Title 21

Volume 4 CHAPTER I SUBCHAP C

Subchapter C - Drugs: General

21:4.0.1.1.1PART 200
PART 200 - GENERAL
21:4.0.1.1.1.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.1.1.1.1SECTION 200.5
     200.5 Mailing of important information about drugs.
21:4.0.1.1.1.1.1.2SECTION 200.7
     200.7 Supplying pharmacists with indications and dosage information.
21:4.0.1.1.1.1.1.3SECTION 200.10
     200.10 Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers.
21:4.0.1.1.1.1.1.4SECTION 200.11
     200.11 Use of octadecylamine in steam lines of drug establishments.
21:4.0.1.1.1.1.1.5SECTION 200.15
     200.15 Definition of term “insulin.”
21:4.0.1.1.1.2SUBPART B
Subpart B [Reserved]
21:4.0.1.1.1.3SUBPART C
Subpart C - Requirements for Specific Classes of Drugs
21:4.0.1.1.1.3.1.1SECTION 200.50
     200.50 Ophthalmic preparations and dispensers.
21:4.0.1.1.1.3.1.2SECTION 200.51
     200.51 Aqueous-based drug products for oral inhalation.
21:4.0.1.1.1.4SUBPART D
Subpart D [Reserved]
21:4.0.1.1.1.5SUBPART E
Subpart E - Prescription Drug Consumer Price Listing
21:4.0.1.1.1.5.1.1SECTION 200.200
     200.200 Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers.
21:4.0.1.1.2PART 201
PART 201 - LABELING
21:4.0.1.1.2.1SUBPART A
Subpart A - General Labeling Provisions
21:4.0.1.1.2.1.1.1SECTION 201.1
     201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
21:4.0.1.1.2.1.1.2SECTION 201.2
     201.2 Drugs and devices; National Drug Code numbers.
21:4.0.1.1.2.1.1.3SECTION 201.5
     201.5 Drugs; adequate directions for use.
21:4.0.1.1.2.1.1.4SECTION 201.6
     201.6 Drugs; misleading statements.
21:4.0.1.1.2.1.1.5SECTION 201.10
     201.10 Drugs; statement of ingredients.
21:4.0.1.1.2.1.1.6SECTION 201.15
     201.15 Drugs; prominence of required label statements.
21:4.0.1.1.2.1.1.7SECTION 201.16
     201.16 Drugs; Spanish-language version of certain required statements.
21:4.0.1.1.2.1.1.8SECTION 201.17
     201.17 Drugs; location of expiration date.
21:4.0.1.1.2.1.1.9SECTION 201.18
     201.18 Drugs; significance of control numbers.
21:4.0.1.1.2.1.1.10SECTION 201.19
     201.19 Drugs; use of term “infant”.
21:4.0.1.1.2.1.1.11SECTION 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.
21:4.0.1.1.2.1.1.12SECTION 201.21
     201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
21:4.0.1.1.2.1.1.13SECTION 201.22
     201.22 Prescription drugs containing sulfites; required warning statements.
21:4.0.1.1.2.1.1.14SECTION 201.23
     201.23 Required pediatric studies.
21:4.0.1.1.2.1.1.15SECTION 201.24
     201.24 Labeling for systemic antibacterial drug products.
21:4.0.1.1.2.1.1.16SECTION 201.25
     201.25 Bar code label requirements.
21:4.0.1.1.2.1.1.17SECTION 201.26
     201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
21:4.0.1.1.2.2SUBPART B
Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin
21:4.0.1.1.2.2.1.1SECTION 201.50
     201.50 Statement of identity.
21:4.0.1.1.2.2.1.2SECTION 201.51
     201.51 Declaration of net quantity of contents.
21:4.0.1.1.2.2.1.3SECTION 201.55
     201.55 Statement of dosage.
21:4.0.1.1.2.2.1.4SECTION 201.56
     201.56 Requirements on content and format of labeling for human prescription drug and biological products.
21:4.0.1.1.2.2.1.5SECTION 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).
21:4.0.1.1.2.2.1.6SECTION 201.58
     201.58 Waiver of labeling requirements.
21:4.0.1.1.2.3SUBPART C
Subpart C - Labeling Requirements for Over-the-Counter Drugs
21:4.0.1.1.2.3.1.1SECTION 201.60
     201.60 Principal display panel.
21:4.0.1.1.2.3.1.2SECTION 201.61
     201.61 Statement of identity.
21:4.0.1.1.2.3.1.3SECTION 201.62
     201.62 Declaration of net quantity of contents.
21:4.0.1.1.2.3.1.4SECTION 201.63
     201.63 Pregnancy/breast-feeding warning.
21:4.0.1.1.2.3.1.5SECTION 201.64
     201.64 Sodium labeling.
21:4.0.1.1.2.3.1.6SECTION 201.66
     201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
21:4.0.1.1.2.3.1.7SECTION 201.70
     201.70 Calcium labeling.
21:4.0.1.1.2.3.1.8SECTION 201.71
     201.71 Magnesium labeling.
21:4.0.1.1.2.3.1.9SECTION 201.72
     201.72 Potassium labeling.
21:4.0.1.1.2.3.1.10SECTION 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).
