The long-running controversy over lethal-injection drugs helped push the number of executions in 2013 down by about 10%, according to a new report published Thursday.
In 2013, nine states were responsible for 39 executions, four fewer than the 43 carried out in both 2012 and 2011, according to an annual study of the death penalty by the Death Penalty Information Center, a Washington, D.C., nonprofit organization.
With the exception of 2008, in which 37 inmates were put to death, the 2013 figure represents the lowest since 1994, when 31 people were executed.
The number of executions peaked at 98 in 1999. “And since then, it’s been a stairway drop down,” said Richard Dieter, the executive director of the Death Penalty Information Center, an organization largely opposed to the way the death penalty is carried out in the U.S. “The new reality is that the death penalty is marginalized. It’s just not widely depended on as an answer to murder or horrendous crime.”
The numbers were deflated this year at least in part by shortages in lethal-injection drugs. Several states, including North Carolina, Arkansas and California, have essentially halted executions while they search for alternatives to two drugs – sodium thiopental and pentobarbital – that have traditionally been used in lethal-injection procedures. Makers of the drugs have over the past few years stopped their production or mandated that they not be used in executions.
On the other hand, the number of death sentences ticked up slightly in 2013, to 80 from 77 in 2012, according to the report. That number is still well below the recent highs. In 2000, 225 people received death sentences.
A sharp drop in violent crime, the high cost of pursuing executions and shifts in state sentencing laws have all played a role in the drop in death-sentences. And fewer death sentences will likely lead to an even further decline in executions in years to come, predicts Mr. Dieter.
In 2013, southern states carried out 82 percent of the executions, with two states – Texas and Florida – accounting for nearly 60% of them. Oklahaoma, Ohio, Arizona and Missouri were the only other states that executed more than one person.
“The U.S. is a death penalty country, but when viewed more closely, it’s become divided and clustered in just a few areas,” said Mr. Dieter.
Public support for the death penalty, as measured by the latest Gallup poll released in October, declined to 60%, its lowest level in 40 years. In February, Maryland became the sixth state in six years to do away with its death penalty.
http://blogs.wsj.com/law/2013/12/19/drug-shortage-helps-lead-to-fall-in-2013-executions/
Friday, December 20, 2013
Dallas compounding pharmacy announces recall of non-sterile 'sterile' products
Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility assurance. All unexpired lots of sterile compounded products are subject to the recall. Sterile products are injectable medications, IVs, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments.All recalled products have a label that includes Abrams Royal Pharmacy’s name and phone as well as a lot number. While not every label contains an expiration date, consumers can call the pharmacy with the lot number and find out the expiration date.
The recall was issued after a single, isolated report of an adverse event involving a patient in California who received a compounded medication from the pharmacy. Out of an abundance of caution, Abrams Royal is voluntarily recalling all sterile products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
The recalled products were distributed to health care facilities, physicians, and patients from June 17, 2013, through December 17, 2013.
Abrams Royal Pharmacy has begun notifying its customers by mail and is arranging for the return of all recalled medication. To return product or request assistance related to this recall, users should contact Abrams Royal at 214-349-8000 begin_of_the_skype_highlighting
214-349-8000 FREE end_of_the_skype_highlighting , Monday through Friday, between 9:00 a.m. and 5:00 p.m. CST.
Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products. Adverse reactions may be reported to the FDA’s MedWatch program via:
Online:www.fda.gov/medwatch/report.htmMail : use postage-paid, pre-addressed Form FDA 3500 atwww.fda.gov/MedWatch/getforms.htm .Fax: 1-800-FDA-0178
Abrams Royal’s pharmacists deeply regret the disruption that the voluntary recall and temporary suspension of its sterile compounding service have on the pharmacy’s patients, but emphasized that safety is always their first concern.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
The recall was issued after a single, isolated report of an adverse event involving a patient in California who received a compounded medication from the pharmacy. Out of an abundance of caution, Abrams Royal is voluntarily recalling all sterile products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
The recalled products were distributed to health care facilities, physicians, and patients from June 17, 2013, through December 17, 2013.
