Perspectives: Avoiding Poorly Regulated Medicines & Medical Products During Travel

CDC Yellow Book 2024

Health Care Abroad

Author(s): Michael Green

In many low- and middle-income countries, national drug regulatory authorities lack the capacity to monitor and enforce drug quality standards effectively and to keep poor-quality products, including drugs, vaccines, and medical devices, off the market. Consequently, substandard and fake medicines are a public health concern in these locations. Many poor-quality products also are trafficked by pharmacy websites that misrepresent themselves as reputable or located in countries with mature regulatory systems. Even high-income countries are not immune to the problem, because counterfeiters become adept at thwarting the efforts of more advanced regulatory systems.

Poor regulatory oversight breeds poor-quality medicines, whether they are counterfeit, falsified, substandard, or degraded (Box 6-05). A report from the World Health Organization identified that 10% of medical products circulating in low- and middle-income countries are either substandard or falsified. Another study found that 9%–41% of tested drugs failed quality specifications. In specific regions in Africa, Latin America, and Asia, the chance of purchasing a counterfeit drug can be <30%.

Because counterfeit drugs are not made by legitimate manufacturers and are produced under unlawful circumstances, improper or toxic ingredients in these products can cause serious harm. For example, the active pharmaceutical ingredient could be absent, present in small quantities, or replaced with a less effective compound. In addition, the wrong inactive ingredients (excipients) can contribute to poor drug dissolution, bioavailability, and toxicity. As a result, a patient might not respond to treatment or could have adverse reactions to unknown substituted or toxic ingredients.

Vaccines and other products (e.g., condoms, disinfectants, insecticide-treated mosquito nets, masks, water purification devices) also could have quality problems or be counterfeit. Vaccine integrity typically depends on a temperature- controlled supply chain, and, unlike medicines with stated amounts of active ingredients, the potency of vaccines is difficult to monitor and therefore easy to counterfeit. As expected, criminal networks have exploited the coronavirus disease 2019 (COVID-19) pandemic by producing fake vaccines. An international alert issued by INTERPOL resulted in confiscation of thousands of fake vaccines in China and in South Africa. INTERPOL’s Secretary General described the number of seized vaccines as being “the tip of the iceberg.”

Box 6-05 Definitions of poorly regulated medical products


Counterfeit: A counterfeit product bears the unauthorized representation of a registered trademark on a product identical or similar to one for which the trademark is registered.

Falsified: A falsified product falsely represents the product’s identity, source, or both.


Substandard: A substandard product fails to meet national specifications cited in an accepted pharmacopeia or in the manufacturer’s approved dossier.

Degraded: A degraded product has undergone chemical or physical changes due to incorrect storage conditions.

Avoiding Counterfeit Drugs when Traveling

The best way to avoid counterfeit drugs is to reduce the need to purchase medications abroad. Instruct travelers to purchase anticipated amounts of medications for chronic conditions (e.g., arthritis, diabetes, hypertension), medications for travelers’ diarrhea, and prophylactic medications for infectious diseases (e.g., malaria) before traveling. Advise travelers to avoid buying drugs online, because the source of the medication often cannot be verified. Travelers should also be aware that other health-related items obtained abroad (e.g., medical devices, insect repellents, mosquito nets) also could be counterfeit, falsified, or substandard.

In preparation for international travel, travelers should obtain all medicines and other health-related items needed for the trip. Prescriptions written in the United States usually cannot be filled overseas, and although many US prescription medications are available for over-the-counter purchase in foreign countries, some might not be available at all. Because checked baggage can get lost, travelers should pack medications and first aid items in a carry-on bag, and bring extra medicine in case of travel delays. Travelers should carry medicines in their original containers; for prescription drugs, the patient’s name and dose regimen should appear on the container. Travelers also should bring the “patient prescription information” sheet, which provides information on common generic and brand names, use, side effects, precautions, and drug interactions. Travelers should check with the embassies of their destination countries for prohibited drugs; many countries have restrictions on medicines, including over-the-counter medications, entering their borders.

If travelers run out of and require additional medications, they should take steps to ensure the medicines they buy are safe (see Box 6-06 for a traveler checklist of good practices, and Table 6-01 for a list of online resources). One way to ensure medication safety is by comparing distinguishing features of the packaging, especially when authentic packaging is unavailable or if the traveler is not familiar with the brand. For example, the batch and lot numbers, manufacturing date, and expiration date printed on the outside of the box should match what is on the insert or blister pack.

Box 6-06 Purchasing medicines overseas: a good practices checklist for international travelers

☐ Obtain medicines from a legitimate pharmacy; the local US embassy or consulate might be able to help locate legitimate local pharmacies. Do not buy from open markets, street vendors, or suspicious-looking pharmacies; request a receipt when making the purchase.

☐ Do not buy medicines priced substantially lower than the typical price. Although generic medications are usually less expensive, many counterfeit brand names are sold at prices substantially lower than normal.

☐ Make sure the medicines are in their original packages or containers. If you receive medicines as loose tablets or capsules supplied in a plastic bag or envelope, ask the pharmacist to show you the container from which the medicine was dispensed. Record the brand, batch number, and expiration date. Sometimes a wary consumer will prompt the seller into supplying quality medicine rather than a counterfeit or substandard medicine.

☐ Be familiar with your medications. The size, shape, color, and taste of counterfeit medicines might be different from the authentic product. Discoloration, splits, cracks, spots, and stickiness of tablets or capsules are indications of possible counterfeit. These defects also could indicate improper storage. Keep examples of authentic medications to compare if you purchase the same brand.

☐ Be familiar with the packaging. Different color inks, poor-quality printing or packaging materials, and misspelled words are clues to counterfeit drugs. Keep an example of packaging for comparison and observe the expiration date.

Table 6-01 Online resources for travelers purchasing medicines & medical products overseas



Pill Identifier

International Society of Travel Medicine

Database on International Regulations on Importation of Medicines for Personal Use [PDF]

Transportation Security Administration

Disabilities and Medical Conditions

US Centers for Disease Control and Prevention

Counterfeit Medicines

US Customs and Border Protection

Prohibited and Restricted Items (see Medication)

US Food and Drug Administration

Drug Safety and Availability

US Pharmacopeia

Medicines Quality Database (MQDB)

World Health Organization

Substandard and falsified medical products

The following authors contributed to the previous version of this chapter: Michael D. Green

INTERPOL. Fake COVID vaccine distribution network dismantled after INTERPOL alert, 3 March 2021. Available from:

Institute of Medicine. Countering the problem of falsified and substandard drugs. Washington, DC: The National Academics Press; 2013.

Nayyar GML, Bremen JG, Herrington JE. The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives. Am J Trop Med Hyg. 2015;92(6 suppl):2–7.

World Health Organization. Full list of WHO Medical Products Alerts. Available from:

World Health Organization. Medicines: counterfeit medicines [fact sheet no. 275]. Geneva: World Health Organization; 2018. Available from:

. . . perspectives chapters supplement the clinical guidance in this book with additional content, context, and expert opinion. The views expressed do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).