Title 21

Volume 8 CHAPTER I SUBCHAP L

Subchapter L - Regulations Under Certain Other Acts Administered By The Food And Drug Administration

21:8.0.1.5.54PART 1210
PART 1210 - REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
21:8.0.1.5.54.1SUBPART A
Subpart A - General Provisions
21:8.0.1.5.54.1.1.1SECTION 1210.1
     1210.1 Authority.
21:8.0.1.5.54.1.1.2SECTION 1210.2
     1210.2 Scope of act.
21:8.0.1.5.54.1.1.3SECTION 1210.3
     1210.3 Definitions.
21:8.0.1.5.54.2SUBPART B
Subpart B - Inspection and Testing
21:8.0.1.5.54.2.1.1SECTION 1210.10
     1210.10 Availability for examination and inspection.
21:8.0.1.5.54.2.1.2SECTION 1210.11
     1210.11 Sanitary inspection of dairy farms.
21:8.0.1.5.54.2.1.3SECTION 1210.12
     1210.12 Physical examination of cows.
21:8.0.1.5.54.2.1.4SECTION 1210.13
     1210.13 Tuberculin test.
21:8.0.1.5.54.2.1.5SECTION 1210.14
     1210.14 Sanitary inspection of plants.
21:8.0.1.5.54.2.1.6SECTION 1210.15
     1210.15 Pasteurization; equipment and methods.
21:8.0.1.5.54.2.1.7SECTION 1210.16
     1210.16 Method of bacterial count.
21:8.0.1.5.54.2.1.8SECTION 1210.17
     1210.17 Authority to sample and inspect.
21:8.0.1.5.54.2.1.9SECTION 1210.18
     1210.18 Scoring.
21:8.0.1.5.54.3SUBPART C
Subpart C - Permit Control
21:8.0.1.5.54.3.1.1SECTION 1210.20
     1210.20 Application for permit.
21:8.0.1.5.54.3.1.2SECTION 1210.21
     1210.21 Permit number.
21:8.0.1.5.54.3.1.3SECTION 1210.22
     1210.22 Form of tag.
21:8.0.1.5.54.3.1.4SECTION 1210.23
     1210.23 Permits granted on certificates.
21:8.0.1.5.54.3.1.5SECTION 1210.24
     1210.24 Temporary permits.
21:8.0.1.5.54.3.1.6SECTION 1210.25
     1210.25 Permits for pasteurized milk or cream.
21:8.0.1.5.54.3.1.7SECTION 1210.26
     1210.26 Permits for raw milk or cream.
21:8.0.1.5.54.3.1.8SECTION 1210.27
     1210.27 Permits waiving clauses 2 and 5, section 2 of the Federal Import Milk Act.
21:8.0.1.5.54.3.1.9SECTION 1210.28
     1210.28 Permits waiving clause 4, section 2 of the Federal Import Milk Act.
21:8.0.1.5.54.4SUBPART D
Subpart D - Hearings
21:8.0.1.5.54.4.1.1SECTION 1210.30
     1210.30 Hearing procedure for permit denial, suspension, and revocation.
21:8.0.1.5.54.4.1.2SECTION 1210.31
     1210.31 Hearing before prosecution.
21:8.0.1.5.55PART 1230
PART 1230 - REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
21:8.0.1.5.55.1SUBPART A
Subpart A - General Provisions
21:8.0.1.5.55.1.1.1SECTION 1230.2
     1230.2 Scope of the act.
21:8.0.1.5.55.1.1.2SECTION 1230.3
     1230.3 Definitions.
21:8.0.1.5.55.2SUBPART B
Subpart B - Labeling
21:8.0.1.5.55.2.1.1SECTION 1230.10
     1230.10 Placement.
21:8.0.1.5.55.2.1.2SECTION 1230.11
     1230.11 Required wording.
21:8.0.1.5.55.2.1.3SECTION 1230.12
     1230.12 Manufacturer; distributor.
