In recent years, there has been a boom in online pharmacies, many of them dealing in “lifestyle” or “recreational” prescription drugs such as Viagra and Redux. Trans people have participated by purchasing their hormones from some of the same online sources. The reasons for using an online pharmacy rather than a brick-and-mortar pharmacy are varied, but many of those reasons boil down to a division between those who have prescriptions from their physicians and those who don’t.
This article principally covers law and policy in the United States, but also contains similar information for people in Australia and Canada. More information is available concerning US policies for a number of reasons. Americans don’t have national health coverage, so even populations garnering more sympathy, such as seniors on fixed incomes, are taking Canadian bus trips and ordering from South Pacific online pharmacies to get their medications more inexpensively. National health services in countries like the United Kingdom cover the expenses of a transsexual’s medical transition, unlike private insurers in the United States. An added bias in the writing of this article is that the author is an American, and is more successful in searching for information by keywords he recognizes, such as “overseas pharmacy” and “FDA” (the US Food and Drug Administration), and finds other search terms like the Australian “Therapeutic Goods Administration” by luck and chance.
Laws In the United States
Even though The Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits non-approved drugs from entering the United States, the FDA allows patients to bring a 90-day supply of prescription drugs for their personal use (Vogt 2001).
According to the United States Postal Service Publication 52, drugs may be shipped internationally, as long as they are not controlled substances. Controlled substances are defined as those in Schedules I through V of the Controlled Substances Act in 21 U.S.C. 801. Estrogen is not a controlled substance, but testosterone is a Schedule III substance. A list of controlled substances is available here.
A phone call to UPS (United Parcel Service, a private shipper) clarified their policies on imported prescriptions: Prescriptions imported into the US will be delayed for at least one day for FDA inspection. Individuals importing prescription medications should ensure that the following information is provided by the shipper: generic and scientific names of the drug, the manufacturer’s name and address, the quantity being shipped, and the suggested dosage. There should be no more than a 3-month supply shipped. You should also fax a statement to the shipper that the drug is for the receiver’s personal use, as well as a letter from your physician with the doctor’s name and address that indicates you’re in the physician’s care and giving a statement of your condition and reason for using the drug. You should fax these to the shipper so they can provide the information upon exporting the package. In addition, non-citizens importing drugs into the U.S. should also include documentation attesting to their legal residence in the U.S. (UPS 2002).
FedEx requires the drug manufacturer’s name and address, the form and quantity of the drug and type of packaging, the condition being treated, and whether the drug can be obtained in the US be indicated on the commercial invoice, and that a doctor’s prescription accompany the shipment (FedEx 2002).
Online pharmacies operating in the US can voluntarily be monitored by the National Association of Boards of Pharmacy by becoming a Verified Internet Pharmacy Practice Site (VIPPS). To determine if a pharmacy website is a VIPPS, look for the VIPPS seal with a link to the VIPPS website. The FDA recommends checking the NABP site to see if a website is in good standing.
It is illegal to import drugs that were originally manufactured in the United States. It is legal to import foreign-made generic drugs that are approved by the FDA. Approved drugs are listed in the FDA’s Orange Book.
Some online pharmacies offer online consultations, in which the customer enters information like weight, height, symptoms, and other prescription drugs being used. In some cases, there is no physician or pharmacist reading the entered information. Two cases reported were of a person claimed to be 16 years old, and another reported symptoms and other drugs used that clearly contraindicated use of the requested drug, yet in both cases, the pharmacies sent the requested drugs. The Department of Justice has successfully prosecuted doctors who “prescribed” steroids (which were regulated at the time as prescription drugs, rather than controlled substances, as they are now) without establishing legitimate doctor-patient relationships with their customers (Electronic Frontier 2000).
The DEA has issued a regulation defining “prescription” such that it would be impossible to issue a valid prescription for a controlled substance based on an online diagnosis as a regular course of business. (See 21 C.F.R. § 1306.04) Claiming that a properly licenced physician will review the online questionnaire, when that is not the case, is in violation of the Federal Trade Commission Act (“FTC Act”), 15 U.S.C. § 45.
