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Pharmaceuticals & Biotechnology
Whether you are a small business or a large corporation, the you must adhere to laws and regulations governing the pharmaceutical business. This section is a 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.
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Biologics, Blood, & Vaccines
- FDA guide for manufacturers of biological products, blood products and vaccines.
- Blood Establishment Registration & Product Listing
All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65
- Drug & Biologic Approval Process
How biological product, blood products and vaccines are approved by the FDA.
- Guidance, Compliance & Regulatory Information (Biologics)
FDA regulations for biological products, including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
- Development & Approval Process (Center for Biologics Evaluation and Research)
Regulations for developing and marketing biological, blood and vaccine products
- 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.
- Importing & Exporting Biologics
Submission requirements for requesting certificates for exporting products to foreign countries.
- 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.
- Tissue Establishment Registration
Producers of human cells, tissue, and cellular and tissue-based products must register with the FDA and list their human cells, tissues, and cellular and tissue-based products (HCT/Ps).
- ARCOS - Automation of Reports & 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 & 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 & 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 & 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 Resources
Provides links to websites created and maintained by other government agencies and organizations relating to the control of and adherence to the Controlled Substances Act.
- 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 & 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 & 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 : 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 & Approval
- Bringing New Drugs to Market : FAQs
Frequently asked questions on drug development and investigational new drug applications.
- Center for Drug Evaluation & 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 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.
- 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 & 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 & 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 & 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.
- CT Imaging Systems Regulations
Explains how the FDA regulates CT imaging systems.
- Center for Devices & Radiological Health : Compliance Activities
Guide to compliance resources and documents.
- Center for Devices & Radiological Health : Device Advice
A self-service site for medical device and radiation emitting product information.
- Center for Devices & 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 & 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.
- 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 & Animal Feed Regulations
Compliance policy guides.
- Veterinary Medical Products : Compliance FAQs
Answers to frequent questions about complying with regulations regarding veterinary food and drugs.