21:8.0.1.5.55.2.1.4SECTION 1230.13
     1230.13 Labeling of “poison”.
21:8.0.1.5.55.2.1.5SECTION 1230.14
     1230.14 Directions for treatment.
21:8.0.1.5.55.2.1.6SECTION 1230.15
     1230.15 Responsibility for labeling directions for treatment.
21:8.0.1.5.55.2.1.7SECTION 1230.16
     1230.16 Exemption from labeling directions for treatment.
21:8.0.1.5.55.3SUBPART C
Subpart C - Guaranty
21:8.0.1.5.55.3.1.1SECTION 1230.20
     1230.20 General guaranty.
21:8.0.1.5.55.3.1.2SECTION 1230.21
     1230.21 Specific guaranty.
21:8.0.1.5.55.4SUBPART D
Subpart D - Administrative Procedures
21:8.0.1.5.55.4.1.1SECTION 1230.30
     1230.30 Collection of samples.
21:8.0.1.5.55.4.1.2SECTION 1230.31
     1230.31 Where samples may be collected.
21:8.0.1.5.55.4.1.3SECTION 1230.32
     1230.32 Analyzing of samples.
21:8.0.1.5.55.4.1.4SECTION 1230.33
     1230.33 Investigations.
21:8.0.1.5.55.4.1.5SECTION 1230.34
     1230.34 Analysis.
21:8.0.1.5.55.4.1.6SECTION 1230.35
     1230.35 Hearings.
21:8.0.1.5.55.4.1.7SECTION 1230.36
     1230.36 Hearings; when not provided for.
21:8.0.1.5.55.4.1.8SECTION 1230.37
     1230.37 Publication.
21:8.0.1.5.55.5SUBPART E
Subpart E - Imports
21:8.0.1.5.55.5.1.1SECTION 1230.40
     1230.40 Required label information.
21:8.0.1.5.55.5.1.2SECTION 1230.41
     1230.41 Delivery of containers.
21:8.0.1.5.55.5.1.3SECTION 1230.42
     1230.42 Invoices.
21:8.0.1.5.55.5.1.4SECTION 1230.43
     1230.43 Enforcement.
21:8.0.1.5.55.5.1.5SECTION 1230.44
     1230.44 Samples.
21:8.0.1.5.55.5.1.6SECTION 1230.45
     1230.45 No violation; release.
21:8.0.1.5.55.5.1.7SECTION 1230.46
     1230.46 Violation.
21:8.0.1.5.55.5.1.8SECTION 1230.47
     1230.47 Rejected containers.
21:8.0.1.5.55.5.1.9SECTION 1230.48
     1230.48 Relabeling of containers.
21:8.0.1.5.55.5.1.10SECTION 1230.49
     1230.49 Penalties.
21:8.0.1.5.56PART 1240
PART 1240 - CONTROL OF COMMUNICABLE DISEASES
21:8.0.1.5.56.1SUBPART A
Subpart A - General Provisions
21:8.0.1.5.56.1.1.1SECTION 1240.3
     1240.3 General definitions.
21:8.0.1.5.56.1.1.2SECTION 1240.10
     1240.10 Effective bactericidal treatment.
21:8.0.1.5.56.2SUBPART B
Subpart B - Administrative Procedures
21:8.0.1.5.56.2.1.1SECTION 1240.20
     1240.20 Issuance and posting of certificates following inspections.
21:8.0.1.5.56.2.1.2SECTION 1240.30
     1240.30 Measures in the event of inadequate local control.
21:8.0.1.5.56.2.1.3SECTION 1240.45
     1240.45 Report of disease.
21:8.0.1.5.56.3SUBPART C
Subpart C [Reserved]
21:8.0.1.5.56.4SUBPART D
Subpart D - Specific Administrative Decisions Regarding Interstate Shipments
21:8.0.1.5.56.4.1.1SECTION 1240.60
     1240.60 Molluscan shellfish.
21:8.0.1.5.56.4.1.2SECTION 1240.61
     1240.61 Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption.
