| 21:4.0.1.1.1 | PART 200
| PART 200 - GENERAL | |
| 21:4.0.1.1.1.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.1.1.1.1 | SECTION 200.5
| 200.5 Mailing of important information about drugs. | |
| 21:4.0.1.1.1.1.1.2 | SECTION 200.7
| 200.7 Supplying pharmacists with indications and dosage information. | |
| 21:4.0.1.1.1.1.1.3 | SECTION 200.10
| 200.10 Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers. | |
| 21:4.0.1.1.1.1.1.4 | SECTION 200.11
| 200.11 Use of octadecylamine in steam lines of drug establishments. | |
| 21:4.0.1.1.1.1.1.5 | SECTION 200.15
| 200.15 Definition of term “insulin.” | |
| 21:4.0.1.1.1.2 | SUBPART B
| Subpart B [Reserved] | |
| 21:4.0.1.1.1.3 | SUBPART C
| Subpart C - Requirements for Specific Classes of Drugs | |
| 21:4.0.1.1.1.3.1.1 | SECTION 200.50
| 200.50 Ophthalmic preparations and dispensers. | |
| 21:4.0.1.1.1.3.1.2 | SECTION 200.51
| 200.51 Aqueous-based drug products for oral inhalation. | |
| 21:4.0.1.1.1.4 | SUBPART D
| Subpart D [Reserved] | |
| 21:4.0.1.1.1.5 | SUBPART E
| Subpart E - Prescription Drug Consumer Price Listing | |
| 21:4.0.1.1.1.5.1.1 | SECTION 200.200
| 200.200 Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers. | |
| 21:4.0.1.1.2 | PART 201
| PART 201 - LABELING | |
| 21:4.0.1.1.2.1 | SUBPART A
| Subpart A - General Labeling Provisions | |
| 21:4.0.1.1.2.1.1.1 | SECTION 201.1
| 201.1 Drugs; name and place of business of manufacturer, packer, or distributor. | |
| 21:4.0.1.1.2.1.1.2 | SECTION 201.2
| 201.2 Drugs and devices; National Drug Code numbers. | |
| 21:4.0.1.1.2.1.1.3 | SECTION 201.5
| 201.5 Drugs; adequate directions for use. | |
| 21:4.0.1.1.2.1.1.4 | SECTION 201.6
| 201.6 Drugs; misleading statements. | |
| 21:4.0.1.1.2.1.1.5 | SECTION 201.10
| 201.10 Drugs; statement of ingredients. | |
| 21:4.0.1.1.2.1.1.6 | SECTION 201.15
| 201.15 Drugs; prominence of required label statements. | |
| 21:4.0.1.1.2.1.1.7 | SECTION 201.16
| 201.16 Drugs; Spanish-language version of certain required statements. | |
| 21:4.0.1.1.2.1.1.8 | SECTION 201.17
| 201.17 Drugs; location of expiration date. | |
| 21:4.0.1.1.2.1.1.9 | SECTION 201.18
| 201.18 Drugs; significance of control numbers. | |
| 21:4.0.1.1.2.1.1.10 | SECTION 201.19
| 201.19 Drugs; use of term “infant”. | |
| 21:4.0.1.1.2.1.1.11 | SECTION 201.20
| 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use. | |
| 21:4.0.1.1.2.1.1.12 | SECTION 201.21
| 201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use. | |
| 21:4.0.1.1.2.1.1.13 | SECTION 201.22
| 201.22 Prescription drugs containing sulfites; required warning statements. | |
| 21:4.0.1.1.2.1.1.14 | SECTION 201.23
| 201.23 Required pediatric studies. | |
| 21:4.0.1.1.2.1.1.15 | SECTION 201.24
| 201.24 Labeling for systemic antibacterial drug products. | |
| 21:4.0.1.1.2.1.1.16 | SECTION 201.25
| 201.25 Bar code label requirements. | |
| 21:4.0.1.1.2.1.1.17 | SECTION 201.26
| 201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile. | |
| 21:4.0.1.1.2.2 | SUBPART B
| Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin | |
| 21:4.0.1.1.2.2.1.1 | SECTION 201.50
| 201.50 Statement of identity. | |
| 21:4.0.1.1.2.2.1.2 | SECTION 201.51
| 201.51 Declaration of net quantity of contents. | |
| 21:4.0.1.1.2.2.1.3 | SECTION 201.55
| 201.55 Statement of dosage. | |
| 21:4.0.1.1.2.2.1.4 | SECTION 201.56
| 201.56 Requirements on content and format of labeling for human prescription drug and biological products. | |
| 21:4.0.1.1.2.2.1.5 | SECTION 201.57
| 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1). | |
| 21:4.0.1.1.2.2.1.6 | SECTION 201.58
| 201.58 Waiver of labeling requirements. | |
| 21:4.0.1.1.2.3 | SUBPART C
| Subpart C - Labeling Requirements for Over-the-Counter Drugs | |
| 21:4.0.1.1.2.3.1.1 | SECTION 201.60
| 201.60 Principal display panel. | |
| 21:4.0.1.1.2.3.1.2 | SECTION 201.61
| 201.61 Statement of identity. | |
| 21:4.0.1.1.2.3.1.3 | SECTION 201.62
| 201.62 Declaration of net quantity of contents. | |
| 21:4.0.1.1.2.3.1.4 | SECTION 201.63
| 201.63 Pregnancy/breast-feeding warning. | |
| 21:4.0.1.1.2.3.1.5 | SECTION 201.64
| 201.64 Sodium labeling. | |
| 21:4.0.1.1.2.3.1.6 | SECTION 201.66
| 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling. | |
| 21:4.0.1.1.2.3.1.7 | SECTION 201.70
| 201.70 Calcium labeling. | |
| 21:4.0.1.1.2.3.1.8 | SECTION 201.71
| 201.71 Magnesium labeling. | |
| 21:4.0.1.1.2.3.1.9 | SECTION 201.72
| 201.72 Potassium labeling. | |
