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Prescription Drug Advertising
Prescription drug advertising requirements under 21 CFR Part 202 establish rules for how drugs must be advertised. Key provisions include: ingredient information must appear together without intervening matter; ingredient listing order and quantities must match product labels; proprietary names cannot imply unique effectiveness for common substances; inert ingredients cannot be featured to exaggerate value; proprietary names must not create confusion with other drugs; and established names must accompany proprietary names with specified type size and placement requirements throughout advertisements.
Dietary Supplements
21 CFR Part 190 establishes premarket notification requirements for dietary supplements containing new dietary ingredients not previously present in the food supply. Manufacturers or distributors must submit safety information to FDA at least 75 days before introducing such products to interstate commerce, including ingredient identification, usage conditions, safety history, and published evidence supporting safety conclusions. FDA acknowledges receipt and assigns a filing date; the product cannot be marketed during the 75-day review period unless FDA determines no safety concern exists.
General
21 CFR Part 200 establishes general provisions for FDA and drug manufacturers/distributors regarding communication of drug safety and labeling information. It specifies envelope formatting requirements (color-coded borders and statements) for mailing important drug warnings, prescribing information changes, and corrections to physicians and pharmacists. It also authorizes FDA inspection of contract facilities used by pharmaceutical manufacturers and permits pharmacists to receive dosage and indication data from manufacturers.
Guidelines for State Licensing of Wholesale Prescription Drug Distributors
This regulation establishes minimum standards and conditions for state licensing of wholesale prescription drug distributors operating in interstate commerce, implementing the Prescription Drug Marketing Act of 1987. It defines key terms including prescription drugs, wholesale distribution, wholesale distributors, and health care entities, while specifying exemptions from wholesale distribution requirements such as intracompany sales, emergency transfers, drug samples, and certain inter-entity transactions.
Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study
21 CFR Part 180 establishes the regulatory framework for interim approval of food additives and food-contact substances when new safety or functionality concerns arise but evidence does not conclusively prove harm. Interim regulations permit continued use during study periods, subject to specified limitations, mandatory progress reporting every six months, and compliance with good laboratory practice standards. The FDA may revoke interim approvals if adequate studies are not initiated within 60 days or if interim results indicate health hazards.
Food Additive Petitions
21 CFR Part 171 establishes procedural requirements for petitions requesting approval of food additives under section 409(b) of the Federal Food, Drug, and Cosmetic Act. Petitioners must submit detailed information on the additive's chemical identity, composition, manufacturing process, analytical controls, stability data, and safety assessments to the FDA's Office of Food Additive Safety. Submissions must be in triplicate (or quadruplicate for meat/poultry uses) with English translations of foreign materials and supporting documentation.
Prescription Drug Marketing
21 CFR Part 203 establishes procedures and requirements for the distribution of prescription drugs, including bulk drug substances and finished dosage forms, to protect public health and prevent drug diversion. It covers reimportation and wholesale distribution, sales by hospitals and charitable organizations, and distribution of drug samples, implementing the Prescription Drug Marketing Act of 1987 and related amendments.
Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement
21 CFR Part 209 requires authorized dispensers and pharmacies to distribute a standardized side effects statement with each dispensed prescription drug product approved under FDA section 505. The statement directs consumers to call their doctor about side effects and report adverse events to FDA at 1-800-FDA-1088. Distribution must occur with new and refill prescriptions via sticker, vial cap, separate paper, consumer medication information, or FDA-approved Medication Guide, using clear type no smaller than 6-10 points depending on format.
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code
21 CFR Part 207 establishes requirements for registration and listing of domestic and foreign drug establishments manufacturing human drugs (including biologics) and animal drugs. It defines key terms including active pharmaceutical ingredients, bulk drug substances, commercial distribution, and labeling requirements for prescription drugs, OTC drugs, and animal drugs, along with establishment definitions for regulatory compliance and National Drug Code assignment.
General
This regulation establishes FDA policies for fixed-combination prescription drugs, prohibits chlorofluorocarbon propellants in human drugs, and requires annual reporting by manufacturers and sponsors of eligible investigational drugs supplied to eligible patients under the Right to Try Act.
