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NOTES:
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.
321d.
Market names for catfish and ginseng.
(a)
Catfish labeling.
(b)
Ginseng labeling.
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)
Redesignated (g)
(g)
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Repealed.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.
(h)
Administrative detention of foods.
335.
Hearing before report of criminal violation.
335a.
Debarment, temporary denial of approval, and suspension.
(a)
Mandatory debarment; certain drug applications.
(b)
Permissive debarment; certain drug applications; food imports.
(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.
(m)
Devices; mandatory debarment regarding third-party inspections and reviews.
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.
(h)
Reoffer of food previously denied admission.
(i)
Noncompliance with sanitary transportation 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),
(p)
Repealed.
(q)
Nutrition information.
(r)
Nutrition levels and health-related claims.
(s)
Dietary supplements.
(t)
Catfish.
(u)
Ginseng.
(v)
Failure to label; health threat.
(w)
Major food allergen labeling requirements.
(x)
Nonmajor food allergen labeling requirements.
343–1.
National uniform nutrition labeling.
343–2.
Dietary supplement labeling exemptions.
(a)
In general.
(b)
Application.
(c)
Burden of proof.
343–3.
Disclosure.
343a.
Repealed.
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 and exemptions for pesticide chemical residues.
(a)
Requirement for tolerance or exemption.
(b)
Authority and standard for tolerance.
(c)
Authority and standard for exemptions.
(d)
Petition for tolerance or exemption.
(e)
Action on Administrator’s own initiative.
(f)
Special data requirements.
(g)
Effective date, objections, hearings, and administrative review.
(h)
Judicial review.
(i)
Confidentiality and use of data.
(j)
Status of previously issued regulations.
(k)
Transitional provision.
(l)
Harmonization with action under other laws.
(m)
Fees.
(n)
National uniformity of tolerances.
(o)
Consumer right to know.
(p)
Estrogenic substances screening program.
(q)
Schedule for review.
(r)
Temporary tolerance or exemption.
(s)
Savings clause.
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)
Notification relating to food contact substance.
(i)
Amendment or repeal of regulations.
(j)
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.
350c.
Maintenance and inspection of records.
(a)
Records inspection.
(b)
Regulations concerning recordkeeping.
(c)
Protection of sensitive information.
(d)
Limitations.
350d.
Registration of food facilities.
(a)
Registration.
(b)
Facility.
(c)
Rule of construction.
350e.
Sanitary transportation practices.
(a)
Definitions.
(b)
Regulations.
(c)
Contents.
(d)
Waivers.
(e)
Preemption.
(f)
Assistance of other agencies.
SUBCHAPTER V—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) Repealed. (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), (l) Repealed. (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. (u) Identification of manufacturer. (v) Reprocessed single-use devices. (w) New animal drugs. 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. 353a. Pharmacy compounding. (a) In general. (b) Compounded drug. (c) Advertising and promotion. (d) Regulations. (e) Application. (f) “Compounding” defined. 354. Veterinary feed directive drugs. (a) Lawful veterinary feed directive requirement. (b) Labeling and advertising. (c) Nonprescription status. 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. (n) Scientific advisory panels. 355a. Pediatric studies of drugs. (a) Definitions. (b) Market exclusivity for new drugs. (c) Market exclusivity for already-marketed drugs. (d) Conduct of pediatric studies. (e) Delay of effective date for certain application. (f) Notice of determinations on studies requirement. (g) Limitations. (h) Relationship to pediatric research requirements. (i) Labeling supplements. (j) Dissemination of pediatric information. (k) Clarification of interaction of market exclusivity under this section and market exclusivity awarded to an applicant for approval of a drug under section 355 (j) of this title. (l) Prompt approval of drugs under section 355 (j) of this title when pediatric information is added to labeling. (m) Report. (n) Sunset. 355b. Adverse-event reporting. (a) Toll-free number in labeling. (b) Drugs with pediatric market exclusivity. 355c. Research into pediatric uses for drugs and biological products. (a) New drugs and biological products. (b) Marketed drugs and biological products. (c) Meaningful therapeutic benefit. (d) Submission of assessments. (e) Meetings. (f) Scope of authority. (g) Orphan drugs. (h) Integration with other pediatric studies. 