Some drugs that aren't approved by the Food and Drug Administration (FDA) may still be legally sold in the United States. Drugs compounded by licensed physicians, pharmacists, and pharmacies fall into this category. Drugs that are manufactured in other countries and are not from reputable sources, however, cannot be legally sold in the United States; even so, these drugs can sometimes be purchased online. The FDA periodically issues safety warnings for unregulated drugs that are sold in the United States. Recently, the agency issued two such warnings, one for a drug compounded in the United States and sold legally, and one for a drug available overseas that was adulterated and sold in the United States illegally via the Internet.

Unapproved compounded medication. The FDA received an adverse event report of two patients who developed "tissue erosion" after receiving a subcutaneous injection of a compounded drug containing glutamine, arginine, and carnitine (GAC). (See http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompoun.) This product is advertised online for weight loss, muscle maintenance, and muscle building. (When a licensed pharmacist, physician, or pharmacy combines, mixes, or alters ingredients to make a drug, it is referred to as compounding. Drugs may be compounded to meet a particular patient's needs, and these drugs are not typically FDA approved. If a patient is allergic to the dye in an FDA-approved product, for example, that product can be compounded without the dye.) There is no FDA-approved injectable format of GAC. The pharmacy that compounded the product was United Pharmacy, located in West Palm Beach, Florida. The oversight for providers and pharmacies that compound drugs is normally provided by the state board of pharmacy, although the FDA maintains some authority. The FDA became involved in this case after receiving the adverse event report.

The FDA evaluated the product and determined that its pH-10.9-was extremely basic, and much higher than the pH of 3 to 6 normally recommended for injection drugs given subcutaneously. Drugs with a higher pH are available, including FDA-approved products, but they are indicated for parenteral routes that are not subcutaneous. The more basic the pH of a drug, the more pain, irritation, and tissue damage it can cause. United Pharmacy guidelines for GAC allowed for a pH range of 2 to 11. Additionally, in the samples tested by the FDA, no glutamine was detected.

While compounding pharmacists and pharmacies can provide real benefit to patients who need medications tailored to their needs, in cases such as this the safety information related to the chemical attributes of the product, such as pH, was insufficient.

Adulterated product from overseas. The FDA was alerted by the North Carolina Division of Public Health and the Michigan Department of Health and Human Services to an overseas product that was found to contain lead. The product, Balguti Kesaria Ayurvedic Medicine, is manufactured by multiple companies, including Kesari Ayurvedic Pharmacy in India. (See a photo of the label at http://www.fda.gov/Drugs/DrugSafety/ucm570237.htm.) The product is sold online, and has also been brought into the United States by travelers. Labeled "tonic pills for babies," the drug is recommended for use in infants and children to treat rickets, coughs and colds, worms, and teething, among other conditions. An FDA analysis confirmed that Balguti Kesaria contains lead, arsenic, and mercury. These substances are potentially poisonous and very dangerous to the central nervous, renal, and immune systems.

Nurses should always assess patients for use of over-the-counter medications, including herbs and nontraditional medications. If a patient is not responding to treatment or is experiencing unusual adverse effects, the nurse should consider whether the patient could be using either a counterfeit drug or a contaminated, non-FDA-approved drug. Anyone using Balguti Kesaria should be warned about the risks and instructed to stop its use immediately. Patients and their families need to be educated on the risks of taking products sold online from disreputable overseas sources. The FDA encourages nurses and other health care professionals to teach the public these four signs of a fraudulent online pharmacy: no prescription is required, drugs are very inexpensive compared with those available via prescription, the pharmacy ships worldwide, and it is located outside the United States.

The FDA's web page BeSafeRx: Know Your Online Pharmacy contains many resources for patients, including a one-minute patient education video on the risks of buying medications online as well as patient education brochures (see http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Buy). The page also links to an interactive U.S. map patients can use to confirm the legitimacy of an online pharmacy (see https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Bu). After identifying that the pharmacy in question is licensed, patients should confirm that it requires a valid prescription, that it has a physical U.S. address and telephone number, and that a licensed pharmacist is available to answer questions.

Nurses and NPs should use the FDA MedWatch Online Voluntary Reporting form (http://www.fda.gov/medwatch/report.htm) to report any adverse effects they observe from compounded drugs or products purchased from an overseas source.