Bioavailability and Bioequivalence Requirements
21 CFR Part 320 establishes FDA requirements for demonstrating bioavailability and bioequivalence of drug products in new drug applications, abbreviated new drug applications, and supplemental applications. Applicants must submit evidence of in vivo bioavailability for full NDAs or demonstrate bioequivalence to a reference listed drug for abbreviated NDAs, with FDA authority to waive certain requirements or require additional study reports when concerns arise.
Section 804 Importation Program
Section 804 Importation Program establishes FDA procedures for time-limited programs permitting importation of eligible prescription drugs from Canada. The rule defines eligible drugs as FDA-approved medications available in the U.S. that also meet Canadian regulatory requirements, excluding controlled substances, biologics, and certain high-risk formulations like injectables and inhaled drugs. Importers must follow specified compliance, labeling, and adverse event reporting requirements.
Certification and Postmarketing Reporting for Designated Medical Gases
21 CFR Part 230 establishes FDA procedures for certification and postmarketing surveillance of designated medical gases. It requires applicants to submit certifications under the Federal Food, Drug, and Cosmetic Act and defines requirements for adverse event reporting, including serious adverse events. The regulation sets minimum data standards for individual case safety reports and establishes postmarketing safety monitoring systems.
Drugs; Official Names and Established Names
21 CFR Part 299 establishes procedures for designating official and established names for drugs under the Federal Food, Drug, and Cosmetic Act. The regulation defines official names as those designated by the FDA Commissioner under section 508, and established names as official names, compendial names, or common/usual names. The FDA recognizes the U.S. Adopted Names Council for deriving nonproprietary drug names and generally relies on compendial or common names rather than routinely designating new official names.
Controlled Drugs
21 CFR Part 290 establishes requirements for dispensing controlled substances scheduled II–V under the Federal Controlled Substances Act. Drugs in these schedules require prescription-only dispensing unless exempted (e.g., codeine preparations ≤200 mg per 100 mL/g with non-narcotic active ingredients). Labels must carry a federal warning prohibiting unauthorized transfer. Emergency oral prescriptions of Schedule II drugs are permitted when immediate administration is medically necessary and written prescription is impractical.
Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act
21 CFR Part 329 establishes postmarketing adverse event reporting requirements for nonprescription human drugs under FD&C Act Section 760. Manufacturers must submit Individual Case Safety Reports (ICSRs) electronically to FDA containing patient information, adverse event details, suspect product data, reporter information, and responsible person contact details. Reports must include outcomes, dates, medical narratives, test results, product identifiers (NDC, lot number), dosing information, and concomitant medications. Patient names should be replaced with unique identification codes to protect privacy.
Investigational New Drug Application
This regulation establishes procedures and requirements for Investigational New Drug (IND) applications submitted to the FDA. It defines the scope of clinical investigations subject to IND requirements, specifies exemptions (including lawfully marketed drugs, in vitro diagnostics, laboratory research-only drugs, and certain placebo studies), and references institutional review and informed consent standards. The regulation governs which drug products must obtain FDA approval before conducting clinical trials.
Applications for FDA Approval to Market a New Drug
21 CFR Part 314 establishes procedures for submitting new drug applications (NDAs) and abbreviated new drug applications (ANDAs) to the FDA for approval to market new drugs under the Federal Food, Drug, and Cosmetic Act. The regulation outlines the agency's drug review process, defines key terms including active ingredients and exclusivity periods, and sets requirements for amendments, supplements, and postmarketing reports, while excluding designated medical gases and certain biologics subject to separate licensing provisions.
Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research
Part 361 establishes conditions under which radioactive drugs are considered safe and effective for basic research use in human subjects. Research must be approved by a Radioactive Drug Research Committee and meet strict limits on pharmacological dose, radiation dose, and cumulative exposure. Studies must demonstrate qualified investigators, proper licensure, informed consent, institutional review, and adverse event reporting.
International Voluntary Agreements
This regulation establishes standards and procedures for persons in the petroleum industry (producers, transporters, refiners, distributors, and storage operators) to develop voluntary agreements implementing the International Energy Program's information and allocation provisions during international energy supply emergencies, with meetings chaired by DOE and antitrust exemptions provided under the Energy Policy and Conservation Act.