21:8.0.1.5.56.4.1.3SECTION 1240.62
     1240.62 Turtles intrastate and interstate requirements.
21:8.0.1.5.56.4.1.4SECTION 1240.65
     1240.65 Psittacine birds.
21:8.0.1.5.56.4.1.5SECTION 1240.75
     1240.75 Garbage.
21:8.0.1.5.56.5SUBPART E
Subpart E - Source and Use of Potable Water
21:8.0.1.5.56.5.1.1SECTION 1240.80
     1240.80 General requirements for water for drinking and culinary purposes.
21:8.0.1.5.56.5.1.2SECTION 1240.83
     1240.83 Approval of watering points.
21:8.0.1.5.56.5.1.3SECTION 1240.86
     1240.86 Protection of pier water system.
21:8.0.1.5.56.5.1.4SECTION 1240.90
     1240.90 Approval of treatment aboard conveyances.
21:8.0.1.5.56.5.1.5SECTION 1240.95
     1240.95 Sanitation of water boats.
21:8.0.1.5.57PART 1250
PART 1250 - INTERSTATE CONVEYANCE SANITATION
21:8.0.1.5.57.1SUBPART A
Subpart A - General Provisions
21:8.0.1.5.57.1.1.1SECTION 1250.3
     1250.3 Definitions.
21:8.0.1.5.57.2SUBPART B
Subpart B - Food Service Sanitation on Land and Air Conveyances, and Vessels
21:8.0.1.5.57.2.1.1SECTION 1250.20
     1250.20 Applicability.
21:8.0.1.5.57.2.1.2SECTION 1250.21
     1250.21 Inspection.
21:8.0.1.5.57.2.1.3SECTION 1250.22
     1250.22 General requirements.
21:8.0.1.5.57.2.1.4SECTION 1250.25
     1250.25 Source identification and inspection of food and drink.
21:8.0.1.5.57.2.1.5SECTION 1250.26
     1250.26 Special food requirements.
21:8.0.1.5.57.2.1.6SECTION 1250.27
     1250.27 Storage of perishables.
21:8.0.1.5.57.2.1.7SECTION 1250.28
     1250.28 Source and handling of ice.
21:8.0.1.5.57.2.1.8SECTION 1250.30
     1250.30 Construction, maintenance and use of places where food is prepared, served, or stored.
21:8.0.1.5.57.2.1.9SECTION 1250.32
     1250.32 Food-handling operations.
21:8.0.1.5.57.2.1.10SECTION 1250.33
     1250.33 Utensils and equipment.
21:8.0.1.5.57.2.1.11SECTION 1250.34
     1250.34 Refrigeration equipment.
21:8.0.1.5.57.2.1.12SECTION 1250.35
     1250.35 Health of persons handling food.
21:8.0.1.5.57.2.1.13SECTION 1250.38
     1250.38 Toilet and lavatory facilities for use of food-handling employees.
21:8.0.1.5.57.2.1.14SECTION 1250.39
     1250.39 Garbage equipment and disposition.
21:8.0.1.5.57.3SUBPART C
Subpart C - Equipment and Operation of Land and Air Conveyances
21:8.0.1.5.57.3.1.1SECTION 1250.40
     1250.40 Applicability.
21:8.0.1.5.57.3.1.2SECTION 1250.41
     1250.41 Submittal of construction plans.
21:8.0.1.5.57.3.1.3SECTION 1250.42
     1250.42 Water systems; constant temperature bottles.
21:8.0.1.5.57.3.1.4SECTION 1250.43
     1250.43 Ice.
21:8.0.1.5.57.3.1.5SECTION 1250.44
     1250.44 Drinking utensils and toilet articles.
21:8.0.1.5.57.3.1.6SECTION 1250.45
     1250.45 Food handling facilities on railroad conveyances.
21:8.0.1.5.57.3.1.7SECTION 1250.49
     1250.49 Cleanliness of conveyances.
21:8.0.1.5.57.3.1.8SECTION 1250.50
     1250.50 Toilet and lavatory facilities.
21:8.0.1.5.57.3.1.9SECTION 1250.51
     1250.51 Railroad conveyances; discharge of wastes.
21:8.0.1.5.57.3.1.10SECTION 1250.52
     1250.52 Discharge of wastes on highway conveyances.
21:8.0.1.5.57.3.1.11SECTION 1250.53
     1250.53 Discharge of wastes on air conveyances.
21:8.0.1.5.57.4SUBPART D
Subpart D - Servicing Areas for Land and Air Conveyances
21:8.0.1.5.57.4.1.1SECTION 1250.60
     1250.60 Applicability.
21:8.0.1.5.57.4.1.2SECTION 1250.61
     1250.61 Inspection and approval.
21:8.0.1.5.57.4.1.3SECTION 1250.62
     1250.62 Submittal of construction plans.
21:8.0.1.5.57.4.1.4SECTION 1250.63
     1250.63 General requirements.
21:8.0.1.5.57.4.1.5SECTION 1250.65
     1250.65 Drainage.
21:8.0.1.5.57.4.1.6SECTION 1250.67