356. Fast track products. (a) Designation of drug as fast track product. (b) Approval of application for fast track product. (c) Review of incomplete applications for approval of fast track product. (d) Awareness efforts. 356–1. Accelerated approval of priority countermeasures. (a) In general. (b) Use of animal trials. (c) Priority review of drugs and biological products. (d) Definitions. 356a. Manufacturing changes. (a) In general. (b) Validation of effects of changes. (c) Major manufacturing changes. (d) Other manufacturing changes. 356b. Reports of postmarketing studies. (a) Submission. (b) Consideration of information as public information. (c) Status of studies and reports. (d) Disclosure. (e) Notification. 356c. Discontinuance of life saving product. (a) In general. (b) Reduction in notification period. (c) Distribution. 357. Repealed. 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) Registration of 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. (l) Exemption from reporting requirements. (m) List of exempt class II devices; determination by Secretary; publication in Federal Register. (n) Review of report; time for determination by Secretary. (o) Reprocessed single-use devices. (p) Electronic registration. 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; import tolerances. (b) Filing application for uses of new animal drug; contents; patent information; abbreviated application; presubmission conference. (c) Period for submission and 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; combination drugs. (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) Feed mill licenses. (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. (c) Recognition of 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) Repealed. (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. (m) Humanitarian device exemption. (n) Regulation of contact lenses as devices. 360k. State and local requirements respecting devices. (a) General rule. (b) Exempt requirements. 360l. Postmarket surveillance. (a) In general. (b) Surveillance approval. 360m. Accredited persons. (a) In general. (b) Accreditation. (c) Duration. (d) Report.
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.
360hh. Definitions. 360ii. Program of control. (a) Establishment. (b) Powers of Secretary. (c) Record keeping. 360jj. Studies by 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. Repealed. 360rr. Federal-State cooperation. 360ss. State standards.
360aaa. Requirements for dissemination of treatment information on drugs or devices. (a) In general. (b) Specific requirements. (c) Additional information. 360aaa–1. Information authorized to be disseminated. (a) Authorized information. (b) Reference publication. 360aaa–2. Establishment of list of articles and publications disseminated and list of providers that received articles and reference publications. (a) In general. (b) Records. 360aaa–3. Requirement regarding submission of supplemental application for new use; exemption from requirement. (a) In general. (b) Certification on supplemental application; condition in case of completed studies. (c) Certification on supplemental application; condition in case of planned studies. (d) Exemption from requirement of supplemental application. (e) Requirements regarding applications. 360aaa–4. Corrective actions; cessation of dissemination. (a) Postdissemination data regarding safety and effectiveness. (b) Cessation of dissemination. (c) Corrective actions by manufacturers. 360aaa–5. Definitions. 360aaa–6. Rules of construction. (a) Unsolicited request. (b) Dissemination of information on drugs or devices not evidence of intended use. (c) Patent protection. (d) Authorization for dissemination of articles and fees for reprints of articles.
360bbb. Expanded access to unapproved therapies and diagnostics. (a) Emergency situations. (b) Individual patient access to investigational products intended for serious diseases. (c) Treatment investigational new drug applications and treatment investigational device exemptions. (d) Termination. (e) Definitions. 360bbb–1. Dispute resolution. 360bbb–2. Classification of products. (a) Request. (b) Statement. (c) Inaction of Secretary. 360bbb–3. Authorization for medical products for use in emergencies. (a) In general. (b) Declaration of emergency. (c) Criteria for issuance of authorization. (d) Scope of authorization. (e) Conditions of authorization. (f) Duration of authorization. (g) Revocation of authorization. (h) Publication; confidential information. (i) Actions committed to agency discretion. (j) Rules of construction. (k) Relation to other provisions. (l) Option to carry out authorized activities.
