10
CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER I-SHORT TITLE
Sec.
301.
Short title.
SUBCHAPTER II-DEFINITIONS
321.
Definitions; generally.
321a.
"Butter" defined.
321b.
"Package" defined.
321c.
Nonfat dry milk; "milk" defined.
SUBCHAPTER III-PROHIBITED ACTS AND PENALTIES
331.
Prohibited acts.
332.
Injunction proceedings.
(a)
Jurisdiction of courts.
(b)
Violation of injunction.
333.
Penalties.
(a)
Violation of section 331 of this title; second violation; intent to defraud or mislead.
(b)
Prescription drug marketing violations.
(c)
Exceptions in certain cases of good faith, etc.
(d)
Exceptions involving misbranded food.
(e)
Prohibited distribution of human growth hormone.
(f)
Violations related to devices.
333a.
Repealed.
334.
Seizure.
(a)
Grounds and jurisdiction.
(b)
Procedure; multiplicity of pending proceedings.
(c)
Availability of samples of seized goods prior to trial.
(d)
Disposition of goods after decree of condemnation; claims for remission or mitigation of forfeitures.
(e)
Costs.
(f)
Removal of case for trial.
(g)
Administrative restraint; detention orders.
335.
Hearing before report of criminal violation.
335a.
Debarment, temporary denial of approval, and suspension.
(a)
Mandatory debarment.
(b)
Permissive debarment.
(c)
Debarment period and considerations.
(d)
Termination of debarment.
(e)
Publication and list of debarred persons.
(f)
Temporary denial of approval.
(g)
Suspension authority.
(h)
Termination of suspension.
(i)
Procedure.
(j)
Judicial review.
(k)
Certification.
(l)
Applicability.
335b.
Civil penalties.
(a)
In general.
(b)
Procedure.
(c)
Judicial review.
(d)
Recovery of penalties.
(e)
Informants.
335c.
Authority to withdraw approval of abbreviated drug applications.
(a)
In general.
(b)
Procedure.
(c)
Applicability.
(d)
Judicial review.
336.
Report of minor violations.
337.
Proceedings in name of United States; provision as to subpoenas.
SUBCHAPTER IV-FOOD
341.
Definitions and standards for food.
342.
Adulterated food.
(a)
Poisonous, insanitary, etc., ingredients.
(b)
Absence, substitution, or addition of constituents.
(c)
Color additives.
(d)
Confectionery containing alcohol or nonnutritive substance.
(e)
Oleomargarine containing filthy, putrid, etc., matter.
(f)
Dietary supplement or ingredient: safety.
(g)
Dietary supplement: manufacturing practices.
343.
Misbranded food.
(a)
False or misleading label.
(b)
Offer for sale under another name.
(c)
Imitation of another food.
(d)
Misleading container.
(e)
Package form.
(f)
Prominence of information on label.
(g)
Representation as to definition and standard of identity.
(h)
Representation as to standards of quality and fill of container.
(i)
Label where no representation as to definition and standard of identity.
(j)
Representation for special dietary use.
(k)
Artificial flavoring, artificial coloring, or chemical preservatives.
(l)
Pesticide chemicals on raw agricultural commodities.
(m)
Color additives.
(n)
Packaging or labeling of drugs in violation of regulations.
(o)
Saccharin for immediate consumption.
(p)
Saccharin not for immediate consumption.
(q)
Nutrition information.
(r)
Nutrition levels and health-related claims.
(s)
Dietary supplements.
343–1.
National uniform nutrition labeling.
343–2.
Dietary supplement labeling exemptions.
(a)
In general.
(b)
Application.
(c)
Burden of proof.
343a.
Health risks presented by use of saccharin.
(a)
Statement on vending machines dispensing food containing saccharin respecting health risk; regulations.
(b)
Availability and distribution of information; review and revision.
344.
Emergency permit control.
(a)
Conditions on manufacturing, processing, etc., as health measure.
