Compounding of drugs by pharmacists may lack adequate safeguards

If you're a patient that needs drugs in a dose, form or combination not available, your pharmacist may be able to help. Every year, more than 30 million prescription drugs are compounded each year by pharmacists, who are permitted to do so as part of their licensure.

Often, compounding involves simple changes in the mixture to say, provide a pediatric dose of a drug that comes in adult doses--and all of the nearly 200,000 pharmacists in the U.S. are permitted to do this. On the other hand, when pharmacists begin making large volumes of such doses and distribute them, the compounder essentially becomes a drug manufacturer, without facing the level of scrutiny that drug makers face.

Some compounders actually come far too close practicing medicine themselves, critics argue, especially when it comes to promoting a drug class known as "bioidenticals" which are manufactured to be molecularly identical to human hormones. The FDA is on record as saying that claims made by some compounders about these substances are actually untrue.

In extreme cases, compounded substances have been linked to deaths or serious side effects, particularly those made in mass quantities by what some have called a "shadow drug industry."  However, pharmacists note that most compounding is far simpler and safer, and that deaths and harmful side effects are very rare.

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