BACKGROUND: For patients, the prescription container label may be the only 
source of instructions on how to take their medicines. In the United States, the 
legal requirements for a prescription label are set by federal law and state 
statutes. The container should be comparable to that which manufacturers use to 
package drug products and should preserve a product's identity, strength, 
quality, and purity and prevent contamination. Safety features such as a 
child-resistant closure should be provided. Pharmaceutical products purchased 
from international online pharmacies are not approved by the Food and Drug 
Administration (FDA) and may not meet US guidelines for labeling and packaging.
OBJECTIVE: The study objective was to determine whether commonly purchased 
pharmaceutical products obtained from international online pharmacies are 
comparable to products dispensed in the United States with regard to labeling 
and packaging.
METHODS: During March 2006 through January 2007, 41 pharmaceutical oral dosage 
form samples were obtained from international Internet pharmacy websites for 
evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 
generic sildenafil samples. Contents for each package were observed and recorded 
and comparison of the prescription labeling and packaging of these products was 
made with prescription labeling and packaging requirements in the United States.
RESULTS: Of the 41 drug products obtained from online pharmacies from 12 
different countries, only 1 product (from Canada) would meet both labeling and 
packaging guidelines for products dispensed in the United States. Of those not 
meeting the requirements, 7 were dispensed in paper envelopes with label affixed 
that was either handwritten or typed and contained missing information such as 
name and address of dispenser, name of prescriber, name of patient, and 
directions for use. Another 3 products did not have a label affixed to the drug 
product, but information was printed on a paper document enclosed in the 
shipping package, while 28 products did not have labels affixed to the drug 
product. In all, 39 of the 41 drug products' packaging would not meet the US 
guidelines. Aside from the Canadian product, only 1 product from Mexico was 
dispensed in a container that would meet guidelines established in the United 
States. In total, 35 products were not dispensed in plastic vials but were 
dispensed in unit dose packages, paper envelopes with loose dosage forms, 
blister packs of drugs held together with rubber bands, or a combination of 
these packaging forms.
CONCLUSIONS: Results suggest that labeling and packaging standards for 
international generic drug products are not equivalent to labeling and packaging 
standards in the United States. This suggests dissimilar and substandard 
distribution processes compared with those in the United States, which in turn 
presents a challenge to patient comprehension and health literacy and may affect 
patient adherence to drug treatment regimens. These findings have strong 
implications for drug product quality, patient outcomes, therapeutic 
effectiveness, and safety.