Mass. Bill Places Tougher Requirements on Compounding Pharmacies

A Massachusetts bill designed to enhance oversight and quality standards practiced at compounding pharmacies was approved by the state’s Public Health Committee on Tuesday, coming in response to concerns surrounding recalled epidural steroid injections distributed last year by one Massachusetts pharmacy, which have been linked to hundreds of cases of fungal meningitis nationwide.. 

The House measure, which was spearheaded by Jeffrey Sanchez (D–Mass.), will offer stricter guidelines for pharmacies that mix their own medications for individual patients, hoping to prevent a repeat of circumstances that allowed the now-closed New England Compounding Center (NECC) to distribute thousands of vials of contaminated medication.

Compounding pharmacies mix specialized medications for individual patients using FDA approved ingredients. The industry has come under increased scrutiny this year, as questions have been raised about the lenient supervision and oversight provided by state boards that regulate the pharmacies, unlike drug manufacturers who are strictly regulated by the FDA.

While traditionally designed to fill local needs, many compounding pharmacies have begun mass-producing drugs in recent years, selling them on a regional or even national level, which critics say allows them to  operate as stealth drug manufacturers that escape the oversight of federal regulators.

The proposed legislation will create an 11-person unpaid committee, made up of pharmacists and industry experts, which will focus on the oversight of compounding pharmacies in Massachusetts. The new guidelines will also require specialty licensing for compounding pharmacies and will require stricter standards for ongoing education for compounding pharmacists. Penalties for violations will also be implemented.

Surprise inspections and new compounded drug labeling would also be a part of the requirements. The bill would require the state to collect and analyze data concerning adverse events, a practice which is currently only required for major drug manufacturers.

This legislation will hold pharmacies to high standards in quality control and sterility,” Rep. Sánchez said in a statement. “But these are achievable standards, and standards they must meet in order to prevent another tragedy like we witnessed with NECC and Ameridose.”

Legislators say they hope the new standards will fill the “grey area” the compounding pharmacies fall into in the health care industry. The bill will also require pharmacists to report on the volume and type of drugs produced by compounding pharmacies, to stop mass production of compounded drugs.

Eric Kastango, a member of the task force on compounding, said the new measure will serve as a “national model ensuring patient safety and of the robust oversight of the compounding pharmacies.”

The next step for the bill is to be reviewed by the Joint Committee on Ways and Means.

Compounding Pharmacy Concerns

The nationwide fungal meningitis outbreak that surfaced last year has been linked to at least 61 deaths and 749 infections among individuals who received tainted epidural steroid injections mixed by NECC. More than 17,000 doses of the steroid were shipped across 20 states, and nearly 1,500 people received injections.

The scope of compounding pharmacy oversight has come into question more recently as other pharmacies face scrutiny for distributing contaminated drugs. Several cases concerning adverse reactions have been reported stemming from a Tennessee compounding pharmacy, including one incident which seems to involve fungus.

Federal legislation was proposed in April aimed at providing theFDA wider regulatory authority over compounding pharmacies. The measure was aimed at the new breed of compounding pharmacy which creates large quantities of drugs without prescriptions, shipping them across state lines.

That bill received much criticism concerning increased power for the FDA. Many compounding pharmacies failed to comply with stricter guidelines put into place by the FDA following last year’s outbreak.

The FDA has faced sharp criticism for its handling of NECC and the compounding pharmacy industry, with information emerging that federal regulators were aware of problems at NECC since at least 2002, and failed to take steps to address the issues.

Since the outbreak, NECC has been shut down and declared bankruptcy last year in the face mounting fungal meningitis lawsuits and possible criminal charges.