Pharmacies that sell sterile compounded drugs in California may soon have to meet stricter standards following nationwide reports of injury and death from contaminated medications. Opponents say the regulations would drive up costs and hurt consumers.
Sterile compounded drugs may be injected, inhaled or dropped into the eye. Unlike non-sterile compounded medications, which can be swallowed or applied to the skin, sterile drugs pose an increased risk for harm to patients because of how and where they are administered.
Compounded products accounted for up to 3 percent of the $320 billion spent on prescription drugs in the United States in 2011, according to a report from the California State Board of Pharmacy.
Licensed pharmacies may compound, or mix, both sterile and non-sterile drugs to customize prescribed medications by adjusting dosage strength, ingredients and formula to meet individual patient needs. They may also compound existing formulas to reproduce medications that are in short supply from manufacturers.
But the process of sterile compounding has produced some frightening results.
In October 2012, for example, the Massachusetts-based New England Compounding Center shipped tainted epidural steroid injections used to treat pain to 75 medical facilities in 23 states, including California.
The treatments were later linked to cases of fungal meningitis and other infections.
As of last month, of the 14,000 patients who received the injections, 61 people died and about 700 became ill.
Federal investigators found that the compounding facility had made the steroids with a contaminated powder and illegally operated like a pharmaceutical manufacturer, producing large quantities of drugs instead of individual orders, according to a BOP report.
In response, the state Board of Pharmacy authored Senate Bill 294, which aims to ensure that the process and tools for making sterile compounded drugs are safe.
Unlike commercial pharmaceutical manufacturers, which are regulated by the Food and Drug Administration, pharmacies are regulated by individual states.
The bill, introduced by state Sen. Bill Emmerson (R-Redlands), passed the Senate in May. It will be heard by the Assembly Appropriations Committee on Aug. 30.
If passed by the committee, it will be eligible to be heard on the Assembly floor before going back to the Senate for approval of any changes, said Kayla Williams, a spokesperson for Emmerson.
California is not the only state to take action. Sixteen states passed laws this year related to compounding pharmacies, according to the National Conference of State Legislatures.
“Recent events have made it clear that it’s necessary to increase oversight of sterile compounding pharmacies to ensure patient safety,” Emmerson said in a statement to the Acorn. “I have introduced SB 294 to strengthen consumer protection and provide consistent oversight of pharmacies that ship or dispense sterile drug products in California so we can do everything we can to prevent another patient injury or death.”
The law would hold out-ofstate pharmacies to the same standards as facilities in California, requiring the nonresident pharmacies to obtain a license from the state Board of Pharmacy to compound or distribute sterile drugs in California.
A license would be issued only after an inspection of the pharmacy, which would also be subject to annual unannounced inspections.
Out-of-state compounding pharmacies that sell in California would be required to pay the board to inspect their facilities, a cost of around $780 per inspection.
California law currently requires out-of-state pharmacies that distribute sterile compounded drugs in the state to hold either a specialty license issued by the Board of Pharmacy or accreditation from a private agency.
Pharmacies with accreditation do not need a license from the board and are exempt from its regulations, including its inspections.
Under the new law, pharmacies would have to notify the board within 12 hours of recalling sterile drugs compounded by the pharmacy and within 10 days of receiving any disciplinary action from another state or suspension of any accreditation. The pharmacies must also provide the board with a list of the sterile drugs they compound.
Virginia Herold, executive officer of the Board of Pharmacy, said stronger measures are needed to protect the public from unsafe compounded drugs.
“The goal is to have a single standard so we don’t have erratic medications coming in,” Herold said. “We’re making sure that pharmacies that do high-risk compounding meet California standards. Pharmacies should be able to produce safe medication. . . . We do not want anyone to fear medication.”
Lilit Pogosyan, a pharmacist at Park Compounding Pharmacy in Westlake Village, said she would welcome the new law. The multistep process of compounding drugs can leave room for error, she said.
“It does require knowledge and experience not taught in pharmacy school,” Pogosyan said, because “what we learn (at school) might not hold 10 years from now.”
But Vandana Parnami, owner of Simi Pharmacy Compounding & Medical Supplies in Simi Valley, said charging out-of-state compounding pharmacies $780 for inspections could deter them from getting licensed to sell in California, thereby reducing the availability of medicines and causing a spike in prices for consumers.
“I don’t think that is right,” she said. “Not many pharmacies want to be licensed by two states. Independent pharmacies cannot (afford it).”
Parnami, who opened her non-sterile compounding pharmacy a year ago, said the added restrictions would also be bad for her business. Common nonsterile medications she has compounded include liquid Tamiflu for kids, which she made when the manufacturer did not make enough to meet demand.
“If the cost is going to be high, I will think twice about going into sterile compounding,” she said.
Regarding the tainted medication produced by the NECC, Parnami said the pharmacy “didn’t follow existing policies and procedures.” One current requirement to get a sterile compounding license is a “clean room,” or sterile environment for compounding, which the Massachusetts pharmacy did not maintain in sanitary conditions.
“(Regulators) should have enforced those policies, not made more rules,” she said.
To verify if a pharmacy is licensed to sell sterile compounded drugs, visit the Board of Pharmacy website at www.pharmacy.ca.gov.
The site also contains a twominute video with instructions on how to buy prescribed drugs on the Internet.
Pharmaceutical websites may be verified through Verified Internet Pharmacy Practice Sites (VIPPS) or registered with LegitScript.com.