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
Blood Products
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
Drug Evaluation and Approval
Environmental Compliance
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
Veterinary Drugs