ANNUAl LAW LESSON--Regulating Compounding

AssociatesCE Prn
1
“Annual Law Lesson---Regulating Compounding”
• Cultural Competency & Sensitivity Pertaining to Adherence
• Pertussis Update
• Medication Errors-Update
• Superficial Fungal Infections
• CRE Infection
• STD’s---Update & Review
• Latent TB Treatment
• Restless Leg Syndrome
Future topics include:
This is a subscription program. To get continuing education credit, you must subscribe to the program, or pay fee for individual lessons.
The regulatory implications of compounded drugs are significant. It is impossible for drugs compounded by a pharmacist to be approved by the FDA, as this approval process takes years and the patient needs the drug within hours or minutes. With this as the basis, we present the annual lesson that reviews a concept related to pharmacy law and its impact on pharmacy practice.
February 2013

Continue reading here

District Court Enters Permanent Injunction Against Drug Manufacturer and Senior Execs February 1, 2013

.S. District Court Judge Lesley Wells entered a consent decree of permanent injunction against Ben Venue Laboratories Inc., a Bedford, Ohio-based drug manufacturer, the Justice Department announced today.  The permanent injunction was also entered against George P. Doyle, president and chief executive officer, Kimberly A. Kellermann, vice president of operations, and Douglas A. Rich, vice president of quality operations, for Ben Venue. The department, at the request of the Food and Drug Administration (FDA), asked the court to enter the consent decree.

Ben Venue manufactures numerous generic sterile injectable drug products, including cancer medications.   As set forth in the complaint filed by the United States on January 22, FDA conducted an inspection of defendants’ facility from Nov. 7 to Dec. 2, 2011, and documented 10 deviations from current good manufacturing practices.   According to the complaint, the FDA found, among other things, that the company failed to create and follow appropriate procedures to prevent contamination of drugs which were purported to be sterile.   The FDA also found that the company failed to properly clean and maintain its equipment to ensure the safety and quality of the drugs it manufactured.   In addition, the FDA determined that the company failed to conduct adequate investigations of drugs that did not meet their specifications.

Compliance with current good manufacturing practices requirements assures that drugs meet the safety requirements of the law and have the identity and strength and meet the quality and purity characteristics that they purport to or are represented to possess.   FDA regulations, which establish minimum current good manufacturing practices applicable to human drugs, require manufacturers to control all aspects of the processes and procedures by which drugs are manufactured in order to prevent the production of unsafe and ineffective products.

According to the complaint, t he deviations observed by FDA during the November – December 2011 inspection were similar to deviations observed by FDA during its many previous inspections of Ben Venue’s facility.   During FDA’s May 2011 inspection, FDA documented 48   deviations from current good manufacturing practices including an inadequate quality control unit, inadequate and untimely investigations, inadequately designed aseptic processing areas, poor employee aseptic practices, failure to prevent microbial contamination of drug products purporting to be sterile and failure to determine the root cause for microbial contaminants.

As described in the complaint, FDA’s long inspection and regulatory history of Ben Venue, including 35 inspections since 1997, and approximately 40 recalls since February 2002 associated with drugs manufactured at the Ben Venue facility (including 10 recalls in 2011 and 10 recalls in 2012), reflects a continuing pattern of significant deviations from current good manufacturing practices with its drugs.  Some recalls involved drugs contaminated with glass and other particulates.   Additional recalls were based on the company’s inability to assure the drug’s sterility.   Of the roughly 40 recalls, nine were classified by FDA as “Class I,” meaning that FDA determined that there was “a reasonable probability that the use of . . . a violative product will cause serious adverse health consequences or death.”

The consent decree entered resolves the complaint by requiring Ben Venue to take a wide range of actions to correct its violations and ensure that they do not happen again.  The injunction establishes a series of steps which must occur before Ben Venue can fully resume operations, including the retention of an expert to inspect the company’s facility, the development and then implementation of a remediation plan, and an inspection by FDA to confirm that the company’s manufacturing processes are fully compliant with the law.