(b)
Violation of permit; suspension and reinstatement.
(c)
Inspection of permit-holding establishments.
345.
Regulations making exemptions.
346.
Tolerances for poisonous or deleterious substances in food; regulations.
346a.
Tolerances for pesticide chemicals in or on raw agricultural commodities.
(a)
Conditions of safety.
(b)
Establishment of tolerances.
(c)
Exemptions.
(d)
Regulations pursuant to petition; publication of notice; time for issuance; referral to advisory committees; effective date; hearings.
(e)
Regulations pursuant to Administrator's proposals.
(f)
Data submitted as confidential.
(g)
Advisory committees; appointment; composition; compensation; clerical assistance.
(h)
Right of consultation.
(i)
Judicial review.
(j)
Temporary tolerances.
(k)
Regulations based on public hearings before January 1, 1953.
(l)
Pesticides under Federal Insecticide, Fungicide, and Rodenticide Act; functions of Administrator of the Environmental Protection Agency; certifications; hearing; time limitation; opinion; regulations.
(m)
Amendment of regulations.
(n)
Guaranties.
(o)
Payment of fees; services or functions as conditioned on; waiver or refund of fees.
346b.
Authorization of appropriations.
347.
Intrastate sales of colored oleomargarine.
(a)
Law governing.
(b)
Labeling and packaging requirements.
(c)
Sales in public eating places.
(d)
Exemption from labeling requirements.
(e)
Color content of oleomargarine.
347a.
Congressional declaration of policy regarding oleomargarine sales.
347b.
Contravention of State laws.
348.
Food additives.
(a)
Unsafe food additives; exception for conformity with exemption or regulation.
(b)
Petition for regulation prescribing conditions of safe use; contents; description of production methods and controls; samples; notice of regulation.
(c)
Approval or denial of petition; time for issuance of order; evaluation of data; factors.
(d)
Regulation issued on Secretary's initiative.
(e)
Publication and effective date of orders.
(f)
Objections and public hearing; basis and contents of order; statement.
(g)
Judicial review.
(h)
Amendment or repeal of regulations.
(i)
Exemptions for investigational use.
349.
Bottled drinking water standards; publication in Federal Register.
350.
Vitamins and minerals.
(a)
Authority and limitations of Secretary; applicability.
(b)
Labeling and advertising requirements for foods.
(c)
Definitions.
350a.
Infant formulas.
(a)
Adulteration.
(b)
Requirements for quality factors, good manufacturing practices, and retention of records.
(c)
Registration of persons distributing new infant formula.
(d)
Submission of information about new infant formula required.
(e)
Additional notice requirements for manufacturer.
(f)
Procedures applicable to recalls by manufacturer; regulatory oversight.
(g)
Recordkeeping requirements for manufacturer; regulatory oversight and enforcement.
(h)
Exemptions; regulatory oversight.
(i)
Nutrient requirements.
350b.
New dietary ingredients.
(a)
In general.
(b)
Petition.
(c)
"New dietary ingredient" defined.
SUBCHAPTER V-DRUGS AND DEVICES
Part A-Drugs and Devices
351.
Adulterated drugs and devices.
(a)
Poisonous, insanitary, etc., ingredients; adequate controls in manufacture.
(b)
Strength, quality, or purity differing from official compendium.
(c)
Misrepresentation of strength, etc., where drug is unrecognized in compendium.
(d)
Mixture with or substitution of another substance.
(e)
Devices not in conformity with performance standards.
(f)
Certain class III devices.
(g)
Banned devices.
(h)
Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions.
(i)
Failure to comply with requirements under which device was exempted for investigational use.
352.
Misbranded drugs and devices.
(a)
False or misleading label.
(b)
Package form; contents of label.
(c)
Prominence of information on label.
(d)
Habit forming substances.
(e)
Designation of drugs or devices by established names.
(f)
Directions for use and warnings on label.
(g)
Representations as recognized drug; packing and labeling; inconsistent requirements for designation of drug.