21:4.0.1.1.2.4SUBPART D
Subpart D - Exemptions From Adequate Directions for Use
21:4.0.1.1.2.4.1.1SECTION 201.100
     201.100 Prescription drugs for human use.
21:4.0.1.1.2.4.1.2SECTION 201.105
     201.105 Veterinary drugs.
21:4.0.1.1.2.4.1.3SECTION 201.115
     201.115 New drugs or new animal drugs.
21:4.0.1.1.2.4.1.4SECTION 201.116
     201.116 Drugs having commonly known directions.
21:4.0.1.1.2.4.1.5SECTION 201.117
     201.117 Inactive ingredients.
21:4.0.1.1.2.4.1.6SECTION 201.119
     201.119 In vitro diagnostic products.
21:4.0.1.1.2.4.1.7SECTION 201.120
     201.120 Prescription chemicals and other prescription components.
21:4.0.1.1.2.4.1.8SECTION 201.122
     201.122 Drugs for processing, repacking, or manufacturing.
21:4.0.1.1.2.4.1.9SECTION 201.125
     201.125 Drugs for use in teaching, law enforcement, research, and analysis.
21:4.0.1.1.2.4.1.10SECTION 201.127
     201.127 Drugs; expiration of exemptions.
21:4.0.1.1.2.4.1.11SECTION 201.128
     201.128 Meaning of “intended uses”.
21:4.0.1.1.2.4.1.13SECTION 201.129
     201.129 Drugs; exemption for radioactive drugs for research use.
21:4.0.1.1.2.5SUBPART E
Subpart E - Other Exemptions
21:4.0.1.1.2.5.1.1SECTION 201.150
     201.150 Drugs; processing, labeling, or repacking.
21:4.0.1.1.2.5.1.2SECTION 201.161
     201.161 Medical gases.
21:4.0.1.1.2.6SUBPART F
Subpart F - Labeling Claims for Drugs in Drug Efficacy Study
21:4.0.1.1.2.6.1.1SECTION 201.200
     201.200 Disclosure of drug efficacy study evaluations in labeling and advertising.
21:4.0.1.1.2.7SUBPART G
Subpart G - Specific Labeling Requirements for Specific Drug Products
21:4.0.1.1.2.7.1.1SECTION 201.300
     201.300 Notice to manufacturers, packers, and distributors of glandular preparations.
21:4.0.1.1.2.7.1.2SECTION 201.301
     201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
21:4.0.1.1.2.7.1.3SECTION 201.302
     201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
21:4.0.1.1.2.7.1.4SECTION 201.303
     201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.
21:4.0.1.1.2.7.1.5SECTION 201.304
     201.304 Tannic acid and barium enema preparations.
21:4.0.1.1.2.7.1.6SECTION 201.305
     201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
21:4.0.1.1.2.7.1.7SECTION 201.306
     201.306 Potassium salt preparations intended for oral ingestion by man.
21:4.0.1.1.2.7.1.8SECTION 201.307
     201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
21:4.0.1.1.2.7.1.9SECTION 201.308
     201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
21:4.0.1.1.2.7.1.10SECTION 201.309
     201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
21:4.0.1.1.2.7.1.11SECTION 201.310
     201.310 Phenindione; labeling of drug preparations intended for use by man.
21:4.0.1.1.2.7.1.12SECTION 201.311
     201.311 [Reserved]
21:4.0.1.1.2.7.1.13SECTION 201.312
     201.312 Magnesium sulfate heptahydrate; label declaration on drug products.
21:4.0.1.1.2.7.1.14SECTION 201.313
     201.313 Estradiol labeling.
21:4.0.1.1.2.7.1.15SECTION 201.314
     201.314 Labeling of drug preparations containing salicylates.
21:4.0.1.1.2.7.1.16SECTION 201.315
     201.315 Over-the-counter drugs for minor sore throats; suggested warning.
21:4.0.1.1.2.7.1.17SECTION 201.316
     201.316 Drugs with thyroid hormone activity for human use; required warning.
21:4.0.1.1.2.7.1.18SECTION 201.317
     201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
21:4.0.1.1.2.7.1.19SECTION 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
21:4.0.1.1.2.7.1.20SECTION 201.320
     201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
21:4.0.1.1.2.7.1.21SECTION 201.323
     201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.
