Individuals & Families
Small Businesses
Nonprofits
Employers
Employee Benefits Brokers
PEOs
Credit Unions
Membership Groups
Legal Information
Sign In
/
U.S. Code of Federal Regula...
/
Title 21-Food and Drugs
/
CHAPTER I—FOOD AND DRUG ADM...
/
PART 202—PRESCRIPTION DRUG ADVERTISING
PART 202—PRESCRIPTION DRUG ADVERTISING
§ 202.1 - Prescription-drug advertisements.
§ 202.1 - Prescription-drug advertisements.
§ 203.1 - Scope.
§ 203.2 - Purpose.
§ 203.3 - Definitions.
§ 203.10 - Restrictions on reimportation.
§ 203.11 - Applications for reimportation to provide emergency medical care.
§ 203.12 - An appeal from an adverse decision by the district office.
§ 203.20 - Sales restrictions.
§ 203.22 - Exclusions.
§ 203.23 - Returns.
§ 203.30 - Sample distribution by mail or common carrier.
§ 203.31 - Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer).
§ 203.32 - Drug sample storage and handling requirements.
§ 203.33 - Drug sample forms.
§ 203.34 - Policies and procedures; administrative systems.
§ 203.35 - Standing requests.
§ 203.36 - Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping.
§ 203.37 - Investigation and notification requirements.
§ 203.38 - Sample lot or control numbers; labeling of sample units.
§ 203.39 - Donation of drug samples to charitable institutions.
§ 203.50 - Requirements for wholesale distribution of prescription drugs.
§ 203.60 - Request and receipt forms, reports, and records.
§ 203.70 - Application for a reward.
§ 205.1 - Scope.
§ 205.2 - Purpose.
§ 205.3 - Definitions.
§ 205.4 - Wholesale drug distributor licensing requirement.
§ 205.5 - Minimum required information for licensure.
§ 205.6 - Minimum qualifications.
§ 205.7 - Personnel.
§ 205.8 - Violations and penalties.
§ 205.50 - Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
§ 206.1 - Scope.
§ 206.3 - Definitions.
§ 206.7 - Exemptions.
§ 206.10 - Code imprint required.
§ 207.1 - What definitions and interpretations of terms apply to this part?
§ 207.3 - Bulk drug substance.
§ 207.5 - What is the purpose of this part?
§ 207.9 - Who does this part cover?
§ 207.13 - Who is exempt from the registration and listing requirements?
§ 207.17 - Who must register?
§ 207.21 - When must initial registration information be provided?
§ 207.25 - What information is required for registration?
§ 207.29 - What are the requirements for reviewing and updating registration information?
§ 207.33 - What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
§ 207.35 - What changes require a new NDC?
§ 207.37 - What restrictions pertain to the use of the NDC?
§ 207.41 - Who must list drugs and what drugs must they list?
§ 207.45 - When, after initial registration of an establishment, must drug listing information be submitted?
§ 207.49 - What listing information must a registrant submit for a drug it manufactures?
§ 207.53 - What listing information must a registrant submit for a drug that it repacks or relabels?
§ 207.54 - What listing information must a registrant submit for a drug that it salvages?
§ 207.55 - What additional drug listing information may FDA require?
§ 207.57 - What information must registrants submit when updating listing information and when?
§ 207.61 - How is registration and listing information provided to FDA?
§ 207.65 - How can a waiver of the electronic submission requirement be obtained?
§ 207.69 - What are the requirements for an official contact and a United States agent?
§ 207.77 - What legal status is conferred by registration and listing?
§ 207.81 - What registration and listing information will FDA make available for public disclosure?
§ 208.1 - Scope and purpose.
§ 208.3 - Definitions.
§ 208.20 - Content and format of a Medication Guide.
§ 208.24 - Distributing and dispensing a Medication Guide.
§ 208.26 - Exemptions and deferrals.
§ 209.1 - Scope and purpose.
§ 209.2 - Definitions.
§ 209.10 - Content and format of the side effects statement.
§ 209.11 - Dispensing and distributing the side effects statement.
§ 210.1 - Status of current good manufacturing practice regulations.
§ 210.2 - Applicability of current good manufacturing practice regulations.
§ 210.3 - Definitions.
§ 211.1 - Scope.
§ 211.3 - Definitions.
§ 211.22 - Responsibilities of quality control unit.
§ 211.25 - Personnel qualifications.
§ 211.28 - Personnel responsibilities.
§ 211.34 - Consultants.
§ 211.42 - Design and construction features.
§ 211.44 - Lighting.
§ 211.46 - Ventilation, air filtration, air heating and cooling.
§ 211.48 - Plumbing.
§ 211.50 - Sewage and refuse.
§ 211.52 - Washing and toilet facilities.
§ 211.56 - Sanitation.
§ 211.58 - Maintenance.
§ 211.63 - Equipment design, size, and location.
§ 211.65 - Equipment construction.
§ 211.67 - Equipment cleaning and maintenance.
§ 211.68 - Automatic, mechanical, and electronic equipment.
§ 211.72 - Filters.
§ 211.80 - General requirements.
§ 211.82 - Receipt and storage of untested components, drug product containers, and closures.
§ 211.84 - Testing and approval or rejection of components, drug product containers, and closures.