(h)
Deteriorative drugs; packing and labeling.
(i)
Drug; misleading container; imitation; offer for sale under another name.
(j)
Health-endangering when used as prescribed.
(k)
Insulin not properly certified.
(l)
Antibiotic drugs improperly certified.
(m)
Color additives; packing and labeling.
(n)
Prescription drug advertisements: established name; quantitative formula; side effects, contraindications, and effectiveness; prior approval; false advertising; labeling; construction of the Convention on Psychotropic Substances.
(o)
Drugs or devices from nonregistered establishments.
(p)
Packaging or labeling of drugs in violation of regulations.
(q)
Restricted devices using false or misleading advertising or used in violation of regulations.
(r)
Restricted devices not carrying requisite accompanying statements in advertisements and other descriptive printed matter.
(s)
Devices subject to performance standards not bearing requisite labeling.
(t)
Devices for which there has been a failure or refusal to give required notification or to furnish required material or information.
353.
Exemptions and consideration for certain drugs, devices, and biological products.
(a)
Regulations for goods to be processed, labeled, or repacked elsewhere.
(b)
Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws.
(c)
Sales restrictions.
(d)
Distribution of drug samples.
(e)
Wholesale distributors; guidelines for licensing; definitions.
(f)
Veterinary prescription drugs.
(g)
Regulation of combination products.
354.
Repealed.
355.
New drugs.
(a)
Necessity of effective approval of application.
(b)
Filing application; contents.
(c)
Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order.
(d)
Grounds for refusing application; approval of application; "substantial evidence" defined.
(e)
Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to public health.
(f)
Revocation of order refusing, withdrawing or suspending approval of application.
(g)
Service of orders.
(h)
Appeal from order.
(i)
Exemptions of drugs for research; discretionary and mandatory conditions; direct reports to Secretary.
(j)
Abbreviated new drug applications.
(k)
Records and reports; required information; regulations and orders; access to records.
(l)
Public disclosure of safety and effectiveness data.
(m)
"Patent" defined.
356.
Certification of drugs containing insulin.
(a)
Standards for certification.
(b)
Regulations.
(c)
Tests or methods of assay; revision.
357.
Certification of drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug.
(a)
Regulations prescribed by Secretary; release prior to certification; "antibiotic drug" defined.
(b)
Provisions of regulations.
(c)
Exemption of drugs not involving safety and efficacy of use; considerations; certification after exemption; labeling and advertising claims.
(d)
Exemption of drugs stored, processed, and labeled at plants other than manufacturer's, used in manufacture of other drugs or for investigational purposes; discretionary and mandatory conditions; direct reports to Secretary.
(e)
Exempted new drugs subject to section 355 of this title; request for certification of exempted drug; determination of compliance with sections 351(b) and 352(g) of this title.
(f)
Filing of petitions; contents; notice; answer; public hearing; orders.
(g)
Records and reports; professional ethics and interests of patients; examination of data; access to records.
(h)
Issuance of regulations; conditions; amendment or repeal of regulations; effective date; procedure; lack of substantial evidence.
358.
Authority to designate official names.
(a)
Necessity or desirability; use in official compendiums; infringement of trademarks.
(b)
Review of names in official compendiums.
(c)
Determinations of complexity, usefulness, multiplicity, or lack of name; designation by Secretary.
(d)
Revised official names; compilation, publication, and public distribution of listings.
(e)
Request by compiler of official compendium for designation of name.
359.
Nonapplicability of subchapter to cosmetics.
360.
Registration of producers of drugs or devices.
(a)
Definitions.
(b)
Annual registration.
(c)
New producers.
(d)
Additional establishments.
(e)
Registration number; uniform system for identification of devices intended for human use.
(f)
Availability of registrations for inspection.
(g)
Exclusions from application of section.
(h)
Inspection of premises.
(i)
Foreign establishments.