360ccc. Conditional approval of new animal drugs for minor use and minor species. (a) Application requirements; contents; restrictions. (b) Order of approval or hearing. (c) Order of approval or refusal after hearing. (d) Effective period; renewal; refusal of renewal. (e) Withdrawal of conditional approval. (f) Labeling. (g) Amendment of application. (h) Order of approval after conditional approval period termination. (i) Judicial review. (j) Definition. 360ccc–1. Index of legally marketed unapproved new animal drugs for minor species. (a) Establishment and content. (b) Conferences. (c) Request for determination of eligibility for inclusion in index. (d) Request for addition to index. (e) Index contents; publication. (f) Removal from index; suspended listing. (g) Regulations concerning exemptions for investigational use. (h) Labeling contents. (i) Records and reports. (j) Public disclosure of safety and effectiveness data. 360ccc–2. Designated new animal drugs for minor use or minor species. (a) Designation. (b) Grants and contracts for development of designated new animal drugs. (c) Exclusivity for designated new animal drugs. SUBCHAPTER VI—COSMETICS 361. Adulterated cosmetics. 362. Misbranded cosmetics. 363. Regulations making exemptions. 364. Repealed. SUBCHAPTER VII—GENERAL AUTHORITY
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. (h) Guidance documents. 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. (a) In general. (b) Food transportation records. 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. (f) Recordkeeping. (g) Inspections by accredited persons. 374a. Inspections relating to food allergens. 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.
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.
379f. Recovery and retention of fees for freedom of information requests. (a) In general. (b) Use of fees. (c) Waiver of fees.
379g. Definitions. 379h. Authority to assess and use drug fees. (a) Types of fees. (b) Fee revenue amounts. (c) Adjustments. (d) Fee waiver or reduction. (e) Effect of failure to pay fees. (f) Limitations. (g) Crediting and availability of fees. (h) Collection of unpaid fees. (i) Written requests for waivers, reductions, and refunds. (j) Construction.
379i. Definitions. 379j. Authority to assess and use device fees. (a) Types of fees. (b) Fee revenue amounts. (c) Annual fee setting. (d) Small businesses; fee waiver and fee reduction regarding premarket approval fees. (e) Small businesses; fee reduction regarding premarket notification submissions. (f) Effect of failure to pay fees. (g) Conditions. (h) Crediting and availability of fees. (i) Collection of unpaid fees. (j) Written requests for refunds. (k) Construction.
379j–11. Definitions. 379j–12. Authority to assess and use animal drug fees. (a) Types of fees. (b) Fee amounts. (c) 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) Written requests for waivers, reductions, and refunds. (j) Construction. (k) Abbreviated new animal drug applications.
379k. Information system. 379l. Education. (a) In general. (b) Intramural fellowships and other training programs.
379o. Environmental impact.
379r. National uniformity for nonprescription drugs. (a) In general. (b) Exemption. (c) Scope. (d) Exceptions. (e) No effort on product liability law. (f) State enforcement authority. 379s. Preemption for labeling or packaging of cosmetics. (a) In general. (b) Exemption. (c) Scope. (d) No effect on product liability law. (e) State initiative.
