Food and Drugs
`
`21
`
`PARTS 170 TO 199
`Revised as of April 1, 1998
`
`CONTAINING
`A CODIFICATION OF DOCUMENTS
`OF GEi~ERAL APPLiCABiliiY
`ANO FUTURE EFFECT
`
`AS OF APRIL 1, 1998
`
`With Ancillaries
`
`Published by
`the Office of the Federal Register
`National Archives and Records
`Administration
`
`as a Special Edition of
`the Federal Register
`
`TEVA_MS_0045346
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1007 - Page 1
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`

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`U.S. GOVERNMENT PRINTING OFFICE
`
`WASHINGTON : 1998
`
`For s<il(' hy IJ.S. Cov('rnmr.nt Prinrinr, Offirf'
`Superintendent of Documents, !\·!ail Stop: SSOP, \.\'ashington. DC 20402-9328
`
`TEVA_MS_0045347
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1007 - Page 2
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`

`
`Table of Contents
`
`Page
`v
`
`Explanation
`
`Title 21:
`
`Chapler I-Food and Drug A<lrninislralion. Deparlrnenl of Heallh
`and Hunu1n SP.rvir:P.,s (Contintff:<l)
`
`~
`
`Finding Aid~.
`
`lvialerial Approved for lncorpuraliun b).: Reference
`
`·rabic of CFi< i"it:ics and Chapt:crs
`
`A1phahctir:a1 T .ist of Agr:nr:ir:s Appearing in the CFR
`
`Reclesignal.icn1 Table
`
`List of CF!{ Sections Affected.
`
`551
`
`565
`
`581
`
`591
`
`593
`
`iii
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`TEVA_MS_0045348
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`

`
`Cite this Code: CFR
`
`To cite the regulations in
`this volume use title,
`pa1~t a~rid sectioJ1 T1um
`ber. Thus, 21CFR170.3
`refers to title 2i, part
`170, section 3.
`
`iv
`
`TEVA_MS_0045349
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`

`
`Explanation
`
`lhc Code of Federal l{cgulations is a codification of the general and pcrn1ancnt
`rules published in the Federal Register by the ExecuUve deparhnenl.s and agen(cid:173)
`cies of the Federal GovernrnenL The Code is divided inl.o 50 tll.h~s v.'hic:h represenl
`broad areas subject to Federal regulation. Each title is divided into chapters
`\Vlti{:11 usually i1t~ar· U1c 11a111c t1[" U1t~ issuir1g <:1gcrn:y. F.a{:/1 {:/1aphT i,..,
`l"ur·U1cr sub(cid:173)
`divided into p<Irts r.ovcring spcrifir r·cgul<Itory <Irc<Is .
`.!:::<.ach Yolun.1c of the Code is revised at least once each calendar ycctr and issued
`on a quarterly basis approxirnal.ely as follo\vs:
`;-io;;; nf l;-in11;:oiry 1
`TitlP 1 thrn11gh Titl0 lfi
`. .......... <Is of April l
`Title 17 thr·ough Title 27.
`Title 28 thr·ough Title 41 .................................................................. ns of .July l
`litle 42 through 'l'itle 50.
`..as of October 1
`
`lhe appropriate revision date is printed on the cover of each volume.
`
`LEGAL STATUS
`
`lllL' cuIILL'IIL'> u1 u1e i'L"<lera1 l"-L"gi::.Ler are l'L'l.jLLirL"<l Lu Ue juu1c1a11y IIuLicc<l (44
`U.S.C. 1507). lhe Code of Federal l{egulations is pri1na facie evidence of the text
`ofjhporigin~il doc-1nnPnl.-; (44 IJ.S.C:. lSHl)
`
`HO\•V TO lJSE THE CODF. OF FEDERAT, REGl,ll ,ATTONS
`
`The Co<le of Federal Regulations is kept. up t.o <late b.v the in<livi<lual issues
`of the Federal Register. These t.Vvu publications rnust. be use<l together t.o <let.er-
`1Tiine the latest version of any given rule.
`lo determine \Vhether a Code volume has been an1ended since its revision date
`{in this case, A .. pri! 1, 1998), consult the "List of CFR Sections .l'\~ffected {LS.A~)."
