The U.S. Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs and ship them across state lines under proposed legislation announced on Friday.

The proposal from a bipartisan group of U.S. senators comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid distributed by the New England Compounding Center.

The proposal would draw a distinction between traditional compounding pharmacies, which make drugs based on specific prescriptions for individual patients, and those such as NECC, which make products without prescriptions for physicians to keep for future use.

"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," Iowa Democrat Tom Harkin, chairman of the Senate health committee that developed the draft legislation, said in a statement.

The bill would create a new class of drugmaker that would be regulated by the FDA but would be exempt from the full raft of regulations that apply to traditional pharmaceutical companies.

For example, these "compounding manufacturers" would not be required to submit their products to the FDA for approval before selling them. Nor would they be required to negotiate the labeling of their drugs with the FDA; they would only be required to indicate that the products are compounded and list certain other specified information.

These companies would no longer be licensed as pharmacies. They would be required to register with the FDA, and report to the agency any problems reported by patients or physicians. They would also be required to pay an annual fee to defray the cost of FDA inspections.

Compounding manufacturers would not be allowed to compound biologic products made from live organisms or other complex drugs. And they would be prohibited from compounding FDA-approved drugs unless they are in short supply.

Traditional compounding pharmacies would continue to be licensed and regulated by state boards of pharmacy.

A spokeswoman for the FDA, Erica Jefferson, said the agency was reviewing the draft "and looks forward to continuing to work closely with the committee to address existing limitations in the law."

It is unclear how many of the nation's roughly 2,800 compounding pharmacies would fall into the new category, but initial estimates put the number at fewer than 500. They would be defined not by their sales volume, but by whether they make products that are at high risk for contamination and sell them across state lines.

Ever since the meningitis outbreak, the FDA has been pilloried by Republicans in Congress, who say the agency should have been more aggressive in its oversight of NECC.

The FDA concedes as much but has argued that a complex legal landscape has hampered its ability to regulate the industry since compounding pharmacies have historically been regulated by the states and have not been required to register with the FDA.

The proposed legislation encourages greater communication among states and between states and the FDA.

Related:

Report: FDA faltered in deadly meningitis outbreak

Violations found at 32 compounding pharmacies

One of the nearly 14,000 patients given potentially tainted injections of pain medicine sued the maker of the treatment in what may be the first of a wave of lawsuits over a deadly U.S. meningitis outbreak that shows no signs of abating.

The lawsuit was filed in a Minnesota federal court on Thursday by a woman who said she was given a steroid injection for back pain and has experienced symptoms consistent with meningitis. She is awaiting the results of tests.

Federal and state health authorities have confirmed 14 meningitis deaths nationwide since people who received the injections began coming to emergency rooms last month in Tennessee, the state with the most cases.

The number of people who contracted meningitis has risen rapidly in a week, and reached 169 on Thursday, an increase of 32 from the previous day.

The outbreak has turned into a major national health scandal with multiple investigations launched and a leading lawmaker, Senator Richard Blumenthal of Connecticut, calling for a criminal probe of the company at the center of the storm, New England Compounding Center of Massachusetts.

The Massachusetts health regulator accused the company on Thursday of flouting state laws for pharmacies. The compounding company has recalled the suspect product, surrendered its operating license and has said it is cooperating with the investigations.

Federal and state regulators also have come under scrutiny for allowing an obscure pharmaceuticals sector known as compounding to grow rapidly without much federal oversight. Compounders take drug ingredients and make specialized treatments for patients. The industry has grown so large that some of the companies operate more like drug manufacturers than pharmacies, critics say.

The U.S. Centers for Disease Control and Prevention said on Thursday it was working furiously to contain the meningitis outbreak from medications shipped to 23 states. Eleven of those states have reported cases of meningitis and there have been deaths in six states.

Of the 14,000 people at risk of infection, medical practitioners were still trying to reach about 2,000 patients to warn them to be tested immediately.

"We are not out of the woods yet," said Dr. Todd Weber, manager of the CDC response to the meningitis outbreak, during a briefing on Thursday.

While most of the patients at risk received epidural injections to alleviate back pain, the CDC spoke of a new concern on Thursday about patients who received injections in joints such as a knee or ankle.

They disclosed that a Michigan patient who had received an injection in an ankle, developed an infection. Tests have not yet been completed to determine if it is a fungal infection.

The CDC said all people who might have received the injections in joints from the suspect product also should seek medical attention.

Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea and it must be treated quickly to improve chances of survival. Fungal meningitis is a rare form and is not contagious.

