AUTHENTICATED ,
`U S. GOVERNMENT
`INFORMATION ^
`CPO
`
`Food and Drugs
`
`21
`
`PARTS 170 TO 199
`Revised as of April 1, 1998
`
`CONTAINING
`A CODIFICATION OF DOCUMENTS
`OF GENERAL APPLICABILITY
`AND 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
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1018 - Page 1
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`

`

`U.S. GOVERNMENT PRINTING OFFICE
`WASHINGTON : 1998
`
`For sale by U.S. Government Printing Office
`Superintendent of Documents, Mail Stop: SSOP. Washington, DC 20402-9328
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1018 - Page 2
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`

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`Table of Contents
`
`Explanation
`
`Title 21:
`
`Chapter I—Food and Drug Administration, Department of Health
`and Human Services (Continued) ............................................................
`
`Finding Aids;
`
`Material Approved for Incorporation by Reference
`
`Table of CFR Titles and Chapters
`
`Alphabetical List of Agencies Appearing in the CFR
`
`Redesignation Table
`
`List of CFR Sections Affected
`
`Page
`V
`
`3
`
`551
`
`565
`
`581
`
`591
`
`593
`
`111
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1018 - Page 3
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`Cite this Code: CFR
`
`To cite the regulations in
`this volume use title,
`part and section num­
`ber. Thus, 21 CFR 170.3
`refers to title 21, part
`170, section 3.
`
`IV
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1018 - Page 4
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`Explanation
`
`The Code of Federal Regulations is a codification of the general and permanent
`rules published in the Federal Register by the Executive departments and agen­
`cies of the Federal Government. The Code is divided into 50 titles which represent
`broad areas subject to Federal regulation. Each title is divided into chapters
`which usually bear the name of the issuing agency. Each chapter is further sub­
`divided into parts covering specific regulatory areas.
`Each volume of the Code is revised at least once each calendar year and issued
`on a quarterly basis approximately as follows:
`as of January 1
`Title 1 through Title 16..
`.....as of April 1
`Title 17 through Title 27
`...... as of July 1
`Title 28 through Title 41
`.as of October 1
`Title 42 through Title 50
`The appropriate revision date is printed on the cover of each volume.
`LEGAL STATUS
`The contents of the Federal Register are required to be Judicially noticed (44
`U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text
`of the original documents (44 U.S.C. 1510).
`HOW TO USE THE CODE OF FEDERAL REGULATIONS
`The Code of Federal Regulations is kept up to date by the individual issues
`of the Federal Register. These two publications must be used together to deter­
`mine the latest version of any given rule.
`To determine whether a Code volume has been amended since its revision date
`(in this case, April 1, 1998), consult the "List of CFR Sections Affected (LSA),’’
`which is issued monthly, and the "Cumulative List of Parts Affected, which
`appears in the Reader Aids section of the daily Federal Register, These two lists
`will Identify the Federal Register page number of the latest amendment of any
`given rule.
`EFFECTIVE AND EXPIRATION DATES
`Each volume of the Code contains amendments published in the Federal Reg­
`ister since the last revision of that volume of the Code. Source citations for
`the regulations are referred to by volume number and page number of the Federal
`Register and date of publication. Publication dates and effective dates are usu­
`ally not the same and care must be exercised by the user in determining the
`actual effective date. In instances where the effective date is beyond the cut­
`off date for the Code a note has been inserted to reflect the future effective
`date. In those instances where a regulation published in the Federal Register
`states a date certain for expiration, an appropriate note will be Inserted following
`the text.
`0MB CONTROL NUMBERS
`The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal agencies
`to display an 0MB control number with their information collection request.
`
`V
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`Many agencies have begun publishing numerous 0MB control numbers as amend­
`ments to existing regulations in the CFR. These 0MB numbers are placed as
`close as possible to the applicable recordkeeping or reporting requirements.
`OBSOLETE PROVISIONS
`Provisions that become obsolete before the revision date stated on the cover
`of each volume are not carried. Code users may find the text of provisions in
`effect on a given date in the past by using the appropriate numerical list of
`sections affected. For the period before January 1, 1986, consult either the List
`of CFR Sections Affected, 1949-1963, 1964-1972, or 1973-1985, published in seven sep­
`arate volumes. For the period beginning January 1, 1986, a “List of CFR Sections
`Affected” is published at the end of each CFR volume.