(j)
Filing of lists of drugs and devices manufactured, prepared, propagated and compounded by registrants; statements; accompanying disclosures.
(k)
Report preceding introduction of devices into interstate commerce.
360a.
Repealed.
360b.
New animal drugs.
(a)
Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research.
(b)
Filing application for uses of new animal drug; contents; patent information; abbreviated application.
(c)
Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order; abbreviated applications; withdrawal periods; effective date of approval; relationship to other applications; withdrawal or suspension of approval; bioequivalence; filing of additional patent information.
(d)
Grounds for refusing application; approval of application; factors; "substantial evidence" defined.
(e)
Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to health of man or animals.
(f)
Revocation of order refusing, withdrawing or suspending approval of application.
(g)
Service of orders.
(h)
Appeal from order.
(i)
Publication in Federal Register; effective date and revocation or suspension of regulation.
(j)
Exemption of drugs for research; discretionary and mandatory conditions.
(k)
Food containing new animal drug considered unadulterated while approval of application for such drug is effective.
(l)
Records and reports; required information; regulations and orders; examination of data; access to records.
(m)(1)
Filing application for uses of animal feed containing new animal drug; contents.
(2)
Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order.
(3)
Grounds for refusing application; approval of application; approval effective during existence of subsection (i) regulation.
(4)
Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to health of man or animals.
(5)
Records and reports; regulations and orders; access to records.
(n)
Abbreviated applications for new animal drugs; contents, filing, etc.; lists of approved drugs.
(o)
"Patent" defined.
(p)
Safety and effectiveness data.
360c.
Classification of devices intended for human use.
(a)
Classes of devices.
(b)
Classification panels.
(c)
Classification panel organization and operation.
(d)
Panel recommendation; publication; priorities.
(e)
Classification changes.
(f)
Initial classification and reclassification of certain devices.
(g)
Information.
(h)
Definitions.
(i)
Substantial equivalence.
360d.
Performance standards.
(a)
Reasonable assurance of safe and effective performance; periodic evaluation.
(b)
Establishment of a standard.
360e.
Premarket approval.
(a)
General requirement.
(b)
Regulation to require premarket approval.
(c)
Application for premarket approval.
(d)
Action on application for premarket approval.
(e)
Withdrawal and temporary suspension of approval of application.
(f)
Product development protocol.
(g)
Review.
(h)
Service of orders.
(i)
Revision.
360f.
Banned devices.
(a)
General rule.
(b)
Special effective date.
360g.
Judicial review.
(a)
Petition; record.
(b)
Additional data, views, and arguments.
(c)
Standard for review.
(d)
Finality of judgments.
(e)
Remedies.
(f)
Statement of reasons.
360h.
Notification and other remedies.
(a)
Notification.
(b)
Repair, replacement, or refund.
(c)
Reimbursement.
(d)
Effect on other liability.
(e)
Recall authority.
360i.
Records and reports on devices.
(a)
General rule.
(b)
User reports.
(c)
Persons exempt.
(d)
Certification.
(e)
Device tracking.
(f)
Reports of removals and corrections.
360j.
General provisions respecting control of devices intended for human use.
(a)
General rule.
(b)
Custom devices.
(c)
Trade secrets.
(d)
Notices and findings.
(e)
Restricted devices.
(f)
Good manufacturing practice requirements.
(g)
Exemption for devices for investigational use.
(h)
Release of information respecting safety and effectiveness.
(i)
Proceedings of advisory panels and committees.
(j)
Traceability.
(k)
Research and development.
(l)
Transitional provisions for devices considered as new drugs or antibiotic drugs.
(m)
Humanitarian device exemption.
360k.
State and local requirements respecting devices.
(a)
General rule.
(b)
Exempt requirements.
360l.
Postmarket surveillance.
(a)
In general.
(b)
Surveillance approval.
Part B-Drugs for Rare Diseases or Conditions
360aa.
Recommendations for investigations of drugs for rare diseases or conditions.