`\Vhich is issued n1onthly. and the "Cun1ulative List of Parts Affected.·· \Vhich
`appears in the Reader Aids sect.ion of the <lail.v Federal Register. These t.vvo lists
`\Vill i<lent.i().' the Federal Register page nurnber of the lat.est. arnendrnent. of any
`given rule.
`
`HFECllVE AND EXPJ]{Al'ION DATES
`
`F;-irh volun1c of the Code contains a1nendrncnts published in the Federal Reg(cid:173)
`ister since the last revision of that volu1ne of the Code. Source citations for
`I.he regulal.ions are referred t.o by volurne rnnnber and page rnnnber of I.he Federal
`Register and date of publication. Publication dates and effective dates are usu(cid:173)
`ally not the san1e and care must be exercised by the user in detcrn1ining the
`nr:tuil1 etfer:t.ive dilr.e. Tn instilnr:es \.vhere the effer:t.ive dilt.e is beyond r.he r:ur.(cid:173)
`off date for the Code a note has been inserted to reflect the future effecti'\'e
`date ln those instances \Mhere a regulation published in the Federal .R_egister
`states a date certain for expiration, an appropriate note \Vill be inserted follov,ling
`I.he t.exl.
`
`OMB CO"ITROT, NUMBERS
`
`The Papen.'v·ork Reduction Ac.t of 1980 (Pt1b. 1, Dfi-:i11) 1e1tui1e:-. reue1r11 agencies
`to display an OI\:1B control nun1ber \'Vith their information collection request.
`
`v
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`TEVA_MS_0045350
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`rvlany agencies have begun publishing numerous O_\lB control nun1bers as an1end(cid:173)
`ments to existing regulations in the C.FR. l'hese O.\ilB nun1bers are placed as
`
`OBSOLF.TF. PROVISIONS
`
`Provisions U1aL hec:on1e obsolete hel'on-~ I.he revision date sl.al.ed on the c:over
`of each volun1e are not carried. Code users n1a.).r find the text of pro'\'isions in
`effect on a given date in the past by using the appropriate nun1erical list of
`ser:tions <'ltfer:tcrL For the perio<l hcforl' Janu<'IJ"')' 1_ 1986, ronsult either the J.ist
`uf CFR SecLiuns .a~ffecLe<l, 1949-1963. 1964-1972, ur 1973-1985. published in seven sep(cid:173)
`arate volun1es . .For the period beginning January 1, 198U, a "List of C.Fl{ Sections
`. .\ffected" is published at the end of each C.Fl{ volun1e.
`
`T'JCORPORATJON BY RFFFRENCF
`
`tvnac is incorporacion by rcfCrcncc/ incorporarion by reference \Vas es-rablished
`by statute and allo\vs Federal agencies to nleet the require1nent to publish regu(cid:173)
`lations in Lhe Federal :R_egisler bv referring Lo rnalerials ~1lre~vJy published else(cid:173)
`\Vhere . .For an incorporation to be valid, the Director of the .Federal Register
`must approve it. 'l "he legal effect of incorporation by reference is that the n1ate(cid:173)
`rial is treaLed as ii" ii vvere published in l"ull in Lhe Federal Register (5 lJ.S.C.
`552(a)). 'l'his n1aterial, like an:y other proper!_).' issued regulation, has the force
`of lavv.
`H111ai is a proper incuiporaiiun b_y reference? The Direclor of Lhe Federal Regisler
`·,vill approve an incorporation by reference only \.Vhen the requircn1cnts of 1 CFH.
`part 51 are n1et. Sorne of the elernents on \>vhir:h approval is base<l are:
`(21_)
`'l'he incorporation "\Nill substantially reduce the volun1e of n1aterial pub(cid:173)
`lished in the Federal Register.
`(b) 'l"he n1atter incorporated is in fact available to the extent necessary to
`afford fairness and uniformity in the adn1inistrative process.
`(c) 'l'he incorporating docun1ent is drafted and subn1itted for publication in
`accordance \Vith 1 CFR part 51.
`Properly approved incorporations by reference in this volun1e are listed in the
`Finding . .\ids at the end of this ·volume.