| 21:4.0.1.1.2.3.1.10 | SECTION 201.80
| 201.80 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1). | |
| 21:4.0.1.1.2.4 | SUBPART D
| Subpart D - Exemptions From Adequate Directions for Use | |
| 21:4.0.1.1.2.4.1.1 | SECTION 201.100
| 201.100 Prescription drugs for human use. | |
| 21:4.0.1.1.2.4.1.2 | SECTION 201.105
| 201.105 Veterinary drugs. | |
| 21:4.0.1.1.2.4.1.3 | SECTION 201.115
| 201.115 New drugs or new animal drugs. | |
| 21:4.0.1.1.2.4.1.4 | SECTION 201.116
| 201.116 Drugs having commonly known directions. | |
| 21:4.0.1.1.2.4.1.5 | SECTION 201.117
| 201.117 Inactive ingredients. | |
| 21:4.0.1.1.2.4.1.6 | SECTION 201.119
| 201.119 In vitro diagnostic products. | |
| 21:4.0.1.1.2.4.1.7 | SECTION 201.120
| 201.120 Prescription chemicals and other prescription components. | |
| 21:4.0.1.1.2.4.1.8 | SECTION 201.122
| 201.122 Drugs for processing, repacking, or manufacturing. | |
| 21:4.0.1.1.2.4.1.9 | SECTION 201.125
| 201.125 Drugs for use in teaching, law enforcement, research, and analysis. | |
| 21:4.0.1.1.2.4.1.10 | SECTION 201.127
| 201.127 Drugs; expiration of exemptions. | |
| 21:4.0.1.1.2.4.1.11 | SECTION 201.128
| 201.128 Meaning of “intended uses”. | |
| 21:4.0.1.1.2.4.1.13 | SECTION 201.129
| 201.129 Drugs; exemption for radioactive drugs for research use. | |
| 21:4.0.1.1.2.5 | SUBPART E
| Subpart E - Other Exemptions | |
| 21:4.0.1.1.2.5.1.1 | SECTION 201.150
| 201.150 Drugs; processing, labeling, or repacking. | |
| 21:4.0.1.1.2.5.1.2 | SECTION 201.161
| 201.161 Medical gases. | |
| 21:4.0.1.1.2.6 | SUBPART F
| Subpart F - Labeling Claims for Drugs in Drug Efficacy Study | |
| 21:4.0.1.1.2.6.1.1 | SECTION 201.200
| 201.200 Disclosure of drug efficacy study evaluations in labeling and advertising. | |
| 21:4.0.1.1.2.7 | SUBPART G
| Subpart G - Specific Labeling Requirements for Specific Drug Products | |
| 21:4.0.1.1.2.7.1.1 | SECTION 201.300
| 201.300 Notice to manufacturers, packers, and distributors of glandular preparations. | |
| 21:4.0.1.1.2.7.1.2 | SECTION 201.301
| 201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations. | |
| 21:4.0.1.1.2.7.1.3 | SECTION 201.302
| 201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. | |
| 21:4.0.1.1.2.7.1.4 | SECTION 201.303
| 201.303 Labeling of drug preparations containing significant proportions of wintergreen oil. | |
| 21:4.0.1.1.2.7.1.5 | SECTION 201.304
| 201.304 Tannic acid and barium enema preparations. | |
| 21:4.0.1.1.2.7.1.6 | SECTION 201.305
| 201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings. | |
| 21:4.0.1.1.2.7.1.7 | SECTION 201.306
| 201.306 Potassium salt preparations intended for oral ingestion by man. | |
| 21:4.0.1.1.2.7.1.8 | SECTION 201.307
| 201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale. | |
| 21:4.0.1.1.2.7.1.9 | SECTION 201.308
| 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale. | |
| 21:4.0.1.1.2.7.1.10 | SECTION 201.309
| 201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement. | |
| 21:4.0.1.1.2.7.1.11 | SECTION 201.310
| 201.310 Phenindione; labeling of drug preparations intended for use by man. | |
| 21:4.0.1.1.2.7.1.12 | SECTION 201.311
| 201.311 [Reserved] | |
| 21:4.0.1.1.2.7.1.13 | SECTION 201.312
| 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. | |
| 21:4.0.1.1.2.7.1.14 | SECTION 201.313
| 201.313 Estradiol labeling. | |
| 21:4.0.1.1.2.7.1.15 | SECTION 201.314
| 201.314 Labeling of drug preparations containing salicylates. | |
| 21:4.0.1.1.2.7.1.16 | SECTION 201.315
| 201.315 Over-the-counter drugs for minor sore throats; suggested warning. | |
| 21:4.0.1.1.2.7.1.17 | SECTION 201.316
| 201.316 Drugs with thyroid hormone activity for human use; required warning. | |
| 21:4.0.1.1.2.7.1.18 | SECTION 201.317
| 201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning. | |
| 21:4.0.1.1.2.7.1.19 | SECTION 201.319
| 201.319 Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions. | |
| 21:4.0.1.1.2.7.1.20 | SECTION 201.320
| 201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. | |
| 21:4.0.1.1.2.7.1.21 | SECTION 201.323
| 201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition. | |
| 21:4.0.1.1.2.7.1.22 | SECTION 201.325
| 201.325 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information. | |
| 21:4.0.1.1.2.7.1.23 | SECTION 201.326
| 201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling. | |
| 21:4.0.1.1.2.7.1.24 | SECTION 201.327