Abrams Royal Pharmacy has begun notifying its customers by mail and is arranging for the return of all recalled medication. To return product or request assistance related to this recall, users should contact Abrams Royal at 214-349-8000 begin_of_the_skype_highlighting
214-349-8000 FREE end_of_the_skype_highlighting , Monday through Friday, between 9:00 a.m. and 5:00 p.m. CST.Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products. Adverse reactions may be reported to the FDA’s MedWatch program via:
Online:www.fda.gov/medwatch/report.htmMail : use postage-paid, pre-addressed Form FDA 3500 atwww.fda.gov/MedWatch/getforms.htm .Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Many doctors report trouble getting cancer drugs
NEW YORK (Reuters Health) - More than eight in 10 U.S. cancer specialists have struggled to find the drugs they need to best treat their patients, a new survey has found.
Hoffman is the medication outcomes and safety officer at St. Jude Children's Research Hospital in Memphis, Tennessee.
"It demonstrates that chemotherapy shortages frequently force chemotherapy regimens to be changed or delayed, which may lead to increased costs or even worse outcomes," he told Reuters Health in an email.
One report published a year ago found fewer patients survived Hodgkin lymphoma - a type of immune system cancer - when doctors had to switch from using the standard chemotherapy drug to a substitute.
Such shortages have happened in the U.S. since 2006 but have been becoming more common. In October, the U.S. Food and Drug Administration (FDA) issued a strategic plan designed to prevent shortages and proposed requiring drug companies to promptly notify it if a supply problem looms. But the FDA cannot compel action to prevent a shortage.
"In the last five years, there's been a three-fold increase in the number of shortages reported," Gogineni said.
Sometimes shortages happen because a company didn't make enough of a given drug. Or the company could be trying to get more people to use a more profitable drug instead of a less profitable one.
To gauge the current problem, Gogineni's team sent surveys to 454 cancer doctors in late 2012 and early 2013; 250 responded.
The vast majority - about 83 percent - said they couldn't prescribe the preferred drug at least once in the last six months.
More than three-quarters of them said the shortages forced major changes in treatment. That included switching to different drug combinations, delaying treatment or skipping doses.
Most doctors who encountered shortages said they had to substitute more expensive brand-name drugs for cheaper generic versions. For instance, some reported using a colon cancer drug that is 140 times more expensive per cycle than the drug that was unavailable, Gogineni and her colleagues wrote.
"One thing we were surprised about was that, despite the frequency of shortages, nearly two-thirds of the oncologists we surveyed had no formal guidance to try to make the right next-best decision" when seeking a substitute drug, Gogineni said.
"There ideally should be guidelines to help physicians manage shortages so they know there's a specific alternative drug."
The survey couldn't determine how many patients are likely to be affected by drug shortages. Gogineni said people with cancer should ask their doctor whether they might be affected.
"Knowing at the outset that there might be a change or modification of the treatment plan is something patients should be advised of as soon as possible rather than be surprised by it," she said. It may allow them to go somewhere else, where the supply is sufficient, to complete their treatment.
http://news.yahoo.com/many-doctors-report-trouble-getting-cancer-drugs-221137752.html
Such drug shortages could affect people with colon cancer, breast cancer and leukemia. They include chemotherapy drugs prescribed after a tumor has spread.
"These are drugs used for common and curable cancers," Dr. Keerthi Gogineni of the Hospital of the University of Pennsylvania in Philadelphia told Reuters Health.
"It is becoming increasingly difficult for patients with cancer to receive the lifesaving treatments they need," she and her colleagues write in a letter published in the New England Journal of Medicine. The shortages "compromise the delivery of standard cancer care and lead to higher costs."
Their work builds on an earlier survey, released in March, of pharmacists and other health professionals who buy cancer drugs for hospitals. In that study, 16 percent said shortages had caused problems for patients, including more disease progression or additional treatment-related complications.
A co-author of that survey, James M. Hoffman, said the new study "adds additional evidence for the harmful consequences of chemotherapy drug shortages on cancer patients."
Hoffman is the medication outcomes and safety officer at St. Jude Children's Research Hospital in Memphis, Tennessee.
"It demonstrates that chemotherapy shortages frequently force chemotherapy regimens to be changed or delayed, which may lead to increased costs or even worse outcomes," he told Reuters Health in an email.
One report published a year ago found fewer patients survived Hodgkin lymphoma - a type of immune system cancer - when doctors had to switch from using the standard chemotherapy drug to a substitute.
Such shortages have happened in the U.S. since 2006 but have been becoming more common. In October, the U.S. Food and Drug Administration (FDA) issued a strategic plan designed to prevent shortages and proposed requiring drug companies to promptly notify it if a supply problem looms. But the FDA cannot compel action to prevent a shortage.
