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SUMMARY OF REGISTRATION AND LISTING REQUIREMENTS FOR THE MANUFACTURE OR DISTRIBUTION OF HUMAN PHARMACEUTICALS |
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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 |