Most people infected so far have displayed symptoms within two weeks of receiving the medication and as long as 42 days afterward. They cautioned that patients should be vigilant for several months if they received one of the injections.

Health authorities said more than 50 vials of the steroid, out of more than 17,000, had so far been confirmed as contaminated with more tests underway.

The lawsuit is Barbe Puro v. New England Compounding Pharmacy Inc, U.S. District Court, District of Minnesota, No. 12-2605.

More coverage of meningitis outbreak:

Officials: We didn't have power to stop infection

Compounding pharmacies: Heroes or villains?

ERs: Frontline in fight against fungal meningitis

The potential scope of the meningitis outbreak that has killed at least five people widened dramatically Thursday as health officials warned that hundreds, perhaps thousands, of patients who got steroid back injections in 23 states could be at risk.

Clinics and medical centers rushed to contact patients who may have received the apparently fungus-contaminated shots. And the Food and Drug Administration urged doctors not to use any products at all from the Massachusetts pharmacy that supplied the suspect steroid solution.

It is not clear how many patients received tainted injections, or even whether everyone who got one will get sick.

So far, 35 people in six states — Tennessee, Virginia, Maryland, Florida, North Carolina and Indiana — have contracted fungal meningitis, and five of them have died, according to the Centers for Disease Control and Prevention. All had received steroid shots for back pain, a highly common treatment.

In an alarming indication the outbreak could get a lot bigger, Massachusetts health officials said the pharmacy involved, the New England Compounding Center of Framingham, Mass., has recalled three lots consisting of a total of 17,676 single-dose vials of the steroid, preservative-free methylprednisolone acetate.

Outbreak points to pharmacy problem

An unknown number of those vials reached 75 clinics and other facilities in 23 states between July and September, federal health officials said. Several hundred of the vials, maybe more, have been returned unused, one Massachusetts official said.

But many other vials were used. At one clinic in Evansville, Ind., more than 500 patients got shots from the suspect lots, officials said. At two clinics in Tennessee, more than 900 patients — perhaps many more — did.

The investigation began about two weeks ago after a case was diagnosed in Tennessee. The time from infection to onset of symptoms is anywhere from a few days to a month, so the number of people stricken could rise.

Investigators this week found contamination in a sealed vial of the steroid at the New England company, according to FDA officials. Tests are under way to determine if it is the same fungus blamed in the outbreak.

The company has shut down operations and said it is working with regulators to identify the source of the infection.

"Out of an abundance of caution, we advise all health care practitioners not to use any product" from the company, said Ilisa Bernstein, director of compliance for the FDA's Center for Drug Evaluation and Research.

Tennessee has by far the most cases with 25, including three deaths. Deaths have also been reported in Virginia and Maryland.

Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe headache, nausea, dizziness and fever.

The type of fungal meningitis involved is not contagious like the more common forms. It is caused by a fungus often found in leaf mold and is treated with high-dose antifungal medications, usually given intravenously in a hospital. The common mold aspergillus was cultured from 5 patients, the CDC said Thursday.

Robert Cherry, 71, a patient who received a steroid shot at a clinic in Berlin, Md., about a month ago, went back Thursday morning after hearing it had received some of the tainted medicine.

"So far, I haven't had any symptoms ... but I just wanted to double check with them," Cherry said. "They told me to check my temperature and if I have any symptoms, I should report straight to the emergency room, and that's what I'll do."

The New England company is what is known as a compounding pharmacy. These pharmacies custom-mix solutions, creams and other medications in doses or in forms that generally aren't commercially available.

Other compounding pharmacies have been blamed in recent years for serious and sometimes deadly outbreaks caused by contaminated medicines.

Two people were blinded in Washington, D.C., in 2005. Three died in Virginia in 2006 and three more in Oregon the following year. Twenty-one polo horses died in Florida in 2009. Earlier this year, 33 people in seven states developed fungal eye infections.

Compounding pharmacies are not regulated as closely as drug manufacturers, and their products are not subject to FDA approval.

A national shortage of many drugs has forced doctors to seek custom-made alternatives from compounding pharmacies.

The New England company at the center of the outbreak makes dozens of other medical products, state officials said. But neither the company nor health officials would identify them.

The company said in a statement Thursday that despite the FDA warning, "there is no indication of any potential issues with other products." It called the deaths and illnesses tragic and added: "The thoughts and prayers of everyone employed by NECC are with those who have been affected."

A 2011 state inspection of the Framingham facility gave the business a clean bill of health.

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