Voluntary Greenhouse Gas Reporting Program: General Guidelines
This regulation establishes the Voluntary Reporting of Greenhouse Gases Program under the Energy Policy Act of 1992, setting procedures and requirements for entities to submit annual reports of greenhouse gas emissions, reductions, and sequestration activities. Reporting entities must file entity statements, use approved calculation methods, maintain records, and obtain certifications. Entities may report emissions back to 1990 and reductions back to 1991. Registration of reductions requires achievement after 2002 and compliance with entity-wide emission inventory quality standards, with different requirements for large and small emitters.
Standby Mandatory International Oil Allocation
This regulation implements U.S. obligations under the International Energy Program (IEP) to enable mandatory international oil allocation during energy supply emergencies. It applies to firms engaged in producing, transporting, refining, distributing or storing oil under U.S. jurisdiction. The rule remains on standby status and activates only when the President determines allocation is necessary to fulfill IEP obligations and notifies Congress; it reverts to standby within 60 days of emergency deactivation.
Renewable Energy Production Incentives
10 CFR Part 451 establishes Department of Energy incentive payment procedures for qualified renewable energy facilities owned by states, political subdivisions, not-for-profit cooperatives, public utilities, Indian tribes, or Native corporations. Eligible renewable sources include solar, wind, ocean, geothermal, and biomass energy. Payments are based on net electric energy generated and sold, with facility eligibility determined by date of first use and permit receipt.
Certification, Compliance, and Enforcement for Consumer Products and Commercial and Industrial Equipment
10 CFR Part 429 establishes procedures for certification, compliance determination, and enforcement of energy conservation standards for consumer products and commercial/industrial equipment including HVAC systems, boilers, refrigeration equipment, and electric motors. Manufacturers must comply with applicable energy conservation standards from 10 CFR Parts 430 and 431, with certification conducted by independent, nationally recognized programs following ISO/IEC 17025 and NIST standards.
Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended
10 CFR Part 170 establishes fees charged by the Nuclear Regulatory Commission for licensing services, inspection services, and special projects under the Atomic Energy Act of 1954. The regulation applies to applicants and holders of various nuclear licenses and approvals, including byproduct material licenses, source material licenses, special nuclear material licenses, power reactor operating licenses, spent fuel storage facilities, and import/export licenses, as well as fees for reactor operator examinations, inspections, and preapplication reviews.
Epidemiology and Other Health Studies Financial Assistance Program
DOE regulation establishing grant and cooperative agreement procedures for epidemiological and health studies research, education, and communication activities. Covers health effects from DOE operations and energy production, including studies of worker and community health near DOE facilities, toxic substance exposure (including beryllium), and biomarker use for exposure recognition.
Collection of Information
10 CFR Part 207 establishes procedures for the Department of Energy to collect and enforce compliance with energy information reporting requirements under the Energy Supply and Environmental Coordination Act of 1974. It defines energy information broadly to include fuel reserves, exploration, production, distribution, consumption data, and related corporate and financial information. The regulation outlines violation procedures, notice requirements, and remedial order processes for entities failing to provide or circumventing energy information collection.
Mandatory Petroleum Price Regulations
This regulation establishes mandatory reporting requirements for crude oil producers conducting enhanced oil recovery projects. Operators must file annual prepaid expenses reports with the Department of Energy by January 31 each year, documenting the nature, timing, and allocation of prepaid expenses for injectants, fuels, and other items used in tertiary recovery operations after September 30, 1981. Reporting continues until all prepaid expenses and their actual use are fully documented.
Collection of Foreign Oil Supply Agreement Information
This regulation requires persons with equity interests or contractual rights to extract crude oil from foreign countries to report detailed information about their supply agreements to the Department of Energy, including parties, production volumes, pricing terms, payment obligations, and contract terms. Reports must be submitted within 60 days of forms issuance, 14 days of agreement execution, or upon material changes, with joint operators able to designate a single participant to report on behalf of the operation.
General Allocation and Price Rules
10 CFR Part 210 establishes recordkeeping requirements for firms subject to DOE allocation and price rules. Records must be maintained for transactions and expenses prior to specified dates, with ongoing obligations for firms involved in DOE litigation, those making restitutionary payments under orders, and firms undergoing audits. Record retention periods vary by firm category and may be extended or terminated by DOE notification.