| 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing. | |
| 21:4.0.1.1.2.7.1.25 | SECTION 201.328
| 201.328 Labeling of medical gas containers. | |
| 21:4.0.1.1.2.7.1.26.1 | APPENDIX Appendix A
| Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA | |
| 21:4.0.1.1.3 | PART 202
| PART 202 - PRESCRIPTION DRUG ADVERTISING | |
| 21:4.0.1.1.3.0.1.1 | SECTION 202.1
| 202.1 Prescription-drug advertisements. | |
| 21:4.0.1.1.4 | PART 203
| PART 203 - PRESCRIPTION DRUG MARKETING | |
| 21:4.0.1.1.4.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.4.1.1.1 | SECTION 203.1
| 203.1 Scope. | |
| 21:4.0.1.1.4.1.1.2 | SECTION 203.2
| 203.2 Purpose. | |
| 21:4.0.1.1.4.1.1.3 | SECTION 203.3
| 203.3 Definitions. | |
| 21:4.0.1.1.4.2 | SUBPART B
| Subpart B - Reimportation | |
| 21:4.0.1.1.4.2.1.1 | SECTION 203.10
| 203.10 Restrictions on reimportation. | |
| 21:4.0.1.1.4.2.1.2 | SECTION 203.11
| 203.11 Applications for reimportation to provide emergency medical care. | |
| 21:4.0.1.1.4.2.1.3 | SECTION 203.12
| 203.12 An appeal from an adverse decision by the district office. | |
| 21:4.0.1.1.4.3 | SUBPART C
| Subpart C - Sales Restrictions | |
| 21:4.0.1.1.4.3.1.1 | SECTION 203.20
| 203.20 Sales restrictions. | |
| 21:4.0.1.1.4.3.1.2 | SECTION 203.22
| 203.22 Exclusions. | |
| 21:4.0.1.1.4.3.1.3 | SECTION 203.23
| 203.23 Returns. | |
| 21:4.0.1.1.4.4 | SUBPART D
| Subpart D - Samples | |
| 21:4.0.1.1.4.4.1.1 | SECTION 203.30
| 203.30 Sample distribution by mail or common carrier. | |
| 21:4.0.1.1.4.4.1.2 | SECTION 203.31
| 203.31 Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer). | |
| 21:4.0.1.1.4.4.1.3 | SECTION 203.32
| 203.32 Drug sample storage and handling requirements. | |
| 21:4.0.1.1.4.4.1.4 | SECTION 203.33
| 203.33 Drug sample forms. | |
| 21:4.0.1.1.4.4.1.5 | SECTION 203.34
| 203.34 Policies and procedures; administrative systems. | |
| 21:4.0.1.1.4.4.1.6 | SECTION 203.35
| 203.35 Standing requests. | |
| 21:4.0.1.1.4.4.1.7 | SECTION 203.36
| 203.36 Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping. | |
| 21:4.0.1.1.4.4.1.8 | SECTION 203.37
| 203.37 Investigation and notification requirements. | |
| 21:4.0.1.1.4.4.1.9 | SECTION 203.38
| 203.38 Sample lot or control numbers; labeling of sample units. | |
| 21:4.0.1.1.4.4.1.10 | SECTION 203.39
| 203.39 Donation of drug samples to charitable institutions. | |
| 21:4.0.1.1.4.5 | SUBPART E
| Subpart E - Wholesale Distribution | |
| 21:4.0.1.1.4.5.1.1 | SECTION 203.50
| 203.50 Requirements for wholesale distribution of prescription drugs. | |
| 21:4.0.1.1.4.6 | SUBPART F
| Subpart F - Request and Receipt Forms, Reports, and Records | |
| 21:4.0.1.1.4.6.1.1 | SECTION 203.60
| 203.60 Request and receipt forms, reports, and records. | |
| 21:4.0.1.1.4.7 | SUBPART G
| Subpart G - Rewards | |
| 21:4.0.1.1.4.7.1.1 | SECTION 203.70
| 203.70 Application for a reward. | |
| 21:4.0.1.1.5 | PART 205
| PART 205 - GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS | |
| 21:4.0.1.1.5.0.1.1 | SECTION 205.1
| 205.1 Scope. | |
| 21:4.0.1.1.5.0.1.2 | SECTION 205.2
| 205.2 Purpose. | |
| 21:4.0.1.1.5.0.1.3 | SECTION 205.3
| 205.3 Definitions. | |
| 21:4.0.1.1.5.0.1.4 | SECTION 205.4
| 205.4 Wholesale drug distributor licensing requirement. | |
| 21:4.0.1.1.5.0.1.5 | SECTION 205.5
| 205.5 Minimum required information for licensure. | |
| 21:4.0.1.1.5.0.1.6 | SECTION 205.6
| 205.6 Minimum qualifications. | |
| 21:4.0.1.1.5.0.1.7 | SECTION 205.7
| 205.7 Personnel. | |
| 21:4.0.1.1.5.0.1.8 | SECTION 205.8
| 205.8 Violations and penalties. | |
| 21:4.0.1.1.5.0.1.9 | SECTION 205.50
| 205.50 Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records. | |
| 21:4.0.1.1.6 | PART 206
| PART 206 - IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE | |
| 21:4.0.1.1.6.0.1.1 | SECTION 206.1
| 206.1 Scope. | |
| 21:4.0.1.1.6.0.1.2 | SECTION 206.3
| 206.3 Definitions. | |
| 21:4.0.1.1.6.0.1.3 | SECTION 206.7
| 206.7 Exemptions. | |
| 21:4.0.1.1.6.0.1.4 | SECTION 206.10
| 206.10 Code imprint required. | |
| 21:4.0.1.1.7 | PART 207
| PART 207 - REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE | |
| 21:4.0.1.1.7.1 | SUBPART A
| Subpart A - General | |
| 21:4.0.1.1.7.1.1.1 | SECTION 207.1
| 207.1 What definitions and interpretations of terms apply to this part | |
| 21:4.0.1.1.7.1.1.2 | SECTION 207.3
| 207.3 Bulk drug substance. | |
| 21:4.0.1.1.7.1.1.3 | SECTION 207.5
| 207.5 What is the purpose of this part | |
| 21:4.0.1.1.7.1.1.4 | SECTION 207.9
