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 _ 53T74 Fe_le_ Regis_ee_ / VoL S¢ N¢o 249 [ F_day, December _, 19e9 [ Notices
 THC is labile to a_ o_dstion fo_tLng ¢ Currently, there _ o_y fott_ phtnte DP_ ins Cosmetic Act entphasLces t_
 cannabtuol (C_N]. Cannabldiol (CBD}, seed lu theL_ natural states for medical need to carry out scientifically read
 in the presence ot oxygen and light end purposes Lu tl_ United States. Tares stud3es as well as the need to control th_
 upon heating, is conve_ to ethan _ utilized in crude _xtrsc_ fonu. tnvs_ttgationsl drug supply and obtaLu
 cannabielsoic acids. These _clude ipecac and opium h'Jonned consent ot the subject or
 8. It l_ not known how smelting o¢ extrecc_, which must meet standards for patients The _lrttg used in the study mu_
 burnir_ m_iuana plant material a_¢cts potency and purl_ eetabBsh_d _ The be able to be trend to the patient, and
 the chemical composition of Utffte# S_m Ph_zr_cope/_ baler they the L_ves_/gatur must submit annual
 cannabh_oids and their products. A can b_ _sed for medical p_rpose=o In reports to FDA and report adver_
 large n_be_ of pyrolytic products _s contest _o wriations in cec_abL_oid reactions.
 produced by btu'rgn_ that have not be_ content evident in ce_ru_b_ hat.tally _& The protocols for the L_TDs with
 identified for most of the constituents Lu oectu'r_ opium dertvativ_ _aLu marijuana, especia_y the state Wotoc_
 C_nn_bi_. Smok_ _s a dosage form to _sn_t_t_vely _table and the p_tenc_ and the protocols tot Ludividua| p_ttt_,
 deliver _exijuane to the human body _ _au be chemically standardi_e_L did not describe controlled stu_eeo
 vz_u_table for medical t_atment due to: So Modem ch_u8 re_amh t_ based on Con_._l|ed _tud_es are necessary _s th_
 (1) Lack of standard_r_tton o_ the the _e of we_odeF_ed prep_a_ons of basis of a New Dr_ Applicat_o_ (_A_
 n_.ri_u_a. (_) lsck of knowledge of the p_e compotmd_ which, when No h_A for mariiuana hss been
 smount_ of each constR_ent available, admb_stere_ to patients, _ow submitted to FDA for epproValo Thu_
 {3] lack of knowledse of the ac_ of reproducible _suh& The p_ob_em,_ marijuana _mams an lnves_e_o_
 the chemicals while burnous, {_] amount seeoc_ted with u_Lr_ natucal drug eublact to IND _qcdrements_ _h_
 of product LiSa=ted be_ dependent on _ub_tencee as _'_Ss _clud_ the _abtli_y to the lack of an approved ND_
 _he L_viduars smoking technique, _d to re.late the doses of active marijuana l_ not available by
 (5) possible carcL_ogenic effect of constituents, and the mr=faction of the pre_cHptfon in the United States.
 smoking. 'There ere no ch',_ge which a_ active con=tRuants with othe_ _. _ of January _ _087, the_ wer_
 delivered by stuck/n8 which are potentially _ctive compounds L_ the 30 active INDs for marijuana; _ INDs
 me_ca_y used Lu the United State_ natural subs_ce_ The p_sence of for ma_iuana have been discontinued
 6. Cmutobi_ eeti_ _ w_s one of the ac_ve c6nst_tuent_ in _ost natazal _ _, The National Institute on _8
 F_r_t plants to be used by man for fiber, may vary based o_ genetic factors, Abuse (N_)A) has shipped a total of
 food, medicL_e, _d in social and co_:u_ of oriSOn and _rowLu8 180,700 ma_juana cigarettes for hvL_
 religious rituals. There were conditions. A_ a rs_ulL most natural studies from _970 to 1988. Fift_-nLne
 approx_nate|y 2.0 traditional medicinal cL_age cannes meet established quality thousand (59,000} cigarettes were
 uses of cannabis prepa_at_ose in the con_di stand.de Lu the U_ed Stete_ shipped to eight sponsors for haman _.