379v. Safety report disclaimers. 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. (f) Labeling of exported drugs. (g) Warning notice of importation in violation of chapter. (h) Protection against adulteration of food. (i) Testing for rapid detection of adulteration of food. (j) Temporary holds at ports of entry. (k) Importation by debarred persons. (l) Failure to register. (m) Prior notice of imported food shipments. (n) Labeling of food refused admission. (o) Registration statement. 382. Exports of certain unapproved products. (a) Drugs or devices intended for human or animal use which require approval or licensing. (b) List of eligible countries for export; criteria for addition to list; direct export; petition for exemption. (c) Investigational use exemption. (d) Anticipation of market authorization. (e) Diagnosis, prevention, or treatment of tropical disease. (f) Prohibition of export of drug or device. (g) Notification of Secretary. (h) References to Secretary and term “drug”. (i) Exportation. 383. Office of International Relations. (a) Establishment. (b) Agreements with foreign countries. (c) Harmonizing regulatory requirements. 384. Importation of prescription drugs. (a) Definitions. (b) Regulations. (c) Limitation. (d) Information and records. (e) Testing. (f) Registration of foreign sellers. (g) Suspension of importation. (h) Approved labeling. (i) Charitable contributions. (j) Waiver authority for importation by individuals. (k) Construction. (l) Effectiveness of section. (m) Authorization of appropriations. 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) Mission. (c) Interagency collaboration. (d) Commissioner. (e) Technical and scientific review groups. (f) Agency plan for statutory compliance. (g) Annual report. 393a. Office of Pediatric Therapeutics. (a) Establishment. (b) Duties. (c) Staff. 394. Scientific review groups. 395. Loan repayment program. (a) In general. (b) Applicability of certain provisions. (c) Authorization of appropriations. 396. Practice of medicine. 397. Contracts for expert review. (a) In general. (b) Review of expert review. 398. Notices to States regarding imported food. (a) In general. (b) Rule of construction. 399. Grants to States for inspections. (a) In general. (b) Notices regarding adulterated imported food. (c) Authorization of appropriations.
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) Repealed. (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), (l) Repealed. (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. (u) Identification of manufacturer. (v) Reprocessed single-use devices. (w) New animal drugs. 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. 353a. Pharmacy compounding. (a) In general. (b) Compounded drug. (c) Advertising and promotion. (d) Regulations. (e) Application. (f) “Compounding” defined. 354. Veterinary feed directive drugs. (a) Lawful veterinary feed directive requirement. (b) Labeling and advertising. (c) Nonprescription status. 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. (n) Scientific advisory panels. 355a. Pediatric studies of drugs. (a) Definitions. (b) Market exclusivity for new drugs. (c) Market exclusivity for already-marketed drugs. (d) Conduct of pediatric studies. (e) Delay of effective date for certain application. (f) Notice of determinations on studies requirement. (g) Limitations. (h) Relationship to pediatric research requirements. (i) Labeling supplements. (j) Dissemination of pediatric information. (k) Clarification of interaction of market exclusivity under this section and market exclusivity awarded to an applicant for approval of a drug under section 355 (j) of this title. (l) Prompt approval of drugs under section 355 (j) of this title when pediatric information is added to labeling. (m) Report. (n) Sunset. 355b. Adverse-event reporting. (a) Toll-free number in labeling. (b) Drugs with pediatric market exclusivity. 355c. Research into pediatric uses for drugs and biological products. (a) New drugs and biological products. (b) Marketed drugs and biological products. (c) Meaningful therapeutic benefit. (d) Submission of assessments. (e) Meetings. (f) Scope of authority. (g) Orphan drugs. (h) Integration with other pediatric studies. 356. Fast track products. (a) Designation of drug as fast track product. (b) Approval of application for fast track product. (c) Review of incomplete applications for approval of fast track product. (d) Awareness efforts. 356–1. Accelerated approval of priority countermeasures. (a) In general. (b) Use of animal trials. (c) Priority review of drugs and biological products. (d) Definitions. 356a. Manufacturing changes. (a) In general. (b) Validation of effects of changes. (c) Major manufacturing changes. (d) Other manufacturing changes. 356b. Reports of postmarketing studies. (a) Submission. (b) Consideration of information as public information. (c) Status of studies and reports. (d) Disclosure. (e) Notification. 356c. Discontinuance of life saving product. (a) In general. (b) Reduction in notification period. (c) Distribution. 357. Repealed. 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) Registration of 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. (l) Exemption from reporting requirements. (m) List of exempt class II devices; determination by Secretary; publication in Federal Register. (n) Review of report; time for determination by Secretary. (o) Reprocessed single-use devices. (p) Electronic registration. 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; import tolerances. (b) Filing application for uses of new animal drug; contents; patent information; abbreviated application; presubmission conference. (c) Period for submission and 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; combination drugs. (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) Feed mill licenses. (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. (c) Recognition of 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) Repealed. (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. (m) Humanitarian device exemption. (n) Regulation of contact lenses as devices. 360k. State and local requirements respecting devices. (a) General rule. (b) Exempt requirements. 360l. Postmarket surveillance. (a) In general. (b) Surveillance approval. 360m. Accredited persons. (a) In general. (b) Accreditation. (c) Duration. (d) Report.