Administrative Procedures with Respect to the Import and Export of Natural Gas
Establishes administrative procedures and rules for obtaining Department of Energy authorizations to import or export natural gas under the Natural Gas Act. Defines key terms including "natural gas," "contested proceedings," "interested persons," and procedural roles for decisional employees and the Assistant Secretary for Fossil Energy. Implements delegated authority from the DOE Act to regulate natural gas trade.
Procedures for Acquisition of Petroleum for the Strategic Petroleum Reserve
This regulation establishes procedures for the Department of Energy to acquire petroleum products for the Strategic Petroleum Reserve, including purchase, exchange, and deferral mechanisms. It defines key terms such as backwardation, contango, deferral, and exchange, and outlines the roles of contracting officers and relevant DOE offices in managing SPR petroleum acquisitions under federal acquisition regulations.
Annual Fees for Reactor Licenses and Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by the NRC
This regulation establishes annual fee requirements for persons holding nuclear reactor licenses, fuel cycle licenses, materials licenses, Certificates of Compliance, sealed source and device registrations, and quality assurance program approvals issued by the NRC. Fees apply to operating test reactors, research reactors, power reactors, and combined license holders after power ascension testing completion, as well as materials licensees and government agencies. The regulation defines key terms including budget authority and bundled units for small modular reactors, with bundled units up to 4,500 MWt assessed as single units.
Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
This regulation establishes registration requirements for manufacturers, distributors, importers, and exporters of List I chemicals under DEA jurisdiction. Registration is mandatory for entities handling ephedrine, pseudoephedrine, phenylpropanolamine, and other designated List I chemicals. Annual fees apply: $3,699 for manufacturers and $1,850 for distributors, importers, and exporters. Registration must be submitted online via the DEA's secure portal with payment by ACH transfer or credit card. Separate registrations are required for independent activities (manufacturing, distributing, importing, exporting).
User Fees
21 CFR Part 1150 establishes user fee requirements for tobacco product manufacturers and importers under the Federal Food, Drug, and Cosmetic Act. Domestic manufacturers and importers must pay their proportional share of annual FDA user fees based on product removals. Monthly reporting to FDA is required by the 20th of each month, including identification information, units of product removed by class (cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, roll-your-own tobacco), and Federal excise taxes paid.
Orders for Schedule I and II Controlled Substances
This regulation establishes procedures for ordering Schedule I and II controlled substances under the Controlled Substances Act. It specifies who may obtain DEA Form 222 or issue electronic orders (registered persons only), exemptions from ordering requirements, and authorization procedures including power of attorney provisions for agents to execute orders on behalf of registrants.
Required Warnings for Cigarette Packages and Advertisements
This regulation establishes requirements for warning labels on cigarette packages and advertisements sold in the United States. It defines key terms including cigarette, manufacturer, distributor, and retailer, and clarifies that retailers are not liable for compliant packaging supplied by licensed manufacturers, though they remain responsible for advertisements they display or alter.
Schedules of Controlled Substances
21 CFR Part 1308 establishes the schedules of controlled substances under the Controlled Substances Act, assigning DEA code numbers to opiates, opium derivatives, hallucinogenic substances, depressants, and other controlled drugs for identification and registration purposes. Applicants for procurement quotas, import/export permits, and registrants handling controlled substances must reference the appropriate code numbers on applications and declarations.
Medical Device Tracking Requirements
21 CFR Part 821 establishes mandatory tracking requirements for class II and III medical devices that meet FDA criteria, including those likely to cause serious adverse health consequences, implanted for over one year, or used as life-sustaining/supporting devices outside facilities. Manufacturers must trace devices from production through distributors to patients; failure to comply constitutes misbranding and a prohibited act. Manufacturers bear primary responsibility and must notify FDA if discontinuing business, with tracking records transferred or responsibility reassigned in writing.
Medical Device Recall Authority
21 CFR Part 810 establishes FDA procedures for exercising medical device recall authority under the Federal Food, Drug, and Cosmetic Act. It defines key terms including recall, correction, removal, serious adverse health consequences, and unique device identifiers, and outlines requirements for cease distribution orders and mandatory recall strategies applicable to device manufacturers, distributors, and user facilities.
