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 21 § 385 FOOD _a_v DRUGS
 (li) if the 1Lied drug h_ been withdraws from _,]e, for the period of
 withdrawal from silo or, if earlier, Me period ending on the date the S_,cretary
 determines that the wi_clrawal from sale _ sot for sdety or effectiveness
 A notice of the removal sha|] 5_ published in the Fe4eral F_atero
 (?) For purpo_e_ o! this subs_n:
 (A) The term °%i_vs_,bi_t_ ° means the rate and eexte_t _ which the active
 mg_nZ Or _ers_u_c Mgredient M _bsorb_ from a drug and beeomes
 _vai]_b|e at the si._ of drug sctiOno
 (B) A drug sh_ be cor_idered to be bioequiva_ent _ _ listed drug _
 (|) the _te end extent of absorption of the drug do not show a signi_csnt
 diffez_nce from the r_ _n_ extent of absorp_n o_ the listed drug when
 admmM_d st the same moMr dose of _e thersl_uti˘ ingredient under
 similar _xpe_dmentM _ndidon_ _ either s single dose, or multiple doses; or
 (|D the extent of abso_tion of the 8rug does hoe show • significant
 difference from the extent of absorption of _he _is_te_ drug when admL_is-
 feted at the same molar d_ of Uhe therspeu_/c _ng_edient under similar
 expe_dmenta_ conditions _n either _t single dose or _lu_tiple doses and the
 _fferenee from the ]iswd drug in the rote of absorption of the drug B
 intent_ons|_ _ t_ted h_ its proposed labeling, is not essentia_ W the
 a_m_nmen_ of effect/re body drug concentrations on chronic use, and
 considered medically insignificant fo'_ the drug.
 (1) In the c._e of zmy drug for which an spprovM of an _pplioa:..ion filed under
 subsection _b) er _) of this s_'t._n is m effects the applicant shall establish and
 rrut_n_i_ such _or_, and make such reports te the Seezeta_j, of data _]sting
 ˘_nica] experience and other d_ or information, _ceiv_d or otherwise Obtained by
 such tppli_ant with reelect to such drug° _ the Secretary may by genes] r_g'ulao
 _o_, or by order with _es_c_ W such applics_on, p_scn%_ on _e b_i_ of s finding
 that such reco_s and _por't_ _e nsoessa_ in o_r to em_ble 'the Sec_7 to
 determiner or facilltat_ • deu_rmins6on, whether then _s or may be ground for°
 mvok_ng subsect._o_ (e) of this section: P_ed, hou, e_r, That regula_/on_ and
 orders issued under th_ subsee_on and under subsection (_ of _his sec_on shall have
 due regard for _e professiox_al ethi_ of _e medical profession and the i_r_s_ of,
 patients and shal_ _rovid_, when the Se_r_t_r_ deems _% _ b_ appropria_, for the
 .... e_mina_on, _pon reque_t_ by the pe_o_ _o whom such _u]a_ons or orde_ s_
 applicable, of simi1_z information received or otherwise ob_a/n_d by the sac_'.
 (_) Every person r_uh_4 under this sec'_on te msin_ir_ _eo_s, and eveR,
 _r_on in charge or custody Uhereof, shall, upon request of m_ officer or employs
 , designated by _he Sec_re_._D', permit such officer or employee at _|l _onsble _mee
 to have access _ and _py and verify _uch reco_,
 Safety sad effectiveness dab and informa_on which h_ been submittal M a_
 app|iet_o_ under sub_eetWn (b) of th_ section for _ drug and which h_ _ot
 p_vlou_y been dmc_o_ed to _e public shall _ made evailabl@ to the public, upon
 _quest_ units extJr_o_ina_V _'i_umetancee _z_ shown_
 {|) if no work t_ be_n_ or _ll be undertaken to h,v@ _e _pplle_ort approved,
 (_) If the Sec_ has de_nrdned tl_t the applka_io_ _a _ot spprovsb|_ and
 (_) ff approval of .the sppl_cstlor, u_der subs_tion (e.) of this _ec_on
 _dthd_w_ and all levi appeals _ve been e_h_us_,
 (4) L_ the Secze_ h_ determ_ that _uch drug is not • new drug, or
 (_) upon the effective dan of the approval of the fi_s_ appl!cstio_ under
 s_bs_ion O) of this see_on whleh _fem _ such d_u_ or upon the _ upon
 which the sppmv_] of an _ppl_c_ion under subsect_o= _ _f thM ss_._on which
 .... _fe_ _ such dr_a_ _uld b_ m_e effee_ve i_ such _m _pplicatio_ _d been

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