| 207.9 Who does this part cover | |
| 21:4.0.1.1.7.1.1.5 | SECTION 207.13
| 207.13 Who is exempt from the registration and listing requirements | |
| 21:4.0.1.1.7.2 | SUBPART B
| Subpart B - Registration | |
| 21:4.0.1.1.7.2.1.1 | SECTION 207.17
| 207.17 Who must register | |
| 21:4.0.1.1.7.2.1.2 | SECTION 207.21
| 207.21 When must initial registration information be provided | |
| 21:4.0.1.1.7.2.1.3 | SECTION 207.25
| 207.25 What information is required for registration | |
| 21:4.0.1.1.7.2.1.4 | SECTION 207.29
| 207.29 What are the requirements for reviewing and updating registration information | |
| 21:4.0.1.1.7.3 | SUBPART C
| Subpart C - National Drug Code | |
| 21:4.0.1.1.7.3.1.1 | SECTION 207.33
| 207.33 What is the National Drug Code (NDC), how is it assigned, and what are its requirements | |
| 21:4.0.1.1.7.3.1.2 | SECTION 207.35
| 207.35 What changes require a new NDC | |
| 21:4.0.1.1.7.3.1.3 | SECTION 207.37
| 207.37 What restrictions pertain to the use of the NDC | |
| 21:4.0.1.1.7.4 | SUBPART D
| Subpart D - Listing | |
| 21:4.0.1.1.7.4.1.1 | SECTION 207.41
| 207.41 Who must list drugs and what drugs must they list | |
| 21:4.0.1.1.7.4.1.2 | SECTION 207.45
| 207.45 When, after initial registration of an establishment, must drug listing information be submitted | |
| 21:4.0.1.1.7.4.1.3 | SECTION 207.49
| 207.49 What listing information must a registrant submit for a drug it manufactures | |
| 21:4.0.1.1.7.4.1.4 | SECTION 207.53
| 207.53 What listing information must a registrant submit for a drug that it repacks or relabels | |
| 21:4.0.1.1.7.4.1.5 | SECTION 207.54
| 207.54 What listing information must a registrant submit for a drug that it salvages | |
| 21:4.0.1.1.7.4.1.6 | SECTION 207.55
| 207.55 What additional drug listing information may FDA require | |
| 21:4.0.1.1.7.4.1.7 | SECTION 207.57
| 207.57 What information must registrants submit when updating listing information and when | |
| 21:4.0.1.1.7.5 | SUBPART E
| Subpart E - Electronic Format for Registration and Listing | |
| 21:4.0.1.1.7.5.1.1 | SECTION 207.61
| 207.61 How is registration and listing information provided to FDA | |
| 21:4.0.1.1.7.5.1.2 | SECTION 207.65
| 207.65 How can a waiver of the electronic submission requirement be obtained | |
| 21:4.0.1.1.7.6 | SUBPART F
| Subpart F - Miscellaneous | |
| 21:4.0.1.1.7.6.1.1 | SECTION 207.69
| 207.69 What are the requirements for an official contact and a United States agent | |
| 21:4.0.1.1.7.6.1.2 | SECTION 207.77
| 207.77 What legal status is conferred by registration and listing | |
| 21:4.0.1.1.7.6.1.3 | SECTION 207.81
| 207.81 What registration and listing information will FDA make available for public disclosure | |
| 21:4.0.1.1.8 | PART 208
| PART 208 - MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS | |
| 21:4.0.1.1.8.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.8.1.1.1 | SECTION 208.1
| 208.1 Scope and purpose. | |
| 21:4.0.1.1.8.1.1.2 | SECTION 208.3
| 208.3 Definitions. | |
| 21:4.0.1.1.8.2 | SUBPART B
| Subpart B - General Requirements for a Medication Guide | |
| 21:4.0.1.1.8.2.1.1 | SECTION 208.20
| 208.20 Content and format of a Medication Guide. | |
| 21:4.0.1.1.8.2.1.2 | SECTION 208.24
| 208.24 Distributing and dispensing a Medication Guide. | |
| 21:4.0.1.1.8.2.1.3 | SECTION 208.26
| 208.26 Exemptions and deferrals. | |
| 21:4.0.1.1.9 | PART 209
| PART 209 - REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT | |
| 21:4.0.1.1.9.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.9.1.1.1 | SECTION 209.1
| 209.1 Scope and purpose. | |
| 21:4.0.1.1.9.1.1.2 | SECTION 209.2
| 209.2 Definitions. | |
| 21:4.0.1.1.9.2 | SUBPART B
| Subpart B - Requirements | |
| 21:4.0.1.1.9.2.1.1 | SECTION 209.10
| 209.10 Content and format of the side effects statement. | |
| 21:4.0.1.1.9.2.1.2 | SECTION 209.11
| 209.11 Dispensing and distributing the side effects statement. | |
| 21:4.0.1.1.10 | PART 210
| PART 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL | |
| 21:4.0.1.1.10.0.1.1 | SECTION 210.1
| 210.1 Status of current good manufacturing practice regulations. | |
| 21:4.0.1.1.10.0.1.2 | SECTION 210.2
| 210.2 Applicability of current good manufacturing practice regulations. | |
| 21:4.0.1.1.10.0.1.3 | SECTION 210.3
| 210.3 Definitions. | |
| 21:4.0.1.1.11 | PART 211
| PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS | |
| 21:4.0.1.1.11.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.11.1.1.1 | SECTION 211.1