Postmarket Surveillance
21 CFR Part 822 establishes postmarket surveillance requirements for class II and III medical devices under the Federal Food, Drug, and Cosmetic Act. Manufacturers must implement surveillance plans for devices where failure poses serious health risks, are implanted long-term, support life outside healthcare facilities, or have significant pediatric use. The regulation defines key terms, responsibilities of designated persons and investigators, and procedures for collecting, analyzing, and reporting safety data to protect public health.
New Animal Drugs for Investigational Use
This regulation establishes exemptions from FDA approval requirements for new animal drugs intended solely for investigational use, including in vitro laboratory tests and clinical trials in animals. Distributors must ensure proper labeling, maintain records of shipments for two years, and verify that recipients are conducting legitimate research. Edible products from investigational animals cannot enter the food supply without FDA or USDA authorization.
Unique Device Identification
21 CFR Part 830 establishes requirements for unique device identification (UDI) of medical devices. The regulation defines key terms including UDI, device identifier, production identifier, labeler, and automatic identification and data capture (AIDC) technology. UDIs must adequately identify devices through distribution and use, comprising a fixed device identifier and conditional production identifier elements such as lot/batch number, serial number, expiration date, or manufacturing date. The Global Unique Device Identification Database (GUDID) serves as the repository for device identification information.
Records and Reports of Listed Chemicals and Certain Machines; Importation and Exportation of Certain Machines
21 CFR Part 1310 establishes record-keeping and reporting requirements for regulated persons who handle DEA-designated listed chemicals and certain machines (tableting and encapsulating equipment). The regulation specifies two lists of chemicals subject to oversight, allows the DEA Administrator to add or remove substances via Federal Register notice, and requires manufacturers and distributors to maintain transaction records and file reports, particularly for ephedrine, pseudoephedrine, phenylpropanolamine, and gamma hydroxybutyric acid when shipped via postal or commercial carriers.
Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of Marihuana
21 CFR Part 1318 establishes regulatory controls for the registration and manufacturing of marihuana, including cultivation, growth, and harvest procedures. Registered manufacturers must deliver their total cannabis crops to the Administration within four months of harvest, with the Administration taking physical possession and controlling access. Applicants must demonstrate compliance with statutory requirements and public interest considerations under the Controlled Substances Act and international Single Convention obligations.
Importation and Exportation of Controlled Substances
21 CFR Part 1312 establishes procedures for importation, exportation, and transshipment of controlled substances. Importers must obtain DEA authorization through registration and permits (for Schedules I-II and certain Schedule III-V substances) or import declarations (for other Schedule III-V substances). Each shipment requires separate authorization, and applicants must submit detailed information including drug names, dosage forms, NDC numbers, and quantities on DEA Form 357 through the DEA Diversion Control Division secure network.
Labeling and Packaging Requirements for Controlled Substances
21 CFR Part 1302 establishes labeling and packaging requirements for controlled substances distributed in the United States. Manufacturers must print schedule symbols on commercial containers and labeling in a prominent, easily identifiable manner. Specific exemptions apply to containers too small to accommodate labels, clinical research involving blind studies, and exported substances. All containers must be sealed to detect tampering. These requirements apply to imported controlled substances but not to those intended for export.
Clinical Chemistry and Clinical Toxicology Devices
21 CFR Part 862 establishes the FDA classification framework for clinical chemistry and clinical toxicology devices intended for human use. It defines the scope of device regulation, specifies that calibrators used with these devices are classified as Class II regardless of the device's classification due to their critical role in measurement accuracy, and outlines the premarket approval requirements and effective dates for devices classified as Class III.
Prescriptions
21 CFR Part 1306 establishes procedures for prescribing and dispensing controlled substances to patients. It defines who may issue prescriptions (authorized individual practitioners), requires prescriptions be issued for legitimate medical purposes in the usual course of professional practice, and sets forth prescription format requirements including patient/practitioner information and drug details. Special provisions apply to Schedule III-V narcotic drugs used for maintenance or detoxification treatment.
Records and Reports of Registrants
21 CFR Part 1304 establishes recordkeeping and reporting requirements for registrants under the Controlled Substances Act, including manufacturers, distributors, importers, researchers, and practitioners. Registrants must maintain inventories and file reports as required by the Act; individual practitioners have limited recordkeeping obligations except for maintenance or detoxification treatments. Records may be consolidated into one system covering all controlled substance activities conducted under a single registration.