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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Medical Device Reporting
21 CFR Part 803 establishes medical device reporting requirements for device user facilities, manufacturers, importers, and distributors. Device user facilities must report deaths and serious injuries caused or contributed to by devices, maintain adverse event files, and submit annual summaries. Manufacturers and importers must report similar events and device malfunctions, while distributors must maintain incident records without reporting obligations. These requirements protect public health by ensuring devices remain safe, effective, and not adulterated or misbranded.
General
21 CFR Part 700 establishes general provisions and definitions for cosmetic products under the Federal Food, Drug, and Cosmetic Act. Key definitions include cosmetic product, ingredients, flavors, fragrances, proprietary ingredients, and manufacturing/packaging processes. The regulation defines commercial distribution thresholds (>$1,000 annual gross sales), establishes requirements for ingredient chemical descriptions, and outlines procedures for reporting allergic reactions and bodily injuries associated with cosmetic use.
Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
21 CFR Part 1315 establishes procedures for setting annual importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. The regulation applies to DEA-registered manufacturers and importers of these bulk chemicals and drug products, defines quota types including assessment of annual needs, individual manufacturing quotas, procurement quotas, and import quotas, and exempts personal imports not exceeding 7.5 grams per substance in any 30-day period.
Administrative Functions, Practices, and Procedures
21 CFR Part 1316 establishes administrative inspection procedures under the Controlled Substances Act and Controlled Substances Import and Export Act. The regulation authorizes DEA inspectors to enter controlled premises to inspect records, verify inventory, collect samples, and examine equipment and materials related to controlled substances and listed chemicals manufacturing, distribution, and storage.
Exemption Requests and Substantial Equivalence Reports
21 CFR Part 1107 establishes the FDA's process for granting exemptions from substantial equivalence reporting requirements for minor modifications to legally marketed tobacco products involving changes to tobacco additives. Manufacturers must submit detailed requests to the Center for Tobacco Products demonstrating that the modification is minor, does not require a substantial equivalence report to protect public health, and does not increase appeal to minors, toxicity, addictiveness, or abuse liability.
Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
21 CFR Part 1301 establishes registration procedures for manufacturers, distributors, dispensers, importers, and exporters of controlled substances under the Controlled Substances Act. Every person engaged in these activities must obtain DEA registration unless exempt. Online pharmacies must obtain a modified registration to dispense controlled substances via the Internet. Separate registrations are required for each principal place of business where such activities occur.
Records and Reports
21 CFR Part 1002 establishes record-keeping and reporting requirements for manufacturers, dealers, and distributors of electronic products, particularly radiation-emitting devices. Manufacturers must submit performance data, technical safety information, and test data to the FDA's Center for Devices and Radiological Health. Exemptions apply to products solely for export, components sold to other manufacturers, U.S. Government products with national security restrictions, and certain diagnostic x-ray equipment assemblers. Trade secret information is kept confidential.
Voluntary Registration of Cosmetic Product Establishments
21 CFR Part 710 establishes a voluntary registration program for cosmetic product establishments in the US. Manufacturers and packagers of cosmetic products must register with the FDA within 30 days of beginning operations using Form FD-2511, providing establishment name, address, business trading names, and business type. Registration is not required for beauty shops, retailers, physicians, hospitals, research facilities, or other exempt entities. No registration fee applies, and registration does not indicate FDA approval.
Performance Standards for Electronic Products: General
Performance standards for electronic products under 21 CFR Part 1010 establish certification and labeling requirements to control electronic product radiation. Manufacturers must certify conformance to applicable standards via permanently affixed labels or tags, with certification based on individual product testing or qualified manufacturing programs. The regulation covers general provisions for radiation control and includes specific provisions for laser products incorporating certified laser systems.
Mammography
21 CFR Part 900 implements the Mammography Quality Standards Act (MQSA) by establishing procedures for FDA-approved accreditation bodies to evaluate mammography facilities and setting minimum national quality standards. The regulation defines key terms related to mammography operations, including accreditation bodies, adverse events (poor image quality, delayed reporting, unqualified personnel), air kerma measurement, and continuing education requirements for clinical staff.
Medical Devices; Reports of Corrections and Removals
21 CFR Part 806 establishes requirements for medical device manufacturers and importers to report corrections and removals to the FDA. Device manufacturers must promptly report actions that reduce health risks or remedy violations of the Federal Food, Drug, and Cosmetic Act, while maintaining records of all corrections and removals. Exempt actions include performance improvements that do not reduce health risk, market withdrawals, routine servicing, and stock recovery.
Premarket Tobacco Product Applications
21 CFR Part 1114 establishes procedures and requirements for submitting premarket tobacco product applications (PMTAs) to the FDA, including evaluation procedures and postmarket reporting obligations. The regulation defines key terms such as tobacco product accessories, additives, adverse experiences, brand characteristics, and composition, and specifies the scope of applicability, excluding premium cigars and modified risk tobacco product applications unless they seek dual marketing orders.
General
21 CFR Part 1105 establishes FDA's premarket submission requirements for tobacco products. The regulation specifies grounds for refusing to accept applications, including submissions that lack required contact information, English translation, proper FDA forms, product identification details, environmental assessments, or a U.S. agent signature for foreign applicants. Accepted submissions receive a tracking number and processing acknowledgement.
Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
21 CFR Part 607 establishes establishment registration and product listing requirements for manufacturers of human blood and blood products, as well as manufacturers of licensed devices and biological products used in device manufacturing. The regulation defines key terms including blood products, establishments, manufacturing processes, and commercial distribution, and applies to blood banks, plasma donor centers, transfusion services, and independent testing laboratories.
Public Availability of Information
21 CFR Part 1401 establishes procedures for the Office of National Drug Control Policy (ONDCP) to implement the Freedom of Information Act (FOIA). It defines ONDCP's mission to coordinate federal anti-drug efforts and outlines rules for public information requests, fee categories, and dispute resolution mechanisms.
Requirements for Electronic Orders and Prescriptions
21 CFR Part 1311 establishes requirements for electronic orders and prescriptions of controlled substances, particularly Schedule I and II drugs. It mandates that electronic transmission systems meet authentication, nonrepudiation, and message integrity standards, with digital signatures using Public Key Infrastructure (PKI) technology identified as compliant. The regulation incorporates by reference cryptographic security standards from NIST, including FIPS publications 140-2, 180-2, and 180-3.
Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food
21 CFR Part 579 establishes safety standards for using ionizing radiation in animal feed and pet food production. Facilities may use gamma rays (cobalt-60, cesium-137) or electrons (up to 10 MeV) to treat complete animal diets and ingredients. For poultry feed, additional X-ray sources are permitted. Minimum effective dose for salmonella control is 2.0 kGy; maximum is 25 kGy. Facilities must comply with Part 507 and incorporate applicable Part 179 food irradiation regulations.