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Title 21

Food and Drugs

Parts 1 to 99

Revised as of April 1, 2013

Containing a codification of documents

of general applicability and future effect

As of April 1, 2013

Published by the Office of the Federal Register

National Archives and Records Administration

as a Special Edition of the Federal Register

VerDate Mar2010 18:00 Apr 25, 2013 Jkt 229068 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Q:\21\21V1.TXT ofr150 PsN: PC150

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U.S. GOVERNMENT OFFICIAL EDITION NOTICE

Legal Status and Use of Seals and Logos

The seal of the National Archives and Records Administration

(NARA) authenticates the Code of Federal Regulations (CFR) as

the official codification of Federal regulations established under

the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the

contents of the CFR, a special edition of the Federal Register, shall

be judicially noticed. The CFR is prima facie evidence of the origi-

nal documents published in the Federal Register (44 U.S.C. 1510).

It is prohibited to use NARAs official seal and the stylized Code

of Federal Regulations logo on any republication of this material

without the express, written permission of the Archivist of the

United States or the Archivists designee. Any person using

NARAs official seals and logos in a manner inconsistent with the

provisions of 36 CFR part 1200 is subject to the penalties specified

in 18 U.S.C. 506, 701, and 1017.

Use of ISBN Prefix

This is the Official U.S. Government edition of this publication

and is herein identified to certify its authenticity. Uese of the 0

16 ISBN prefix is for U.S. Government Printing Office Official Edi-

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http://bookstore.gpo.gov

Phone: toll-free (866) 512-1800; DC area (202) 512-1800


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Table of ContentsPage

Explanation ................................................................................................ v

Title 21:

Chapter IFood and Drug Administration, Department of Health

and Human Services .................................................................... 3

Finding Aids:

Table of CFR Titles and Chapters ....................................................... 467

Alphabetical List of Agencies Appearing in the CFR ......................... 487

List of CFR Sections Affected ............................................................. 497


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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 1.1refers to title 21, part 1,section 1.


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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:

Title 1 through Title 16..............................................................as of January 1

Title 17 through Title 27 .................................................................as of April 1

Title 28 through Title 41 ..................................................................as of July 1

Title 42 through Title 50 .............................................................as of October 1

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, 2013), 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.

OMB CONTROL NUMBERS

The Paperwork Reduction Act of 1980 (Pub. L. 96511) requires Federal agencies

to display an OMB control number with their information collection request.


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Many agencies have begun publishing numerous OMB control numbers as amend-

ments to existing regulations in the CFR. These OMB numbers are placed as

close as possible to the applicable recordkeeping or reporting requirements.

PAST PROVISIONS OF THE CODE

Provisions of the Code that are no longer in force and effect as of the revision

date stated on the cover of each volume are not carried. Code users may find

the text of provisions in effect on any given date in the past by using the appro-

priate List of CFR Sections Affected (LSA). For the convenience of the reader,

a List of CFR Sections Affected is published at the end of each CFR volume.

For changes to the Code prior to the LSA listings at the end of the volume,

consult previous annual editions of the LSA. For changes to the Code prior to

2001, consult the List of CFR Sections Affected compilations, published for 1949-

1963, 1964-1972, 1973-1985, and 1986-2000.

[RESERVED] TERMINOLOGY

The term [Reserved] is used as a place holder within the Code of Federal

Regulations. An agency may add regulatory information at a [Reserved] loca-

tion at any time. Occasionally [Reserved] is used editorially to indicate that

a portion of the CFR was left vacant and not accidentally dropped due to a print-

ing or computer error.

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.

What if the material incorporated by reference cannot be found? If you have any

problem locating or obtaining a copy of material listed as an approved incorpora-

tion 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, 8601 Adelphi Road, College Park, MD 20740-6001, or

call 202-741-6010.

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 I NDEX AND FINDING AIDS.

This volume contains the Parallel Table of Authorities and Rules. A list of CFR

titles, chapters, subchapters, and parts and an alphabetical list of agencies pub-

lishing in the CFR are also included in this volume.


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An index to the text of Title 3The 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 daily Federal Reg-

ister.

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 agencys name appears at the top of

odd-numbered pages.

For inquiries concerning CFR reference assistance, call 2027416000 or write

to the Director, Office of the Federal Register, National Archives and Records

Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail

[email protected].

SALES

The Government Printing Office (GPO) processes all sales and distribution of

the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area, 202-

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ELECTRONIC SERVICES

The full text of the Code of Federal Regulations, the LSA (List of CFR SectionsAffected), The United States Government Manual, the Federal Register, Public

Laws, Public Papers of the Presidents of the United States, Compilation of Presi-

dential Documents and the Privacy Act Compilation are available in electronic

format via www.ofr.gov. For more information, contact the GPO Customer Con-

tact Center, U.S. Government Printing Office. Phone 202-512-1800, or 866-512-1800

(toll-free). E-mail, [email protected].

The Office of the Federal Register also offers a free service on the National

Archives and Records Administrations (NARA) World Wide Web site for public

law numbers, Federal Register finding aids, and related information. Connect

to NARAs web site at www.archives.gov/federal-register .

The e-CFR is a regularly updated, unofficial editorial compilation of CFR ma-

terial and Federal Register amendments, produced by the Office of the Federal

Register and the Government Printing Office. It is available at www.ecfr.gov.

CHARLES A. BARTH,

Director,

Office of the Federal Register.

April 1, 2013.


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THIS TITLE

Title 21FOOD AND DRUGS is composed of nine volumes. The parts in these

volumes are arranged in the following order: Parts 199, 100169, 170199, 200299,

300499, 500599, 600799, 8001299 and 1300 to end. The first eight volumes, con-

taining parts 11299, comprise Chapter IFood and Drug Administration, Depart-

ment of Health and Human Services. The ninth volume, containing part 1300 toend, includes Chapter IIDrug Enforcement Administration, Department of Jus-

tice, and Chapter IIIOffice of National Drug Control Policy. The contents of

these volumes represent all current regulations codified under this title of the

CFR as of April 1, 2013.

For this volume, Jonn V. Lilyea was Chief Editor. The Code of Federal Regula-

tions publication program is under the direction of Michael L. White, assisted

by Ann Worley.


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Title 21Food and

Drugs(This book contains parts 1 to 99)

Part

CHAPTER IFood and Drug Administration, Department ofHealth and Human Services ............................................... 1


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CHAPTER IFOOD AND DRUG

ADMINISTRATION, DEPARTMENT OF HEALTH

AND HUMAN SERVICES

EDITORIAL NOTE: Nomenclature changes to chapter I appear at 66 FR 56035, Nov. 6, 2001, 69FR 13717, Mar. 24, 2004, and 69 FR 18803, Apr. 9, 2004.

SUBCHAPTER AGENERAL

Part Page

1 General enforcement regulations ............................ 52 General administrative rulings and decisions ......... 503 Product jurisdiction ................................................ 554 Regulation of combination products ....................... 605 Organization ............................................................ 637 Enforcement policy ................................................. 71

10 Administrative practices and procedures ................ 8111 Electronic records; electronic signatures ............... 11512 Formal evidentiary public hearing ......................... 11913 Public hearing before a public board of inquiry ...... 13614 Public hearing before a public advisory committee 14115 Public hearing before the Commissioner ................ 16816 Regulatory hearing before the Food and Drug Ad-

ministration ......................................................... 17117 Civil money penalties hearings ............................... 17719 Standards of conduct and conflicts of interest ....... 19220 Public information .................................................. 19421 Protection of privacy .............................................. 22525 Environmental impact considerations .................... 24126 Mutual recognition of pharmaceutical good manu-

facturing practice reports, medical device qual-ity system audit reports, and certain medical de-vice product evaluation reports: United Statesand the European Community ............................. 253

50 Protection of human subjects ................................. 28354 Financial disclosure by clinical investigators ........ 29556 Institutional Review Boards ................................... 29958 Good laboratory practice for nonclinical labora-

tory studies .......................................................... 308


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21 CFR Ch. I (4113 Edition)

Part Page

60 Patent term restoration .......................................... 32270 Color additives ........................................................ 32971 Color additive petitions .......................................... 33773 Listing of color additives exempt from certifi-

cation ................................................................... 34474 Listing of color additives subject to certification .. 39680 Color additive certification ..................................... 43381 General specifications and general restrictions for

provisional color additives for use in foods,drugs, and cosmetics ............................................ 439

82 Listing of certified provisionally listed colors andspecifications ....................................................... 4468398 [Reserved]99 Dissemination of information on unapproved/new

uses for marketed drugs, biologics, and devices ... 452


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SUBCHAPTER AGENERAL

PART 1GENERAL ENFORCEMENTREGULATIONS

Subpart AGeneral Provisions

Sec.1.1 General.1.3 Definitions.1.4 Authority citations.