`INCORPORATION BY REFERENCE
`What is incorporation by reference? Incorporation by reference was established
`by statute and allows Federal agencies to meet the requirement to publish regu­
`lations in the Federal Register by referring to materials already published else­
`where. For an Incorporation to be valid, the Director of the Federal Register
`must approve it. The legal effect of incorporation by reference is that the mate­
`rial is treated as if it were published in full in the Federal Register (5 U.S.C.
`552(a)). This material, like any other properly issued regulation, has the force
`of law.
`What is a proper incorporation by reference? The Director of the Federal Register
`will approve an incorporation by reference only when the requirements of 1 CFR
`part 51 are met. Some of the elements on which approval is based are:
`(a) The incorporation will substantially reduce the volume of material pub­
`lished in the Federal Register.
`(b) The matter incorporated is in fact available to the extent necessary to
`afford fairness and uniformity in the administrative process.
`(c) The incorporating document is drafted and submitted for publication in
`accordance with 1 CFR part 51.
`Properly approved incorporations by reference in this volume are listed in the
`Finding Aids at the end of this volume.
`What if the material incorporated by reference cannot be found? If you have any
`problem locating or obtaining a copy of material listed in the Finding Aids of
`this volume as an approved incorporation by reference, please contact the agency
`that issued the regulation containing that Incorporation. If, after contacting the
`agency, you find the material is not available, please notify the Director of the
`Federal Register, National Archives and Records Administration, Washington DC
`20408, or call (202) 523-4534.
`CFR INDEXES AND TABULAR GUIDES
`A subject index to the Code of Federal Regulations is contained in a separate
`volume, revised annually as of January 1, entitled CFR Index and Finding Aids.
`This volume contains the Parallel Table of Statutory Authorities and Agency
`Rules (Table I), and Acts Requiring Publication in the Federal Register (Table
`II). A list of CFR titles, chapters, and parts and an alphabetical list of agencies
`publishing in the CFR are also included in this volume.
`An index to the text of "Title 3—The President” is carried within that volume.
`The Federal Register Index is issued monthly in cumulative form. This index
`is based on a consolidation of the “Contents” entries in the dally Federal Reg­
`ister.
`
`vi
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`A List of CFR Sections Affected (LSA) is published monthly, keyed to the
`revision dates of the 50 CFR titles.
`REPUBLICATION OF MATERIAL
`There are no restrictions on the republication of material appearing in the
`Code of Federal Regulations.
`INQUIRIES
`For a legal interpretation or explanation of any regulation in this volume,
`contact the issuing agency. The issuing agency’s name appears at the top of
`odd-numbered pages.
`For inquiries concerning CFR reference assistance, call 202-523-5227 or write
`the Director, Office of the Federal Register, National Archives and Records
`to
`Administration, Washington, DC 20408.
`SALES
`The Government Printing Office (GPO) processes all sales and distribution of
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`ELECTRONIC SERVICES
`The full text of the Code of Federal Regulations, The United States Govern­
`ment Manual, the Federal Register, Public Laws, Weekly Compllatmn of Presi­
`dential Documents and the Privacy Act Compilation are available in electronic
`format at www.access.gpo.gov/nara (“GPO Access”). For more information, con-
`Electronic Information Dissemination Services, U.S. Government Printing
`tact
`Office. Phone 202-512-1530, or 888-293-6498 (toll-free). E-mail, gpoaccess@gpo.gov.
`The Office of the Federal Register also offers a free service on the National
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`to GPO Access.
`
`Raymond A. Mosley,
`Director,
`Office of the Federal Register,
`
`April 1, 1998.
`
`Vll
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1018 - Page 8
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1018 - Page 8
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`THIS TITLE
`
`Title 21—Food and Drugs is composed of nine volumes. The parts in these
`volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200-299,
`300-499, 500-599, 600-799, 800-1299 and 1300-end. The first eight volumes, containing
`parts 1-1299, comprise Chapter I—Food and Drug Administration, Department of
`Health and Human Services. The ninth volume, containing part 1300 to end, in­
`cludes Chapter II—Drug Enforcement Administration, Department of Justice, and
`Chapter III—Office of National Drug Control Policy, The contents of these vol-
`represent all current regulations codified under this title of the CFR as
`umes
`of April 1, 1998,
`Redesignation tables for Chapter I—Food and Drug Administration appear in
`the Finding Aids section for the volumes containing parts 170-199 and 500-599,
`For this volume, Melanie L. Marcec was Chief Editor. The Code of Federal
`Regulations publication program is under the direction of Frances D. McDonald,
`assisted by Alomha S, Morris.