`HI bat if tbe 111aterial incorporated b_y reference cannot be found? lf _you have an_y
`problen1 locating or obtaining a copy of n1aterial lis-red in -rhc Finding Aids of
`this volu1ne as an approved incorporation by reference, please contact the agency
`LhaL issued Lhe regnh1Lion conL~1ining Lh~1L incorporalion. If. afler conL~1cting Lhe
`agency, you find the material is not available, please notify the Director of the
`Federal Register .. '\Jational Archives and Records Administration. VVashington DC
`2040R, or ca 11 (202) 52~-45~4.
`
`CFR TNDEXF.S AND TABULAR CIJTDES
`A sut~jec:I. index Lo I.he Code or Federal Regulal.ions is c:onl.ainecl in a separate
`vohnne, revised annually as or .Jar111ar.v 1. enl.it.led CFR l'\JIJl-.X i\NIJ FI'\JIJINC A1us.
`'l"his volume contains the Parallel '!'able of Statutory Authorities and . .\gency
`Rules (l"able 1), and Acts Requiring Publication in the .Federal Register (!'able
`TT). A list of CFR titles, r:hapters, and parts an<l an alphabetir:al 1 ist of agenr:ies
`publishing in the CFR are also included in this volun1e.
`An index Lo I.he l.exL ol '·T1l.1e 3-The Presldenl · ls c:arr1ed \Vll.hln 1.hal. vo1urne.
`l'he .Federal Register lndex is issued monthly in cun1ulative forn1. 'l"his index
`l,l1111.e111.:-. ent.des in t.he daily Federal Reg-
`
`L-. ud.'>eu on a c.onso1 idat.ion of t.he .. ,.., - --~- -~-'"
`
`ister.
`
`vi
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`TEVA_MS_0045351
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1007 - Page 6
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`A List of C.FH. Sections Affected (LS.'\) is published monthly', ke).red to the
`revision dates of the 50 C.FR titles.
`
`REPUBLICATION OF MATERIAL
`lhcre arc no restrictions on the republication of nlatcrial appearing in the
`Code or Federal Regulations.
`
`T'JQUTRTES
`
`.For a legal interpretation or explanation of any regulation in this volu1ne.
`c:onl.ac:l. I.he issuing agenc:y. The issuing agency's narne appears al. I.he Lop of
`odd-numbered pages.
`For inquiries r:onr:crning CFR rcfcrr:nr:r: assist.anr:r:, r:all 202-523-5227 or· \Vritr:
`lo l.he Uireclor. Office of lhe Federal H.egisler .. '\Jalional Archives and H.ecords
`. .\dn1inistration. Washington. DC 20408.
`SALES
`lhe Gnvernment Printing Office (GPO) processes all sales and distribution of
`the CFR. For pay1nent by credit card. call 202-512-1800. J\:1-F. 8 a.111. to 4 p.111.
`e.s.I. or fax )/Our order l.o 202-512-2233, 24 hours a da.v For payrnenl by c:hec:k,
`v.·1·ile lo lhe Superinlendenl of Docu1nenls, Alln: T'..Jevv OrdeI~. P.O. Box 371954.
`Pittsburgh. PA 15250-7954. For GPO Customer Service call 202-512-1803.
`
`EL.i::C'i"KO.\iiC SE.K.ViC.i::S
`
`lhc full text of the Code of Federal l{cgulations. 'l"hc United States Covcrn-
`111c1Tt i\:ianuai. the Fedcrai i<.egist:cr. Pubiic Lavvs. V\icekiy Co1npiiation of Presi(cid:173)
`denl.ial Doc:urnent.s and l.he Privacy Acl. Cornpilal.lon are available in elec:t.ronic:
`format at '"'''""·'v.access.gpo.gov/nara ("GPO .U..ccess''). For n1ore inforrnation. con(cid:173)
`tact Electronic Information Dissen1ination Services, U.S. Governn1ent Printing
`Offir:c. Phone 202-512-1530, or 888-293-6498 (t.oll-frr:r'). E-rnail.gpoar:rr:ss@gpo.gov
`lhc Office of the Federal H.egistcr also offers a free service on the National
`Arc:hives and Rec:ords Adrninist.ral.ion's (NARA) \Vorld \•Viele \A/eh sit.e l"or public:
`la'h· nun1hers. becleral 1-<egisl.er linding aicls, ancl relal.ed inl<H"Tnal.ic)n. C<1nnec:I
`to .'\J . .\RA.'s v.reb site at \.V\l\llN.nara.gov/fedreg. 'lhe NARA site also contains links
`to GPO Access.
