Under Construction

(Response 6) We do not change the rule on the basis of these comments, as the final rule contains provisions to protect against an SIP that is addressed to unscrupulous online pharmacies as foreign sellers. Although there are pharmacy sites that operate legally and offer comfort, privacy and warranties for the purchase of drugs, we agree that there are many unscrupulous online pharmacies that sell drugs at very low prices, often without a prescription or in accordance with other safety features, followed by state-licensed pharmacies in the United States (ref. 1 and 2). The final rule defines “Foreign Seller” as “Foreign Seller” refers to a Start Printed 62098 facility within Canada that participates in the distribution of a licensed drug subject to imported or proposed medical prescription in the United States. The final rule also requires a foreign vendor to have an active drug licensing for the wholesale sale of Health Canada drugs and must be registered with the province`s supervisory authorities in order to market the drugs authorized by the HPFB. The final rule also states that a foreign seller cannot be licensed by a provincial regulator with an international pharmacy license to distribute drugs authorized by countries other than Canada that are not authorized to be distributed in Canada. A foreign seller must also be registered with the FDA in accordance with Section 804 of the FD-C Act. The final rule also includes a number of supply chain requirements for foreign sellers. In addition, the FDA retains the authority not to approve an SIP or to stop an SIP without proven that the foreign seller meets all relevant safety criteria. (Comment 47) Several comments deal with the liability of a foreign seller with respect to the ISS. One comment indicated that the ISS should be “unique,” but that the ISS could be duplicated among foreign sellers. The comment also suggests that the ISS would not allow a manufacturer to trace, since the ISS does not contain the manufacturer`s serial number, unlike the product identifier. A comment is intended to clarify the information that a foreign seller must keep about a manufacturer`s products.

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