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Showing 101–131 of 131 regulations
Voluntary Filing of Cosmetic Product Ingredient Composition Statements
21 CFR Part 720 establishes a voluntary program for manufacturers, packers, and distributors of cosmetic products to file ingredient composition statements with the FDA on Form FDA 2512. Filings must occur within 180 days of the rule's effective date for existing products, or within 60 days of commercial distribution for new products. The filing requires disclosure of product name, manufacturer details, brand name, cosmetic category, and complete ingredient listings, with information made available to poison control centers and licensed physicians for safety and medical purposes.
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.
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.
Hematology and Pathology Devices
21 CFR Part 864 establishes the regulatory framework for hematology and pathology devices intended for human use in commercial distribution. It outlines classification requirements, premarket approval timelines for Class III devices, and exemptions from premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act. Manufacturers must demonstrate substantial equivalence to existing devices and comply with applicable FDA guidance.
Minimum Required Warning Statements
21 CFR Part 1143 establishes definitions and minimum required warning statements for tobacco products subject to federal regulation. It defines key terms including cigars, cigarettes, roll-your-own tobacco, accessories, and components, and specifies packaging and point-of-sale requirements. The regulation mandates warning statements on packaging and advertisements for cigarette tobacco, roll-your-own tobacco, cigars, and other covered tobacco products, including warnings regarding nicotine addictiveness.
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.
Importation of Electronic Products
CFR Part 1005 establishes importation requirements for electronic products subject to federal radiation control standards. Imported electronic products must bear compliance certification labels or tags; non-complying products are refused entry unless brought into compliance through a petition process. The regulation provides procedures for sample testing, inspection, notification, and hearing rights for importers.
Retail Sale of Scheduled Listed Chemical Products
This regulation establishes requirements for retail sales of scheduled listed chemical products (ephedrine, pseudoephedrine, phenylpropanolamine) for personal use. It sets daily purchase limits (3.6 grams per substance per day), packaging requirements for nonliquid forms (blister packs or unit dose packets), and mandates loss reporting to the DEA within 15 days. Requirements apply to face-to-face retail sales and mail-order sales through regulated sellers and distributors.
Importation and Exportation of List I and List II Chemicals
21 CFR Part 1313 establishes procedures for importing, exporting, transshipping and in-transit shipment of List I and List II chemicals under the Chemical Diversion and Trafficking Act. Importers and exporters must notify the DEA at least 15 days before importing chemicals meeting threshold quantities, file declarations on DEA Form 486/486A, establish documented business relationships with customers, and maintain required records including supplier information and transaction frequency.
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.
Food Additive Petitions
21 CFR Part 571 establishes the procedure for submitting food additive petitions to the FDA under the Federal Food, Drug, and Cosmetic Act. Petitioners must submit applications in triplicate with detailed information on the food additive's chemical identity, composition, manufacturing methods, analytical controls, stability data, and proposed uses. The regulation specifies content requirements including physical/chemical/biological properties, specifications, impurities, and manufacturing details for each entity involved in production.
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.
Miscellaneous
21 CFR Part 1307 establishes miscellaneous provisions for controlled substance regulation under DEA authority. It clarifies that state and federal law requirements remain in effect, allows practitioners to request regulatory exceptions, permits registered dispensers to distribute controlled substances to other practitioners up to 5% of their annual dispensed volume without separate distributor registration, and exempts incidental controlled substance manufacturing by registered manufacturers from additional registration requirements.
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 CFR Part 807 establishes registration and device listing requirements for manufacturers and initial importers of medical devices. The regulation defines key terms including commercial distribution, establishment, manufacture, official correspondent, and initial importer. It outlines exemptions from commercial distribution requirements, including internal transfers within affiliated companies, investigational use devices, and certain pre-1976 Class III devices. Device manufacturers and importers must register establishments annually and maintain current officer/director information with the FDA.
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.
Disposal
21 CFR Part 1317 establishes procedures for safe disposal of controlled substances by registered practitioners and other registrants. Authorized methods include on-site destruction, delivery to reverse distributors, return to manufacturers, or DEA assistance. Records and periodic reports to the DEA are required for regular disposals, with conditions set by the Special Agent in Charge to prevent diversion.
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.
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.
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.
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).
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.
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.
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.
Quotas
This regulation establishes procedures for DEA quotas on Schedule I and II controlled substances. It defines three quota types—aggregate production, individual manufacturing, and procurement—and five subcategories covering commercial sale, transfers, product development, and replacement of disposed material. Quotas limit the total and per-manufacturer quantities of controlled substance APIs that may be produced or procured annually for pharmaceutical manufacturing.
Notification of Defects or Failure to Comply
21 CFR Part 1003 establishes notification requirements for manufacturers of electronic products regarding defects or non-compliance with Federal standards, particularly those involving unintended or excessive electronic product radiation emissions that pose injury risk. Manufacturers must immediately notify the Secretary and relevant dealers, distributors, and purchasers upon discovery of defects or compliance failures in products manufactured after October 1968.
Definitions
21 CFR Part 1300 establishes definitions for controlled substances under the Controlled Substances Act and related regulations. Key definitions include anabolic steroids (controlled hormonal substances chemically related to testosterone), automated dispensing systems for medication management, and basic chemical classes of controlled substances. The regulation clarifies DEA authority and distinguishes between controlled substances and dietary ingredients or botanical compounds that are exempt from classification.
Enhancement and Standardization of Climate-Related Disclosures for Investors
Public-company climate disclosure rule covering governance, strategy, risk management, GHG metrics (Scope 1 and 2 for large filers), and financial statement impacts.