Subpart BGeneral Labeling Requirements

1.20 Presence of mandatory label informa-tion.

1.21 Failure to reveal material facts.1.23 Procedures for requesting variations

and exemptions from required labelstatements.

1.24 Exemptions from required label state-ments.

Subparts CD [Reserved]

Subpart EImports and Exports

1.83 Definitions.1.90 Notice of sampling.1.91 Payment for samples.1.94 Hearing on refusal of admission.1.95 Application for authorization to relabel

and recondition.

1.96 Granting of authorization to relabeland recondition.

1.97 Bonds.1.99 Costs chargeable in connection with re-

labeling and reconditioning inadmissibleimports.

1.101 Notification and recordkeeping.

Subparts FG [Reserved]

Subpart HRegistration of Food Facilities

GENERAL PROVISIONS

1.225 Who must register under this subpart?1.226 Who does not have to register under

this subpart?1.227 What definitions apply to this sub-

part?

PROCEDURES FOR REGISTRATION OF FOODFACILITIES

1.230 When must you register?1.231 How and where do you register?1.232 What information is required in the

registration?1.233 What optional items are included in

the registration form?1.234 How and when do you update your fa-

cilitys registration information?1.235 How and when do you cancel your fa-

cilitys registration information?

ADDITIONAL PROVISIONS

1.240 What other registration requirements

apply?

1.241 What are the consequences of failing

to register, update, or cancel your reg-

istration?

1.242 What does assignment of a registra-

tion number mean?

1.243 Is food registration information avail-

able to the public?

Subpart IPrior Notice of Imported Food

GENERAL PROVISIONS

1.276 What definitions apply to this sub-

part?

1.277 What is the scope of this subpart?

REQUIREMENTS TO SUBMIT PRIOR NOTICE OF

IMPORTED FOOD

1.278 Who is authorized to submit prior no-

tice?

1.279 When must prior notice be submitted

to FDA?

1.280 How must you submit prior notice?

1.281 What information must be in a prior

notice?

1.282 What must you do if information

changes after you have received con-firmation of a prior notice from FDA?

CONSEQUENCES

1.283 What happens to food that is imported

or offered for import without adequate

prior notice?

1.284 What are the other consequences of

failing to submit adequate prior notice

or otherwise failing to comply with this

subpart?

1.285 What happens to food that is imported

or offered for import from unregistered

facilities that are required to register

under subpart H of this part?

Subpart JEstablishment, Maintenance,and Availability of Records

GENERAL PROVISIONS

1.326 Who is subject to this subpart?

1.327 Who is excluded from all or part of the

regulations in this subpart?

1.328 What definitions apply to this sub-

part?

1.329 Do other statutory provisions and reg-

ulations apply?

1.330 Can existing records satisfy the re-

quirements of this subpart?


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21 CFR Ch. I (4113 Edition)1.1

REQUIREMENTS FOR NONTRANSPORTERS TO ES-

TABLISH AND MAINTAIN RECORDS TO IDEN-

TIFY THE NONTRANSPORTER AND TRANS-

PORTER IMMEDIATE PREVIOUS SOURCES OFFOOD

1.337 What information must nontrans-porters establish and maintain to iden-tify the nontransporter and transporterimmediate previous sources of food?

REQUIREMENTS FOR NONTRANSPORTERS TO ES-

TABLISH AND MAINTAIN RECORDS TO IDEN-

TIFY THE NONTRANSPORTER AND TRANS-

PORTER IMMEDIATE SUBSEQUENT RECIPIENTS

OF FOOD

1.345 What information must nontrans-porters establish and maintain to iden-tify the nontransporter and transporterimmediate subsequent recipients of food?

REQUIREMENTS FOR TRANSPORTERS TOESTABLISH AND MAINTAIN RECORDS

1.352 What information must transportersestablish and maintain?

GENERAL REQUIREMENTS

1.360 What are the record retention require-ments?

1.361 What are the record availability re-quirements?

1.362 What records are excluded from thissubpart?

1.363 What are the consequences of failing

to establish or maintain records or makethem available to FDA as required bythis subpart?

COMPLIANCE DATES

1.368 What are the compliance dates for thissubpart?

Subpart KAdministrative Detention ofFood for Human or Animal Consumption

GENERAL PROVISIONS

1.377 What definitions apply to this sub-part?

1.378 What criteria does FDA use to order adetention?

1.379 How long may FDA detain an articleof food?

1.380 Where and under what conditionsmust the detained article of food be held?

1.381 May a detained article of food be de-livered to another entity or transferredto another location?

1.382 What labeling or marking require-ments apply to a detained article of food?

1.383 What expedited procedures apply whenFDA initiates a seizure action against adetained perishable food?

1.384 When does a detention order termi-nate?

HOW DOES FDA ORDER A DETENTION?

1.391 Who approves a detention order?

1.392 Who receives a copy of the detentionorder?

1.393 What information must FDA includein the detention order?

WHAT IS THE APPEAL PROCESS FOR A

DETENTION ORDER?

1.401 Who is entitled to appeal?

1.402 What are the requirements for submit-ting an appeal?

1.403 What requirements apply to an infor-mal hearing?

1.404 Who serves as the presiding officer foran appeal, and for an informal hearing?

1.405 When does FDA have to issue a deci-sion on an appeal?

1.406 How will FDA handle classified infor-mation in an informal hearing?

AUTHORITY: 15 U.S.C. 1333, 1453, 1454, 1455,4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331,333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362,371, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C.216, 241, 243, 262, 264.

SOURCE: 42 FR 15553, Mar. 22, 1977, unlessotherwise noted.

Subpart AGeneral Provisions

1.1 General.

(a) The provisions of regulations pro-mulgated under the Federal Food,Drug, and Cosmetic Act with respect tothe doing of any act shall be applicablealso to the causing of such act to bedone.

(b) The definitions and interpreta-tions of terms contained in sections 201and 900 of the Federal Food, Drug, andCosmetic Act (21 U.S.C. 321 and 387)shall be applicable also to such termswhen used in regulations promulgatedunder that act.

(c) The definition ofprincipal displaypanel in 101.1, 201.60, 501.1, 701.10 and801.60 of this chapter; and the require-ments pertaining to uniform location,

lack of qualification, and separation ofthe net quantity declaration in101.105(f), 201.62(e), 501.105(f), 701.13(f)and 801.62(e) of this chapter to type sizerequirements for net quantity declara-tion in 101.105(i), 201.62(h), 501.105(i),701.13(i) and 801.62(h) of this chapter, toinitial statement of ounces in the dualdeclaration of net quantity in101.105(j) and (m), 201.62(i) and (k),501.105(j) and (m), 701.13(j) and (m) and


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Food and Drug Administration, HHS 1.20

801.62(i) and (k) of this chapter, to ini-tial statement of inches in declarationof net quantity in 201.62(m), 701.13(o)and 801.62(m) of this chapter, to initialstatement of square inches in declara-tion of net quantity in 201.62(n),701.13(p) and 801.62(n) of this chapter, toprohibition of certain supplemental netquantity statements in 101.105(o),201.62(o), 501.105(o), 701.13(q) and801.62(o) of this chapter, and toservings representations in 501.8 ofthis chapter are provided for solely bythe Fair Packaging and Labeling Act.

The other requirements of this part areissued under both the Fair Packagingand Labeling Act and the FederalFood, Drug, and Cosmetic Act, or bythe latter act solely, and are not lim-ited in their application by section 10of the Fair Packaging and LabelingAct.

[42 FR 15553, Mar. 22, 1977, as amended at 58FR 17085, Apr. 1, 1993; 75 FR 73953, Nov. 30,2010]

1.3 Definitions.

(a) Labeling includes all written,printed, or graphic matter accom-panying an article at any time whilesuch article is in interstate commerce

or held for sale after shipment or deliv-ery in interstate commerce.