§ 211.86 - Use of approved components, drug product containers, and closures.
§ 211.87 - Retesting of approved components, drug product containers, and closures.
§ 211.89 - Rejected components, drug product containers, and closures.
§ 211.94 - Drug product containers and closures.
§ 211.100 - Written procedures; deviations.
§ 211.101 - Charge-in of components.
§ 211.103 - Calculation of yield.
§ 211.105 - Equipment identification.
§ 211.110 - Sampling and testing of in-process materials and drug products.
§ 211.111 - Time limitations on production.
§ 211.113 - Control of microbiological contamination.
§ 211.115 - Reprocessing.
§ 211.122 - Materials examination and usage criteria.
§ 211.125 - Labeling issuance.
§ 211.130 - Packaging and labeling operations.
§ 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
§ 211.134 - Drug product inspection.
§ 211.137 - Expiration dating.
§ 211.142 - Warehousing procedures.
§ 211.150 - Distribution procedures.
§ 211.160 - General requirements.
§ 211.165 - Testing and release for distribution.
§ 211.166 - Stability testing.
§ 211.167 - Special testing requirements.
§ 211.170 - Reserve samples.
§ 211.173 - Laboratory animals.
§ 211.176 - Penicillin contamination.
§ 211.180 - General requirements.
§ 211.182 - Equipment cleaning and use log.
§ 211.184 - Component, drug product container, closure, and labeling records.
§ 211.186 - Master production and control records.
§ 211.188 - Batch production and control records.
§ 211.192 - Production record review.
§ 211.194 - Laboratory records.
§ 211.196 - Distribution records.
§ 211.198 - Complaint files.
§ 211.204 - Returned drug products.
§ 211.208 - Drug product salvaging.
§ 212.1 - What are the meanings of the technical terms used in these regulations?
§ 212.2 - What is current good manufacturing practice for PET drugs?
§ 212.5 - To what drugs do the regulations in this part apply?
§ 212.10 - What personnel and resources must I have?
§ 212.20 - What activities must I perform to ensure drug quality?
§ 212.30 - What requirements must my facilities and equipment meet?
§ 212.40 - How must I control the components I use to produce PET drugs and the containers and closures I package them in?
§ 212.50 - What production and process controls must I have?
§ 212.60 - What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
§ 212.61 - What must I do to ensure the stability of my PET drug products through expiry?
§ 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?
§ 212.71 - What actions must I take if a batch of PET drug product does not conform to specifications?
§ 212.80 - What are the requirements associated with labeling and packaging PET drug products?
§ 212.90 - What actions must I take to control the distribution of PET drug products?
§ 212.100 - What do I do if I receive a complaint about a PET drug product produced at my facility?
§ 212.110 - How must I maintain records of my production of PET drugs?
§ 216.23 - Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.
§ 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
§ 225.1 - Current good manufacturing practice.
§ 225.10 - Personnel.
§ 225.20 - Buildings.
§ 225.30 - Equipment.
§ 225.35 - Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.
§ 225.42 - Components.
§ 225.58 - Laboratory controls.
§ 225.65 - Equipment cleanout procedures.
§ 225.80 - Labeling.
§ 225.102 - Master record file and production records.
§ 225.110 - Distribution records.
§ 225.115 - Complaint files.
§ 225.120 - Buildings and grounds.
§ 225.130 - Equipment.
§ 225.135 - Work and storage areas.
§ 225.142 - Components.
§ 225.158 - Laboratory assays.
§ 225.165 - Equipment cleanout procedures.
§ 225.180 - Labeling.
§ 225.202 - Formula, production, and distribution records.
§ 226.1 - Current good manufacturing practice.
§ 226.10 - Personnel.
§ 226.20 - Buildings.
§ 226.30 - Equipment.
§ 226.40 - Production and control procedures.
§ 226.42 - Components.
§ 226.58 - Laboratory controls.
§ 226.80 - Packaging and labeling.
§ 226.102 - Master-formula and batch-production records.
§ 226.110 - Distribution records.
§ 226.115 - Complaint files.
§ 250.11 - Thyroid-containing drug preparations intended for treatment of obesity in humans.
§ 250.12 - Stramonium preparations labeled with directions for use in self-medication regarded as misbranded.
§ 250.100 - Amyl nitrite inhalant as a prescription drug for human use.
§ 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.
§ 250.102 - Drug preparations intended for human use containing certain “coronary vasodilators”.
§§ 250.103-250.104 - Gelsemium-containing preparations regarded as prescription drugs.
§ 250.105 - Gelsemium-containing preparations regarded as prescription drugs.
§§ 250.106-250.107 - Potassium permanganate preparations as prescription drugs.
§ 250.108 - Potassium permanganate preparations as prescription drugs.
§ 250.201 - Preparations for the treatment of pernicious anemia.
§ 250.250 - Hexachlorophene, as a component of drug and cosmetic products.
§ 290.1 - Controlled substances.
§ 290.2 - Exemption from prescription requirements.
§ 290.5 - Drugs; statement of required warning.
§ 290.6 - Spanish-language version of required warning.
§ 290.10 - Definition of emergency situation.
§ 299.3 - Definitions and interpretations.
§ 299.4 - Established names for drugs.
§ 299.5 - Drugs; compendial name.