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FEDERAL REGISTER $25.00 domestic; 36.00 foreign ($2.50 monthly)

CODE OF FEDERAL REGULATIONS $195.00 domestic; $245.00 foreign

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Title 21—Food and Drugs

(This book contains Parts 1 to 119)

Part

CHAPTER 1— Food and Drug Administration, Department of Health, Educa

tion, and Welfare

1

CROSS REFERENCES: Federal Trade Commission: See Commercial Practices, 16 CFR

Chapter I. Bureau of Customs, Department of the Treasury: See Customs Duties, 19 CFR Chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR

Chapter I. Intoxicating Liquors, 27 CFR Chapter I.

CHAPTER FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH, EDUCATION,

AND WELFARE

(Parts 1 to 119)

SUBCHAPTER A-GENERAL

Part 1

2 3 4 5 8 9

Regulations for the enforcement of the Federal Food, Drug, and Cosmetic

Act and the Fair Packaging and Labeling Act.
Administrative functions, practices, and procedures.
Statements of general policy or interpretation.
Official records and information.
Food; exemptions from labeling requirements.
Color additives.
Color certification.

SUBCHAPTER B-FOOD AND FOOD PRODUCTS

10 Definitions and standards for food.
14 Cacao products.
15 Cereal flours and related products.
16 Macaroni and noodle products.
17

Bakery products. 18 Milk and cream. 19 Cheeses, processed cheeses, cheese foods, cheese spreads, and related foods. 20 Frozen desserts. 22 Food flavorings. 25 Dressings for food. 27 Canned fruits and fruit juices. 28 Fruit pies. 29 Fruit butters, fruit jellies, fruit preserves, and related products. 31 Nonalcoholic beverages. 36 Shellfish. 37 Fish. 42 Eggs and egg products. 45 Oleomargarine, margarine. 46 Nut products. 51 Canned vegetables. 53 Tomato products. 85 Seafood inspection. 86–119 [Reserved]

SUBCHAPTER A-GENERAL

PART 1-REGULATIONS FOR THE EN- Sec.

1.102b Drugs and devices in package form; FORCEMENT OF THE FEDERAL

labeling re name and place of busiFOOD, DRUG, AND COSMETIC ACT

ness of manufacturer, packer, or AND THE FAIR PACKAGING AND

distributor. LABELING ACT

1.102c Prescription and insulin-containing

drugs in package form; labeling re GENERAL

declaration of net quantity of conSec.

tents. 1.1 General.

1.102d Over-the-counter drugs and devices in 1.18 Foods, drugs, devices, and cosmetics;

package form; labeling re declaralabeling; procedure for requesting

tion of net quantity of contents. variations and exemptions from re

1.109 Drugs and devices; forms of making quired label statements.

required statements. 1.1b Packages; definition; presence of man

1.104 Drugs; statement of ingredients. datory label information.

1.106 Prescription-drug advertisements. 1.1c Exemptions from required label state- 1.106 Drugs and devices; directions for use. ments.

1.107 Drugs and devices; exemptions. 1.1d "Cents-off," coupon, or other savings

1.108 Drugs and devices; statement of pol. representations.

loy re Spanish-language versions of 1.1e Package size savings.

required labeling statements.

1.109 Drugs; statement of required warning DEFINITIONS

on controlled substances listed in 1.2 Labeling; label; definitions.

schedule II, III, or IV or Federal 1.8 Difference of opinion among experts.

Controlled Substances Act.
PROHIBITED ACTS AND PENALTIES

1.110 Definition of emergency situation.

1.116 Definition of term "insulin." 1.4 Guaranty.

COSMETICS 1.5 Guaranty; definition, and suggested forms.

1.201 Cosmetic; labeling; misbranding. 1.6 Presentation of views under section

1.2012 Cosmetics in package form; principal 806 of the act.

display panel.

1.20€ Cosmetics in package form; labeling FOOD

re identity. 1.7 Food in package form; principal dis

1.202a Cosmetics in package form; labeling play panel.

re name and place of business of 1.8 Food in package form, labeling; iden

manufacturer, packer, or distri'). tity.

utor. 1.8a Food labeling, name and place of busi

1.202b Cosmetics in package form; labeling ness of manufacturer, packer, or dis

re declaration of net quantity of tributor.

contents. 1.8b Food labeling: declaration of net 1.203 Cosmetic; labeling requirements, form quantity of contents; when exempt.

of stating. 1.8c Food labeling; number of servings.

1.204 Cosmetic; labeling requirements; ex1.9 Food; labeling; prominence of re

emptions. quired statements.

IMPORTS AND EXPORTS 1.10 Food; labeling; designation of ingredients.

1.916 Definitions. 1.11 Special dietary uses.

1.316 Notice of sampling. 1.12 Food; labeling; artificial flavoring or

1.817 Payment for samples. coloring, chemical preservatives.

1.318 Hearing. 1.15 Food; labeling; misbranding.

1.319 Application for authorization. 1.16 Animal feed labeling; collective names

1.320 Granting of authorisation. for feed ingredients.

1.321 Bonds.

1.322 Costs chargeable in connection with DRUGS AND DEVICES

relabeling and reconditioning inad.

missible imports. 1.100 Drugs; name. 1.101 Drugs and devices; labeling, mis

ADMINISTRATIVE branding.

1.700 Examinations and investigations, 1.101a Over-the-counter drugs and devices in

samples.
package form; principal display
panel.

GENERAL 1.102 Prescription and insulin-containing AUTHORITY: $ $ 1.1 to 1.1e issued under secs.

drugs in package form; labeling re 4, 6, 80 Stat. 1297, 1299, 1300, secs. 403, 602, identity.

701, 52 Stat. 1047, 1050, 1064, 1056; 16 U.S.O. 1.102a Over-the-counter drugs and devices in 1453, 1455, 21 U.S.C. 343, 352, 362, 371, unless package form; labeling re identity. otherwise noted.

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