- About Online Pharmacies
- Affordable Medication Advocacy
- Benefits and Risks
- Buying Controlled Medication Online Has Serious Risks
- Counterfeit Medications
- Drug Companies and Intellectual Property Rights
- How Much Can You Save?
- International Pharmacy Regulations
- Our Pharmacy Verification Program
- Rogue Pharmacies
- Types of Pharmacies
- U.S. Pharmacy Regulations
U.S. Pharmaceutical and Pharmacy Regulations
In the U.S., the Food and Drug Administration (FDA), a division of the U.S. Department of Health and Human Services, is responsible for regulating medication sold in the United States. New drug reviews, inspections of drug manufacturing establishments, post-market surveillance, and drug recalls are carried out by the FDA. The U.S. FDA is not responsible for regulating medication sold in other countries.
Pharmacies and pharmacists are regulated and licensed by states. Pharmacy regulations can differ a little from state to state but all require the presence and management of licensed pharmacists, and strict enforcement of safe dispensing practices and storage requirements. The regulation of controlled substances, drug products with stronger and addictive ingredients is the responsibility of the Drug Enforcement Agency (DEA). U.S. pharmacies must have a DEA-issued license to sell controlled substances.
The National Association of Boards of Pharmacy (NABP), the umbrella trade group representing state pharmacy boards, created the Verified Internet Pharmacy Practice Site (VIPPS) program in 1999 responding to public concerns about websites selling drugs without abiding by federal and state laws. As of July 31st, 2015, there are 40 VIPPS-certified online pharmacies, approximately 25% of which are members-only pharmacy benefit programs. The NABP's VIPPS program is closed to all Canadian and other non-US pharmacies that sell medications internationally to persons in the U.S.
For people living in the U.S., the potential benefits of buying from a U.S. online pharmacy rather than a foreign online pharmacy often include:
- Lower prices on generics — in fact, generic prices at some U.S. online pharmacies are often half the Canadian price due to greater competition in the U.S. market
- Acceptance of prescription drug insurance to purchase drugs
- Lower shipping charges
- Easier recourse to legal action if you are wronged by the online pharmacy
- Generally strong pharmaceutical and pharmacy safety regulations, although many other countries have similarly strong regulations.
If you do not have insurance, or your insurance does not cover the brand name drugs you need, U.S. pharmacies are almost always far more expensive than their foreign counterparts.
International Online Pharmacies: Personal Drug Imports Are Generally Permitted But Not Technically Legal
Personal Drug Importation:
Since 2000, millions of Americans with inadequate or no drug coverage, as well as those seeking critical medications that are not available domestically, have purchased medication from foreign pharmacies, mostly using online pharmacies. This process is known as personal drug importation. The U.S. government generally does not stop individuals from importing medication for their own use (usually up to a three-month supply of non-controlled drugs), however, under most circumstances, it is technically illegal. According to the FDA, no one has ever been prosecuted for personal drug importation (importing small quantities of medication for personal use).
The FDA provides personal drug importation guidelines for its personnel.
While the law allows the FDA and the U.S. Customs and Border Patrol to detain and refuse international prescription orders arriving through the mail, less than one percent are actually stopped. In these cases, under U.S. law, you will be informed by the FDA that your drug order has been detained or refused and that you are allowed to challenge their decision to take away your medication to try and have it released. To learn how to provide testimony to the FDA if they take your medication, you can go to Prescription Justice Action Group. The U.S FDA regulates the safety and efficacy of medications sold in U.S. pharmacies. Medications dispensed from outside the U.S. are regulated for safety and efficacy by pharmaceutical/pharmacy regulatory authorities in other countries.
Watch Marcia Crosse, PhD, director for the Health Care Team at the U.S. Government Accountability Office (GAO) explain FDA's personal drug importation policies:
Wholesale Drug Importation
Unlike personal drug importation, wholesale drug importation is dedicated to the domestic re-sale of imported pharmaceuticals. Businesses and people engaging in illegal wholesale drug importation are often the focus of serious criminal enforcement action by the FDA. Due to the unusually high drug prices in the U.S., safe wholesale drug importation could help lower drug prices in U.S. pharmacies. The safety challenges of wholesale drug importation, however, are beyond the purview of PharmacyChecker.com's programs, which are designed to provide information to help individuals seeking safe and affordable medication online for their own use only.