Pharmaceuticals & Biotechnology

Guide to complying with laws and regulations that apply to producers, distributors and marketers of human and veterinary drugs, medicines, biologics, medical devices and equipment, and controlled substances.

Biologics

• Biological Products : FAQs
  Frequently asked questions about the evaluation and approval of biological products.
  
  
• Biologics Exports Certification Requirements and Requests
  Submission requirements for requesting certificates for exporting products to foreign countries.
  
  
• Center for Biologics Evaluation and Research : Guidelines
  Directory of CBER guidelines.
  
  
• Center for Biologics Evaluation and Research : Manufacturers Assistance
  Provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.
  
  
• National Select Agent Registry
  Oversees the activities of possession of biological agents and toxins that potentially pose a severe threat to public, animal or plant health, or to animal or plant products. Site allows regulated entities to download application packages, submit forms electronically, view current regulations regarding select agents, and access additional resource information.
  
  
• Therapeutic Biological Products : FAQs
  These frequently asked questions have been developed to help small pharmaceutical businesses understand the regulatory process for therapeutic biological products.
  

Blood Products

• Blood and Plasma Products : Guidance for Industry
  Regulatory compliance guidance for blood and plasma establishments.
  

Controlled Substances

• ARCOS - Automation of Reports and Consolidated Ordering System
  Provides documents to assist manufacturers and distributors report their controlled substances transactions. These include the Electronic Data Interchange (EDI) Program, Error Report Notices, a National Drug Code Dictionary, the Personal Computer Field Edit Program, Q&As, Registrant Bulletins and Handbook.
  
  
• ARCOS Electronic Data Interchange (EDI) Program
  Provides description of DEA's ARCOS EDI Program, which permits DEA registered manufacturers and distributors to log into the Diversion Control Program's website and transmit their required monthly or quarterly ARCOS reports using a secure web portal.
  
  
• ARCOS Error Report Notices
  Provides DEA's end of report 'trailers' that is on each Daily Transaction Processing Report generated by the ARCOS-2 system in response to registrants who file ARCOS reports with DEA. Notices contain information for manufacturers and distributors regarding the ARCOS reporting process.
  
  
• ARCOS Personal Computer Field Edit Program
  Includes description of DEA's software program that provides the paper-based forms reporter a more efficient and economical method for collecting, editing storing and reporting ARCOS transactions to DEA via diskette.
  
  
• ARCOS Questions and Answers
  Provides a series of questions and answers raised most often by registrants regarding the Automation of Reports and Consolidated Orders System (ARCOS).
  
  
• ARCOS Registrant Bulletins
  Provides ARCOS Registrant Bulletins to assist DEA registered manufacturers and distributors with the preparation and submission of required DEA controlled substance transaction reports to ARCOS.
  
  
• ARCOS Registrant Handbook (PDF version)
  Contains PDF version of DEA's ARCOS Registrant Handbook, which provides guidance and information in a plain language format on the requirements of submitting ARCOS reports for participating manufacturers and distributors.
  
  
• ARCOS Registrant Handbook
  Provides guidance and information in a plain language format on the requirements of submitting ARCOS reports for participating manufacturers and distributors.
  
  
• Chemical Handler Registration Process
  Provides general information about the registration process for handlers of regulated chemicals under the Controlled Substances Act (CSA).
  
  
• Chemical Program Advisories to the Public
  Provides DEA's regulated chemical advisories to the public and registered chemical handlers to alert them to potential illicit uses of licit chemicals. Other information such as recalls, registration requirements, and a special surveillance list is also on this webpage.
  
  
• Chemical Program Q&A
  Addresses commonly asked questions regarding registration and reporting requirements of regulated chemical handlers as well as clarifying questions that address specific chemical laws under the Controlled Substances Act (CSA).
  
  
• Chemical Reporting Change of Address
  Notifies DEA registered chemical handlers of a change in address for the submission of chemical import/export declarations, import/export of tableting or encapsulating machines, and other related reports.
  
  
• Controlled Substance Import/Export Applications and Declarations
  Provides links to import/export of controlled substances forms, including an application for permit and an import/export declaration as well as a quick reference guide, and a Conversion Factors for Controlled Substances table (for use in computing base product).
  
  
• Controlled Substance Ordering System and Certification
  Provides information about DEA's electronic Controlled Substance Ordering System (CSOS), such as digital certificates, DEA's e-commerce policies, reporting requirements, and contact information for program support.
  
  
• Controlled Substance Registration
  Provides links drug registration and application information.
  
  
• Controlled Substances Act of 1970
  Full text of the Controlled Substances Act.
  
  
• Cumulative Chemical Threshold Transactions
  Provides guidance about reporting cumulative threshold transactions of Listed Chemicals as required by the Controlled Substances Act (CSA).
  
  
• DEA Registrant Manuals Webpage
  DEA registrant manuals provide guidance and information on the requirements of the Controlled Substances Act of 1970 (CSA) and its implementing regulations in a plain language format for specific registrant types.
  
  
• Drug Enforcement Agency Chemical Program
  Provides information for the handlers of regulated chemical products under the Controlled Substances Act (CSA).
  
  
• Drug Enforcement Agency Online Forms
  Provides links to required DEA Forms, such as registration applications, quota applications and year-end reports, import/export declarations (listed chemicals), import/export permit applications and declarations (controlled substances), drug destruction, theft or loss of controlled substances report, forms to submit changes in registration information, request for duplicate registration certificates, and request additional Schedules I-II order forms.
  
  
• List of Regulated Chemicals Under the Controlled Substances Act
  Provides links to the section of the Code of Federal Regulations (21 CFR 1310.02) that lists the chemicals regulated under the Controlled Substances Act (CSA).
  