“This consent decree restricts Ben Venue from manufacturing and distributing certain drugs until the company fully complies with the law,” said Stuart F. Delery, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division.  “As this case demonstrates, the Department of Justice and FDA will work together to protect the health and safety of Americans by making sure that those who produce and distribute prescription drugs follow the law.”

“This resolution comes following nearly three dozen inspections which revealed inadequate quality control, including contaminated drugs, and led to approximately 40 recalls on products from this facility alone,” said Steven M. Dettelbach, U.S. Attorney for the Northern District of Ohio. “The Justice Department and the Food and Drug Administration will continue to place its highest priority on protecting consumers.”

Under the decree, Ben Venue may continue to manufacture and distribute a subset of their drugs (listed on Attachment A to the decree), which FDA has determined are currently in shortage (domestically or abroad) or are vulnerable to shortage.   However, prior to distribution of each batch of these drugs, the company’s expert must conduct a batch-by-batch review and certify that no deviations occurred during the manufacture of the drug that would adversely affect the safety or quality of the batch.

Principal Deputy Assistant Attorney General Delery thanked the FDA for referring this matter to the Department of Justice.  Jeffrey Steger, Assistant Director of the Consumer Protection Branch of the Justice Department and Michele Svonkin, Counsel at FDA’s Office of the Chief Counsel, brought this case on behalf of the United States.

source found here

Republicans say FDA withholds key meningitis docs Feb. 1, 2013, 3:34 p.m. PST

AP

WASHINGTON (AP) — House Republicans are threatening to subpoena documents from the Food and Drug Administration as part of an ongoing investigation into whether the agency could have prevented a deadly outbreak of meningitis caused by contaminated drugs.

Republicans on the Energy and Commerce Committee said Friday that the FDA has three weeks to turn over internal documents concerning its oversight of the New England Compounding Center. The pharmacy produced a contaminated steroid, used mainly to treat back pain, that is blamed for fungal meningitis that has killed 45 people and sickened more than 600.

The outbreak was first identified in September and Congress has been investigating the case since October. But their inquiry has been slowed by the complex overlap of state and federal laws and regulations that govern specialty pharmacies like the Framingham, Mass.-based NECC.

The FDA inspected the pharmacy three times between 2002 and 2005 and issued a warning letter in 2006 ordering NECC to stop mass-producing drugs outside the scope of its license. But regulators never shut the operation down. At a November hearing, FDA Commissioner Margaret Hamburg said the agency decided to defer the issue to Massachusetts Board of Pharmacy, which had more direct oversight of the company.

While the agency has turned over the documents related to its inspections, Republicans say they want to see internal memos about the agency's decision-making process.

"FDA has produced no communications from staff and officials at FDA headquarters, who were actually making the decisions about how to address the situation," according to the letter, signed by Chairman Fred Upton and four other Republicans. They point out that the Massachusetts Board of Pharmacy, "a much smaller entity than the FDA," produced all the documents requested by the committee before the November hearing.

Agency spokeswoman Erica Jefferson said late Friday that the FDA is working to respond to the committee, and has turned over more than 3,500 pages of documents to Congress since October.

"These documents include correspondence from FDA's district offices and FDA headquarters as well as inspectional documents and adverse event records from the 2002-2006 timeframe," Jefferson said in a statement.

The lawmakers say they will consider issuing a subpoena if the FDA doesn't turn over key internal memos related to the case by Feb. 25.

Compounding pharmacies produce specialized drug formulations for patients with unusual prescription needs, for instance those allergic to widely used ingredients. All Pharmacies have long been regulated by state pharmacy boards, many of which date back to the 19th century. But since the 1990s, the FDA has taken a larger role in policing compounding pharmacies, some of which have grown into large businesses. The NECC shipped more than 17,600 doses of a pain injection to 23 states. The firm has been closed since October and filed for Chapter 11 bankruptcy in December.

House Republicans ask FDA for meningitis documents

WASHINGTON (Reuters) - House Republicans on Friday set a deadline for the U.S. Food and Drug Administration to produce documents related to the deadly meningitis outbreak that swept across the nation in late 2012.

Leaders of the House Energy and Commerce Committee first requested, in October, documents related to FDA's oversight of New England Compounding Center, the now defunct, Boston-areacompounding pharmacy that was at the center of the outbreak.

