US Law and Overseas Online Pharmacies II
In addition, the FDA often acts with the intent to protect consumers, but causes other issues to surface. For example the FDA recently acted to halt the bogus sale of ‘homeopathic hCG’ drops used for weight loss, because of many complaints and findings that the products for sale contained no hCG. By banning the advertising of treatments tying hCG to weight loss, the FDA harmed legitimate medical practices that use real hCG in effective programs by banning their ability to get their message out, even though these services have significant rates of success in treating obesity. Effective medical treatments, like doctor supervised weight loss injections using hCG may no longer use Google Adwords to promote these services and the international component is even more complicated. The face to face relationship is not even considered here.
And that’s part of the crux, according to online pharmacies. A “face-to-face” relationship is subjective, and many online operations operate as an adjunct to the patient’s own doctor, provided that the patient submits medical records that document a condition for which requested medication is deemed appropriate.
Importation of any prescription drug violates 21 USC, Section 301(aa), unless certain conditions are met:
1. The drug is imported from Canada, from a seller registered with the Secretary (i.e. with FDA) (hence the popularity of Canadian online pharmacies);
2. The drug is imported from a licensed pharmacy for personal use by an individual – and not for resale – in quantities that don’t exceed a 90-day supply;
3. The drug is accompanied with a copy of a valid prescription;
4. The drug is a prescription drug that’s approved by the Secretary;
5. The drug is in the form of a final finished dosage that was manufactured in an establishment that’s registered under section 510; and
6. The drug is imported under such other conditions as the Secretary determines to be necessary in order to ensure public safety.
Here’s a few more legalities in regards to online pharmacies to chew on – and it’s not all bad news:
Federal law specifies that enforcement should be focused on specific cases where the importation by an individual poses a significant threat to public health, and discretion is to be exercised to permit individuals to make such importations in those circumstances in which the prescription drug or device imported doesn’t 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. This does not include controlled substances, which is why Customs is able to screen and intercept drugs sent by mail.