By Jennifer Johnson Backer
Compounding drugs, particularly sterile injectables, has fallen under the scrutiny of the FDA because of a string of recent health emergencies. In 2012, an outbreak of fungal meningitis was linked to an injectable steroid that
The FDA does not approve drugs made by compounding pharmacies; instead, a compounding
The bill, the Pharmaceutical Compounding Quality and Accountability Act, was approved by the Senate Health, Education, Labor and Pensions Committee and will now head to the full Senate. The House has not yet drafted a bill, but a subcommittee held a hearing Thursday about state and federal compounding rules.
Senate Health, Education, Labor and Pensions Committee member Sen. Lamar Alexander, R-Tenn., said the legislation erases confusion over who regulates pharmacies and manufacturing facilities and clarifies who oversees each business.
“Putting one agency on the flagpole for each of these businesses will mean greater safety for American families so they don’t have to question whether the drugs they take are safe,” Lamar said in a prepared statement on May 15, the day he helped introduce the legislation.
While the Senate bill would establish a new category of FDA regulatory oversight for large-scale pharmacies that function more like manufacturers, traditional retail compounding pharmacies that do not ship across state lines would remain under state control. Currently, state laws vary widely, so a company that is considered a drug maker in one state could be classified as a retail compounding pharmacy in another state.
Most of the problems associated with drug compounding have been tied to the emergence of firms with pharmacy licenses making and distributing drugs in a way that’s outside the bounds of traditional pharmacy compounding. Many of those pharmacies mass produce injectables for hospitals and larger clients – which is different than traditional retail compounding pharmacies.
Already, the bill is under fire from consumer advocacy and public health groups, who say the legislation does not adequately address health risks from smaller retail compounding pharmacies. They also want the FDA to have oversight of compounding pharmacies that sell everything from oral drugs to topical creams.
Brett Wright, the owner of Benevere Pharmacy, a retail compounding pharmacy in Collierville, says he supports the new legislation and believes it would increase patient safety. Unlike large-scale pharmacies that function more like mass manufacturers, Wright’s pharmacy requires a physician’s prescription and does not produce sterile injectables or ship across state lines.
Most retail compounding pharmacies like Benevere Pharmacy specialize in custom-making medications that are tailored to meet the medical needs of an individual patient. Sometimes compounding is needed because a patient may be allergic to a certain dye, or an elderly patient may need a medicine in a liquid or suppository form that is not available. In other cases, compounding is necessary because a drug has been discontinued.
The number of drug shortages reported to the FDA gained 41 percent to 251 shortages in 2011, compared to 178 shortages reported in 2010. The agency says it continues to see an increasing number of shortages, including drugs used to treat cancer, anesthetics used for patients undergoing surgery, drugs needed for emergency medicine and injectable drugs. The FDA also has reported a spike in the number of medications that have been discontinued.
In its current form, the bill would not impact smaller retail compounding pharmacies like Benevere Pharmacy. Wright says he welcomes legislation that clarifies the rules, but wants to make sure any new legislation doesn’t restrict his ability to meet the needs of his customers, like a four-year-old patient who can’t swallow his seizure medication. Benevere Pharmacy compounds that medication into a liquid form.
“It’s not an overly complicated process, and it is life-saving for that patient,” he said.