Codex Alimentarius Commission - A Threat to Mankind

Codex Alimentarius Commission - A Threat to Mankind

Nearly 30 million packages of prescription drugs are estimated to be shipped into the United States each year--a supply worth more than $4.5 billion.

U.S. Consumers To save money, millions of uninsured and underinsured U.S. consumers purchase drugs from online pharmacies in Canada, India, the UK and other countries and receive their purchases by mail. Especially for uninsured Americans taking prescription drugs for chronic health conditions, a major attraction of online pharmacies abroad is that nearly every country, except the U.S., controls its drug prices. Shoppers can easily obtain 50 to 80 percent or more savings at foreign pharmacies, in comparison to US prices. Very rarely are these orders investigated because U.S. authorities are much more worried about controlling illegal pharmacies in the U.S., not consumers themselves. In fact, the Washington Post reported that ".. millions of Americans have turned to Mexico and other countries in search of bargain drugs...U.S. Customs estimates 10 million U.S. citizens bring in medications at land borders each year. An additional 20 million packages of pharmaceuticals arrive annually by international mail from Thailand, India, South Africa and other points. Still more packages come from online pharmacies in Canada."

Until about 2005, American consumers looking abroad most commonly turned to Canadian pharmacies for affordable medications. Today, many consumers head to online pharmacies in India, South Africa and other countries where drug prices are often lower than in Canada.

A report in the journal Clinical Therapeutics found that U.S. consumers face a risk of getting counterfeit drugs because of the rising Internet sales of drugs, projected to reach $75 billion by 2010.

Overseas online pharmacies and U.S. law Legality and risks of purchasing drugs online depend on the specific kind and amount of drug being purchased.

While rarely enforced, it is usually illegal to purchase controlled substances from an overseas pharmacy. Generally speaking, a person purchasing a controlled substance from such a pharmacy may be violating two federal laws which can carry stiff penalties. The act of importation of the drug from overseas violates 21 USC, Section 952 (up to 5 years in prison and $250,000 fine for importation of non-narcotic Schedule III, IV, or V drugs; possibly more for narcotics and Schedule I and II drugs). The act of simple possession of a controlled substance without a valid prescription violates 21 USC, Section 844 (up to 1 year in prison and $1,000 fine). Note that FDA does not recognize online prescriptions; in order for the prescription to be valid, there has to be a face-to-face relationship between the patient and the health care professional prescribing the drug. What exactly constitutes a "face-to-face" relationship is considered by many online pharmacies to be a subjective definition which would allow them to operate as an adjunct to the patient''s own physician if the patient submits medical records documenting a condition for which the requested medication is deemed appropriate for treatment. Sections 956 and 1301 provide exemptions for travellers who bring small quantities of controlled substances in or out of the country in person, but these exemptions do not cover delivery via a mail carrier.

  • Importation of any prescription drug (not necessarily a controlled substance) violates 21 USC, Section 301(aa), unless the following conditions are met (as listed in Section 804):
  • The drug is imported from Canada, from a seller registered with the Secretary (i.e. with FDA);
  • The drug is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply;
  • The drug is accompanied by a copy of a valid prescription;
  • The drug is a prescription drug approved by the Secretary;

The drug is in the form of a final finished dosage that was manufactured in an establishment registered under section 510; and

  • The drug is imported under such other conditions as the Secretary determines to be necessary to ensure public safety.

The law further specifies that enforcement should be focused on cases in which the importation by an individual poses a significant threat to public health, and discretion should be exercised to permit individuals to make such importations in circumstances in which the prescription drug or device imported does not appear to present an unreasonable risk to the individual.

According to Department of Homeland Security Appropriations Act, Section 535, Customs and Border Patrol are not allowed to prevent people from importing FDA-approved prescription drugs. Although originally the law was worded to cover all prescription drugs, countries of origin, and methods of delivery, its final edition specifies that it only applies to importation from Canada, and to "...individuals transporting on their person a personal-use quantity of the prescription drug, not to exceed a 90-day supply". Controlled substances are also explicitly excluded. Therefore, it does not disallow Customs to screen and intercept drugs sent by mail.

It is also technically illegal to import "non-approved" drugs (21 USC sections 331(d) and 355(a)); however, FDA policies suggest that, under certain circumstances, the patients may be allowed to keep these drugs.

Individual U.S. states may implement their own laws regulating importation, possession, and trafficking in prescription drugs and/or controlled substances.

For several years, the states of Nevada, Minnesota, Illinois and Wisconsin have run official state programs to help their residents order lower-cost drugs from abroad to save money.

Most online pharmacies worldwide will send consumers a free replacement order if their order is not received for any reason, including customs seizure (some do require the customer to submit a copy of the seizure letter they received from customs, in order to prevent fraudulent claims of non-receipt).