     1250.67 Watering equipment.
21:8.0.1.5.57.4.1.7SECTION 1250.70
     1250.70 Employee conveniences.
21:8.0.1.5.57.4.1.8SECTION 1250.75
     1250.75 Disposal of human wastes.
21:8.0.1.5.57.4.1.9SECTION 1250.79
     1250.79 Garbage disposal.
21:8.0.1.5.57.5SUBPART E
Subpart E - Sanitation Facilities and Conditions on Vessels
21:8.0.1.5.57.5.1.1SECTION 1250.80
     1250.80 Applicability.
21:8.0.1.5.57.5.1.2SECTION 1250.81
     1250.81 Inspection.
21:8.0.1.5.57.5.1.3SECTION 1250.82
     1250.82 Potable water systems.
21:8.0.1.5.57.5.1.4SECTION 1250.83
     1250.83 Storage of water prior to treatment.
21:8.0.1.5.57.5.1.5SECTION 1250.84
     1250.84 Water in galleys and medical care spaces.
21:8.0.1.5.57.5.1.6SECTION 1250.85
     1250.85 Drinking fountains and coolers; ice; constant temperature bottles.
21:8.0.1.5.57.5.1.7SECTION 1250.86
     1250.86 Water for making ice.
21:8.0.1.5.57.5.1.8SECTION 1250.87
     1250.87 Wash water.
21:8.0.1.5.57.5.1.9SECTION 1250.89
     1250.89 Swimming pools.
21:8.0.1.5.57.5.1.10SECTION 1250.90
     1250.90 Toilets and lavatories.
21:8.0.1.5.57.5.1.11SECTION 1250.93
     1250.93 Discharge of wastes.
21:8.0.1.5.57.5.1.12SECTION 1250.95
     1250.95 Insect control.
21:8.0.1.5.57.5.1.13SECTION 1250.96
     1250.96 Rodent control.
21:8.0.1.5.58PART 1251-1269
PARTS 1251-1269 [RESERVED]
21:8.0.1.5.59PART 1270
PART 1270 - HUMAN TISSUE INTENDED FOR TRANSPLANTATION
21:8.0.1.5.59.1SUBPART A
Subpart A - General Provisions
21:8.0.1.5.59.1.1.1SECTION 1270.1
     1270.1 Scope.
21:8.0.1.5.59.1.1.2SECTION 1270.3
     1270.3 Definitions.
21:8.0.1.5.59.2SUBPART B
Subpart B - Donor Screening and Testing
21:8.0.1.5.59.2.1.1SECTION 1270.21
     1270.21 Determination of donor suitability for human tissue intended for transplantation.
21:8.0.1.5.59.3SUBPART C
Subpart C - Procedures and Records
21:8.0.1.5.59.3.1.1SECTION 1270.31
     1270.31 Written procedures.
21:8.0.1.5.59.3.1.2SECTION 1270.33
     1270.33 Records, general requirements.
21:8.0.1.5.59.3.1.3SECTION 1270.35
     1270.35 Specific records.
21:8.0.1.5.59.4SUBPART D
Subpart D - Inspection of Tissue Establishments
21:8.0.1.5.59.4.1.1SECTION 1270.41
     1270.41 Inspections.
21:8.0.1.5.59.4.1.2SECTION 1270.42
     1270.42 Human tissue offered for import.
21:8.0.1.5.59.4.1.3SECTION 1270.43
     1270.43 Retention, recall, and destruction of human tissue.
21:8.0.1.5.60PART 1271
PART 1271 - HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
21:8.0.1.5.60.1SUBPART A
Subpart A - General Provisions
21:8.0.1.5.60.1.1.1SECTION 1271.1
     1271.1 What are the purpose and scope of this part
21:8.0.1.5.60.1.1.2SECTION 1271.3
     1271.3 How does FDA define important terms in this part
21:8.0.1.5.60.1.1.3SECTION 1271.10
     1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do
21:8.0.1.5.60.1.1.4SECTION 1271.15
     1271.15 Are there any exceptions from the requirements of this part
21:8.0.1.5.60.1.1.5SECTION 1271.20
     1271.20 If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply
21:8.0.1.5.60.2SUBPART B
Subpart B - Procedures for Registration and Listing
21:8.0.1.5.60.2.1.1SECTION 1271.21
     1271.21 When do I register, submit an HCT/P list, and submit updates
21:8.0.1.5.60.2.1.2SECTION 1271.22
     1271.22 How do I register and submit an HCT/P list
21:8.0.1.5.60.2.1.3SECTION 1271.23
     1271.23 How is a waiver from the electronic format requirements requested
21:8.0.1.5.60.2.1.4SECTION 1271.25
     1271.25 What information is required for establishment registration and HCT/P listing
21:8.0.1.5.60.2.1.5SECTION 1271.26
     1271.26 When must I amend my establishment registration
