drugs._Necess_ty of effective approvsl of app_|-
 ee_tio_
 (a) No person shR]l introduce or deliver for introduction into inter-
 _tste commerce any new drugs unless aa approva| of an application
 fi|ed pursuant _ subsection (b) of this _ection is effective with re-
 spat to st_ch dr_go
 (b) Any person may file with the Secretary a_ application with re-
 spect to any drug subject to the provisions of subsection (a) of this
 sect_Ono Such persou shall submit to the Secretary as s part of the
 application (I) fu|_ reports of investigations which have beer made to
 show whether or r_ot such drug is safe _or use and whether such drug
 is effective in use; (2) a full list of the articles used as components
 o_ such drug; (_) a full statement of the composition of such drug;
 (4) s full description Of the methods used in, and the facilities and
 controls _sed for, _he manufacture, processing, and packing of such
 drug; (_) such samples of such drug _nd of the arlicles used a_ İom-
 po_ents thereof as the Secretary may :require; and (_) specimens of
 ...... the labeling proposed to be used for such drug.
 ef _e_rim_f_ _r_ _'@_ _s_e_eee of e_ie_
 (c) Within one hundred and eighty days after the filing of an a_
 plicatio_ under this subsection, or such additional period as may be
 agreed upon by the Secretary and the applicant0 the Secretary shall el-
 ....
 thez_
 (_) approve the application if he then finds that none of the
 g_unds for denying approva_ specified in subsection (d) of this
 section applies, or