21:4.0.1.1.2.7.1.22SECTION 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.
21:4.0.1.1.2.7.1.23SECTION 201.326
     201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
21:4.0.1.1.2.7.1.24SECTION 201.327
     201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
21:4.0.1.1.2.7.1.25SECTION 201.328
     201.328 Labeling of medical gas containers.
21:4.0.1.1.2.7.1.26.1APPENDIX Appendix A
  Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA
21:4.0.1.1.3PART 202
PART 202 - PRESCRIPTION DRUG ADVERTISING
21:4.0.1.1.3.0.1.1SECTION 202.1
     202.1 Prescription-drug advertisements.
21:4.0.1.1.4PART 203
PART 203 - PRESCRIPTION DRUG MARKETING
21:4.0.1.1.4.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.4.1.1.1SECTION 203.1
     203.1 Scope.
21:4.0.1.1.4.1.1.2SECTION 203.2
     203.2 Purpose.
21:4.0.1.1.4.1.1.3SECTION 203.3
     203.3 Definitions.
21:4.0.1.1.4.2SUBPART B
Subpart B - Reimportation
21:4.0.1.1.4.2.1.1SECTION 203.10
     203.10 Restrictions on reimportation.
21:4.0.1.1.4.2.1.2SECTION 203.11
     203.11 Applications for reimportation to provide emergency medical care.
21:4.0.1.1.4.2.1.3SECTION 203.12
     203.12 An appeal from an adverse decision by the district office.
21:4.0.1.1.4.3SUBPART C
Subpart C - Sales Restrictions
21:4.0.1.1.4.3.1.1SECTION 203.20
     203.20 Sales restrictions.
21:4.0.1.1.4.3.1.2SECTION 203.22
     203.22 Exclusions.
21:4.0.1.1.4.3.1.3SECTION 203.23
     203.23 Returns.
21:4.0.1.1.4.4SUBPART D
Subpart D - Samples
21:4.0.1.1.4.4.1.1SECTION 203.30
     203.30 Sample distribution by mail or common carrier.
21:4.0.1.1.4.4.1.2SECTION 203.31
     203.31 Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer).
21:4.0.1.1.4.4.1.3SECTION 203.32
     203.32 Drug sample storage and handling requirements.
21:4.0.1.1.4.4.1.4SECTION 203.33
     203.33 Drug sample forms.
21:4.0.1.1.4.4.1.5SECTION 203.34
     203.34 Policies and procedures; administrative systems.
21:4.0.1.1.4.4.1.6SECTION 203.35
     203.35 Standing requests.
21:4.0.1.1.4.4.1.7SECTION 203.36
     203.36 Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping.
21:4.0.1.1.4.4.1.8SECTION 203.37
     203.37 Investigation and notification requirements.
21:4.0.1.1.4.4.1.9SECTION 203.38
     203.38 Sample lot or control numbers; labeling of sample units.
21:4.0.1.1.4.4.1.10SECTION 203.39
     203.39 Donation of drug samples to charitable institutions.
21:4.0.1.1.4.5SUBPART E
Subpart E - Wholesale Distribution
21:4.0.1.1.4.5.1.1SECTION 203.50
     203.50 Requirements for wholesale distribution of prescription drugs.
21:4.0.1.1.4.6SUBPART F
Subpart F - Request and Receipt Forms, Reports, and Records
21:4.0.1.1.4.6.1.1SECTION 203.60
     203.60 Request and receipt forms, reports, and records.
21:4.0.1.1.4.7SUBPART G
Subpart G - Rewards
21:4.0.1.1.4.7.1.1SECTION 203.70
     203.70 Application for a reward.
21:4.0.1.1.5PART 205
PART 205 - GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
21:4.0.1.1.5.0.1.1SECTION 205.1
     205.1 Scope.
21:4.0.1.1.5.0.1.2SECTION 205.2
     205.2 Purpose.
21:4.0.1.1.5.0.1.3SECTION 205.3
     205.3 Definitions.
21:4.0.1.1.5.0.1.4SECTION 205.4
     205.4 Wholesale drug distributor licensing requirement.
21:4.0.1.1.5.0.1.5SECTION 205.5
     205.5 Minimum required information for licensure.
21:4.0.1.1.5.0.1.6SECTION 205.6
     205.6 Minimum qualifications.
21:4.0.1.1.5.0.1.7SECTION 205.7
     205.7 Personnel.
21:4.0.1.1.5.0.1.8SECTION 205.8
     205.8 Violations and penalties.
21:4.0.1.1.5.0.1.9SECTION 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.