21:8.0.1.5.60.2.1.6SECTION 1271.27
     1271.27 Will FDA assign me a registration number
21:8.0.1.5.60.2.1.7SECTION 1271.37
     1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings
21:8.0.1.5.60.3SUBPART C
Subpart C - Donor Eligibility
21:8.0.1.5.60.3.1.1SECTION 1271.45
     1271.45 What requirements does this subpart contain
21:8.0.1.5.60.3.1.2SECTION 1271.47
     1271.47 What procedures must I establish and maintain
21:8.0.1.5.60.3.1.3SECTION 1271.50
     1271.50 How do I determine whether a donor is eligible
21:8.0.1.5.60.3.1.4SECTION 1271.55
     1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain
21:8.0.1.5.60.3.1.5SECTION 1271.60
     1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete
21:8.0.1.5.60.3.1.6SECTION 1271.65
     1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited
21:8.0.1.5.60.3.1.7SECTION 1271.75
     1271.75 How do I screen a donor
21:8.0.1.5.60.3.1.8SECTION 1271.80
     1271.80 What are the general requirements for donor testing
21:8.0.1.5.60.3.1.9SECTION 1271.85
     1271.85 What donor testing is required for different types of cells and tissues
21:8.0.1.5.60.3.1.10SECTION 1271.90
     1271.90 Are there other exceptions and what labeling requirements apply
21:8.0.1.5.60.4SUBPART D
Subpart D - Current Good Tissue Practice
21:8.0.1.5.60.4.1.1SECTION 1271.145
     1271.145 Prevention of the introduction, transmission, or spread of communicable diseases.
21:8.0.1.5.60.4.1.2SECTION 1271.150
     1271.150 Current good tissue practice requirements.
21:8.0.1.5.60.4.1.3SECTION 1271.155
     1271.155 Exemptions and alternatives.
21:8.0.1.5.60.4.1.4SECTION 1271.160
     1271.160 Establishment and maintenance of a quality program.
21:8.0.1.5.60.4.1.5SECTION 1271.170
     1271.170 Personnel.
21:8.0.1.5.60.4.1.6SECTION 1271.180
     1271.180 Procedures.
21:8.0.1.5.60.4.1.7SECTION 1271.190
     1271.190 Facilities.
21:8.0.1.5.60.4.1.8SECTION 1271.195
     1271.195 Environmental control and monitoring.
21:8.0.1.5.60.4.1.9SECTION 1271.200
     1271.200 Equipment.
21:8.0.1.5.60.4.1.10SECTION 1271.210
     1271.210 Supplies and reagents.
21:8.0.1.5.60.4.1.11SECTION 1271.215
     1271.215 Recovery.
21:8.0.1.5.60.4.1.12SECTION 1271.220
     1271.220 Processing and process controls.
21:8.0.1.5.60.4.1.13SECTION 1271.225
     1271.225 Process changes.
21:8.0.1.5.60.4.1.14SECTION 1271.230
     1271.230 Process validation.
21:8.0.1.5.60.4.1.15SECTION 1271.250
     1271.250 Labeling controls.
21:8.0.1.5.60.4.1.16SECTION 1271.260
     1271.260 Storage.
21:8.0.1.5.60.4.1.17SECTION 1271.265
     1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
21:8.0.1.5.60.4.1.18SECTION 1271.270
     1271.270 Records.
21:8.0.1.5.60.4.1.19SECTION 1271.290
     1271.290 Tracking.
21:8.0.1.5.60.4.1.20SECTION 1271.320
     1271.320 Complaint file.
21:8.0.1.5.60.5SUBPART E
Subpart E - Additional Requirements for Establishments Described in § 1271.10
21:8.0.1.5.60.5.1.1SECTION 1271.330
     1271.330 Applicability.
21:8.0.1.5.60.5.1.2SECTION 1271.350
     1271.350 Reporting.
21:8.0.1.5.60.5.1.3SECTION 1271.370
     1271.370 Labeling.
21:8.0.1.5.60.6SUBPART F
Subpart F - Inspection and Enforcement of Establishments Described in § 1271.10
21:8.0.1.5.60.6.1.1SECTION 1271.390
     1271.390 Applicability.
21:8.0.1.5.60.6.1.2SECTION 1271.400
     1271.400 Inspections.
21:8.0.1.5.60.6.1.3SECTION 1271.420
     1271.420 HCT/Ps offered for import.
21:8.0.1.5.60.6.1.4SECTION 1271.440
     1271.440 Orders of retention, recall, destruction, and cessation of manufacturing.
21:8.0.1.5.61PART 1272-1299
PARTS 1272-1299 [RESERVED]