R.I. Draft Rules for Importing Canadian Drugs Include Product Liability

June 16, 2005

The Rhode Island Health Department has drafted guidelines that would govern drug imports from Canada, and help ensure the medications meet quality and safety standards in Rhode Island.

The proposed rules would be another step toward allowing the state to license Canadian pharmacies.

Under the proposed regulations, Canadian pharmacies would be allowed to ship only drugs that are approved by the U.S. Food and Drug Administration, and to follow FDA rules regarding the processing and handling of drugs. They’d also need to document where the drugs were manufactured.

The rules would require pharmacies buy $5 million in product liability insurance, offer patients counseling on their medications, and maintain patient confidentiality.

“We want to make sure that they’re getting the same quality drugs and the same safety that they’re getting in Rhode Island,” said Health director David Gifford.

The draft regulations were to be the subject of a public hearing this week at the Health Department in Providence.

The Rhode Island Pharmacists’ Association said it won’t know whether the proposed rules offer enough protection until they’re tested. Pharmacists and pharmaceutical companies have opposed drug imports.

Two senior citizens advocacy groups said the $5 million product liability insurance requirement is too expensive.

The draft guidelines also would prohibit imports of several kinds of drugs, including controlled substances, drugs that can spoil in transit, and drugs that are often counterfeited. Also, any dispute over drug imports would need to be heard in a Rhode Island court.

Four Canadian pharmacies applied for licenses under regulations drafted by the Health Department in January, but their applications hadn’t been processed before the latest revisions began.

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