21:4.0.1.1.6PART 206
PART 206 - IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
21:4.0.1.1.6.0.1.1SECTION 206.1
     206.1 Scope.
21:4.0.1.1.6.0.1.2SECTION 206.3
     206.3 Definitions.
21:4.0.1.1.6.0.1.3SECTION 206.7
     206.7 Exemptions.
21:4.0.1.1.6.0.1.4SECTION 206.10
     206.10 Code imprint required.
21:4.0.1.1.7PART 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
21:4.0.1.1.7.1SUBPART A
Subpart A - General
21:4.0.1.1.7.1.1.1SECTION 207.1
     207.1 What definitions and interpretations of terms apply to this part
21:4.0.1.1.7.1.1.2SECTION 207.3
     207.3 Bulk drug substance.
21:4.0.1.1.7.1.1.3SECTION 207.5
     207.5 What is the purpose of this part
21:4.0.1.1.7.1.1.4SECTION 207.9
     207.9 Who does this part cover
21:4.0.1.1.7.1.1.5SECTION 207.13
     207.13 Who is exempt from the registration and listing requirements
21:4.0.1.1.7.2SUBPART B
Subpart B - Registration
21:4.0.1.1.7.2.1.1SECTION 207.17
     207.17 Who must register
21:4.0.1.1.7.2.1.2SECTION 207.21
     207.21 When must initial registration information be provided
21:4.0.1.1.7.2.1.3SECTION 207.25
     207.25 What information is required for registration
21:4.0.1.1.7.2.1.4SECTION 207.29
     207.29 What are the requirements for reviewing and updating registration information
21:4.0.1.1.7.3SUBPART C
Subpart C - National Drug Code
21:4.0.1.1.7.3.1.1SECTION 207.33
     207.33 What is the National Drug Code (NDC), how is it assigned, and what are its requirements
21:4.0.1.1.7.3.1.2SECTION 207.35
     207.35 What changes require a new NDC
21:4.0.1.1.7.3.1.3SECTION 207.37
     207.37 What restrictions pertain to the use of the NDC
21:4.0.1.1.7.4SUBPART D
Subpart D - Listing
21:4.0.1.1.7.4.1.1SECTION 207.41
     207.41 Who must list drugs and what drugs must they list
21:4.0.1.1.7.4.1.2SECTION 207.45
     207.45 When, after initial registration of an establishment, must drug listing information be submitted
21:4.0.1.1.7.4.1.3SECTION 207.49
     207.49 What listing information must a registrant submit for a drug it manufactures
21:4.0.1.1.7.4.1.4SECTION 207.53
     207.53 What listing information must a registrant submit for a drug that it repacks or relabels
21:4.0.1.1.7.4.1.5SECTION 207.54
     207.54 What listing information must a registrant submit for a drug that it salvages
21:4.0.1.1.7.4.1.6SECTION 207.55
     207.55 What additional drug listing information may FDA require
21:4.0.1.1.7.4.1.7SECTION 207.57
     207.57 What information must registrants submit when updating listing information and when
21:4.0.1.1.7.5SUBPART E
Subpart E - Electronic Format for Registration and Listing
21:4.0.1.1.7.5.1.1SECTION 207.61
     207.61 How is registration and listing information provided to FDA
21:4.0.1.1.7.5.1.2SECTION 207.65
     207.65 How can a waiver of the electronic submission requirement be obtained
21:4.0.1.1.7.6SUBPART F
Subpart F - Miscellaneous
21:4.0.1.1.7.6.1.1SECTION 207.69
     207.69 What are the requirements for an official contact and a United States agent
21:4.0.1.1.7.6.1.2SECTION 207.77
     207.77 What legal status is conferred by registration and listing
21:4.0.1.1.7.6.1.3SECTION 207.81
     207.81 What registration and listing information will FDA make available for public disclosure
21:4.0.1.1.8PART 208
PART 208 - MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
21:4.0.1.1.8.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.8.1.1.1SECTION 208.1
     208.1 Scope and purpose.
21:4.0.1.1.8.1.1.2SECTION 208.3
     208.3 Definitions.
21:4.0.1.1.8.2SUBPART B
Subpart B - General Requirements for a Medication Guide
21:4.0.1.1.8.2.1.1SECTION 208.20
     208.20 Content and format of a Medication Guide.
21:4.0.1.1.8.2.1.2SECTION 208.24
     208.24 Distributing and dispensing a Medication Guide.
21:4.0.1.1.8.2.1.3SECTION 208.26
     208.26 Exemptions and deferrals.
21:4.0.1.1.9PART 209
PART 209 - REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT
21:4.0.1.1.9.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.9.1.1.1SECTION 209.1
