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OT: There’s No Such Thing as an “FDA-Approved” Pharmacy
By JLP | May 10, 2007
Lately, I have been swamped with emails with “FDA-Approved Pharmacy” in the subject line. I bet I get 5 or 10 emails per day of this nature. I have always known that the Food and Drug Administration oversees food and drugs but pharmacies? So, I sent them an email and asked them about it and this is the response I got (it’s kind of long, but I didn’t want to truncate it):
Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.
FDA does not approve pharmacies. The growth in online drug sales by reputable pharmacies can greatly benefit consumers by increasing access to medical information and pharmaceutical products and, in some cases, reducing the costs of drugs. But online drug sales can also present serious risks to unsuspecting purchasers.
The Internet has created a new marketplace for drug products that are illegal in the traditional marketplace. Unapproved new drugs (including counterfeit drugs), expired or illegally diverted pharmaceuticals, and products marketed with fraudulent health claims are readily available on the Internet. Prescription drugs can be obtained without a prescription and without the guidance and monitoring of a healthcare professional.
We are concerned about the public health implications of Internet drug sales and are working actively with other State and Federal agencies to ensure that the safeguards Congress has enacted over the years to protect the public health and safety protect those traveling the virtual highway as well as those on Main Street.
To help keep consumers as informed as possible about Internet drug sales, we have developed a list of do’s and don’ts. At the end of this message, we have attached a copy of this list.
Visit http://www.fda.gov/oc/buyonline/default.htm for several articles and Q&A’s regarding buying medicine online.
You may also direct your complaints concerning problem websites at the FDA website: http://www.fda.gov/oc/buyonline/buyonlineform.htm
———————————————————————-Internet Drug Sales Do’s and Don’ts
The FDA is making the following recommendations for those people considering ordering pharmaceuticals from an Internet site.
1. Don’t use Web sites that are not registered on a search engine. Internet systems list the sites that subscribe with their service.
2. Don’t purchase drug products from sites that offer to prescribe drugs outside of the customary physician-patient relationship. Under Federal and State laws, to receive a prescription for the first time, generally a patient must be physically examined by a licensed healthcare practitioner who determines the appropriate treatment and issues a prescription for an FDA-approved drug. In a situation where the customary physician-patient relationship does not exist, the patient is essentially practicing self-diagnosis. Consequently, the risk of adverse events resulting from drug interactions, allergic reactions, contraindications, and improper dosing is greatly magnified. We are also concerned about the proliferation of sites that substitute a simple questionnaire for a face-to-face examination and patient supervision by a healthcare practitioner.
3. Don’t purchase from sites that offer unapproved medications for sale require linking to another site to purchase the drug, or are foreign web sites.
Some medications sold on the Internet may be legal in a foreign country, but are not approved for use in the United States. Some products may include addictive and dangerous substances. Products not approved for sale in the United States generally do not conform to the good manufacturing practices and quality assurance procedures required by U.S. laws and regulations. Web sites that do not provide a U.S. phone number and address also should be avoided.
4. Do consult your healthcare provider regarding the selection of any drug product.
Your healthcare provider is familiar with your current health status and past medical history. A Web site can be created to look like a legitimate pharmacy when in fact both the seller and the product may be illegitimate.
Valid prescriptions should be filled by a registered pharmacist working in a licensed pharmacy that meets State practice standards.
5. Do check with the National Association of Boards of Pharmacy (NABP).
If in doubt about an Internet pharmacy Web site, check with the NABP to see if an Internet firm has a valid pharmacy license and meets other state standards. The NABP Internet address is: http://www.nabp.net6. Do contact your healthcare provider if you have a question about a drug. We recommend that you contact your healthcare provider or a licensed pharmacist to determine whether a drug is FDA-approved for marketing in the United States.
FDA is working with Federal and State agencies to maximize the benefits of Internet pharmacies and take action against violators of the Federal Food, Drug, and Cosmetic Act and relevant regulations.
For more consumer information on buying medicine over the Internet, visit FDA’s website
If you have a specific complaint about unsolicited commercial e-mail (spam), use the form at:
https://rn.ftc.gov/dod/wsolcq$.startup?Z_ORG_CODE=PU01.
You can forward spam directly to the Commission at UCE@FTC.GOV without using the complaint form.
1-877-FTC-HELP (382-4357)Please also forward the weblink to webcomplaints@oc.fda.gov
Best regards,
RC
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug AdministrationThis communication is consistent with 21CFR10.85(k) and constitutes and informal communication that represents our best judgment at this time but does not constitute and advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
I would hope that people wouldn’t buy drugs through spam emails but you never know. Anyway, I thought this information was worth sharing.
Topics: Miscellaneous | 1 Comment »
May 11th, 2007 at 9:06 am
When it comes to prescription drugs, I would not order from anyone that was not an established name in the US. Walgreens or Eckerds, for example.
Over the counter items I would buy in store with off-brands such as at Target or the grocery store. But never online. I just assume every spam email I get is a scam (either a direct scam or a legal one by tricking you into signing up for a monthly charge without knowing it).