Company may have been improperly distributing nearly 1,000 controlled substances, including cocaine, morphine and ketamine that fall under the purview of Drug Enforcement Agency
WASHINGTON, D.C. – With new cases being reported of fungal infection involving a different pain-relieving steroid manufactured by the New England Compounding Center (NECC), today Congressman Edward J. Markey (D-Mass.) called on the Department of Justice (DOJ) to commence an investigation into whether the company may have violated laws and regulations related to how controlled substances can be sold. The list of recalled NECC drug products appears to include nearly 1,000 formulations that contain controlled substances that fall under the jurisdiction of the Drug Enforcement Agency (DEA). DEA regulations state that retail pharmacies that compound or sell controlled substances must be registered with the agency and are only permitted to sell compounds containing controlled substances directly to patients in response to a patient-specific prescription unless the pharmacy is registered with the DEA as a manufacturer/supplier. DEA has informed Rep. Markey’s office that the NECC is not registered with the DEA as a manufacturer/supplier, and media reports indicate that NECC appears to have been distributing compounded drugs that were not associated with a patient-specific prescription to healthcare facilities. Nearly 18,000 vials of contaminated drugs from NECC have been shipped to 76 healthcare facilities in 24 states.
“This is a matter that I believe requires further investigation by the DEA to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances,” writes Rep. Markey, senior member of the Energy and Commerce Committee, in the letter to the Department of Justice.
A copy of the letter to DOJ can be found HERE.
"The types of medications being compounded by NECC included controlled substances such as cocaine, morphine and ketamine and require the highest level of federal oversight,” said Rep. Markey in separate comments. “We need to know if NECC violated federal law and is subject to enforcement action beyond any violations it may be subject to at the state level.”
In the letter to the Justice Department, Rep. Markey asks for responses to questions that include:
- What types of controlled substances is NECC currently authorized to use to compound drugs under DEA regulations?
- Has the DEA issued any guidance for compounding pharmacies in handling controlled substances?
- How many DEA enforcement actions were brought against pharmacies that failed to comply with DEA’s regulations related to controlled substances?
- What are the enforcement actions that could be taken against a pharmacy that violates DEA’s controlled substances regulations?
- Does DOJ believe it has sufficient statutory authority and resources to perform its oversight and enforcement responsibilities with respect to compounding pharmacies? If not, what recommendations does the Department have to strengthen its capabilities to perform its duties in this area?
Rep. Markey plans to introduce legislation to address gaps in federal regulation and strengthen the Food and Drug Administration (FDA) authority to do oversight of compounding pharmacies.