(b) Label means any display of writ-ten, printed, or graphic matter on theimmediate container of any article, orany such matter affixed to any con-sumer commodity or affixed to or ap-pearing upon a package containing anyconsumer commodity.

1.4 Authority citations.

(a) For each part of its regulations,the Food and Drug Administration in-cludes a centralized citation of all ofthe statutory provisions that provideauthority for any regulation that is in-cluded in that part.

(b) The agency may rely on any oneor more of the authorities that are list-ed for a particular part in imple-menting or enforcing any section inthat part.

(c) All citations of authority in thischapter will list the applicable sectionsin the organic statute if the statute isthe Federal Food, Drug, and CosmeticAct, the Public Health Service Act, orthe Fair Packaging and Labeling Act.

References to an act or a section there-of include references to amendments tothat act or section. These citationswill also list the corresponding UnitedStates Code (U.S.C.) sections. For ex-ample, a citation to section 701 of theFederal Food, Drug, and Cosmetic Actwould be listed: Sec. 701 of the FederalFood, Drug, and Cosmetic Act (21U.S.C. 371).

(d) If the organic statute is one otherthan those specified in paragraph (c) ofthis section, the citations of authorityin this chapter generally will list only

the applicable U.S.C. sections. For ex-ample, a citation to section 552 of theAdministrative Procedure Act would belisted: 5 U.S.C. 552. The agency may,where it determines that such meas-ures are in the interest of clarity andpublic understanding, list the applica-ble sections in the organic statute andthe corresponding U.S.C. section in thesame manner set out in paragraph (c)of this section. References to an act ora section thereof include references toamendments to that act or section.

(e) Where there is no U.S.C. provi-sion, the agency will include a citationto the U.S. Statutes at Large. Cita-tions to the U.S. Statutes at Large will

refer to volume and page.(f) The authority citations will in-

clude a citation to executive delega-tions (i.e., Executive Orders), if any,necessary to link the statutory author-ity to the agency.

[54 FR 39630, Sept. 27, 1989]

Subpart BGeneral LabelingRequirements

1.20 Presence of mandatory label in-formation.

The term package means any con-tainer or wrapping in which any food,drug, device, or cosmetic is enclosed

for use in the delivery or display ofsuch commodities to retail purchasers,but does not include:

(a) Shipping containers or wrappingsused solely for the transportation ofany such commodity in bulk or inquantity to manufacturers, packers,processors, or wholesale or retail dis-tributors;

(b) Shipping containers or outerwrappings used by retailers to ship or


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deliver any such commodity to retailcustomers if such containers and wrap-pings bear no printed matter per-taining to any particular commodity;or

(c) Containers subject to the provi-sions of the Act of August 3, 1912 (37Stat. 250, as amended; 15 U.S.C. 231233), the Act of March 4, 1915 (38 Stat.1186, as amended; 15 U.S.C. 234236), theAct of August 31, 1916 (39 Stat. 673, asamended; 15 U.S.C. 251256), or the Actof May 21, 1928 (45 Stat. 635, as amend-ed; 15 U.S.C. 257257i).

(d) Containers used for tray pack dis-plays in retail establishments.

(e) Transparent wrappers or con-tainers which do not bear written,printed, or graphic matter obscuringthe label information required by thispart.

A requirement contained in this partthat any word, statement, or other in-formation appear on the label shall notbe considered to be complied with un-less such word, statement, or informa-tion also appears on the outer con-tainer or wrapper of the retail packageof the article, or, as stated in para-graph (e) of this section, such informa-

tion is easily legible by virtue of thetransparency of the outer wrapper orcontainer. Where a consumer com-modity is marketed in a multiunit re-tail package bearing the mandatorylabel information as required by thispart and the unit containers are not in-tended to be sold separately, the netweight placement requirement of 101.105(f) applicable to such unit con-tainers is waived if the units are incompliance with all the other require-ments of this part.

[42 FR 15553, Mar. 22, 1977, as amended at 75FR 73953, Nov. 30, 2010]

1.21 Failure to reveal material facts.

(a) Labeling of a food, drug, device,cosmetic, or tobacco product shall bedeemed to be misleading if it fails toreveal facts that are:

(1) Material in light of other rep-resentations made or suggested bystatement, word, design, device or anycombination thereof; or

(2) Material with respect to con-sequences which may result from use ofthe article under: (i) The conditions

prescribed in such labeling or (ii) suchconditions of use as are customary orusual.

(b) Affirmative disclosure of materialfacts pursuant to paragraph (a) of thissection may be required, among otherappropriate regulatory procedures, by

(1) Regulations in this chapter pro-mulgated pursuant to section 701(a) ofthe act; or

(2) Direct court enforcement action.

(c) Paragraph (a) of this section doesnot:

(1) Permit a statement of differencesof opinion with respect to warnings (in-cluding contraindications, precautions,adverse reactions, and other informa-tion relating to possible product haz-ards) required in labeling for food,drugs, devices, cosmetics, or tobaccoproducts under the Federal Food, Drug,and Cosmetic Act.

(2) Permit a statement of differencesof opinion with respect to the effective-ness of a drug unless each of the opin-ions expressed is supported by substan-tial evidence of effectiveness as definedin sections 505(d) and 512(d) of the act.

[42 FR 15553, Mar. 22, 1977, as amended at 77FR 5176, Feb. 2, 2012]

1.23 Procedures for requesting vari-ations and exemptions from re-quired label statements.

Section 403(e) of the act (in this part1, the term act means the FederalFood, Drug, and Cosmetic Act) pro-vides for the establishment by regula-tion of reasonable variations and ex-emptions for small packages from therequired declaration of net quantity ofcontents. Section 403(i) of the act pro-vides for the establishment by regula-tion of exemptions from the requireddeclaration of ingredients where suchdeclaration is impracticable, or resultsin deception or unfair competition.

Section 502(b) of the act provides forthe establishment by regulation of rea-sonable variations and exemptions forsmall packages from the required dec-laration of net quantity of contents.Section 602(b) of the act provides forthe establishment by regulation of rea-sonable variations and exemptions forsmall packages from the required dec-laration of net quantity of contents.Section 5(b) of the Fair Packaging and


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Labeling Act provides for the establish-ment by regulation of exemptions fromcertain required declarations of netquantity of contents, identity of com-modity, identity and location of manu-facturer, packer, or distributor, andfrom declaration of net quantity ofservings represented, based on a find-ing that full compliance with such re-quired declarations is impracticable ornot necessary for the adequate protec-tion of consumers, and a further find-ing that the nature, form, or quantityof the packaged consumer commodity

or other good and sufficient reasonsjustify such exemptions. The Commis-sioner, on his own initiative or on peti-tion of an interested person, may pro-pose a variation or exemption basedupon any of the foregoing statutoryprovisions, including proposed findingsif section 5(b) of the Fair Packagingand Labeling Act applies, pursuant toparts 10, 12, 13, 14, 15, 16, and 19 of thischapter.

1.24 Exemptions from required labelstatements.

The following exemptions are grant-ed from label statements required bythis part:

(a) Foods. (1) While held for sale, afood shall be exempt from the requireddeclaration of net quantity of contentsspecified in this part if said food is re-ceived in bulk containers at a retail es-tablishment and is accurately weighed,measured, or counted either within theview of the purchaser or in compliancewith the purchasers order.

(2) Random food packages, as definedin 101.105(j) of this chapter, bearing la-bels declaring net weight, price perpound or per specified number ofpounds, and total price shall be exemptfrom the type size, dual declaration,and placement requirements of 101.105of this chapter if the accurate state-

ment of net weight is presented con-spicuously on the principal displaypanel of the package. In the case offood packed in random packages at oneplace for subsequent shipment and saleat another, the price sections of thelabel may be left blank provided theyare filled in by the seller prior to retailsale. This exemption shall also apply touniform weight packages of cheese andcheese products labeled in the same

manner and by the same type of equip-ment as random food packages exempt-ed by this paragraph (a)(2) except thatthe labels shall bear a declaration ofprice per pound and not price per speci-fied number of pounds.

(3) Individual serving-size packagesof foods containing less than 12 ounceor less than 12 fluid ounce for use inrestaurants, institutions, and pas-senger carriers, and not intended forsale at retail, shall be exempt from therequired declaration of net quantity ofcontents specified in this part.