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 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. Repealed. 360rr. Federal-State cooperation. 360ss. State standards.
Part D—Dissemination of Treatment Information
360aaa. Requirements for dissemination of treatment information on drugs or devices. (a) In general. (b) Specific requirements. (c) Additional information. 360aaa–1. Information authorized to be disseminated. (a) Authorized information. (b) Reference publication. 360aaa–2. Establishment of list of articles and publications disseminated and list of providers that received articles and reference publications. (a) In general. (b) Records. 360aaa–3. Requirement regarding submission of supplemental application for new use; exemption from requirement. (a) In general. (b) Certification on supplemental application; condition in case of completed studies. (c) Certification on supplemental application; condition in case of planned studies. (d) Exemption from requirement of supplemental application. (e) Requirements regarding applications. 360aaa–4. Corrective actions; cessation of dissemination. (a) Postdissemination data regarding safety and effectiveness. (b) Cessation of dissemination. (c) Corrective actions by manufacturers. 360aaa–5. Definitions. 360aaa–6. Rules of construction. (a) Unsolicited request. (b) Dissemination of information on drugs or devices not evidence of intended use. (c) Patent protection. (d) Authorization for dissemination of articles and fees for reprints of articles.
Part E—General Provisions Relating to Drugs and Devices
360bbb. Expanded access to unapproved therapies and diagnostics. (a) Emergency situations. (b) Individual patient access to investigational products intended for serious diseases. (c) Treatment investigational new drug applications and treatment investigational device exemptions. (d) Termination. (e) Definitions. 360bbb–1. Dispute resolution. 360bbb–2. Classification of products. (a) Request. (b) Statement. (c) Inaction of Secretary. 360bbb–3. Authorization for medical products for use in emergencies. (a) In general. (b) Declaration of emergency. (c) Criteria for issuance of authorization. (d) Scope of authorization. (e) Conditions of authorization. (f) Duration of authorization. (g) Revocation of authorization. (h) Publication; confidential information. (i) Actions committed to agency discretion. (j) Rules of construction. (k) Relation to other provisions. (l) Option to carry out authorized activities.
Part F—New Animal Drugs for Minor Use and Minor Species
360ccc. Conditional approval of new animal drugs for minor use and minor species. (a) Application requirements; contents; restrictions. (b) Order of approval or hearing. (c) Order of approval or refusal after hearing. (d) Effective period; renewal; refusal of renewal. (e) Withdrawal of conditional approval. (f) Labeling. (g) Amendment of application. (h) Order of approval after conditional approval period termination. (i) Judicial review. (j) Definition. 360ccc–1. Index of legally marketed unapproved new animal drugs for minor species. (a) Establishment and content. (b) Conferences. (c) Request for determination of eligibility for inclusion in index. (d) Request for addition to index. (e) Index contents; publication. (f) Removal from index; suspended listing. (g) Regulations concerning exemptions for investigational use. (h) Labeling contents. (i) Records and reports. (j) Public disclosure of safety and effectiveness data. 360ccc–2. Designated new animal drugs for minor use or minor species. (a) Designation. (b) Grants and contracts for development of designated new animal drugs. (c) Exclusivity for designated new animal drugs. 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. (h) Guidance documents. 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. (a) In general. (b) Food transportation records. 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. (f) Recordkeeping. (g) Inspections by accredited persons. 374a. Inspections relating to food allergens. 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 revenue amounts. (c) Adjustments. (d) Fee waiver or reduction. (e) Effect of failure to pay fees. (f) Limitations. (g) Crediting and availability of fees. (h) Collection of unpaid fees. (i) Written requests for waivers, reductions, and refunds. (j) Construction.
