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- 21 CFR 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 CFR 1271.15 · Are there any exceptions from the requirements of this part?
- 21 CFR 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 CFR 1271.21 · When do I register, submit an HCT/P list, and submit updates?
- 21 CFR 1271.22 · How do I register and submit an HCT/P list?
- 21 CFR 1271.23 · How is a waiver from the electronic format requirements requested?
- 21 CFR 1271.25 · What information is required for establishment registration and HCT/P listing?
- 21 CFR 1271.26 · When must I amend my establishment registration?
- 21 CFR 1271.27 · Will FDA assign me a registration number?
- 21 CFR 1271.37 · Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?
- 21 CFR 1271.45 · What requirements does this subpart contain?
- 21 CFR 1271.47 · What procedures must I establish and maintain?
- 21 CFR 1271.50 · How do I determine whether a donor is eligible?
- 21 CFR 1271.55 · What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
- 21 CFR 1271.60 · What quarantine and other requirements apply before the donor-eligibility determination is complete?
- 21 CFR 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 CFR 1271.75 · How do I screen a donor?
- 21 CFR 1271.80 · What are the general requirements for donor testing?
- 21 CFR 1271.85 · What donor testing is required for different types of cells and tissues?
- 21 CFR 1271.90 · Are there other exceptions and what labeling requirements apply?
- 21 CFR 1271.145 · Prevention of the introduction, transmission, or spread of communicable diseases.
- 21 CFR 1271.150 · Current good tissue practice requirements.
- 21 CFR 1271.155 · Exemptions and alternatives.
- 21 CFR 1271.160 · Establishment and maintenance of a quality program.
- 21 CFR 1271.170 · Personnel.
- 21 CFR 1271.180 · Procedures.
- 21 CFR 1271.190 · Facilities.
- 21 CFR 1271.195 · Environmental control and monitoring.
- 21 CFR 1271.200 · Equipment.
- 21 CFR 1271.210 · Supplies and reagents.
- 21 CFR 1271.215 · Recovery.
- 21 CFR 1271.220 · Processing and process controls.
- 21 CFR 1271.225 · Process changes.
- 21 CFR 1271.230 · Process validation.
- 21 CFR 1271.250 · Labeling controls.
- 21 CFR 1271.260 · Storage.
- 21 CFR 1271.265 · Receipt, predistribution shipment, and distribution of an HCT/P.
- 21 CFR 1271.270 · Records.
- 21 CFR 1271.290 · Tracking.
- 21 CFR 1271.320 · Complaint file.
- 21 CFR 1271.330 · Applicability.
- 21 CFR 1271.350 · Reporting.
- 21 CFR 1271.370 · Labeling.
- 21 CFR 1271.390 · Applicability.
- 21 CFR 1271.400 · Inspections.
- 21 CFR 1271.420 · HCT/Ps offered for import.
- 21 CFR 1271.440 · Orders of retention, recall, destruction, and cessation of manufacturing.
- 21 CFR 1300.01 · Definitions relating to controlled substances.
- 21 CFR 1300.02 · Definitions relating to listed chemicals.
- 21 CFR 1300.03 · Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances.
- 21 CFR 1300.04 · Definitions relating to the dispensing of controlled substances by means of the Internet.
- 21 CFR 1300.05 · Definitions relating to the disposal of controlled substances.
- 21 CFR 1300.06 · Definitions relating to emergency medical services agencies.
- 21 CFR 1301.01 · Scope of this part 1301.
- 21 CFR 1301.02 · Definitions. Link
- 21 CFR 1301.03 · Information; special instructions.
- 21 CFR 1301.11 · Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.
- 21 CFR 1301.12 · Separate registrations for separate locations.
- 21 CFR 1301.13 · Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.
- 21 CFR 1301.14 · Filing of application; acceptance for filing; defective applications.
- 21 CFR 1301.15 · Additional information.
- 21 CFR 1301.16 · Amendments to and withdrawal of applications.
- 21 CFR 1301.17 · Special procedures for certain applications.
- 21 CFR 1301.18 · Research protocols.
- 21 CFR 1301.19 · Special requirements for online pharmacies.
- 21 CFR 1301.20 · Registration for emergency medical services agencies.
- 21 CFR 1301.21 · Exemption from fees.
- 21 CFR 1301.22 · Exemption of agents and employees; affiliated practitioners.
- 21 CFR 1301.23 · Exemption of certain military and other personnel.
- 21 CFR 1301.24 · Exemption of law enforcement officials.
- 21 CFR 1301.25 · Registration regarding ocean vessels, aircraft, and other entities.
- 21 CFR 1301.26 · Exemptions from import or export requirements for personal medical use.
- 21 CFR 1301.27 · Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.
- 21 CFR 1301.28-1301.29 · §§ 1301.28-1301.29 [Reserved]
- 21 CFR 1301.31 · Administrative review generally.
- 21 CFR 1301.32 · Action on applications for research in Schedule I substances.
- 21 CFR 1301.33 · Application for bulk manufacture of Schedule I and II substances.
- 21 CFR 1301.34 · Application for importation of Schedule I and II substances.
- 21 CFR 1301.35 · Certificate of registration; denial of registration.
- 21 CFR 1301.36 · Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.
- 21 CFR 1301.37 · Order to show cause.
- 21 CFR 1301.41 · Hearings generally.
- 21 CFR 1301.42 · Purpose of hearing.
- 21 CFR 1301.43 · Request for hearing or appearance; waiver; default.
- 21 CFR 1301.44 · Burden of proof.
- 21 CFR 1301.45 · Time and place of hearing.
- 21 CFR 1301.46 · Final order.
- 21 CFR 1301.51 · Modification in registration.
- 21 CFR 1301.52 · Termination of registration; transfer of registration; distribution upon discontinuance of business.
- 21 CFR 1301.71 · Security requirements generally.
- 21 CFR 1301.72 · Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas.
- 21 CFR 1301.73 · Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.
- 21 CFR 1301.74 · Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs.
- 21 CFR 1301.75 · Physical security controls for practitioners.
- 21 CFR 1301.76 · Other security controls for practitioners.
- 21 CFR 1301.77 · Security controls for freight forwarding facilities.
- 21 CFR 1301.78-1301.79 · -1301.79 [Reserved]
- 21 CFR 1301.80 · Security controls for emergency medical services agencies.
- 21 CFR 1301.90 · Employee screening procedures.
- 21 CFR 1301.91 · Employee responsibility to report drug diversion.