Beginning in 2012, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) became involved in investigating, monitoring, and responding to a multistate outbreak of fungal meningitis.  According to the CDC website for the outbreak, the investigation is still ongoing and there have been 750 cases across 20 states with 64 deaths.  The investigation found that the fungal meningitis, as well as other infections, came from contaminated steroid injections that were preservative-free made by NECC and Ameridose.

After the tragic, widespread outbreak, lawmakers got involved in order to provide more controls over the facilities that produced the tainted medications.  Yesterday, the House passed a bill to regulate specialty pharmacies, reports the Wall Street Journal.  The bill focused on compounding centers, also known as specialty pharmacies.  According to CNN, compounding pharmacists customize medications to fit an individual’s needs.  Doctors sometimes need to prescribe custom medications when the existing drugs produced by manufacturers will not work for the specific patient.  Common situations in which a custom medication is needed include a dosage that is too large or a patient allergy to a non-active ingredient, such as a dye, in the original product.

In certain settings, compounding is more common.  Compounding pharmacists often work in neighborhood and chain drugstores, but compounded medications only account for one to three percent of filled prescriptions.  Hospitals often need compounded medications to get the right dosage for surgeries and for their pediatric patients.  In cases of drug shortages, compounding can fill the gaps by producing more doses through custom orders.  In general, compounding produces only a few small doses for a specific patient.  However, large-scale production may occur where it helps to reduce cost per dose.

Pharmacy Practice News describes the bill that passed as a “bipartisan compounding bill” that also includes provisions related to systems to monitor the distribution of all prescription medications.  The bill, formally titled the Drug Quality and Security Act, would strengthen the FDA’s authority over larger compounding pharmacies that manufacture customized medicines in bulk quantities for intra- and interstate distribution. The bill also establishes a “track and trace” system to monitor the distribution of prescription medicines from manufacture to end user. The measure seeks to prevent counterfeit drugs from entering the pharmaceutical supply chain.

The new legislation, which was finalized by House and Senate committee members earlier this week, focuses largely on separating traditional compounders and non-traditional compounders, named “outsourcing facilities.”  Requirements on the latter have been added and will be enforced by the FDA.  Traditional compounders will continue to be regulated by the State.