  
• Pharmacists Manual for Controlled Substances
  Manual to help pharmacies comply with Controlled Substances Act regulations.
  
  
• Prescription and Controlled Substances : FAQs
  Frequently asked questions about prescribing and dispensing controlled substances.
  
  
• Suspicious Chemical Orders
  Provides information about suspicious chemical orders as well as hyperlinks to portions of DEA's Chemical Handler's Manual intended to assist chemical manufacturers, distributors, wholesalers and retailers of drug products in this area.
  
  
• Title 21 Regulations and Codified Controlled Substances Act
  Contains links to those sections of the Controlled Substances Act (CSA) and its implementing regulations that DEA has jurisdiction over regarding controlled substances and listed chemicals.
  
  
• Title 21 Required Reporting Under the Controlled Substances Act
  Provides links to DEA reporting requirements under the Controlled Substances Act (CSA).
  

Dietary Supplements

• Dietary Supplements : A Guide to FDA Regulations
  Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.
  
  
• Dietary Supplements : An Advertising Guide for Industry
  Advertisers must comply with laws concerning unfair or deceptive acts or practices to ensure consumers get accurate information about dietary supplements.
  

Drug Evaluation and Approval

• Bringing New Drugs to Market : FAQs
  Frequently asked questions on drug development and investigational new drug applications.
  
  
• Center for Drug Evaluation and Research : Guidance for Industry
  Search for FDA guidance documents, which represent the agency's current thinking on particular topics of interest to pharmaceutical manufacturers.
  
  
• Combination Products : FAQs
  Frequently questions asked about FDA's review and evaluation process for combined, drug and device products.
  
  
• Current Good (Drug) Manufacturing Practice Regulations
  Regulations related to the manufacturing, processing, packing and holding of drugs.
  
  
• Drug Application Regulatory Compliance
  Explains regulations that must be followed in order to get a new drug approved by the FDA.
  
  
• Drug Approval Application Process
  Guide to FDA's drug approval application process.
  
  
• Drug Firm Annual Registration Status
  Forms for registration of producers of drugs and listing of drugs in commercial distribution.
  
  
• Orphan Drugs : FAQs
  Commonly asked questions concerning evaluation and approval of orphan drugs.
  
  
• Over-the-Counter Drugs Regulatory Process : FAQs
  Frequently asked questions about the evaluation and approval of over-the-counter drugs.
  
  
• Small Pharmaceutical Business Assistance
  Guide to help ease the drug application process for small drug manufacturers.
  

Environmental Compliance

• Pharmaceutical Industry Profile : Environmental Regulations
  This sector notebook provides the profile of the pharmaceutical industry.
  
  
• Pharmaceuticals Sector Program, Environmental Protection Agency
  Environmental compliance assistance information for the pharmaceutical industry.
  

General FDA Resources

• FDA Forms
  Provides a portal to all forms required of businesses regulated by the FDA.
  
  
• FDA Guidance Documents for Regulated Industries
  Provides a portal to all guidance documents for businesses regulated by the FDA.
  
  
• FDA Guidance for Regulated Industries
  One-stop resource that provides links to FDA's regulatory guidance, forms, contacts, meetings and workshops.
  
  
• FDA Guide for Labeling and Advertising
  This guidance is intended to clarify for applicants the requirements for product name placement, size, and prominence in labeling and advertising for human and animal prescription drugs and biological products.
  
  
• Import and Export of Human Drugs and Biologics
  A guide to complying with the Federal Food, Drug and Cosmetic Act in the areas of international trade of drugs and biologics.
  
  
• Importing Food, Drugs, Cosmetics and Medical Devices into the U.S.
  Information related to products subject to FDA's control of foods (except for certain meats and poultry products), drugs (human, animal and biological), cosmetics, medical devices and radiation emitting devices, etc., offered for entry into the United States through U.S. Customs, in support of FDA's regulatory activities.
  
  
• Product Recalls : Guidance for Industry
  This guidance document is intended to provide guidance and instructions to FDA regulated industry for obtaining information to help fulfill the Agency's plans regarding product recalls.
  
  
• Small Business Guide to the FDA
  Guide to help ease the regulatory burden for small entities regulated by the FDA.
  

Medical Devices

• CT Imaging Systems Regulations
  Explains how the FDA regulates CT imaging systems.
  
  
• Center for Devices and Radiological Health : Compliance Activities
  Guide to compliance resources and documents.
  
  
• Center for Devices and Radiological Health : Device Advice
  A self-service site for medical device and radiation emitting product information.
  
  
• Center for Devices and Radiological Health : Registration and Device Listing
  Information about registering medical devices with the FDA. Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA.
  
  
• FDA Center for Devices and Radiological Health : Guidance Documents Database
  Searchable database of guidance documents.
  
  
• Medical Device Reporting : General Information
  Frequently asked questions about Medical Device Reporting requirements.
  
  
• Medical Device Reporting for Manufacturers
  This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the final rule dated December 11, 1995.
  

Veterinary Drugs

• Center for Veterinary Medicine : Compliance Resources for Industry
  Guide to complying with FDA rules to guarantee the safety of animal derived foods and drugs.
  
  
• Medicated Feed Mill Licensing
  Information about licensing requirements under the Animal Drug Availability Act of 1996.
  
  
• Veterinary Adverse Drug Experience Reporting
  Process and procedures for reporting adverse reactions to veterinary drugs.
  
  
• Veterinary Drug Approval Process
  Information and requirements for review and approval of animal drugs.
  
  
• Veterinary Drugs and Animal Feed Regulations
  Compliance policy guides.
  
  
• Veterinary Medical Products : Compliance FAQs
  Answers to frequent questions about complying with regulations regarding veterinary food and drugs.