(4) Individually wrapped pieces ofpenny candy and other confectionery ofless than one-half ounce net weight perindividual piece shall be exempt fromthe labeling requirements of this partwhen the container in which such con-fectionery is shipped is in conformancewith the labeling requirements of thispart. Similarly, when such confec-tionery items are sold in bags or boxes,such items shall be exempt from the la-beling requirements of this part, in-cluding the required declaration of netquantity of contents specified in thispart when the declaration on the bagor box meets the requirements of this

part.(5)(i) Soft drinks packaged in bottles

shall be exempt from the placement re-quirements for the statement of iden-tity prescribed by 101.3 (a) and (d) ofthis chapter if such statement appearsconspicuously on the bottle closure.When such soft drinks are marketed ina multiunit retail package, the multi-unit retail package shall be exemptfrom the statement of identity declara-tion requirements prescribed by 101.3of this chapter if the statement of iden-tity on the unit container is not ob-scured by the multiunit retail package.

(ii) A multiunit retail package forsoft drinks shall be exempt from the

declaration regarding name and placeof business required by 101.5 of thischapter if the package does not obscurethe declaration on unit containers or ifit bears a statement that the declara-tion can be found on the unit con-tainers and the declaration on the unitcontainers complies with 101.5 of thischapter. The declaration required by 101.5 of this chapter may appear onthe top or side of the closure of bottled


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soft drinks if the statement is con-spicuous and easily legible.

(iii) Soft drinks packaged in bottleswhich display other required label in-formation only on the closure shall beexempt from the placement require-ments for the declaration of contentsprescribed by 101.105(f) of this chapterif the required content declaration isblown, formed, or molded into the sur-face of the bottle in close proximity tothe closure.

(iv) Where a trademark on a softdrink package also serves as, or is, a

statement of identity, the use of suchtrademark on the package in lines notparallel to the base on which the pack-age rests shall be exempted from therequirement of 101.3(d) of this chapterthat the statement be in lines parallelto the base so long as there is also atleast one statement of identity in linesgenerally parallel to the base.

(v) A multiunit retail package forsoft drinks in cans shall be exemptfrom the declaration regarding nameand place of business required by 101.5of this chapter if the package does notobscure the declaration on unit con-tainers or if it bears a statement thatthe declaration can be found on the

unit containers and the declaration onthe unit containers complies with 101.5 of this chapter. The declarationrequired by 101.5 of this chapter mayappear on the top of soft drinks in cansif the statement is conspicuous andeasily legible, provided that when thedeclaration is embossed, it shall appearin type size at least one-eighth inch inheight, or if it is printed, the type sizeshall not be less than one-sixteenthinch in height. The declaration mayfollow the curvature of the lid of thecan and shall not be removed or ob-scured by the tab which opens the can.

(6)(i) Ice cream, french ice cream, icemilk, fruit sherbets, water ices, quies-

cently frozen confections (with or with-out dairy ingredients), special dietaryfrozen desserts, and products made insemblance of the foregoing, whenmeasured by and packaged in 12-liquidpint and 12-gallon measure-containers,as defined in the Measure ContainerCode of National Bureau of StandardsHandbook 44, Specifications, Toler-ances, and Other Technical Require-ments for Weighing and Measuring De-

vices, Sec. 4.45 Measure-Containers,which is incorporated by reference, areexempt from the requirements of 101.105(b)(2) of this chapter to the ex-tent that net contents of 8fluid ouncesand 64fluid ounces (or 2 quarts) maybe expressed as 12 pint and 12 gallon,respectively. Copies are available fromthe Center for Food Safety and AppliedNutrition (HFS150), Food and DrugAdministration, 5100 Paint BranchPkwy., College Park, MD 20740, or atthe National Archives and Records Ad-ministration (NARA). For information

on the availability of this material atNARA, call 2027416030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ibrllocations.html.

(ii) The foods named in paragraph(a)(6)(i) of this section, when measuredby and packaged in 1liquid pint, 1liq-uid quart, and 12-gallon measure-con-tainers, as defined in the MeasureContainer Code of National Bureau ofStandards Handbook 44, Specifica-tions, Tolerances, and Other TechnicalRequirements for Weighing and Meas-uring Devices, Sec. 4.45 Measure-Con-tainers, which is incorporated by ref-erence, are exempt from the dual net-

contents declaration requirement of 101.105(j) of this chapter. Copies areavailable from the Center for FoodSafety and Applied Nutrition (HFS150), Food and Drug Administration,5100 Paint Branch Pkwy., College Park,MD 20740, or at the National Archivesand Records Administration (NARA).For information on the availability ofthis material at NARA, call 2027416030, or go to: http://www.archives.gov/

federallregister/codeloflfederallregulations/ibrllocations.html.

(iii) The foods named in paragraph(a)(6)(i) of this section, when measuredby and packaged in 12-liquid pint, 1liq-

uid pint, 1liquid quart, 12-gallon, and1gallon measured-containers, as de-fined in the Measure Container Codeof National Bureau of Standards Hand-book 44, Specifications, Tolerances,and Other Technical Requirements forWeighing and Measuring Devices, Sec.4.45 Measure-Containers, which is in-corporated by reference, are exemptfrom the requirement of 101.105(f) ofthis chapter that the declaration of net


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contents be located within the bottom30 percent of the principal displaypanel. Copies are available from theCenter for Food Safety and Applied Nu-trition (HFS150), Food and Drug Ad-ministration, 5100 Paint Branch Pkwy.,College Park, MD 20740, or at the Na-tional Archives and Records Adminis-tration (NARA). For information onthe availability of this material atNARA, call 2027416030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ibrllocations.html.

(7)(i) Milk, cream, light cream, coffeeor table cream, whipping cream, lightwhipping cream, heavy or heavy whip-ping cream, sour or cultured sourcream, half-and-half, sour or culturedhalf-and-half, reconstituted or recom-bined milk and milk products, con-centrated milk and milk products,skim or skimmed milk, vitamin D milkand milk products, fortified milk andmilk products, homogenized milk, fla-vored milk and milk products, butter-milk, cultured buttermilk, culturedmilk or cultured whole buttermilk,low-fat milk (0.5 to 2.0 percent but-terfat), and acidified milk and milkproducts, when packaged in containers

of 8 and 64fluid-ounce capacity, areexempt from the requirements of 101.105(b)(2) of this chapter to the ex-tent that net contents of 8 fluid ouncesand 64 fluid ounces (or 2 quarts) may beexpressed as 12 pint and 12 gallon, re-spectively.

(ii) The products listed in paragraph(a)(7)(i) of this section, when packagedin glass or plastic containers of12-pint,1pint, 1quart, 12-gallon, and 1galloncapacities are exempt from the place-ment requirement of 101.105(f) of thischapter that the declaration of netcontents be located within the bottom30 percent of the principal displaypanel, provided that other required

label information is conspicuously dis-played on the cap or outside closureand the required net quantity of con-tents declaration is conspicuouslyblown, formed, or molded into or per-manently applied to that part of theglass or plastic container that is at orabove the shoulder of the container.

(iii) The products listed in paragraph(a)(7)(i) of this section, when packagedin containers of 1pint, 1quart, and 12-

gallon capacities are exempt from thedual net-contents declaration require-ment of 101.105(j) of this chapter.

(8) Wheat flour products, as definedby 137.105, 137.155, 137.160, 137.165,137.170, 137.175, 137.180, 137.185, 137.200,and 137.205 of this chapter, packaged:

(i) In conventional 2, 5, 10, 25, 50, and 100pound packages are exemptfrom the placement requirement of 101.105(f) of this chapter that the dec-laration of net contents be locatedwithin the bottom 30 percent of thearea of the principal display panel ofthe label; and

(ii) In conventional 2pound packagesare exempt from the dual net-contentsdeclaration requirement of 101.105(j)of this chapter provided the quantity ofcontents is expressed in pounds.