"In the last five years, there's been a three-fold increase in the number of shortages reported," Gogineni said.
Sometimes shortages happen because a company didn't make enough of a given drug. Or the company could be trying to get more people to use a more profitable drug instead of a less profitable one.
To gauge the current problem, Gogineni's team sent surveys to 454 cancer doctors in late 2012 and early 2013; 250 responded.
The vast majority - about 83 percent - said they couldn't prescribe the preferred drug at least once in the last six months.
More than three-quarters of them said the shortages forced major changes in treatment. That included switching to different drug combinations, delaying treatment or skipping doses.
Most doctors who encountered shortages said they had to substitute more expensive brand-name drugs for cheaper generic versions. For instance, some reported using a colon cancer drug that is 140 times more expensive per cycle than the drug that was unavailable, Gogineni and her colleagues wrote.
"One thing we were surprised about was that, despite the frequency of shortages, nearly two-thirds of the oncologists we surveyed had no formal guidance to try to make the right next-best decision" when seeking a substitute drug, Gogineni said.
"There ideally should be guidelines to help physicians manage shortages so they know there's a specific alternative drug."
The survey couldn't determine how many patients are likely to be affected by drug shortages. Gogineni said people with cancer should ask their doctor whether they might be affected.
"Knowing at the outset that there might be a change or modification of the treatment plan is something patients should be advised of as soon as possible rather than be surprised by it," she said. It may allow them to go somewhere else, where the supply is sufficient, to complete their treatment.
William Greene, St. Jude's chief pharmaceutical officer, said the survey shows the problem is particularly severe for patients treated in private or community settings.
"Much of the previous discussion on shortages has come from large health-systems and academic settings," he told Reuters Health in an email. "Smaller office-based practices often do not have the market power or other resources to obtain needed drugs in a shortage situation."
SOURCE: http://bit.ly/1cAW8sg New England Journal of Medicine, online December 18, 2013.
http://news.yahoo.com/many-doctors-report-trouble-getting-cancer-drugs-221137752.html
Today's Shortages
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ASHP/FDA
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Atorvastatin Tablets
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Azithromycin Injection
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Cefazolin Injection
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Isosorbide Dinitrate Immediate
Release Tablets
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Naproxen Oral Suspension
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Rocuronium Injection
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Tiopronin Tablets
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Vancomycin Hydrochloride
Injection
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Wednesday, December 18, 2013
Tuesday, December 17, 2013
Pharmagen Partners with Bagel Boy Equity Group II, LLC and prepares to Launch its Industry Consolidation Strategy
SILVER SPRING, Md., Dec. 17, 2013 /PRNewswire/ -- Pharmagen, Inc. (OTCBB: PHRX) (the "Company" or "Pharmagen") announces that is has executed an agreement with Bagel Boy Equity Group II, LLC, whereby its Managing Partner, Richard A. Wolpow will become Chairman of the Board of Directors and interim Chief Operating Officer ("COO"). Wolpow will work closely with Pharmagen's CEO, Mackie Barch, and the rest of its executive team using the Company as the platform for deploying a roll-up consolidation plan in the hard-to-find secondary wholesale and sterile compounding market. Pharmagen's goal will be to build a fully integrated state-of-the-art distribution and supply chain that will drive revenue and EBITDA growth for shareholders.
"We have been looking at this space for the past year and believe Pharmagen has the right platform for the overall success of the plan," says Richard A. Wolpow, managing partner of Bagel Boy Equity Group II LLC, a private family office he controls. As a component to the deal Bagel Boy Equity Group will lead a Bridge Financing that will help kick-off the plan that has been in development for the past months including a detailed capital restructure plan.
The market is made of a lot of quality smaller secondary wholesale companies and compounding laboratories that are all running into similar problems; regulations are getting tighter, supply chain is shrinking along with revenues and profits. Without change, many of these companies may not survive and/or have an exit strategy in the future. "Pharmagen has made significant investments across the board; from its focus to become a cGMP complaint laboratory, industry changing IT platform, and drug productions models, the Company is poised to become a best-in-class provider" continued Wolpow.
"This is all very exciting stuff; working together we created an acquisition class of preferred stock that represents a non-dilutable interest in the Company. It provides offerings of cash and stock, executive management positions, performance bonuses and seats on the Board of Directors. There are a lot of talented competitors out there that we are confident understand what is going on in this market and that change is needed to adapt to the times. We have already identified a handful of acquisition targets that would like to join us on this journey," Wolpow continued.