| 211.1 Scope. | |
| 21:4.0.1.1.11.1.1.2 | SECTION 211.3
| 211.3 Definitions. | |
| 21:4.0.1.1.11.2 | SUBPART B
| Subpart B - Organization and Personnel | |
| 21:4.0.1.1.11.2.1.1 | SECTION 211.22
| 211.22 Responsibilities of quality control unit. | |
| 21:4.0.1.1.11.2.1.2 | SECTION 211.25
| 211.25 Personnel qualifications. | |
| 21:4.0.1.1.11.2.1.3 | SECTION 211.28
| 211.28 Personnel responsibilities. | |
| 21:4.0.1.1.11.2.1.4 | SECTION 211.34
| 211.34 Consultants. | |
| 21:4.0.1.1.11.3 | SUBPART C
| Subpart C - Buildings and Facilities | |
| 21:4.0.1.1.11.3.1.1 | SECTION 211.42
| 211.42 Design and construction features. | |
| 21:4.0.1.1.11.3.1.2 | SECTION 211.44
| 211.44 Lighting. | |
| 21:4.0.1.1.11.3.1.3 | SECTION 211.46
| 211.46 Ventilation, air filtration, air heating and cooling. | |
| 21:4.0.1.1.11.3.1.4 | SECTION 211.48
| 211.48 Plumbing. | |
| 21:4.0.1.1.11.3.1.5 | SECTION 211.50
| 211.50 Sewage and refuse. | |
| 21:4.0.1.1.11.3.1.6 | SECTION 211.52
| 211.52 Washing and toilet facilities. | |
| 21:4.0.1.1.11.3.1.7 | SECTION 211.56
| 211.56 Sanitation. | |
| 21:4.0.1.1.11.3.1.8 | SECTION 211.58
| 211.58 Maintenance. | |
| 21:4.0.1.1.11.4 | SUBPART D
| Subpart D - Equipment | |
| 21:4.0.1.1.11.4.1.1 | SECTION 211.63
| 211.63 Equipment design, size, and location. | |
| 21:4.0.1.1.11.4.1.2 | SECTION 211.65
| 211.65 Equipment construction. | |
| 21:4.0.1.1.11.4.1.3 | SECTION 211.67
| 211.67 Equipment cleaning and maintenance. | |
| 21:4.0.1.1.11.4.1.4 | SECTION 211.68
| 211.68 Automatic, mechanical, and electronic equipment. | |
| 21:4.0.1.1.11.4.1.5 | SECTION 211.72
| 211.72 Filters. | |
| 21:4.0.1.1.11.5 | SUBPART E
| Subpart E - Control of Components and Drug Product Containers and Closures | |
| 21:4.0.1.1.11.5.1.1 | SECTION 211.80
| 211.80 General requirements. | |
| 21:4.0.1.1.11.5.1.2 | SECTION 211.82
| 211.82 Receipt and storage of untested components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.3 | SECTION 211.84
| 211.84 Testing and approval or rejection of components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.4 | SECTION 211.86
| 211.86 Use of approved components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.5 | SECTION 211.87
| 211.87 Retesting of approved components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.6 | SECTION 211.89
| 211.89 Rejected components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.7 | SECTION 211.94
| 211.94 Drug product containers and closures. | |
| 21:4.0.1.1.11.6 | SUBPART F
| Subpart F - Production and Process Controls | |
| 21:4.0.1.1.11.6.1.1 | SECTION 211.100
| 211.100 Written procedures; deviations. | |
| 21:4.0.1.1.11.6.1.2 | SECTION 211.101
| 211.101 Charge-in of components. | |
| 21:4.0.1.1.11.6.1.3 | SECTION 211.103
| 211.103 Calculation of yield. | |
| 21:4.0.1.1.11.6.1.4 | SECTION 211.105
| 211.105 Equipment identification. | |
| 21:4.0.1.1.11.6.1.5 | SECTION 211.110
| 211.110 Sampling and testing of in-process materials and drug products. | |
| 21:4.0.1.1.11.6.1.6 | SECTION 211.111
| 211.111 Time limitations on production. | |
| 21:4.0.1.1.11.6.1.7 | SECTION 211.113
| 211.113 Control of microbiological contamination. | |
| 21:4.0.1.1.11.6.1.8 | SECTION 211.115
| 211.115 Reprocessing. | |
| 21:4.0.1.1.11.7 | SUBPART G
| Subpart G - Packaging and Labeling Control | |
| 21:4.0.1.1.11.7.1.1 | SECTION 211.122
| 211.122 Materials examination and usage criteria. | |
| 21:4.0.1.1.11.7.1.2 | SECTION 211.125
| 211.125 Labeling issuance. | |
| 21:4.0.1.1.11.7.1.3 | SECTION 211.130
| 211.130 Packaging and labeling operations. | |
| 21:4.0.1.1.11.7.1.4 | SECTION 211.132
| 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. | |
| 21:4.0.1.1.11.7.1.5 | SECTION 211.134
| 211.134 Drug product inspection. | |
| 21:4.0.1.1.11.7.1.6 | SECTION 211.137
| 211.137 Expiration dating. | |
| 21:4.0.1.1.11.8 | SUBPART H
| Subpart H - Holding and Distribution | |
| 21:4.0.1.1.11.8.1.1 | SECTION 211.142
| 211.142 Warehousing procedures. | |
| 21:4.0.1.1.11.8.1.2 | SECTION 211.150
| 211.150 Distribution procedures. | |
| 21:4.0.1.1.11.9 | SUBPART I
| Subpart I - Laboratory Controls | |
| 21:4.0.1.1.11.9.1.1 | SECTION 211.160
| 211.160 General requirements. | |
| 21:4.0.1.1.11.9.1.2 | SECTION 211.165
| 211.165 Testing and release for distribution. | |
| 21:4.0.1.1.11.9.1.3 | SECTION 211.166
| 211.166 Stability testing. | |
| 21:4.0.1.1.11.9.1.4 | SECTION 211.167