     209.1 Scope and purpose.
21:4.0.1.1.9.1.1.2SECTION 209.2
     209.2 Definitions.
21:4.0.1.1.9.2SUBPART B
Subpart B - Requirements
21:4.0.1.1.9.2.1.1SECTION 209.10
     209.10 Content and format of the side effects statement.
21:4.0.1.1.9.2.1.2SECTION 209.11
     209.11 Dispensing and distributing the side effects statement.
21:4.0.1.1.10PART 210
PART 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
21:4.0.1.1.10.0.1.1SECTION 210.1
     210.1 Status of current good manufacturing practice regulations.
21:4.0.1.1.10.0.1.2SECTION 210.2
     210.2 Applicability of current good manufacturing practice regulations.
21:4.0.1.1.10.0.1.3SECTION 210.3
     210.3 Definitions.
21:4.0.1.1.11PART 211
PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
21:4.0.1.1.11.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.11.1.1.1SECTION 211.1
     211.1 Scope.
21:4.0.1.1.11.1.1.2SECTION 211.3
     211.3 Definitions.
21:4.0.1.1.11.2SUBPART B
Subpart B - Organization and Personnel
21:4.0.1.1.11.2.1.1SECTION 211.22
     211.22 Responsibilities of quality control unit.
21:4.0.1.1.11.2.1.2SECTION 211.25
     211.25 Personnel qualifications.
21:4.0.1.1.11.2.1.3SECTION 211.28
     211.28 Personnel responsibilities.
21:4.0.1.1.11.2.1.4SECTION 211.34
     211.34 Consultants.
21:4.0.1.1.11.3SUBPART C
Subpart C - Buildings and Facilities
21:4.0.1.1.11.3.1.1SECTION 211.42
     211.42 Design and construction features.
21:4.0.1.1.11.3.1.2SECTION 211.44
     211.44 Lighting.
21:4.0.1.1.11.3.1.3SECTION 211.46
     211.46 Ventilation, air filtration, air heating and cooling.
21:4.0.1.1.11.3.1.4SECTION 211.48
     211.48 Plumbing.
21:4.0.1.1.11.3.1.5SECTION 211.50
     211.50 Sewage and refuse.
21:4.0.1.1.11.3.1.6SECTION 211.52
     211.52 Washing and toilet facilities.
21:4.0.1.1.11.3.1.7SECTION 211.56
     211.56 Sanitation.
21:4.0.1.1.11.3.1.8SECTION 211.58
     211.58 Maintenance.
21:4.0.1.1.11.4SUBPART D
Subpart D - Equipment
21:4.0.1.1.11.4.1.1SECTION 211.63
     211.63 Equipment design, size, and location.
21:4.0.1.1.11.4.1.2SECTION 211.65
     211.65 Equipment construction.
21:4.0.1.1.11.4.1.3SECTION 211.67
     211.67 Equipment cleaning and maintenance.
21:4.0.1.1.11.4.1.4SECTION 211.68
     211.68 Automatic, mechanical, and electronic equipment.
21:4.0.1.1.11.4.1.5SECTION 211.72
     211.72 Filters.
21:4.0.1.1.11.5SUBPART E
Subpart E - Control of Components and Drug Product Containers and Closures
21:4.0.1.1.11.5.1.1SECTION 211.80
     211.80 General requirements.
21:4.0.1.1.11.5.1.2SECTION 211.82
     211.82 Receipt and storage of untested components, drug product containers, and closures.
21:4.0.1.1.11.5.1.3SECTION 211.84
     211.84 Testing and approval or rejection of components, drug product containers, and closures.
21:4.0.1.1.11.5.1.4SECTION 211.86
     211.86 Use of approved components, drug product containers, and closures.
21:4.0.1.1.11.5.1.5SECTION 211.87
     211.87 Retesting of approved components, drug product containers, and closures.
21:4.0.1.1.11.5.1.6SECTION 211.89
     211.89 Rejected components, drug product containers, and closures.
21:4.0.1.1.11.5.1.7SECTION 211.94
     211.94 Drug product containers and closures.
21:4.0.1.1.11.6SUBPART F
Subpart F - Production and Process Controls