(9)(i) Twelve shell eggs packaged in acarton designed to hold 1 dozen eggsand designed to permit the division ofsuch carton by the retail customer atthe place of purchase into two portionsof one-half dozen eggs each are exemptfrom the labeling requirements of thispart with respect to each portion ofsuch divided carton if the carton, whenundivided, is in conformance with the

labeling requirements of this part.(ii) Twelve shell eggs packaged in a

carton designed to hold 1 dozen eggsare exempt from the placement re-quirements for the declaration of con-tents prescribed by 101.105(f) of thischapter if the required content declara-tion is otherwise placed on the prin-cipal display panel of such carton andif, in the case of such cartons designedto permit division by retail customersinto two portions of one-half dozeneggs each, the required content dec-laration is placed on the principal dis-play panel in such a manner that thecontext of the content declaration isdestroyed upon division of the carton.

(10) Butter as defined in 42 Stat. 1500(excluding whipped butter):

(i) In 8ounce and in 1pound pack-ages is exempt from the requirementsof 101.105(f) of this chapter that thenet contents declaration be placedwithin the bottom 30 percent of thearea of the principal display panel;

(ii) In 1pound packages is exemptfrom the requirements of 101.105(j)(1)of this chapter that such declaration be


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in terms of ounces and pounds, to per-mit declaration of 1pound or onepound; and

(iii) In 4ounce, 8ounce, and 1poundpackages with continuous label copywrapping is exempt from the require-ments of 101.3 and 101.105(f) of thischapter that the statement of identityand net contents declaration appear inlines generally parallel to the base onwhich the package rests as it is de-signed to be displayed, provided thatsuch statement and declaration are notso positioned on the label as to be mis-

leading or difficult to read as the pack-age is customarily displayed at retail.

(11) Margarine as defined in 166.110of this chapter and imitations thereofin 1pound rectangular packages, ex-cept for packages containing whippedor soft margarine or packages thatcontain more than four sticks, are ex-empt from the requirement of 101.105(f) of this chapter that the dec-laration of the net quantity of contentsappear within the bottom 30 percent ofthe principal display panel and fromthe requirement of 101.105(j)(1) of thischapter that such declaration be ex-pressed both in ounces and in pounds topermit declaration of 1-pound or

one pound, provided an accuratestatement of net weight appears con-spicuously on the principal displaypanel of the package.

(12) Corn flour and related products,as they are defined by 137.211, 137.215,and 137.230 through 137.290 of thischapter, packaged in conventional 5,10, 25, 50, and 100pound bags are ex-empt from the placement requirementof 101.105(f) of this chapter that thedeclaration of net contents be locatedwithin the bottom 30 percent of thearea of the principal display panel ofthe label.

(13)(i) Single strength and less thansingle strength fruit juice beverages,

imitations thereof, and drinking waterwhen packaged in glass or plastic con-tainers of 12-pint, 1pint, 1quart, 12-gallon, and 1gallon capacities are ex-empt from the placement requirementof 101.105(f) of this chapter that thedeclaration of net contents be locatedwithin the bottom 30 percent of theprincipal display panel: Provided, Thatother required label information isconspicuously displayed on the cap or

outside closure and the required netquantity of contents declaration isconspicuously blown, formed, or mold-ed into or permanently applied to thatpart of the glass or plastic containerthat is at or above the shoulder of thecontainer.

(ii) Single strength and less than sin-gle strength fruit juice beverages, imi-tations thereof, and drinking waterwhen packaged in glass, plastic, orpaper (fluid milk type) containers of 1pint, 1quart, and 12-gallon capacitiesare exempt from the dual net-contents

declaration requirement of 101.105(j)of this chapter.

(iii) Single strength and less thansingle strength fruit juice beverages,imitations thereof, and drinking waterwhen packaged in glass, plastic, orpaper (fluid milk type) containers of 8and 64fluid-ounce capacity, are ex-empt from the requirements of 101.105(b)(2) of this chapter to the ex-tent that net contents of 8 fluid ouncesand 64 fluid ounces (or 2 quarts) may beexpressed as 12 pint (or half pint) and 12gallon (or half gallon), respectively.

(14) The unit containers in a multi-unit or multicomponent retail foodpackage shall be exempt from regula-

tions of section 403 (e)(1), (g)(2), (i)(2),(k), and (q) of the act with respect tothe requirements for label declarationof the name and place of business ofthe manufacturer, packer, or dis-tributor; label declaration of ingredi-ents; and nutrition information when:

(i) The multiunit or multicomponentretail food package labeling meets allthe requirements of this part;

(ii) The unit containers are securelyenclosed within and not intended to beseparated from the retail packageunder conditions of retail sale; and

(iii) Each unit container is labeledwith the statement This Unit Not La-beled For Retail Sale in type size not

less than one-sixteenth of an inch inheight. The word Individual may beused in lieu of or immediately pre-ceding the word Retail in the state-ment.

(b) Drugs. Liquid over-the-counterveterinary preparations intended forinjection shall be exempt from the dec-laration of net quantity of contents interms of the U.S. gallon of 231 cubicinches and quart, pint, and fluid-ounce


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subdivisions thereof as required by 201.62 (b), (i), and (j) of this chapter,and from the dual declaration require-ments of 201.62(i) of this chapter, ifsuch declaration of net quantity ofcontents is expressed in terms of theliter and milliliter, or cubic centi-meter, with the volume expressed at 68F (20 C).

(c) Cosmetics. Cosmetics in packagescontaining less than one-fourth ounceavoirdupois or one-eighth fluid ounceshall be exempt from compliance withthe requirements of section 602(b)(2) of

the Federal Food, Drug, and CosmeticAct and section 4(a)(2) of the FairPackaging and Labeling Act:

(1) When such cosmetics are affixedto a display card labeled in conform-ance with all labeling requirements ofthis part; or

(2) When such cosmetics are sold atretail as part of a cosmetic packageconsisting of an inner and outer con-tainer and the inner container is notfor separate retail sale and the outercontainer is labeled in conformancewith all labeling requirements of thispart.

[42 FR 15553, Mar. 22, 1977, as amended at 47

FR 946, Jan. 8, 1982; 47 FR 32421, July 27, 1982;49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3,1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr.2, 1996; 66 FR 56035, Nov. 6, 2001]

Subparts CD [Reserved]

Subpart EImports and Exports

1.83 Definitions.

For the purposes of regulations pre-scribed under section 801(a), (b), and (c)of the Federal Food, Drug, and Cos-metic Act:

(a) The term owner or consigneemeans the person who has the rights ofa consignee under the provisions of sec-

tions 483, 484, and 485 of the Tariff Actof 1930, as amended (19 U.S.C. 1483, 1484,1485).

(b) The term district director meansthe director of the district of the Foodand Drug Administration having juris-diction over the port of entry throughwhich an article is imported or offeredfor import, or such officer of the dis-trict as he may designate to act in hisbehalf in administering and enforcing

the provisions of section 801 (a), (b),and (c).

1.90 Notice of sampling.

When a sample of an article offeredfor import has been requested by thedistrict director, the collector of cus-toms having jurisdiction over the arti-cle shall give to the owner or consigneeprompt notice of delivery of, or inten-tion to deliver, such sample. Upon re-ceipt of the notice, the owner or con-signee shall hold such article and notdistribute it until further notice from

the district director or the collector ofcustoms of the results of examinationof the sample.

1.91 Payment for samples.

The Food and Drug Administrationwill pay for all import samples whichare found to be in compliance with therequirements of the Federal Food,Drug, and Cosmetic Act. Billing for re-imbursement should be made by theowner or consignee to the Food andDrug Administration district head-quarters in whose territory the ship-ment was offered for import. Paymentfor samples will not be made if the ar-ticle is found to be in violation of the

act, even though subsequently broughtinto compliance under the terms of anauthorization to bring the article intocompliance or rendered not a food,drug, device, or cosmetic as set forth in 1.95.

1.94 Hearing on refusal of admission.

(a) If it appears that the article maybe subject to refusal of admission, thedistrict director shall give the owner orconsignee a written notice to that ef-fect, stating the reasons therefor. Thenotice shall specify a place and a pe-riod of time during which the owner orconsignee shall have an opportunity tointroduce testimony. Upon timely re-

quest giving reasonable grounds there-for, such time and place may bechanged. Such testimony shall be con-fined to matters relevant to the admis-sibility of the article, and may be in-troduced orally or in writing.

(b) If such owner or consignee sub-mits or indicates his intention to sub-mit an application for authorization torelabel or perform other action tobring the article into compliance with


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the act or to render it other than afood, drug, device, or cosmetic, suchtestimony shall include evidence insupport of such application. If such ap-plication is not submitted at or priorto the hearing, the district directorshall specify a time limit, reasonablein the light of the circumstances, forfiling such application.