`
`IX
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1018 - Page 9
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`Food and Drug Administration, HHS
`of A- is 0,3 and the average value of y is
`0.7.
`(b) The additive meets the following
`specifications:
`(1) The methoxy content shall be not
`less than 3.5 percent and not more than
`6.5 percent, calculated as OCH3, and the
`ethoxy content shall be not less than
`14.5 percent and not more than 19 per­
`cent, calculated as OC2H5, both meas­
`ured on the dry sample.
`(2) The viscosity of an aqueous solu­
`tion, 2.5 grams of the material in 100
`milliliters of water, at 20 °C, is 20 to 60
`centipoises.
`(3) The ash content on a dry basis has
`a maximum of 0.6 percent.
`(c) The food additive is used as an
`aerating, emulsifying, and foaming
`agent, in an amount not in excess of
`that reasonably required to produce its
`intended effect.
`§ 172.874 Hydroxypropyl
`methylcellulose.
`The food additive hydroxypropyl
`methylcellulose (CAS Reg. No. 9004-65­
`3) may be safely used in food, except in
`standardized foods which do not pro­
`vide for such use if:
`(a) The additive complies with the
`definition and specifications prescribed
`in the National Formulary, 12th edi­
`tion.
`(b) It is used or intended for use as an
`emulsifier, film former, protective col­
`loid, stabilizer, suspending agent, or
`thickener, in accordance with good
`manufacturing practice.
`(c) To insure safe use of the additive,
`the container of the additive, in addi­
`tion to being labeled as required by the
`general provisions of the act, shall be
`accompanied by labeling which con­
`tains adequate directions for use to
`provide a final product that complies
`with the limitations prescribed in para­
`graph (b) of this section.
`[42 FR 14491, Mar. 15, 1977, as amended at 47
`FR 38273, Aug. 31, 1982]
`§ 172.876 Castor oil.
`The food additive castor oil may be
`safely used in accordance with the fol­
`lowing conditions:
`
`§172.878
`(a) The additive meets the specifica­
`tions of the United States Pharma­
`copeia XX (1980),
`(b) The additive is used or intended
`for use as follows;
`Use and Limitations
`Hard candy production—As a release agent
`and antisticking agent, not to exceed 500
`parts per million in hard candy.
`Vitamin and mineral tablets—As a compo­
`nent of protective coatings.
`[42 FR 14491, Mar, 15, 1977, as amended at 49
`FR 10105, Mar. 19, 1984]
`§ 172.878 White mineral oil.
`White mineral oil may be safely used
`in food in accordance with the follow­
`ing conditions:
`(a) White mineral oil is a mixture of
`liquid hydrocarbons, essentially par­
`affinic and naphthenic in nature ob­
`tained from petroleum. It is refined to
`meet the following specifications:
`(1) It meets the test requirements of
`the United States Pharmacopeia XX
`(1980) for readily carbonizable sub­
`stances (page 532).
`(2) It meets the test requirements of
`U.S.P. XVII for sulfur compounds (page
`400).
`(3) It meets the specifications pre­
`scribed in the “Journal of the Associa­
`tion of Official Analytical Chemists,"
`Volume 45, page 66 (1962), which is in­
`corporated by reference, after correc­
`tion of the ultraviolet absorbance for
`any absorbance due to added anti­
`oxidants. Copies of the material incor­
`porated by reference are available from
`the Center for Food Safety and Applied
`Nutrition (HFS-200), Food and Drug
`Administration, 200 C St. SW., Wash­
`ington, DC 20204, or available for in­
`spection at the Office of the Federal
`Register, 800 North Capitol Street,
`NW., suite 700, Washington, DC 20408,
`(b) White mineral oil may contain
`any antioxidant permitted in food by
`regulations issued in accordance with
`section 409 of the Act, in an amount
`not greater than that required to
`produce its intended effect.
`(c) White mineral oil is used or in­
`tended for use as follows:
`
`99
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1018 - Page 10
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