21:4.0.1.1.11.6.1.1SECTION 211.100
     211.100 Written procedures; deviations.
21:4.0.1.1.11.6.1.2SECTION 211.101
     211.101 Charge-in of components.
21:4.0.1.1.11.6.1.3SECTION 211.103
     211.103 Calculation of yield.
21:4.0.1.1.11.6.1.4SECTION 211.105
     211.105 Equipment identification.
21:4.0.1.1.11.6.1.5SECTION 211.110
     211.110 Sampling and testing of in-process materials and drug products.
21:4.0.1.1.11.6.1.6SECTION 211.111
     211.111 Time limitations on production.
21:4.0.1.1.11.6.1.7SECTION 211.113
     211.113 Control of microbiological contamination.
21:4.0.1.1.11.6.1.8SECTION 211.115
     211.115 Reprocessing.
21:4.0.1.1.11.7SUBPART G
Subpart G - Packaging and Labeling Control
21:4.0.1.1.11.7.1.1SECTION 211.122
     211.122 Materials examination and usage criteria.
21:4.0.1.1.11.7.1.2SECTION 211.125
     211.125 Labeling issuance.
21:4.0.1.1.11.7.1.3SECTION 211.130
     211.130 Packaging and labeling operations.
21:4.0.1.1.11.7.1.4SECTION 211.132
     211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
21:4.0.1.1.11.7.1.5SECTION 211.134
     211.134 Drug product inspection.
21:4.0.1.1.11.7.1.6SECTION 211.137
     211.137 Expiration dating.
21:4.0.1.1.11.8SUBPART H
Subpart H - Holding and Distribution
21:4.0.1.1.11.8.1.1SECTION 211.142
     211.142 Warehousing procedures.
21:4.0.1.1.11.8.1.2SECTION 211.150
     211.150 Distribution procedures.
21:4.0.1.1.11.9SUBPART I
Subpart I - Laboratory Controls
21:4.0.1.1.11.9.1.1SECTION 211.160
     211.160 General requirements.
21:4.0.1.1.11.9.1.2SECTION 211.165
     211.165 Testing and release for distribution.
21:4.0.1.1.11.9.1.3SECTION 211.166
     211.166 Stability testing.
21:4.0.1.1.11.9.1.4SECTION 211.167
     211.167 Special testing requirements.
21:4.0.1.1.11.9.1.5SECTION 211.170
     211.170 Reserve samples.
21:4.0.1.1.11.9.1.6SECTION 211.173
     211.173 Laboratory animals.
21:4.0.1.1.11.9.1.7SECTION 211.176
     211.176 Penicillin contamination.
21:4.0.1.1.11.10SUBPART J
Subpart J - Records and Reports
21:4.0.1.1.11.10.1.1SECTION 211.180
     211.180 General requirements.
21:4.0.1.1.11.10.1.2SECTION 211.182
     211.182 Equipment cleaning and use log.
21:4.0.1.1.11.10.1.3SECTION 211.184
     211.184 Component, drug product container, closure, and labeling records.
21:4.0.1.1.11.10.1.4SECTION 211.186
     211.186 Master production and control records.
21:4.0.1.1.11.10.1.5SECTION 211.188
     211.188 Batch production and control records.
21:4.0.1.1.11.10.1.6SECTION 211.192
     211.192 Production record review.
21:4.0.1.1.11.10.1.7SECTION 211.194
     211.194 Laboratory records.
21:4.0.1.1.11.10.1.8SECTION 211.196
     211.196 Distribution records.
21:4.0.1.1.11.10.1.9SECTION 211.198
     211.198 Complaint files.
21:4.0.1.1.11.11SUBPART K
Subpart K - Returned and Salvaged Drug Products
21:4.0.1.1.11.11.1.1SECTION 211.204
     211.204 Returned drug products.
21:4.0.1.1.11.11.1.2SECTION 211.208
     211.208 Drug product salvaging.
21:4.0.1.1.12PART 212
PART 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
21:4.0.1.1.12.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.12.1.1.1SECTION 212.1
     212.1 What are the meanings of the technical terms used in these regulations
21:4.0.1.1.12.1.1.2SECTION 212.2
