Foreign Acquired Medications
Under Pharmacy Services, the federal guidance to surveyors has brought up obtaining medications from foreign countries.
"It has been reported that some residents and/or facilities may be obtaining medications from foreign sources. Medications obtained from foreign sources may present safety issues since they have been manufactured or held outside of the jurisdiction of the United States (U.S.) regulatory system. These medications may not be safe and effective for their intended uses. The Federal Food, Drug, and Cosmetic Act (FFDCA) strictly limits the types of drugs that may be imported into the U.S. Medications imported into the U.S. may violate the FFDCA if they are unapproved by the FDA, labeled incorrectly, or dispensed without a valid prescription. The facility should, in collaboration with the pharmacist, assure that medications are provided or obtained from approved sources and do not violate the FFDCA.
If it is determined that the facility is providing/obtaining foreign medications that are not FDA approved for use by the residents, the State Agency must make referrals to appropriate agencies, such as the FDA; depending on the medication classification, the Drug Enforcement Administration; State Board of Nursing; State Board of Pharmacy; and the State Licensure Board for Nursing Home Administrators."