| 211.167 Special testing requirements. | |
| 21:4.0.1.1.11.9.1.5 | SECTION 211.170
| 211.170 Reserve samples. | |
| 21:4.0.1.1.11.9.1.6 | SECTION 211.173
| 211.173 Laboratory animals. | |
| 21:4.0.1.1.11.9.1.7 | SECTION 211.176
| 211.176 Penicillin contamination. | |
| 21:4.0.1.1.11.10 | SUBPART J
| Subpart J - Records and Reports | |
| 21:4.0.1.1.11.10.1.1 | SECTION 211.180
| 211.180 General requirements. | |
| 21:4.0.1.1.11.10.1.2 | SECTION 211.182
| 211.182 Equipment cleaning and use log. | |
| 21:4.0.1.1.11.10.1.3 | SECTION 211.184
| 211.184 Component, drug product container, closure, and labeling records. | |
| 21:4.0.1.1.11.10.1.4 | SECTION 211.186
| 211.186 Master production and control records. | |
| 21:4.0.1.1.11.10.1.5 | SECTION 211.188
| 211.188 Batch production and control records. | |
| 21:4.0.1.1.11.10.1.6 | SECTION 211.192
| 211.192 Production record review. | |
| 21:4.0.1.1.11.10.1.7 | SECTION 211.194
| 211.194 Laboratory records. | |
| 21:4.0.1.1.11.10.1.8 | SECTION 211.196
| 211.196 Distribution records. | |
| 21:4.0.1.1.11.10.1.9 | SECTION 211.198
| 211.198 Complaint files. | |
| 21:4.0.1.1.11.11 | SUBPART K
| Subpart K - Returned and Salvaged Drug Products | |
| 21:4.0.1.1.11.11.1.1 | SECTION 211.204
| 211.204 Returned drug products. | |
| 21:4.0.1.1.11.11.1.2 | SECTION 211.208
| 211.208 Drug product salvaging. | |
| 21:4.0.1.1.12 | PART 212
| PART 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS | |
| 21:4.0.1.1.12.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.12.1.1.1 | SECTION 212.1
| 212.1 What are the meanings of the technical terms used in these regulations | |
| 21:4.0.1.1.12.1.1.2 | SECTION 212.2
| 212.2 What is current good manufacturing practice for PET drugs | |
| 21:4.0.1.1.12.1.1.3 | SECTION 212.5
| 212.5 To what drugs do the regulations in this part apply | |
| 21:4.0.1.1.12.2 | SUBPART B
| Subpart B - Personnel and Resources | |
| 21:4.0.1.1.12.2.1.1 | SECTION 212.10
| 212.10 What personnel and resources must I have | |
| 21:4.0.1.1.12.3 | SUBPART C
| Subpart C - Quality Assurance | |
| 21:4.0.1.1.12.3.1.1 | SECTION 212.20
| 212.20 What activities must I perform to ensure drug quality | |
| 21:4.0.1.1.12.4 | SUBPART D
| Subpart D - Facilities and Equipment | |
| 21:4.0.1.1.12.4.1.1 | SECTION 212.30
| 212.30 What requirements must my facilities and equipment meet | |
| 21:4.0.1.1.12.5 | SUBPART E
| Subpart E - Control of Components, Containers, and Closures | |
| 21:4.0.1.1.12.5.1.1 | SECTION 212.40
| 212.40 How must I control the components I use to produce PET drugs and the containers and closures I package them in | |
| 21:4.0.1.1.12.6 | SUBPART F
| Subpart F - Production and Process Controls | |
| 21:4.0.1.1.12.6.1.1 | SECTION 212.50
| 212.50 What production and process controls must I have | |
| 21:4.0.1.1.12.7 | SUBPART G
| Subpart G - Laboratory Controls | |
| 21:4.0.1.1.12.7.1.1 | SECTION 212.60
| 212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products | |
| 21:4.0.1.1.12.7.1.2 | SECTION 212.61
| 212.61 What must I do to ensure the stability of my PET drug products through expiry | |
| 21:4.0.1.1.12.8 | SUBPART H
| Subpart H - Finished Drug Product Controls and Acceptance | |
| 21:4.0.1.1.12.8.1.1 | SECTION 212.70
| 212.70 What controls and acceptance criteria must I have for my finished PET drug products | |
| 21:4.0.1.1.12.8.1.2 | SECTION 212.71
| 212.71 What actions must I take if a batch of PET drug product does not conform to specifications | |
| 21:4.0.1.1.12.9 | SUBPART I
| Subpart I - Packaging and Labeling | |
| 21:4.0.1.1.12.9.1.1 | SECTION 212.80
| 212.80 What are the requirements associated with labeling and packaging PET drug products | |
| 21:4.0.1.1.12.10 | SUBPART J
| Subpart J - Distribution | |
| 21:4.0.1.1.12.10.1.1 | SECTION 212.90
| 212.90 What actions must I take to control the distribution of PET drug products | |
| 21:4.0.1.1.12.11 | SUBPART K
| Subpart K - Complaint Handling | |
| 21:4.0.1.1.12.11.1.1 | SECTION 212.100
| 212.100 What do I do if I receive a complaint about a PET drug product produced at my facility | |
| 21:4.0.1.1.12.12 | SUBPART L
| Subpart L - Records | |
| 21:4.0.1.1.12.12.1.1 | SECTION 212.110
| 212.110 How must I maintain records of my production of PET drugs | |
| 21:4.0.1.1.13 | PART 216
| PART 216 - HUMAN DRUG COMPOUNDING | |
| 21:4.0.1.1.13.1 | SUBPART A
| Subpart A - General Provisions [Reserved] | |
| 21:4.0.1.1.13.2 | SUBPART B