     212.2 What is current good manufacturing practice for PET drugs
21:4.0.1.1.12.1.1.3SECTION 212.5
     212.5 To what drugs do the regulations in this part apply
21:4.0.1.1.12.2SUBPART B
Subpart B - Personnel and Resources
21:4.0.1.1.12.2.1.1SECTION 212.10
     212.10 What personnel and resources must I have
21:4.0.1.1.12.3SUBPART C
Subpart C - Quality Assurance
21:4.0.1.1.12.3.1.1SECTION 212.20
     212.20 What activities must I perform to ensure drug quality
21:4.0.1.1.12.4SUBPART D
Subpart D - Facilities and Equipment
21:4.0.1.1.12.4.1.1SECTION 212.30
     212.30 What requirements must my facilities and equipment meet
21:4.0.1.1.12.5SUBPART E
Subpart E - Control of Components, Containers, and Closures
21:4.0.1.1.12.5.1.1SECTION 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
21:4.0.1.1.12.6SUBPART F
Subpart F - Production and Process Controls
21:4.0.1.1.12.6.1.1SECTION 212.50
     212.50 What production and process controls must I have
21:4.0.1.1.12.7SUBPART G
Subpart G - Laboratory Controls
21:4.0.1.1.12.7.1.1SECTION 212.60
     212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products
21:4.0.1.1.12.7.1.2SECTION 212.61
     212.61 What must I do to ensure the stability of my PET drug products through expiry
21:4.0.1.1.12.8SUBPART H
Subpart H - Finished Drug Product Controls and Acceptance
21:4.0.1.1.12.8.1.1SECTION 212.70
     212.70 What controls and acceptance criteria must I have for my finished PET drug products
21:4.0.1.1.12.8.1.2SECTION 212.71
     212.71 What actions must I take if a batch of PET drug product does not conform to specifications
21:4.0.1.1.12.9SUBPART I
Subpart I - Packaging and Labeling
21:4.0.1.1.12.9.1.1SECTION 212.80
     212.80 What are the requirements associated with labeling and packaging PET drug products
21:4.0.1.1.12.10SUBPART J
Subpart J - Distribution
21:4.0.1.1.12.10.1.1SECTION 212.90
     212.90 What actions must I take to control the distribution of PET drug products
21:4.0.1.1.12.11SUBPART K
Subpart K - Complaint Handling
21:4.0.1.1.12.11.1.1SECTION 212.100
     212.100 What do I do if I receive a complaint about a PET drug product produced at my facility
21:4.0.1.1.12.12SUBPART L
Subpart L - Records
21:4.0.1.1.12.12.1.1SECTION 212.110
     212.110 How must I maintain records of my production of PET drugs
21:4.0.1.1.13PART 216
PART 216 - HUMAN DRUG COMPOUNDING
21:4.0.1.1.13.1SUBPART A
Subpart A - General Provisions [Reserved]
21:4.0.1.1.13.2SUBPART B
Subpart B - Compounded Drug Products
21:4.0.1.1.13.2.1.1SECTION 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.
21:4.0.1.1.13.2.1.2SECTION 216.24
     216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
21:4.0.1.1.14PART 225
PART 225 - CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
21:4.0.1.1.14.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.14.1.1.1SECTION 225.1
     225.1 Current good manufacturing practice.
21:4.0.1.1.14.1.1.2SECTION 225.10
     225.10 Personnel.
21:4.0.1.1.14.2SUBPART B
Subpart B - Construction and Maintenance of Facilities and Equipment
21:4.0.1.1.14.2.1.1SECTION 225.20
     225.20 Buildings.
21:4.0.1.1.14.2.1.2SECTION 225.30
     225.30 Equipment.
21:4.0.1.1.14.2.1.3SECTION 225.35
     225.35 Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.
