Retailer Advisory on the Sale of Imported Food and Drug Products
Many retailers carry products including medications and herbal supplements that cater to customers of ethnic origins. Although these products may be appropriate for sale in a foreign country, they may not be appropriate for sale in the United States.
The following criteria must be met prior to sale of such items:
· All medications, both prescription and non-prescription, must be approved for use by the Food and Drug Administration (FDA.)
· All foreign manufacturers must be approved by the FDA.
· All labeling must be complete, and in English. There may also be a complete secondary label in the appropriate foreign language. This labeling must be added by the manufacturer or distributor. This secondary label “sticker’ must not obliterate or cover required information on the package in English and must comply will all FDA labeling laws.
· Prescription Medications.
o These products must comply with the requirements of Section A, above.
o Many items sold outside the United States do not require a prescription, but in the United States a prescription is required. Therefore, only a pharmacy licensed by the State of Connecticut may sell these items.
o The FDA determines prescription requirements, not the foreign country of origin.
· Controlled Substances.
o These products must comply with the requirements of Sections A and B, above.
o Controlled substances are prescription items which meet the medication requirements as defined by the FDA. They must also comply with controlled substance laws administered by the State and Federal Drug Enforcement Administration (DEA) within the United States, not the foreign country of origin.
o The retail sale of controlled substances can only occur from a Connecticut-licensed pharmacy or a hospital pharmacy licensed by the Department of Public Health for “own use.” In these cases, both the Connecticut-licensed pharmacy and the hospital pharmacy must be properly registered with the DEA.
o Retail sale of controlled substances from establishments not licensed as a pharmacy or hospital is a violation of the federal and State Controlled Substance Act.
· Over-the-Counter Medications.
o These products must comply with the requirements of Section A. In addition, a State of Connecticut Non–Legend Drug Permit (PME) is required for these products to be sold at retail.
Licenses for drug products issued by DCP
· Non-legend Drug Permit
Imported Food Products
o Packaged foods products must comply with Federal and State labeling requirements. The labels must be in English, and must clearly and conspicuously contain the following:
o Common or usual name
o Net contents statement in English and metric units
o Responsibility statement – name and address of packer or distributor
o Ingredient statement – list of ingredients in order of predominance by weight
o There must be additional labeling if the product contains an allergen such as, milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts or soybeans.
Licenses for food issued by DCP
· Frozen Desert
· Bottled Water – must be from an approved and licensed vendor. The retailer is not required to get a license.
· Vending – food vending machines must be licensed in Connecticut. The license holder will be either the retailer if they operate the food vending machine directly or if the vending location is rented out to a third party; the third party operator must be the license holder.
All licenses and permits may be downloaded from Department of Consumer Protection's website at this link.