1.95 Application for authorization torelabel and recondition.

Application for authorization torelabel or perform other action to

bring the article into compliance withthe act or to render it other than afood, drug, device or cosmetic may befiled only by the owner or consignee,and shall:

(a) Contain detailed proposals forbringing the article into compliancewith the act or rendering it other thana food, drug, device, or cosmetic.

(b) Specify the time and place wheresuch operations will be carried out andthe approximate time for their comple-tion.

1.96 Granting of authorization torelabel and recondition.

(a) When authorization contemplated

by 1.95 is granted, the district directorshall notify the applicant in writing,specifying:

(1) The procedure to be followed;(2) The disposition of the rejected ar-

ticles or portions thereof;(3) That the operations are to be car-

ried out under the supervision of an of-ficer of the Food and Drug Administra-tion or the U.S. Customs Service, asthe case may be;

(4) A time limit, reasonable in thelight of the circumstances, for comple-tion of the operations; and

(5) Such other conditions as are nec-essary to maintain adequate super-vision and control over the article.

(b) Upon receipt of a written requestfor extension of time to complete suchoperations, containing reasonablegrounds therefor, the district directormay grant such additional time as hedeems necessary.

(c) An authorization may be amendedupon a showing of reasonable groundstherefor and the filing of an amendedapplication for authorization with thedistrict director.

(d) If ownership of an article coveredby an authorization changes before theoperations specified in the authoriza-tion have been completed, the originalowner will be held responsible, unlessthe new owner has executed a bond andobtained a new authorization. Any au-thorization granted under this sectionshall supersede and nullify any pre-viously granted authorization with re-spect to the article.

[42 FR 15553, Mar. 22, 1977, as amended at 54FR 9033, Mar. 3, 1989]

1 .97 Bonds.

(a) The bonds required under section801(b) of the act may be executed bythe owner or consignee on the appro-priate form of a customs single-entryor term bond, containing a conditionfor the redelivery of the merchandiseor any part thereof upon demand of thecollector of customs and containing aprovision for the performance of condi-tions as may legally be imposed for therelabeling or other action necessary tobring the article into compliance withthe act or rendering it other than afood, drug, device, or cosmetic, in suchmanner as is prescribed for such bond

in the customs regulations in force onthe date of request for authorization.The bond shall be filed with the col-lector of customs.

(b) The collector of customs may can-cel the liability for liquidated damagesincurred under the above-mentionedprovisions of such a bond, if he receivesan application for relief therefrom,upon the payment of a lesser amountor upon such other terms and condi-tions as shall be deemed appropriateunder the law and in view of the cir-cumstances, but the collector shall notact under this regulation in any caseunless the district director is in fullagreement with the action.

1.99 Costs chargeable in connectionwith relabeling and reconditioninginadmissible imports.

The cost of supervising the relabelingor other action in connection with animport of food, drugs, devices, or cos-metics which fails to comply with theFederal Food, Drug, and Cosmetic Actshall be paid by the owner or consigneewho files an application requesting


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such action and executes a bond, pursu-ant to section 801(b) of the act, asamended. The cost of such supervisionshall include, but not be restricted to,the following:

(a) Travel expenses of the supervisingofficer.

(b) Per diem in lieu of subsistence ofthe supervising officer when away fromhis home station, as provided by law.

(c) The charge for the services of thesupervising officer, which shall includeadministrative support, shall be com-puted at a rate per hour equal to 266percent of the hourly rate of regularpay of a grade GS11/4 employee, exceptthat such services performed by a cus-toms officer and subject to the provi-sions of the act of February 13, 1911, asamended (sec. 5, 36 Stat. 901, as amend-ed (19 U.S.C. 267)), shall be calculatedas provided in that act.

(d) The charge for the service of theanalyst, which shall include adminis-trative and laboratory support, shall becomputed at a rate per hour equal to266 percent of the hourly rate of reg-ular pay of a grade GS12/4 employee.The rate per hour equal to 266 percentof the equivalent hourly rate of regularpay of the supervising officer (GS11/4)and the analyst (GS12/4) is computedas follows:

Hours

Gross number of working hours in 52 40hr weeks 2,080

Less:

9 legal public holidaysNew Years Day, Wash-ingtons Birthday, Memorial Day, Independ-ence Day, Labor Day, Columbus Day, Vet-erans Day, Thanksgiving Day, and ChristmasDay .................................................................. 72

Annual leave26 d ............................................ 208

Sick leave13 d ................................................ 104

Total ..................................................... 384

Net number of working hours .............. 1,696

Gross number of working hours in 52 40-hr weeks .. 2,080

Working hour equivalent of Government contribu-tions for employee retirement, life insurance, and

health benefits computed at 81

2 pct. of annualrate of pay of employee ......................................... 176

Equivalent annual working hours ......... 2,256

Support required to equal to 1 man-year .................. 2,256

Equivalent gross annual working hourscharged to Food and Drug appro-priation .............................................. 4,512

NOTE: Ratio of equivalent gross annualnumber of working hours charged to Foodand Drug appropriation to net number of an-nual working hours 4,512/1,696=266 pct.

(e) The minimum charge for servicesof supervising officers and of analystsshall be not less than the charge for 1hour, and time after the first hourshall be computed in multiples of 1hour, disregarding fractional parts lessthan 12 hour.

1.101 Notification and recordkeeping.

(a) Scope. This section pertains to no-tifications and records required forhuman drug, biological product, device,animal drug, food, cosmetic, and to-bacco product exports under sections

801 or 802 of the Federal Food, Drug,and Cosmetic Act or (21 U.S.C. 381 and382) or section 351 of the Public HealthService Act (42 U.S.C. 262).

(b) Recordkeeping requirements forhuman drugs, biological products, devices,animal drugs, foods, cosmetics, and to-bacco products exported under or subjectto section 801(e)(1) of the Federal Food,Drug, and Cosmetic Act. Persons export-ing an article under section 801(e)(1) ofthe act or an article otherwise subjectto section 801(e)(1) of the act shallmaintain records as enumerated inparagraphs (b)(1) through (b)(4) of thissection demonstrating that the productmeets the requirements of section

801(e)(1) of the act. Such records shallbe maintained for the same period oftime as required for records subject togood manufacturing practice or qualitysystems regulations applicable to theproduct, except that records pertainingto the export of foods and cosmeticsunder section 801(e)(1) of the act shallbe kept for 3 years after the date of ex-portation. The records shall be madeavailable to the Food and Drug Admin-istration (FDA), upon request, duringan inspection for review and copyingby FDA.

(1) Records demonstrating that theproduct meets the foreign purchasersspecifications: The records must con-

tain sufficient information to matchthe foreign purchasers specificationsto a particular export;

(2) Records demonstrating that theproduct does not conflict with the lawsof the importing country: This mayconsist of either a letter from an ap-propriate foreign government agency,department, or other authorized bodystating that the product has marketingapproval from the foreign government


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21 CFR Ch. I (4113 Edition) 1.101

or does not conflict with that countryslaws, or a notarized certification by aresponsible company official in theUnited States that the product doesnot conflict with the laws of the im-porting country and that includes astatement acknowledging that he orshe is subject to the provisions of 18U.S.C. 1001;

(3) Records demonstrating that theproduct is labeled on the outside of theshipping package that it is intended forexport: This may consist of copies ofany labels or labeling statements, such

as For export only, that are placedon the shipping packages or, if the ex-ported product does not have a ship-ping package or container, on shippinginvoices or other documents accom-panying the exported product; and

(4) Records demonstrating that theproduct is not sold or offered for sale inthe United States: This may consist ofproduction and shipping records for theexported product and promotional ma-terials.

(c) Additional recordkeeping require-ments for partially processed biological

products exported under section 351(h) ofthe Public Health Service Act. In addi-tion to the requirements in paragraph

(b) of this section, persons exporting apartially processed biological productunder section 351(h) of the PublicHealth Service Act shall maintain, forthe same period of time as required forrecords subject to good manufacturingpractice or quality systems regulationsapplicable to the product, and makeavailable to FDA, upon request, duringan inspection for review and copyingby FDA, the following records:

(1) Records demonstrating that theproduct for export is a partially proc-essed biological product and not in aform applicable to the prevention,treatment, or cure of diseases or inju-ries of man;

(2) Records demonstrating that thepartially processed biological productwas manufactured in conformity withcurrent good manufacturing practicerequirements;

(3) Records demonstrating the dis-tribution of the exported partiallyprocessed biological products; and

(4) Copies of all labeling that accom-panies the exported partially processedbiological product and other records

demonstrating that the exported par-tially processed biological product isintended for further manufacture intoa final dosage form outside the UnitedStates; this may include a containerlabel with the statement, Caution:For Further Manufacturing Use Onlyand any package insert.