But it says the agency produced few documents so far and that those it has "raise new and troubling questions" about the agency's oversight of NECC.

"If FDA does not produce all the responsive documents by 5:00 p.m. on February 25, 2013, the committee will move forward with a business meeting to compel their production," the committee said in a release.

"We hope a subpoena will not be necessary for the FDA to cooperate and help us determine what went wrong," said Oversight and Investigations Subcommittee Chairman Tim Murphy of Pennsylvania.

The meningitis outbreak to date has killed 45 people and sickened almost 700 in 19 states, according to the U.S. Centers for Disease Control.

(Reporting by Ros Krasny; Editing by Leslie Gevirtz)

Source found here

State board discusses pharmacy regulation

Posted: Friday, February 1, 2013 9:01 pm By KRISTIN M. HALL Associated Press NASHVILLE (AP) — Members of the Tennessee Board of Pharmacy discussed several options Thursday to increase oversight of sterile compounding pharmacies after last year’s deadly outbreak of fungal meningitis that has sickened hundreds of people across the country. During a meeting in Nashville, board members weighed proposals from the state Department of Health that included changes to pharmacy licenses and stressed the need for more investigators to ensure facilities were sterile. Doctors in Tennessee were the first to link the meningitis outbreak to steroid injections prepared by a Massachusetts compounding pharmacy, which also had a pharmacy license in Tennessee until it was revoked. Across the country, 45 people, including 14 in Tennessee, have died after getting the shots. Locally, Ann Bequette of Martin is listed as one of the Tennessee residents who contracted fungal meningitis last year. She contracted the illness in early October 2012 after having a spinal tap done at the St. Thomas Outpatient Neurology Center in Nashville. She was there for problems she was experiencing with her sciatic nerve. Valerie Nagoshiner, the Tennessee Department of Health’s legislation liaison, asked for the board’s input on several suggestions for changes based on their work investigating the outbreak. One suggestion was creating an alternative licensing for pharmacies that do sterile compounding and more clearly define sterile compounding pharmacies in state regulations. She said that would allow inspectors to focus their efforts on pharmacies that are doing the riskier type of compounding. “We knew that all pharmacies were compounding to some degree, but we didn’t know those that were in sterile compounding that would be falling through the cracks,” Nagoshiner said. Joyce McDaniel, a board member who is not a pharmacist, but represents consumers on the board, said that creating a new licensure wouldn’t have necessarily protected patients in the case of the New England Compounding Center. Compounding pharmacies traditionally create customized medications based on doctors’ instructions or in forms that aren’t commercially available from drug manufacturers. But NECC was acting like a manufacturer, which are federally licensed, and was producing large batches of steroid injections. “We’re talking about manufacturers that were the issue here, and not a local pharmacy,” McDaniel said. Kevin Eidson, a board member and pharmacist, suggested that sterile compounding pharmacies could be identified by a modifier to their license, similar to the modifier required for pharmacists who work with controlled substances. “We do not need another piece of legislation,” he said. Nagoshiner also suggested giving the health commissioner the authority to instantly suspend sterile compounding at a pharmacy if inspectors found certain safety problems. She said it would be similar to the commissioner’s ability to suspend new admissions at nursing homes until corrective action was taken. But Eidson said he wasn’t comfortable with letting Health Department Commissioner John Dreyzehner decide whether to suspend a pharmacy’s operations. “We are the experts as it relates to pharmacy,” Eidson said. “Commissioner Dreyzehner is a physician.” Andrew Holt, the executive director of the board of pharmacy who oversees enforcement state laws pertaining to pharmacy, told the board that five inspectors are responsible for inspecting about 1,900 licensed pharmacies across the state. Holt said based on a recent survey of pharmacies, he estimated there were around 300 to 400 pharmacies doing sterile compounding in the state, but that number could be higher. “Obviously, we are way understaffed when it comes to investigators,” said Charles Stephens, the board president. Holt said his recommendation is that sterile compounding pharmacies be inspected annually at a minimum, but he said he would have to do some additional research to determine how many more inspectors would be needed to perform those inspections. Published in The Messenger 2.1.13 Source found here