● FDA: company complies with standard ○ Regulation of importation, manufacturing market, consumer utilization, marketing ■ Post-marketing surveillance ■ Unregistered products are listed ■ Should have registration number not only LTO (license to operate) the assurance of the safety, efficacy and usefulness of pharmaceutical products through quality control. This will involve the regulation of the importation, manufacture, marketing, and consumer utilization of all drugs and their intermediates