21:4.0.1.1.14.3SUBPART C
Subpart C - Product Quality Control
21:4.0.1.1.14.3.1.1SECTION 225.42
     225.42 Components.
21:4.0.1.1.14.3.1.2SECTION 225.58
     225.58 Laboratory controls.
21:4.0.1.1.14.3.1.3SECTION 225.65
     225.65 Equipment cleanout procedures.
21:4.0.1.1.14.4SUBPART D
Subpart D - Packaging and Labeling
21:4.0.1.1.14.4.1.1SECTION 225.80
     225.80 Labeling.
21:4.0.1.1.14.5SUBPART E
Subpart E - Records and Reports
21:4.0.1.1.14.5.1.1SECTION 225.102
     225.102 Master record file and production records.
21:4.0.1.1.14.5.1.2SECTION 225.110
     225.110 Distribution records.
21:4.0.1.1.14.5.1.3SECTION 225.115
     225.115 Complaint files.
21:4.0.1.1.14.6SUBPART F
Subpart F - Facilities and Equipment
21:4.0.1.1.14.6.1.1SECTION 225.120
     225.120 Buildings and grounds.
21:4.0.1.1.14.6.1.2SECTION 225.130
     225.130 Equipment.
21:4.0.1.1.14.6.1.3SECTION 225.135
     225.135 Work and storage areas.
21:4.0.1.1.14.7SUBPART G
Subpart G - Product Quality Assurance
21:4.0.1.1.14.7.1.1SECTION 225.142
     225.142 Components.
21:4.0.1.1.14.7.1.2SECTION 225.158
     225.158 Laboratory assays.
21:4.0.1.1.14.7.1.3SECTION 225.165
     225.165 Equipment cleanout procedures.
21:4.0.1.1.14.8SUBPART H
Subpart H - Labeling
21:4.0.1.1.14.8.1.1SECTION 225.180
     225.180 Labeling.
21:4.0.1.1.14.9SUBPART I
Subpart I - Records
21:4.0.1.1.14.9.1.1SECTION 225.202
     225.202 Formula, production, and distribution records.
21:4.0.1.1.15PART 226
PART 226 - CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
21:4.0.1.1.15.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.15.1.1.1SECTION 226.1
     226.1 Current good manufacturing practice.
21:4.0.1.1.15.1.1.2SECTION 226.10
     226.10 Personnel.
21:4.0.1.1.15.2SUBPART B
Subpart B - Construction and Maintenance of Facilities and Equipment
21:4.0.1.1.15.2.1.1SECTION 226.20
     226.20 Buildings.
21:4.0.1.1.15.2.1.2SECTION 226.30
     226.30 Equipment.
21:4.0.1.1.15.3SUBPART C
Subpart C - Product Quality Control
21:4.0.1.1.15.3.1.1SECTION 226.40
     226.40 Production and control procedures.
21:4.0.1.1.15.3.1.2SECTION 226.42
     226.42 Components.
21:4.0.1.1.15.3.1.3SECTION 226.58
     226.58 Laboratory controls.
21:4.0.1.1.15.4SUBPART D
Subpart D - Packaging and Labeling
21:4.0.1.1.15.4.1.1SECTION 226.80
     226.80 Packaging and labeling.
21:4.0.1.1.15.5SUBPART E
Subpart E - Records and Reports
21:4.0.1.1.15.5.1.1SECTION 226.102
     226.102 Master-formula and batch-production records.
21:4.0.1.1.15.5.1.2SECTION 226.110
     226.110 Distribution records.
21:4.0.1.1.15.5.1.3SECTION 226.115
     226.115 Complaint files.
21:4.0.1.1.16PART 250
PART 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
21:4.0.1.1.16.1SUBPART A
Subpart A - Drugs Regarded as Misbranded
21:4.0.1.1.16.1.1.1SECTION 250.11
     250.11 Thyroid-containing drug preparations intended for treatment of obesity in humans.
21:4.0.1.1.16.1.1.2SECTION 250.12
     250.12 Stramonium preparations labeled with directions for use in self-medication regarded as misbranded.
21:4.0.1.1.16.2SUBPART B
Subpart B - New Drug or Prescription Status of Specific Drugs
21:4.0.1.1.16.2.1.1SECTION 250.100
     250.100 Amyl nitrite inhalant as a prescription drug for human use.
21:4.0.1.1.16.2.1.2SECTION 250.101
     250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs.
21:4.0.1.1.16.2.1.3SECTION 250.102
     250.102 Drug preparations intended for human use containing certain “coronary vasodilators”.
21:4.0.1.1.16.2.1.4SECTION 250.103-250.104
     250.103-250.104 [Reserved]
21:4.0.1.1.16.2.1.5SECTION 250.105
     250.105 Gelsemium-containing preparations regarded as prescription drugs.
21:4.0.1.1.16.2.1.6SECTION 250.106-250.107
     250.106-250.107 [Reserved]
21:4.0.1.1.16.2.1.7SECTION 250.108
     250.108 Potassium permanganate preparations as prescription drugs.
21:4.0.1.1.16.3SUBPART C
Subpart C - Requirements for Drugs and Foods
21:4.0.1.1.16.3.1.1SECTION 250.201
     250.201 Preparations for the treatment of pernicious anemia.
21:4.0.1.1.16.4SUBPART D
Subpart D - Requirements for Drugs and Cosmetics
21:4.0.1.1.16.4.1.1SECTION 250.250
     250.250 Hexachlorophene, as a component of drug and cosmetic products.
21:4.0.1.1.17PART 290
PART 290 - CONTROLLED DRUGS
21:4.0.1.1.17.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.17.1.1.1SECTION 290.1
     290.1 Controlled substances.
21:4.0.1.1.17.1.1.2SECTION 290.2
     290.2 Exemption from prescription requirements.
21:4.0.1.1.17.1.1.3SECTION 290.5
     290.5 Drugs; statement of required warning.
21:4.0.1.1.17.1.1.4SECTION 290.6
     290.6 Spanish-language version of required warning.
21:4.0.1.1.17.1.1.5SECTION 290.10
     290.10 Definition of emergency situation.
21:4.0.1.1.17.2SUBPART B
Subpart B [Reserved]
21:4.0.1.1.17.3SUBPART C
Subpart C - Requirements for Specific Controlled Drugs [Reserved]
21:4.0.1.1.18PART 299
PART 299 - DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
21:4.0.1.1.18.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.18.1.1.1SECTION 299.3
     299.3 Definitions and interpretations.
21:4.0.1.1.18.1.1.2SECTION 299.4
     299.4 Established names for drugs.
21:4.0.1.1.18.1.1.3SECTION 299.5
     299.5 Drugs; compendial name.