(a)
Request by sponsor; response by Secretary.
(b)
Regulations.
360bb.
Designation of drugs for rare diseases or conditions.
(a)
Request by sponsor; preconditions; "rare disease or condition" defined.
(b)
Notification of discontinuance of drug or application as condition.
(c)
Notice to public.
(d)
Regulations.
360cc.
Protection for drugs for rare diseases or conditions.
(a)
Exclusive approval, certification, or license.
(b)
Exceptions.
360dd.
Open protocols for investigations of drugs for rare diseases or conditions.
360ee.
Grants and contracts for development of drugs for rare diseases and conditions.
(a)
Authority of Secretary.
(b)
Definitions.
(c)
Authorization of appropriations.
Part C-Electronic Product Radiation Control
360hh.
Definitions.
360ii.
Program of control.
(a)
Establishment.
(b)
Powers of Secretary.
(c)
Record keeping.
360jj.
Studies by the Secretary.
(a)
Report to Congress.
(b)
Participation of other Federal agencies.
(c)
Organization of studies and participation.
360kk.
Performance standards for electronic products.
(a)
Promulgation of regulations.
(b)
Administrative procedure.
(c)
Publication in Federal Register.
(d)
Judicial review.
(e)
Availability of record.
(f)
Technical Electronic Product Radiation Safety Standards Committee.
(g)
Review and evaluation.
(h)
Product certification.
360ll.
Notification of defects in and repair or replacement of electronic products.
(a)
Notification; exemption.
(b)
Method of notification.
(c)
Requisite elements of notification.
(d)
Copies to Secretary of communications by manufacturers to dealers or distributors regarding defects.
(e)
Notice from Secretary to manufacturer of defects or failure to comply with standards.
(f)
Correction of defects.
(g)
Effective date.
360mm.
Imports.
(a)
Refusal of admission to noncomplying electronic products.
(b)
Bond.
(c)
Liability of owner or consignee for expenses connected with refusal of admission.
(d)
Designation of agent for purposes of service.
360nn.
Inspection, records, and reports.
(a)
Inspection of premises.
(b)
Record keeping.
(c)
Disclosure of technical data.
(d)
Public nature of reports.
(e)
Trade secrets.
(f)
Information required to identify and locate first purchasers of electronic products.
360oo.
Prohibited acts.
360pp.
Enforcement.
(a)
Jurisdiction of courts.
(b)
Penalties.
(c)
Venue; process.
(d)
Warnings.
(e)
Compliance with regulations.
(f)
Additional remedies.
360qq.
Annual report.
360rr.
Federal-State cooperation.
360ss.
State standards.
SUBCHAPTER VI-COSMETICS
361.
Adulterated cosmetics.
362.
Misbranded cosmetics.
363.
Regulations making exemptions.
364.
Repealed.
SUBCHAPTER VII-GENERAL AUTHORITY
Part A-General Administrative Provisions
371.
Regulations and hearings.
(a)
Authority to promulgate regulations.
(b)
Regulations for imports and exports.
(c)
Conduct of hearings.
(d)
Effectiveness of definitions and standards of identity.
(e)
Procedure for establishment.
(f)
Review of order.
(g)
Copies of records of hearings.
372.
Examinations and investigations.
(a)
Authority to conduct.
(b)
Availability to owner of part of analysis samples.
(c)
Records of other departments and agencies.
(d)
Information on patents for drugs.
(e)
Powers of enforcement personnel.
372a.
Transferred.
373.
Records of interstate shipment.
374.
Inspection.
(a)
Right of agents to enter; scope of inspection; notice; promptness; exclusions.
(b)
Written report to owner; copy to Secretary.
(c)
Receipt for samples taken.
(d)
Analysis of samples furnished owner.
(e)
Accessibility of records.
375.
Publicity.
(a)
Reports.
(b)
Information regarding certain goods.
376.
Examination of sea food on request of packer; marking food with results; fees; penalties.
377.
Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests.
378.
Advertising of foods.
(a)
Determination of misbranding; notification of Federal Trade Commission by Secretary; contents.
(b)
Action by Federal Trade Commission precluding action by Secretary; exception.
(c)
Secretary's determination of imminent hazard to health as suspending applicability of provisions.
(d)
Coordination of action by Secretary with Federal Trade Commission.
379.
Confidential information.
379a.
Presumption of existence of jurisdiction.
379b.
Consolidated administrative and laboratory facility.
(a)
Authority.
(b)
Awarding of contract.
(c)
Donations.
(d)
Authorization of appropriations.
379c.
Transferred.
379d.
Automation of Food and Drug Administration.
(a)
In general.
(b)
Authorization of appropriations.
Part B-Colors
379e.
Listing and certification of color additives for foods, drugs, devices, and cosmetics.
(a)
Unsafe color additives.
(b)
Listing of colors; regulations; issuance, amendment or repeal; referral to advisory committee; report and recommendations; appointment and compensation of advisory committee.
(c)
Certification of colors.
(d)
Procedure for issuance, amendment, or repeal of regulations.
(e)
Fees.
(f)
Exemptions.
Part C-Fees
subpart 1-freedom of information fees
379f.
Recovery and retention of fees for freedom of information requests.
(a)
In general.
(b)
Use of fees.
(c)
Waiver of fees.
subpart 2-fees relating to drugs
379g.
Definitions.
379h.
Authority to assess and use drug fees.
(a)
Types of fees.
(b)
Fee amounts.
(c)
Increases and adjustments.
(d)
Fee waiver or reduction.
(e)
Effect of failure to pay fees.
(f)
Assessment of fees.
(g)
Crediting and availability of fees.
(h)
Collection of unpaid fees.
(i)
Construction.
SUBCHAPTER VIII-IMPORTS AND EXPORTS
381.
Imports and exports.
(a)
Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission.
(b)
Disposition of refused articles.
(c)
Charges concerning refused articles.
(d)
Reimportation.
(e)
Exports.
382.
Exports of certain unapproved products.
(a)
Drugs intended for human or animal use which require approval or licensing.
(b)
Conditions for export; active pursuit of drug approval or licensing; application for export, contents, approval or disapproval; list of eligible countries for export; criteria for list change.
(c)
Report to Secretary by holder of approved application; events requiring report; annual report to Secretary on pursuit of approval of drug.
(d)
Export of drug under approved application prohibited.
(e)
Determination by Secretary of noncompliance, failure of active pursuit of drug approval, imminent hazard of drug to public health, or exportation of drug to noneligible country; notices and hearings; prohibition on exportation of drug.
(f)
Drugs used in prevention or treatment of tropical disease.
(g)
Reference to Secretary and holder of application.
383.
Office of International Relations.
SUBCHAPTER IX-MISCELLANEOUS
391.
Separability clause.
392.
Exemption of meats and meat food products.
(a)
Law determinative of exemption.
(b)
Laws unaffected.
393.
Food and Drug Administration.
(a)
In general.
(b)
Commissioner.
(c)
Technical and scientific review groups.
394.
Scientific review groups.
395.
Loan repayment program.
(a)
In general.
(b)
Applicability of certain provisions.
(c)
Authorization of appropriations.
Chapter Referred to in Other Sections
This chapter is referred to in sections 453, 457, 466, 467, 467f, 601, 607, 620, 679, 802, 811, 829, 902, 1033, 1049, 1052, 1401, 1402, 1403 of this title; title 7 sections 136v, 138i, 1431c, 5341, 6519; title 15 sections 70j, 1261, 1263, 1277, 1457, 1459, 1460, 2057a, 2057b, 2079; title 18 section 42; title 19 section 2578a; title 26 sections 170, 4817; title 35 sections 155, 156, 271; title 42 sections 262, 300aa–22, 300aa–23, 1396r–8, 1786, 3512, 7671.