Summary+Of+Registration+and+Listing+Requirements

Source: http://www.fda.gov/cder/drls/default.htm
 * ** SUMMARY OF REGISTRATION AND LISTING REQUIREMENTS FOR THE MANUFACTURE OR DISTRIBUTION OF HUMAN PHARMACEUTICALS **  ||
 * ** TYPE OF FIRM ** ||  ** REGISTRATION STATUS **   ||  ** LISTING STATUS **   ||
 * Manufacturer including homeopathic & controlled drugs] ||   yes   ||   yes   ||
 * Contract Manufacturer ||   yes   ||   yes   ||
 * Own/Private Label Distributor ||   no   ||   yes   ||
 * Wholesale Distributor ||   no   ||   no   ||
 * Own Label Repacker ||   yes   ||   yes   ||
 * Own Label Relabeler [including recirculizer] ||   yes   ||   yes   ||
 * Contract Relabeler ||   yes   ||   no   ||
 * Contract Testing Laboratory [dosage forms & active ingredient release] ||   yes   ||   no   ||
 * Contract Testing Lab [doing non-release tests] ||   no   ||   no   ||
 * Contract Sub-Manufacturer ||   yes   ||   no   ||
 * IND Manufacturer [Clinical Drugs] ||   no   ||   no   ||
 * NDA and ANDA Manufacturer ||   yes   ||   yes   ||
 * Sponsor/Monitors/Clinical Investigator ||   no   ||   no   ||
 * Contract Sterilizer ||   yes   ||   no   ||
 * Fulfillment Packager [adding substantive labeling] ||   yes   ||   no   ||
 * Mail Order House [adding insubstantial labeling] ||   no   ||   no   ||
 * Printing House ||   no   ||   no   ||
 * Medical Gas Transfiller ||   yes   ||   yes   ||
 * First Aid/Rescue Squad [transfilling for own use] ||   no   ||   no   ||
 * Medical Gas Transfiller [operating out of a van] ||   yes   ||   yes   ||
 * Contract Assembler ||   yes   ||   no   ||
 * Active Drug Substance Manufacturer ||   yes   ||   yes   ||
 * Excipient Drug Manufacturer ||   no   ||   no   ||
 * Manufacturer of Research Drugs ||   no   ||   no   ||
 * Drug Importer ||   no   ||   no   ||
 * Foreign Drug Manufacturer ||   yes   ||   yes   ||
 * Methadone Clinic ||   no   ||   no   ||
 * Retail Pharmacy ||   no   ||   no   ||
 * Manufacturing Pharmacy ||   yes   ||   yes   ||
 * Regional Admixture Pharmacy ||   yes   ||   no   ||