It goes without saying that long term care providers are allowed to administer drugs to patients, and extra care is required when acquiring, receiving, dispensing and administering foreign prescription drugs.
The attached letter (PDF) instructs state survey agency directors on what to do when providers administer foreign drugs. Foreign drugs that purport to be the same as Food and Drug Administration-approved drugs may be substandard and/or dangerous. Providers must make sure that foreign prescription drugs are approved by the FDA and meet U.S. labeling requirements.
Long term care provider facilities administering imported drugs must comply with 42 C.F.R. 483.60 (a). State surveyors certainly have their jobs cut out for them, so providers should do their part by dealing with manufacturers or distributors that comply with the Federal Food, Drug, and Cosmetic Act instead of importing drugs directly from foreign entities.