`
`April r 1.9.98.
`
`XAY!v10ND A. MOSLEY.
`Director.
`Office of" the Federal Register.
`
`vii
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`TEVA_MS_0045352
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`

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`TEVA_MS_0045353
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1007 - Page 8
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`

`
`THIS TITLE
`
`'litlc 21-Fooo A.'\D DRUGS is co111poscd of nine volun1cs. 'lhc parts in these
`·volumes are arranged in the follo\i\'ing order: Parts 1-99, 100-169, 1'70-199. 200-299.
`:l00-499, 500-599, 600-799, R00-1299 and l:lOO-end. The flrsL eighL volurnes, containing
`parl.'-i 1-1299, 1:•inipri.<;<-: Chapl.<-:r T-F(HHl and Drug A1!rnini.c;l.ral.irni. Dr;parl.ni<-:nt ,,r
`Health and Hun1an Scr .. vir:cs. The ninth volu111c, r:ontaining past l'.lOO to end, in(cid:173)
`cludes Chapter 11-Drug Lnforccn1cnt Administration. Department of Justice. and
`Chapter 111-0fficc of National Drug Control Policy. 'J'hc contents of these vol(cid:173)
`un1es represent all current regulations codified under this title of the CFR as
`of April 1, 199R .
`
`.R.cdcsignation tables for Chapter l Food a_._"'1d Drug i\dn1inistration appear in
`the Finding .i'\ids section for the ·volumes containing parts 170-199 and 500-599.
`
`For this ·volu111c, l\1Tcl<J.nic J, 1\,·f31-r:cr \.V<J.s Chief Editor. Thc Code of Fcdcr<J.1
`.R.cgulations publication progran1 is under the direction of Frances D .. VlcDonald,
`assist:ed by . .:\ion1ha S. :viorris.
`
`ix
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`TEVA_MS_0045354
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1007 - Page 9
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`Food and Drug Administration, HHS
`
`of xis 0.:1 and the average value of y is
`0 7.
`(b) 'l'he additive n1eets the follo•Ning
`spec ifir:fltions:
`(1) · l'hc incthoxy content shall be not
`less than ~.5 perc:enL and not rnore than
`6.5 percent. calculated as OCH.~. and the
`ethox_y content shall be not less than
`14.5 percent and not tnorc than 19 per(cid:173)
`cent, calculated as OClH 3 . both n1eas(cid:173)
`urcd on the dry san1plc.
`(2) 'J'he ·viscosity of an aqueous solu(cid:173)
`r.1011, L.:i gr<]rns or rhr: Jll<]t:r;ri<]]
`in iOO
`1nillililers of \Valer, al 20 °C. is 20 Lo 60
`ccntipoiscs.
`(3) The ash content on a dr_y basis has
`a inaxin1un1 of 0.6 percent.
`(c) 'l'he food additive is used as an
`aerating, en1ulsifying, and
`foan1ing
`:-igP.nL, in an :-1n1ount not in P.xces.~; ol
`that reasonably required to produce its
`intended effect.
`
`§ 172.874 Hydroxypropyl
`methylcellulose.
`
`food additive h_y<lrox.ypropyl
`The
`n1ethylcellulose (CAS H.eg. No. 9004-65-
`~) rnay be sa!"ely used in rood, exc:epl. in
`standardized foods \i<othich do not pro(cid:173)
`·vide fo1- such use if.
`(a) The additive complies \Vith the
`definition and specifications prescribed
`in I.he >Jal.ional Forrnular_)/. 12Lh edi(cid:173)
`tion.
`{b) lt is used or intended for use as an
`en1ulsifier. film forn1er, protective col(cid:173)
`loid, <>tn.h!l!?er. <>u<>pend!ng n.gent_ or
`thickener.