 19th century. These included those _efore a _ subst_ce _ay be wed _ outside state.sponsored pragramm Mo_
 recognized in lgth centttW me_c_e as the p_cttce of medicine, |t must have • then ha_ of those, _0.g00 cige_ette_
 well as folkloric use. These uses were composition of active _ngred_ents that were _pped to one sponsor during thai
 based upon tradition and expe_qence has been established and accepted a_ period.
 rather than scientific proof_ Early _tanderd_ Such stendar_2z_o_ which _. Tldrty-four states have passed
 literature is replete wqth reports of the includes identity, purity, potency, and _egislation concerniu8 the use of
 inconsistent OF cont_adictozy effects of quarry, is specked in either a N,_w Dzu_ c_mnabis (mexi_uana} and THC by
 mariiue_a prepa._aLtcns. The cannabis App_icetion (NDA} o_ an offi_al phystctanso Of these states, at least 24
 used for medical purposes in the United c_mpendium such _ The UnRed $_ea define tJ_s use of marijuana and THC e_,
 States end in Western me_c_ne from Pha_m_copeJ_ or Na_'onoJFo_u/_ty. research. Ot these 34 states, o_y 17
 the mid-lgth to the early 20th centm'y _0o There is no dff_erenc_ _ the _tetes (New Mexico, Rlino_ Louislane_
 _a+ csr_abis extract which was o_ally pharmac_Io_cal effect between _he Wash_,gto_ Florida, Micl'figsn, Oregon
 administered as tinctures and pills. _y THC i_olated from csmn_bis end the Colorado, California, Nevada. Ohio,
 _93& mariiuana preparations were synthetically produced THC which is 'West Virginia, Georgia, Arizona, New
 seldom used m medical practice, and _a now market_ in the United Statee_ York, Vermont and Tennessee) had
 American Medical A_ocl_tton st=ted 1_. In the late 1960's. the Depa_uant approved _NDs for marijuana or
 that, "Cap. able at the present Lame is o_ Healt_ Education end Wel_re mar_juana/THC as of March I, _98_. '_'_,
 slightly used for med_cc_al _DHEVV_ initiated a process to facilitate statHponeored programs received
 p_'poss_ * .... h_ 1941. marijuana _esea,_. '_L_ mari[uans and _3-_C_ The marijuana cigsrettes from the NqDA
 passed out ot the NationM Fo_u/a_ FDA reviewed _ves_i._ation_ New Dn_8 durLn8 the period 1978 to 1986. Duri_.g
 and The United Seotea Pho_macope/_ (L_D] application _Or mexijuana _nd this period 10_.700 cigarettes were
 _. Historically, man used natu_a] THCC assisted re==ambers and distributed to those states; California
 plants to treat ver_oue a_huents, With physicians in prep=fLus _ protocoi_ received 38.700 cigarette_ the most of
 the advent of _c_ence, man bega,_ tO se@ end sent out _ormation packets _d _ny =tote. New Mexico received ¢_00
 plant extracts t_ determine their effec_ _odel protocols, cigarettes In the period from 1978 to
 These extracts were crude c_'ugs. Fff_ _2. The _N_ procedure i_ t_¢ process _. Ln 1988_ four state progzsms
 years ago The U_/_ed St_# by which dxt_s are _'oducsd lhto znan received a total of I._ cigarettes _r_
 _ho_m_cope/o listed many cp._da drugs, and _e_ _afsty and effectiveness ia Much _982. = National Conference o_
 In recent LLmes, scientists discovered evaluated over a pedod of years. The the Therepeutic Application of
 that crsde ex'_act_ owed their activity stated objectives of the FDA in Cara_abinoi_ was helcL 'The mpo_t o_
 to chemical compounds and began _at:i_ the clinical teatL_ of new that conterenca indicates that "state
 isolaLLu8 the chemical compounds _m d_'uge ar_ t_ "protect the _ghts and programs in general had a small volu_
 the plants and theL_ ex_sct_ Current safety of htunan _ub_ecte of such testing of participation and a high loss of de/so '_
 technolo_ emphas_es Lbe deve|opme_t while, _t the same LLm_ factl_ta_ the "_a repo_ sd_o cozmluded that the
 of _yuthetlce of natural dru_ by using development and marketlz_ of des_r_ of the state prog_ varied
 the natural _h'uSs u modela_ h_neficial darv_ _hempie_" _a F_ widely.