Overseas pharmacies have overwhelmed US abilities to monitor imports, to the point that “the Internet has rendered existing mechanisms for preventing illegal prescription sales ineffective” (Overseas Internet Pharmacies 2000). Clyde Moore, operator of Overseas Pharmacy says that that 5% of his customers have their packages opened by Customs. “They’ll open a package and send it through but seize an identical package.” (Richards).
Laws in Canada
Similar to the US regulations, the Health Products and Food Branch Inspectorate (HPFBI) allows you to import a three-month supply of a prescription medicine for your personal use, but you must personally bring the drug over the border. Food and Drug Act regulations prohibit the shipment of prescription medicines from outside Canada. There is a potential loophole in that “to prevent delays or interrupt a course of treatment or other situations in which refusal of a shipment at the border could create a health risk, inspectors may allow entry of an initial 3-month supply of a drug, if the drug is packaged in hospital or pharmacy dispensed packaging.” (Source: Health Canada)
Laws in Australia
The Therapeutic Goods Administration (TGA) has an online Q&A-style document entitled “Personal Import Scheme for Unapproved Medicines” that explains what prescription drugs may be imported into Australia, and what may be required to import them. You may bring a three-month supply, at the maximum dose recommended by the manufacturer, of unapproved medicines into Australia in any one importation without any approval required by the TGA, and no more than a fifteen month supply within a twelve month period. The drugs must be for your (or your family member’s) personal use, so you can’t resell or give them away. Controlled substances or those containing human or animal products (except insulin) are not allowed. You cannot import more than fifteen months’ supply within a twelve month period. A prescription is required for SUSDP (Standard for the Uniform Scheduling of Drugs and Poisons) Schedule 4 and 8 drugs. Schedule 8 drugs include all androgenic substances, which would include testosterone, and Schedule 4 drugs are all other prescription drugs (Australian Customs Service, Government of Victoria Australia).
Australian Customs Service Illicit Drugs Unit. Seizures of Performance Enhancing Drugs (PEDs). Retrieved 19 May 2002 from http://www.customs.gov.au/olympics/pedseize.pdf.
The electronic frontier: the challenge of unlawful conduct involving the use of the Internet: a report of the president’s working group on unlawful conduct on the Internet, Appendix A – Executive Order 13,133. (2000 Mar). Retrieved 19 May 2002 from http://www.usdoj.gov/criminal/cybercrime/append.htm.
Fawcett A. (2001 Aug 7). ONLINE Rx: Overseas sources can slash the cost of drugs, but experts prescribe healthy doses of caution. Retrieved 19 May 2002 from http://bernie.house.gov/documents/articles/2001-08-07-rx_drugs.asp.
FedEx representative “Eva,” personal communication, May 18, 2002.
Government of Victoria Australia Department of Human Services, Public Health Division. Summary of Requirements for Medical Practitioners – Drugs, Poisons and Controlled Substances. Retrieved 19 May 2002 from http://www.dhs.vic.gov.au/phd/hprot/drugpois/phsrmp.html.
Health Canada. Taking Medicine Across Borders. Retrieved 19 May 2002 from http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/fact-sht/fact_border_e.pdf.
Overseas internet pharmacies threaten U.S. ability to regulate prescription drug sales. (2000 June 5). Retrieved 19 May 2002 from http://www.adlawbyrequest.com/legislation/OverPharm.shtml.
Richards, Linda. Online pharmacies abound. Retrieved 19 May 2002 from http://pubs.acs.org/subscribe/journals/mdd/v04/i04/html/MDD04DeptSites.html
UPS representative “Jim,” personal communication, May 18, 2002.
Vogt DU, Randall B. (2001 Jan 10). The Prescription Drug Import Provisions of the FY2001 Agriculture Appropriations Act, P.L. 106-387. Congressional Research Service Report for Congress. Retrieved 19 May 2002 from http://rxpolicy.com/studies/crs-106thimports-0101.pdf.