`in accordance
`\Vi th good
`n1anu!"acl.uring pracl.ic:e.
`(c) To insure safe use of the additive,
`the container of the additive. in addi(cid:173)
`Lion Lo being 1:-ibP.1P.d ;-1.~; required by !J1P.
`general provisions of the act, shall be
`ac:cornpanied by
`labeling vvhic:h con(cid:173)
`tains adequate directions for use to
`provide a fin<?.1 produr:t that r:o111plies
`\·ViLh Lhc lirniLaLiun:; prc:o;cribcd in para(cid:173)
`graph (b) of this section.
`,,...,.,
`[42 iR 144S1, ~v·lar. 1 c
`'"· ,,..,,,'
`FR :O:R27:0:, Aug. :0:1. HIRZ]
`
`§ 1 "72.S-76 Castor oii.
`
`The food a<ldilive caslor oil rnay be
`safely used in accordance v-,:iLh Lhe fol(cid:173)
`lo\ving conditions:
`
`§ 172.878
`
`(a) ·rhe additi·ve meets the specifica(cid:173)
`lions of Lhe lJniled Stales Pharrna(cid:173)
`r:npcia XX {!980).
`(b) The additive is used or intended
`for us12 as folln1;vs:
`
`(J~L" and Liu1italiun~
`
`IIard candy prutlucliun-As a release agenL
`and antisticking agent. not to exceed 500
`p;oirts pP.r million in h;oird c;oinrly.
`Vilarnin antl n1incral lalilcls-As a curnpu(cid:173)
`ncnl of prolcclive coaling;;.
`
`[42 FR 14491. iviar. Li. 1977. as a1nended ar 49
`fR 10105, fv1ar. l!:l. 1984]
`
`§ 172.878 White mineral oil.
`
`V...'hil.e rnineral oil rnay be sal'el_y used
`in food in accordance vvith the follo\.v-
`ing conditions:
`(a) VVhitc n1incral oil is a n1ixturc of
`liquid hyrdrocarbons, essentially par(cid:173)
`affinic and naphlhenic in nature ob(cid:173)
`t<?.inr:d fron1 pr:troleun1. It is rr:fined to
`meet the follovving specifications:
`(1) It nleets rhe resr requiren1enrs of
`I.he lJnil.ed SI.al.es Pharrnacopeia XX
`(l9RO)
`for
`rr:adily
`r:ar·honiz<?.h\r: suh(cid:173)
`stances (page 532).
`(2) It nleets the test require1nents of
`U.S.P. XVll for sulfur compounds (page
`400).
`•">lJ<:l.llll.nl.l\Jll,"> !"""'-
`(?\ T+-
`···--+-- +-h-
`~ .. -~~-1-·~-~+-I~--
`-.--
`~"} IL
`Jll<:<:l..">
`I.II<:
`scribed in the "Journal of the Associa(cid:173)
`tion of Official Anal_ytical Chemists,"
`\/olurne 45, page 66 (1962), which is in(cid:173)
`corporated by reference. atter correc(cid:173)
`lion of lhe ulLravioleL absorbance for
`anv ahsorhanc:e due
`l.o added anl.i(cid:173)
`oxidants. Copies of the inaterial incor(cid:173)
`porated by reference are available from
`the Cenler for Food Safel)i cu1d Applied
`Nutrition (HFS-200), Food <?.nd Drug
`.i\dn1inistration. 200 C St. SV\1., \l\'ash(cid:173)
`ington, DC 20204. or nvnih1hle for in(cid:173)
`spection at the Office of the Federal
`Register. 800 North Capitol Street.
`NVV., suite 700, \Nashington, DC 20408.
`(b)
`\1\ihite n1ineral oil ma:y contain
`any antioxidant pcrn1ittcd in food by
`regulations issued in accordance \iVith
`sr:r:tion 409 of the Art
`in an a111ount
`not greater than
`that required
`to
`produce its intended effecl.
`(c) V\ihiLc rnineral oil is used or in(cid:173)
`tended for use as follo\.vs:
`
`99
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`TEVA_MS_0045355
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1007 - Page 10