(d) Notification requirements for drugs,biological products, and devices exportedunder section 802 of the act. (1) Personsexporting a human drug, biologicalproduct, or device under section 802 ofthe act, other than a drug, biologicalproduct, or device for investigationaluse exported under section 802(c) of theact, or a drug, biological product, ordevice exported in anticipation of mar-keting authorization under section802(d) of the act, shall provide writtennotification to FDA. The notificationshall identify:

(i) The products trade name;

(ii) If the product is a drug or biologi-cal product, the products abbreviatedor proper name or, if the product is adevice, the type of device;

(iii) If the product is a drug or bio-logical product, a description of theproducts strength and dosage form or,

if the product is a device, the productsmodel number; and

(iv) If the export is to a country notlisted in section 802(b)(1) of the act, thecountry that is to receive the exportedarticle. The notification may, but isnot required to, identify countries list-ed in section 802(b)(1) of the act orstate that the export is intended for alisted country without identifying thelisted country.

(2) The notification shall be sent tothe following addresses:

(i) For biological products and de-vices regulated by the Center for Bio-logics Evaluation and ResearchDivi-sion of Case Management (HFM610),

Office of Compliance and BiologicsQuality, Center for Biologics Evalua-tion and Research, Food and Drug Ad-ministration, 1401 Rockville Pike, suite200N, Rockville, MD 208521448.

(ii) For human drug products, bio-logical products, and devices regulatedby the Center for Drug Evaluation andResearchDivision of New Drugs andLabeling Compliance, Center for DrugEvaluation and Research, Food and


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Drug Administration, 10903 New Hamp-

shire Ave., Silver Spring, MD 20993

0002.

(iii) For devicesFood and Drug Ad-

ministration, Center for Devices and

Radiological Health, Division of Pro-

gram Operations, 10903 New Hampshire

Ave., Bldg. 66, rm. 5429, Silver Spring,

MD 209930002.

(e) Recordkeeping requirements for

products subject to section 802(g) of the

act. (1) Any person exporting a product

under any provision of section 802 of

the act shall maintain records of alldrugs, biological products, and devices

exported and the countries to which

the products were exported. In addition

to the requirements in paragraph (b) of

this section, such records include, but

are not limited to, the following:

(i) The products trade name;

(ii) If the product is a drug or biologi-

cal product, the products abbreviated

or proper name or, if the product is a

device, the type of device;

(iii) If the product is a drug or bio-

logical product, a description of its

strength and dosage form and the prod-

ucts lot or control number or, if the

product is a device, the productsmodel number;

(iv) The consignees name and ad-

dress; and

(v) The date on which the product

was exported and the quantity of prod-

uct exported.

(2) These records shall be kept at the

site from which the products were ex-

ported or manufactured, and be main-

tained for the same period of time as

required for records subject to good

manufacturing practice or quality sys-

tems regulations applicable to the

product. The records shall be made

available to FDA, upon request, during

an inspection for review and copyingby FDA.

[66 FR 65447, Dec. 19, 2001, as amended at 69

FR 48774, Aug. 11, 2004; 70 FR 14980, Mar. 24,

2005; 74 FR 13112, Mar. 26, 2009; 75 FR 20914,

Apr. 22, 2010; 77 FR 5176, Feb. 2, 2012]

Subparts FG [Reserved]

Subpart HRegistration of FoodFacilities

SOURCE: 68 FR 58960, Oct. 10, 2003, unlessotherwise noted.

GENERAL PROVISIONS

1.225 Who must register under thissubpart?

(a) You must register your facilityunder this subpart if you are theowner, operator, or agent in charge of

either a domestic or foreign facility, asdefined in this subpart, and your facil-ity is engaged in the manufacturing/processing, packing, or holding of foodfor consumption in the United States,unless your facility qualifies for one ofthe exemptions in 1.226.

(b) If you are an owner, operator, oragent in charge of a domestic facility,you must register your facility wheth-er or not the food from the facility en-ters interstate commerce.

(c) If you are the owner, operator, oragent in charge of a facility, you mayauthorize an individual to registeryour facility on your behalf.

1.226 Who does not have to registerunder this subpart?

This subpart does not apply to thefollowing facilities:

(a) A foreign facility, if food fromsuch facility undergoes further manu-facturing/processing (including pack-aging) by another facility outside theUnited States. A facility is not exemptunder this provision if the further man-ufacturing/processing (including pack-aging) conducted by the subsequent fa-cility consists of adding labeling or anysimilar activity of a de minimis nature;

(b) Farms;

(c) Retail food establishments;

(d) Restaurants;

(e) Nonprofit food establishments inwhich food is prepared for, or served di-rectly to, the consumer;

(f) Fishing vessels, including thosethat not only harvest and transportfish but also engage in practices suchas heading, eviscerating, or freezing in-tended solely to prepare fish for hold-ing on board a harvest vessel. However,those fishing vessels otherwise engagedin processing fish are subject to this


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21 CFR Ch. I (4113 Edition) 1.227

subpart. For the purposes of this sec-tion, processing means handling,storing, preparing, shucking, changinginto different market forms, manufac-turing, preserving, packing, labeling,dockside unloading, holding, or head-ing, eviscerating, or freezing otherthan solely to prepare fish for holdingon board a harvest vessel;

(g) Facilities that are regulated ex-clusively, throughout the entire facil-ity, by the U.S. Department of Agri-culture under the Federal Meat Inspec-tion Act (21 U.S.C. 601 et seq.), the Poul-

try Products Inspection Act (21 U.S.C.451 et seq.), or the Egg Products Inspec-tion Act (21 U.S.C. 1031 et seq.);

1.227 What definitions apply to thissubpart?

(a) The act means the Federal Food,Drug, and Cosmetic Act.

(b) In addition, for the purposes ofthis subpart:

(1) Calendar day means every dayshown on the calendar.

(2) Facility means any establishment,structure, or structures under one own-ership at one general physical location,or, in the case of a mobile facility,traveling to multiple locations, that

manufactures/processes, packs, orholds food for consumption in theUnited States. Transport vehicles arenot facilities if they hold food only inthe usual course of business as carriers.A facility may consist of one or morecontiguous structures, and a singlebuilding may house more than one dis-tinct facility if the facilities are underseparate ownership. The private resi-dence of an individual is not a facility.Nonbottled water drinking water col-lection and distribution establishmentsand their structures are not facilities.

(i) Domestic facility means any facilitylocated in any State or Territory of theUnited States, the District of Colum-

bia, or the Commonwealth of PuertoRico that manufactures/processes,packs, or holds food for consumption inthe United States.

(ii) Foreign facility means a facilityother than a domestic facility thatmanufactures/processes, packs, orholds food for consumption in theUnited States.

(3) Farm means a facility in one gen-eral physical location devoted to the

growing and harvesting of crops, theraising of animals (including seafood),or both. Washing, trimming of outerleaves of, and cooling produce are con-sidered part of harvesting. The termfarm includes:

(i) Facilities that pack or hold food,provided that all food used in such ac-tivities is grown, raised, or consumedon that farm or another farm under thesame ownership; and

(ii) Facilities that manufacture/proc-ess food, provided that all food used insuch activities is consumed on that

farm or another farm under the sameownership.

(4) Food has the meaning given insection 201(f) of the act (21 U.S.C.321(f)),

(i) Except for purposes of this sub-part, it does not include:

(A) Food contact substances as de-fined in section 409(h)(6) of the act (21U.S.C. 348(h)(6)), or

(B) Pesticides as defined in 7 U.S.C.136(u).

(ii) Examples of food include fruits,vegetables, fish, dairy products, eggs,raw agricultural commodities for useas food or as components of food, ani-mal feed (including pet food), food and

feed ingredients, food and feed addi-tives, dietary supplements and dietaryingredients, infant formula, beverages(including alcoholic beverages and bot-tled water), live food animals, bakerygoods, snack foods, candy, and cannedfoods.

