A
compounded drug is a medication made by a pharmacist or other healthcare provider in response
to a valid prescription for an individual patient. A compounded drug may be made starting with
medications approved by the Food and Drug Administration (FDA), or with chemical ingredients according
to a formula or recipe.Compounded drugs are not approved for safety and efficacy by the FDA, and they are not manufactured according to strict federal standards. Compounded drugs should not be considered interchangeable with approved products, particularly during drug shortages. Because they are not tested for safety and effectiveness, compounded drugs may pose greater risks for patients.
FDA-approved medicines that are mixed according to the manufacturer's instructions are not considered "compounded drugs" by the FDA.
When is a compounded drug necessary?
A compounded drug may be medically necessary when an FDA-approved product cannot be used to treat an individual patient's condition.
In a March 14, 2006 story appearing on Newsday.com, FDA director of pharmacy affairs notes "There are legitimate public health needs for compounded drugs," adding that compounding should be done on a case by case basis2.
An example of medically necessary compounding includes the modification of a tablet into a liquid for a small child who cannot swallow a pill. In this case, a compounded drug may be the only option for administering a medication essential to treat the child’s condition. Because compounded drugs are made extemporaneously (without previous study) in response to a prescription, there are inherent uncertainties regarding their safety and effectiveness [see Risk Information].
$$$ Dollars and sense?
Pharmacies make more money when they dispense unapproved drugs made from scratch1. A pharmacist interviewed for a story on compounded hormones notes “I don’t want to share our exact profit margin, but it’s good compare with regular prescriptions”1. This money making differential creates an incentive to sell unapproved products, which may impair professionalism and compete with the best interest of patients. The March 14, 2006 Newsday article A warning on asthma drugs: Mass marketed drug compounds sold for less can prove ineffective or harmful to patients reports: "Pharmacies authorized to make customized medications for individual patients have been accused by a consumer organization of illegal mass-production of respiratory drugs in profit-making ventures, which the consumer group says are endangering patients"2 [emphasis added].
1. Ukens C. Compounding pharmacists cash in on bioidentical hormones. Drug Topics February 21, 2005 [on-line].
2. Ricks D. A warning on asthma drugs: Mass-marketed drug compounds sold for less can prove ineffective or harmful to patients. Newsday Inc. [on-line].
