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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
  • 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.
  • 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).

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Controlled Substances

  • 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 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.
  • 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 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.
  • 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.

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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.

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Drug Evaluation & Approval

  • Combination Products : FAQs
    Frequently questions asked about FDA's review and evaluation process for combined, drug and device products.
  • Orphan Drugs : FAQs
    Commonly asked questions concerning evaluation and approval of orphan drugs.

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Environmental Compliance

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General FDA Resources

  • FDA Forms
    Provides a portal to all forms required of businesses regulated by the FDA.
  • 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.
  • 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.

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Medical Devices

  • 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.

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Veterinary Drugs

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