Stockpiles of drugs usually help alleviate public health crisis, but recently a supply of nearly 18,000 doses of a tainted steroid caused one instead. Adding insult to injury, the outbreak probably stemmed from unscrupulous practices made possible by an inconsistently regulated industry.

So far the Centers for Disease Control and Prevention estimates the outbreak has infected 247 people in 15 states and caused 19 deaths. It’s possible that the wave of meningitis cases—caused by fungal contamination—might have been avoided if the drug maker had been subject to Food and Drug Administration testing and regulation. Instead, the firm that made the suspect doses, known as a compounding pharmacy, only has to abide by state laws that regulate pharmacists.

“This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws,” a letter from the U.S. House Committee on Energy and Commerce states.

“Compounding pharmacies can serve an important public health function by mixing or altering medications designed to fulfill special needs of individual patients…. In other cases, however, compounders may simply provide a less expensive version of an FDA-approved product without having to adhere to the rigorous manufacturing standards required of FDA-approved versions.”

There’s some indication that the latter tack was being taken by the New England Compounding Center, which made the corrupted steroid, according to a Reuters investigation of how the company conducted business.

Most states allow compounders to create drugs in response to an individual prescription using FDA-approved materials when a commercial version isn’t available. Examples might include customizing a drug based on a patient’s physical characteristics or to avoid an allergic reaction to a binding agent. At times, doctors prefer to compound drugs because they’re less expensive than what’s commercially available.

There are more than 7,500 compounding pharmacies in the United States, according to the Associated Press. Many mix prescriptions on a case-by-case basis for local doctors or hospitals. Reuters, however, obtained NECC e-mails that indicated the company solicited large-scale orders without getting prescriptions or even the names of patients.

“This organization chose to apparently violate the licensing requirements under which they were allowed to operate," Madeleine Biondolillo of the Massachusetts Department of Public Health told Reuters.

The company is also under investigation by the FDA, possibly for manufacturing drugs and illegally importing FDA-regulated products, and could face criminal charges in the outbreak, according to the New York Times.

While the size of the tainted NECC drug lot is alarming and most likely not within the bounds of its licensure, many in the industry say the situation is not at all unheard of.

“Some of these companies are just setting up big manufacturing shops in the guise of traditional compounding and making drugs that are, for the most part, commercially available,” former FDA counsel Sheldon Bradshaw told the Times earlier this month. “Instead of making fake Rolexes, they are making fake drugs.”

While the phenomenon has been exacerbated by widespread commercial drug shortages and problems within in the drug manufacturing industry, there seems to be a lack of understanding by both doctors and patients about where the medication is coming from.

“We ask for the medication, it’s in stock, we use it,” Anders Cohen, chief of neurosurgery and spine surgery at the Brooklyn Hospital Center, told the Times. “I don’t know if it’s coming from A, B or C. This is kind of a wake-up call about where your stuff is coming from.”

Attempts by the FDA to bring compounding pharmacies under its regulatory jurisdiction were shut down by a 2002 U.S. Supreme Court ruling that found a portion of the legislation unconstitutional, according to the Wall Street Journal. That legislation has never been revived, but last week lawmakers vowed to introduce new oversight for compounding pharmacies.

“It is really unfortunate that it takes a crisis to bring this kind of change, but that is often the case,” Deborah Autor, a Food and Drug Administration deputy commissioner, told the Times.