| Subpart B - Compounded Drug Products | |
| 21:4.0.1.1.13.2.1.1 | SECTION 216.23
| 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act. | |
| 21:4.0.1.1.13.2.1.2 | SECTION 216.24
| 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness. | |
| 21:4.0.1.1.14 | PART 225
| PART 225 - CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS | |
| 21:4.0.1.1.14.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.14.1.1.1 | SECTION 225.1
| 225.1 Current good manufacturing practice. | |
| 21:4.0.1.1.14.1.1.2 | SECTION 225.10
| 225.10 Personnel. | |
| 21:4.0.1.1.14.2 | SUBPART B
| Subpart B - Construction and Maintenance of Facilities and Equipment | |
| 21:4.0.1.1.14.2.1.1 | SECTION 225.20
| 225.20 Buildings. | |
| 21:4.0.1.1.14.2.1.2 | SECTION 225.30
| 225.30 Equipment. | |
| 21:4.0.1.1.14.2.1.3 | SECTION 225.35
| 225.35 Use of work areas, equipment, and storage areas for other manufacturing and storage purpose. | |
| 21:4.0.1.1.14.3 | SUBPART C
| Subpart C - Product Quality Control | |
| 21:4.0.1.1.14.3.1.1 | SECTION 225.42
| 225.42 Components. | |
| 21:4.0.1.1.14.3.1.2 | SECTION 225.58
| 225.58 Laboratory controls. | |
| 21:4.0.1.1.14.3.1.3 | SECTION 225.65
| 225.65 Equipment cleanout procedures. | |
| 21:4.0.1.1.14.4 | SUBPART D
| Subpart D - Packaging and Labeling | |
| 21:4.0.1.1.14.4.1.1 | SECTION 225.80
| 225.80 Labeling. | |
| 21:4.0.1.1.14.5 | SUBPART E
| Subpart E - Records and Reports | |
| 21:4.0.1.1.14.5.1.1 | SECTION 225.102
| 225.102 Master record file and production records. | |
| 21:4.0.1.1.14.5.1.2 | SECTION 225.110
| 225.110 Distribution records. | |
| 21:4.0.1.1.14.5.1.3 | SECTION 225.115
| 225.115 Complaint files. | |
| 21:4.0.1.1.14.6 | SUBPART F
| Subpart F - Facilities and Equipment | |
| 21:4.0.1.1.14.6.1.1 | SECTION 225.120
| 225.120 Buildings and grounds. | |
| 21:4.0.1.1.14.6.1.2 | SECTION 225.130
| 225.130 Equipment. | |
| 21:4.0.1.1.14.6.1.3 | SECTION 225.135
| 225.135 Work and storage areas. | |
| 21:4.0.1.1.14.7 | SUBPART G
| Subpart G - Product Quality Assurance | |
| 21:4.0.1.1.14.7.1.1 | SECTION 225.142
| 225.142 Components. | |
| 21:4.0.1.1.14.7.1.2 | SECTION 225.158
| 225.158 Laboratory assays. | |
| 21:4.0.1.1.14.7.1.3 | SECTION 225.165
| 225.165 Equipment cleanout procedures. | |
| 21:4.0.1.1.14.8 | SUBPART H
| Subpart H - Labeling | |
| 21:4.0.1.1.14.8.1.1 | SECTION 225.180
| 225.180 Labeling. | |
| 21:4.0.1.1.14.9 | SUBPART I
| Subpart I - Records | |
| 21:4.0.1.1.14.9.1.1 | SECTION 225.202
| 225.202 Formula, production, and distribution records. | |
| 21:4.0.1.1.15 | PART 226
| PART 226 - CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES | |
| 21:4.0.1.1.15.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.15.1.1.1 | SECTION 226.1
| 226.1 Current good manufacturing practice. | |
| 21:4.0.1.1.15.1.1.2 | SECTION 226.10
| 226.10 Personnel. | |
| 21:4.0.1.1.15.2 | SUBPART B
| Subpart B - Construction and Maintenance of Facilities and Equipment | |
| 21:4.0.1.1.15.2.1.1 | SECTION 226.20
| 226.20 Buildings. | |
| 21:4.0.1.1.15.2.1.2 | SECTION 226.30
| 226.30 Equipment. | |
| 21:4.0.1.1.15.3 | SUBPART C
| Subpart C - Product Quality Control | |
| 21:4.0.1.1.15.3.1.1 | SECTION 226.40
| 226.40 Production and control procedures. | |
| 21:4.0.1.1.15.3.1.2 | SECTION 226.42
| 226.42 Components. | |
| 21:4.0.1.1.15.3.1.3 | SECTION 226.58
| 226.58 Laboratory controls. | |
| 21:4.0.1.1.15.4 | SUBPART D
| Subpart D - Packaging and Labeling | |
| 21:4.0.1.1.15.4.1.1 | SECTION 226.80
| 226.80 Packaging and labeling. | |
| 21:4.0.1.1.15.5 | SUBPART E
| Subpart E - Records and Reports | |
| 21:4.0.1.1.15.5.1.1 | SECTION 226.102
| 226.102 Master-formula and batch-production records. | |
| 21:4.0.1.1.15.5.1.2 | SECTION 226.110
| 226.110 Distribution records. | |
| 21:4.0.1.1.15.5.1.3 | SECTION 226.115
| 226.115 Complaint files. | |
| 21:4.0.1.1.16 | PART 250
| PART 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS | |
| 21:4.0.1.1.16.1 | SUBPART A
| Subpart A - Drugs Regarded as Misbranded | |
| 21:4.0.1.1.16.1.1.1 | SECTION 250.11
| 250.11 Thyroid-containing drug preparations intended for treatment of obesity in humans. | |
| 21:4.0.1.1.16.1.1.2 | SECTION 250.12
| 250.12 Stramonium preparations labeled with directions for use in self-medication regarded as misbranded. | |
| 21:4.0.1.1.16.2 | SUBPART B
| Subpart B - New Drug or Prescription Status of Specific Drugs | |
| 21:4.0.1.1.16.2.1.1 | SECTION 250.100
