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Washington News: Drug Compounding
Published in the April 2006 Washington State Board of Pharmacy Newsletter
We receive many calls about pharmaceutical compounding practices. One recent call related to the appropriateness of compounding L-tryptophan capsules for human use. According to Food and Drug Administration (FDA), there were 1,500 cases of eosinophilia-myalgia syndrome (EMS) in 1989 that were the direct result of patients taking supplements containing L-tryptophan. Most of these illnesses and three resulting deaths were directly attributed to a contaminated L-tryptophan product that was supplied by a distributor in Japan. However, previous and subsequent reports of EMS have suggested that uncontaminated L-tryptophan may contribute to the development of EMS. In addition, FDA does not recognize L-tryptophan for the treatment of any illness, disease, sign, or symptom. L-tryptophan is also not indicated for any conditions except L-tryptophan replacement, and is only generally recognized as safe and effective for replacement therapy.
While FDA has stated its concern regarding the safety of dietary supplements containing products such as L-tryptophan, the agency has not prohibited the marketing of dietary supplements containing L-tryptophan. The manufacturer is responsible for ensuring the safety of any product that it distributes.
What does this mean for the pharmacist? WAC 246-878-020 states that pharmacists shall receive, store, and use substances that meet official compendia requirements.
In cases where a pharmacist chooses to dispense a substance that does not meet these standards, he or she must use their professional judgment to substantiate the dispensing of that product. It is possible that a pharmacist who fills a product that does not meet compendia standards may be held liable for any adverse events that occur. More specific information about this product can be found at FDA’s Web site at www.cfsan.fda.gov/~dms/ds-tryp1.html and http://www.cfsan.fda.gov.