(5) Holding means storage of food.Holding facilities include warehouses,cold storage facilities, storage silos,grain elevators, and liquid storagetanks.

(6) Manufacturing/processing meansmaking food from one or more ingredi-ents, or synthesizing, preparing, treat-ing, modifying or manipulating food,including food crops or ingredients. Ex-

amples of manufacturing/processing ac-tivities are cutting, peeling, trimming,washing, waxing, eviscerating, ren-dering, cooking, baking, freezing, cool-ing, pasteurizing, homogenizing, mix-ing, formulating, bottling, milling,grinding, extracting juice, distilling,labeling, or packaging.

(7) Nonprofit food establishment meansa charitable entity that prepares orserves food directly to the consumer or


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otherwise provides food or meals forconsumption by humans or animals inthe United States. The term includescentral food banks, soup kitchens, andnonprofit food delivery services. To beconsidered a nonprofit food establish-ment, the establishment must meet theterms of section 501(c)(3) of the U.S. In-ternal Revenue Code (26 U.S.C.501(c)(3)).

(8) Packaging (when used as a verb)means placing food into a containerthat directly contacts the food andthat the consumer receives.

(9) Packing means placing food into acontainer other than packaging thefood.

(10) Restaurant means a facility thatprepares and sells food directly to con-sumers for immediate consumption.Restaurant does not include facili-ties that provide food to interstateconveyances, central kitchens, andother similar facilities that do not pre-pare and serve food directly to con-sumers.

(i) Entities in which food is providedto humans, such as cafeterias,lunchrooms, cafes, bistros, fast food es-tablishments, food stands, saloons, tav-

erns, bars, lounges, catering facilities,hospital kitchens, day care kitchens,and nursing home kitchens are res-taurants; and

(ii) Pet shelters, kennels, and veteri-nary facilities in which food is pro-vided to animals are restaurants.

(11) Retail food establishment means anestablishment that sells food productsdirectly to consumers as its primaryfunction. A retail food establishmentmay manufacture/process, pack, orhold food if the establishments pri-mary function is to sell from that es-tablishment food, including food thatit manufactures/processes, packs, orholds, directly to consumers. A retail

food establishments primary functionis to sell food directly to consumers ifthe annual monetary value of sales offood products directly to consumers ex-ceeds the annual monetary value ofsales of food products to all other buy-ers. The term consumers does not in-clude businesses. A retail food estab-lishment includes grocery stores, con-venience stores, and vending machinelocations.

(12) Trade name means the name ornames under which the facility con-ducts business, or additional names bywhich the facility is known. A tradename is associated with a facility, anda brand name is associated with a prod-uct.

(13) U.S. agent means a person (as de-fined in section 201(e) of the act (21U.S.C. 321(e))) residing or maintaininga place of business in the United Stateswhom a foreign facility designates asits agent for purposes of this subpart. AU.S. agent cannot be in the form of amailbox, answering machine or service,or other place where an individual act-ing as the foreign facilitys agent is notphysically present.

(i) The U.S. agent acts as a commu-nications link between FDA and theforeign facility for both emergency androutine communications. The U.S.agent will be the person FDA contactswhen an emergency occurs, unless theregistration specifies under 1.233(e)another emergency contact.

(ii) FDA will treat representations bythe U.S. agent as those of the foreignfacility, and will consider informationor documents provided to the U.S.

agent the equivalent of providing theinformation or documents to the for-eign facility.

(iii) Having a single U.S. agent forthe purposes of this subpart does notpreclude facilities from having mul-tiple agents (such as foreign suppliers)for other business purposes. A firmscommercial business in the UnitedStates need not be conducted throughthe U.S. agent designated for purposesof this subpart.

(14) You or registrant means theowner, operator, or agent in charge ofa facility that manufactures/processes,packs, or holds food for consumption inthe United States.

PROCEDURES FOR REGISTRATION OF FOODFACILITIES

1.230 When must you register?

The owner, operator, or agent incharge of a facility that manufactures/processes, packs or holds food for con-sumption in the United States mustregister the facility no later than De-cember 12, 2003. The owner, operator, or


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21 CFR Ch. I (4113 Edition) 1.231

agent in charge of a facility that be-gins to manufacture/process, pack, orhold food for consumption in theUnited States on or after December 12,2003, must register before the facilitybegins such activities. An owner, oper-ator, or agent in charge of a facilitymay authorize an individual to registerthe facility on its behalf.

1.231 How and where do you reg-ister?

(a) Electronic registration. (1) To reg-ister electronically, you must register

at http://www.fda.gov/furls, which isavailable for registration 24 hours aday, 7 days a week. This website isavailable from wherever the Internet isaccessible, including libraries, copycenters, schools, and Internet cafes. Anindividual authorized by the owner, op-erator, or agent in charge of a facilitymay also register a facility electroni-cally.

(2) FDA strongly encourages elec-tronic registration for the benefit ofboth FDA and the registrant.

(3) Once you complete your elec-tronic registration, FDA will auto-matically provide you with an elec-tronic confirmation of registration and

a permanent registration number.(4) You will be considered registered

once FDA electronically transmitsyour confirmation and registrationnumber.

(b) Registration by mail or fax. If, forexample, you do not have reasonableaccess to the Internet through any ofthe methods described in paragraph (a)of this section, you may register bymail or fax.

(1) You must register using Form3537. You may obtain a copy of thisform by writing to the U.S. Food andDrug Administration (HFS681), 5600Fishers Lane, Rockville, MD 20857 orby requesting a copy of this form by

phone at 18002167331 or 3015750156.(2) When you receive the form, you

must fill it out completely and legiblyand either mail it to the address inparagraph (b)(1) of this section or fax itto 3014362804 or 18005730846.

(3) If any required information on theform is incomplete or illegible whenFDA receives it, FDA will return theform to you for revision, provided thatyour mailing address or fax number is

legible and valid. When returning aregistration form for revision, FDAwill use the means by which the formwas received by the agency (i.e., bymail or fax).

(4) FDA will enter complete and leg-ible mailed and faxed registration sub-missions into its registration system,along with CD-ROM submissions, assoon as practicable, in the order FDAreceives them.

(5) FDA will then mail to the addressor fax to the fax number on the reg-istration form a copy of the registra-tion as entered, confirmation of reg-istration, and your registration num-ber. When responding to a registrationsubmission, FDA will use the means bywhich the registration was received bythe agency (i.e., by mail or fax).

(6) If any information you previouslysubmitted was incorrect at the time ofsubmission, you must immediately up-date your facilitys registration asspecified in 1.234.

(7) Your facility is considered reg-istered once FDA enters your facilitysregistration data into the registrationsystem and the system generates a reg-istration number.

(c) Registration by CD-ROM for mul-tiple submissions. If, for example, you donot have reasonable access to theInternet through any of the methodsprovided under paragraph (a) of thissection, you may register by CD-ROM.

(1) Registrants submitting their reg-istrations in CD-ROM format must useISO 9660 (CD-R or CD-RW) data format.

(2) These files must be submitted ona portable document format (PDF) ren-dition of the registration form (Form3537) and be accompanied by one signedcopy of the certification statementthat appears on the registration form(Form 3537).

(3) Each submission on the CD-ROM

must contain the same preferred mail-ing address in the appropriate block onForm 3537.

(4) A CD-ROM may contain registra-tions for as many facilities as neededup to the CD-ROMs capacity.

(5) The registration on the CD-ROMfor each separate facility must have aunique file name up to 32 characterslong, the first part of which may beused to identify the parent company.


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(6) You must mail the CD-ROM to theU.S. Food and Drug Administration(HFS681), 5600 Fishers Lane, Rock-ville, MD 20857.

(7) If FDA receives a CD-ROM thatdoes not comply with these specifica-tions, it will return the CD-ROM to thesubmitter unprocessed.

(8) FDA will enter CD-ROM submis-sions that comply with these specifica-tions into its registration system,along with the complete and legiblemailed and faxed submissions, as soonas practicable, in the order FDA re-

ceives them.(9) For each facility on the CD-ROM,

FDA will mail to the preferred mailingaddress a copy of the registration(s) asentered, confirmation of registration,and each fac