| 250.100 Amyl nitrite inhalant as a prescription drug for human use. | |
| 21:4.0.1.1.16.2.1.2 | SECTION 250.101
| 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs. | |
| 21:4.0.1.1.16.2.1.3 | SECTION 250.102
| 250.102 Drug preparations intended for human use containing certain “coronary vasodilators”. | |
| 21:4.0.1.1.16.2.1.4 | SECTION 250.103-250.104
| 250.103-250.104 [Reserved] | |
| 21:4.0.1.1.16.2.1.5 | SECTION 250.105
| 250.105 Gelsemium-containing preparations regarded as prescription drugs. | |
| 21:4.0.1.1.16.2.1.6 | SECTION 250.106-250.107
| 250.106-250.107 [Reserved] | |
| 21:4.0.1.1.16.2.1.7 | SECTION 250.108
| 250.108 Potassium permanganate preparations as prescription drugs. | |
| 21:4.0.1.1.16.3 | SUBPART C
| Subpart C - Requirements for Drugs and Foods | |
| 21:4.0.1.1.16.3.1.1 | SECTION 250.201
| 250.201 Preparations for the treatment of pernicious anemia. | |
| 21:4.0.1.1.16.4 | SUBPART D
| Subpart D - Requirements for Drugs and Cosmetics | |
| 21:4.0.1.1.16.4.1.1 | SECTION 250.250
| 250.250 Hexachlorophene, as a component of drug and cosmetic products. | |
| 21:4.0.1.1.17 | PART 251
| PART 251 - SECTION 804 IMPORTATION PROGRAM | |
| 21:4.0.1.1.17.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.17.1.1.1 | SECTION 251.1
| 251.1 Scope of the part. | |
| 21:4.0.1.1.17.1.1.2 | SECTION 251.2
| 251.2 Definitions. | |
| 21:4.0.1.1.17.2 | SUBPART B
| Subpart B - Section 804 Importation Program Proposals and Pre-Import Requests | |
| 21:4.0.1.1.17.2.1.1 | SECTION 251.3
| 251.3 SIP proposal submission requirements. | |
| 21:4.0.1.1.17.2.1.2 | SECTION 251.4
| 251.4 Review and authorization of importation program proposals. | |
| 21:4.0.1.1.17.2.1.3 | SECTION 251.5
| 251.5 Pre-Import Request. | |
| 21:4.0.1.1.17.2.1.4 | SECTION 251.6
| 251.6 Termination of authorized importation programs. | |
| 21:4.0.1.1.17.2.1.5 | SECTION 251.7
| 251.7 Suspension and revocation of authorized importation programs. | |
| 21:4.0.1.1.17.2.1.6 | SECTION 251.8
| 251.8 Modification or extension of authorized importation programs. | |
| 21:4.0.1.1.17.3 | SUBPART C
| Subpart C - Certain Requirements for Section 804 Importation Programs | |
| 21:4.0.1.1.17.3.1.1 | SECTION 251.9
| 251.9 Registration of Foreign Sellers. | |
| 21:4.0.1.1.17.3.1.2 | SECTION 251.10
| 251.10 Reviewing and updating registration information for Foreign Sellers. | |
| 21:4.0.1.1.17.3.1.3 | SECTION 251.11
| 251.11 Official contact and U.S. agent for Foreign Sellers. | |
| 21:4.0.1.1.17.3.1.4 | SECTION 251.12
| 251.12 Importer responsibilities. | |
| 21:4.0.1.1.17.3.1.5 | SECTION 251.13
| 251.13 Labeling of eligible prescription drugs. | |
| 21:4.0.1.1.17.3.1.6 | SECTION 251.14
| 251.14 Supply chain security requirements for eligible prescription drugs. | |
| 21:4.0.1.1.17.3.1.7 | SECTION 251.15
| 251.15 Qualifying laboratory requirements. | |
| 21:4.0.1.1.17.3.1.8 | SECTION 251.16
| 251.16 Laboratory testing requirements. | |
| 21:4.0.1.1.17.3.1.9 | SECTION 251.17
| 251.17 Importation requirements. | |
| 21:4.0.1.1.17.3.1.10 | SECTION 251.18
| 251.18 Post-importation requirements. | |
| 21:4.0.1.1.17.3.1.11 | SECTION 251.19
| 251.19 Reports to FDA. | |
| 21:4.0.1.1.17.3.1.12 | SECTION 251.20
| 251.20 Severability. | |
| 21:4.0.1.1.17.3.1.13 | SECTION 251.21
| 251.21 Consequences for violations. | |
| 21:4.0.1.1.18 | PART 290
| PART 290 - CONTROLLED DRUGS | |
| 21:4.0.1.1.18.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.18.1.1.1 | SECTION 290.1
| 290.1 Controlled substances. | |
| 21:4.0.1.1.18.1.1.2 | SECTION 290.2
| 290.2 Exemption from prescription requirements. | |
| 21:4.0.1.1.18.1.1.3 | SECTION 290.5
| 290.5 Drugs; statement of required warning. | |
| 21:4.0.1.1.18.1.1.4 | SECTION 290.6
| 290.6 Spanish-language version of required warning. | |
| 21:4.0.1.1.18.1.1.5 | SECTION 290.10
| 290.10 Definition of emergency situation. | |
| 21:4.0.1.1.18.2 | SUBPART B
| Subpart B [Reserved] | |
| 21:4.0.1.1.18.3 | SUBPART C
| Subpart C - Requirements for Specific Controlled Drugs [Reserved] | |
| 21:4.0.1.1.19 | PART 299
| PART 299 - DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES | |
| 21:4.0.1.1.19.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.19.1.1.1 | SECTION 299.3
| 299.3 Definitions and interpretations. | |
| 21:4.0.1.1.19.1.1.2 | SECTION 299.4
| 299.4 Established names for drugs. | |
| 21:4.0.1.1.19.1.1.3 | SECTION 299.5
| 299.5 Drugs; compendial name. | |