subpart 3—fees relating to devices
379i. Definitions. 379j. Authority to assess and use device fees. (a) Types of fees. (b) Fee revenue amounts. (c) Annual fee setting. (d) Small businesses; fee waiver and fee reduction regarding premarket approval fees. (e) Small businesses; fee reduction regarding premarket notification submissions. (f) Effect of failure to pay fees. (g) Conditions. (h) Crediting and availability of fees. (i) Collection of unpaid fees. (j) Written requests for refunds. (k) Construction.
subpart 4—fees relating to animal drugs
379j–11. Definitions. 379j–12. Authority to assess and use animal drug fees. (a) Types of fees. (b) Fee amounts. (c) 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) Written requests for waivers, reductions, and refunds. (j) Construction. (k) Abbreviated new animal drug applications.
Part D—Information and Education
379k. Information system. 379l. Education. (a) In general. (b) Intramural fellowships and other training programs.
Part E—Environmental Impact Review
379o. Environmental impact.
Part F—National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics
379r. National uniformity for nonprescription drugs. (a) In general. (b) Exemption. (c) Scope. (d) Exceptions. (e) No effort on product liability law. (f) State enforcement authority. 379s. Preemption for labeling or packaging of cosmetics. (a) In general. (b) Exemption. (c) Scope. (d) No effect on product liability law. (e) State initiative.
Part G—Safety Reports
379v. Safety report disclaimers. 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. (f) Labeling of exported drugs. (g) Warning notice of importation in violation of chapter. (h) Protection against adulteration of food. (i) Testing for rapid detection of adulteration of food. (j) Temporary holds at ports of entry. (k) Importation by debarred persons. (l) Failure to register. (m) Prior notice of imported food shipments. (n) Labeling of food refused admission. (o) Registration statement. 382. Exports of certain unapproved products. (a) Drugs or devices intended for human or animal use which require approval or licensing. (b) List of eligible countries for export; criteria for addition to list; direct export; petition for exemption. (c) Investigational use exemption. (d) Anticipation of market authorization. (e) Diagnosis, prevention, or treatment of tropical disease. (f) Prohibition of export of drug or device. (g) Notification of Secretary. (h) References to Secretary and term “drug”. (i) Exportation. 383. Office of International Relations. (a) Establishment. (b) Agreements with foreign countries. (c) Harmonizing regulatory requirements. 384. Importation of prescription drugs. (a) Definitions. (b) Regulations. (c) Limitation. (d) Information and records. (e) Testing. (f) Registration of foreign sellers. (g) Suspension of importation. (h) Approved labeling. (i) Charitable contributions. (j) Waiver authority for importation by individuals. (k) Construction. (l) Effectiveness of section. (m) Authorization of appropriations. 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) Mission. (c) Interagency collaboration. (d) Commissioner. (e) Technical and scientific review groups. (f) Agency plan for statutory compliance. (g) Annual report. 393a. Office of Pediatric Therapeutics. (a) Establishment. (b) Duties. (c) Staff. 394. Scientific review groups. 395. Loan repayment program. (a) In general. (b) Applicability of certain provisions. (c) Authorization of appropriations. 396. Practice of medicine. 397. Contracts for expert review. (a) In general. (b) Review of expert review. 398. Notices to States regarding imported food. (a) In general. (b) Rule of construction. 399. Grants to States for inspections. (a) In general. (b) Notices regarding adulterated imported food. (c) Authorization of appropriations.
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