"We are really fortunate to have Richard on the team. It validates all the work we've been doing behind the scenes for the last two years to build a strong foundation for the future. We have a lot of work ahead of us, but are very exciting about what 2014 will bring," said Mackie A. Barch, CEO of Pharmagen.
About Pharmagen
Pharmagen, Inc. ("Pharmagen"), and wholly owned subsidiaries and operating divisions Pharmagen Laboratories, Inc., Pharmagen Distribution, LLC and Pharmagen Nutraceuticals, Inc. offers innovative solutions to the nations sterile pharmaceutical crisis. With a multi-solution approach, Pharmagen is helping to meet the demand of the health provider market through independent wholesale, compounding, and IT solutions. Nationally focused, Pharmagen is a distributor of specialty drugs, compounding and admix pharmacy and producer of over-the-counter ("OTC") branded multivitamins. Pharmagen currently functions as a just-in-time source of supply for hospitals for those products that are hard-to-find.
Contact: 888-264-4597 or info@pharmagenrx.com
Follow Us on Twitter: @pharmagenrx or
The Drug Shortage Report http://drugshortagereport.blogspot.com/
About Bagel Boy Equity Group II, LLC
Bagel Boy Equity Group II, LLC, was founded it Managing Partner, Richard A. Wolpow. Mr Wolpow has been advising and operating small to mid-size private and public companies for over 20 years. He is or has been founder and chief operator of a number of company's primarily in the Healthcare industry. Currently, Mr. Wolpow is on the Board of Directors or three companies, is an operating partner of a healthcare specific private equity firm and is the Trustee for a private charitable trust.
Safe Harbor Statement
Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Pharmagen actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Pharmagen's filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Pharmagen herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Pharmagen disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.
http://online.wsj.com/article/PR-CO-20131217-904085.html?dsk=y
"We have been looking at this space for the past year and believe Pharmagen has the right platform for the overall success of the plan," says Richard A. Wolpow, managing partner of Bagel Boy Equity Group II LLC, a private family office he controls. As a component to the deal Bagel Boy Equity Group will lead a Bridge Financing that will help kick-off the plan that has been in development for the past months including a detailed capital restructure plan.
The market is made of a lot of quality smaller secondary wholesale companies and compounding laboratories that are all running into similar problems; regulations are getting tighter, supply chain is shrinking along with revenues and profits. Without change, many of these companies may not survive and/or have an exit strategy in the future. "Pharmagen has made significant investments across the board; from its focus to become a cGMP complaint laboratory, industry changing IT platform, and drug productions models, the Company is poised to become a best-in-class provider" continued Wolpow.
"This is all very exciting stuff; working together we created an acquisition class of preferred stock that represents a non-dilutable interest in the Company. It provides offerings of cash and stock, executive management positions, performance bonuses and seats on the Board of Directors. There are a lot of talented competitors out there that we are confident understand what is going on in this market and that change is needed to adapt to the times. We have already identified a handful of acquisition targets that would like to join us on this journey," Wolpow continued.
"We are really fortunate to have Richard on the team. It validates all the work we've been doing behind the scenes for the last two years to build a strong foundation for the future. We have a lot of work ahead of us, but are very exciting about what 2014 will bring," said Mackie A. Barch, CEO of Pharmagen.
About Pharmagen
Pharmagen, Inc. ("Pharmagen"), and wholly owned subsidiaries and operating divisions Pharmagen Laboratories, Inc., Pharmagen Distribution, LLC and Pharmagen Nutraceuticals, Inc. offers innovative solutions to the nations sterile pharmaceutical crisis. With a multi-solution approach, Pharmagen is helping to meet the demand of the health provider market through independent wholesale, compounding, and IT solutions. Nationally focused, Pharmagen is a distributor of specialty drugs, compounding and admix pharmacy and producer of over-the-counter ("OTC") branded multivitamins. Pharmagen currently functions as a just-in-time source of supply for hospitals for those products that are hard-to-find.
Contact: 888-264-4597 or info@pharmagenrx.com
Follow Us on Twitter: @pharmagenrx or
The Drug Shortage Report http://drugshortagereport.blogspot.com/
About Bagel Boy Equity Group II, LLC
Bagel Boy Equity Group II, LLC, was founded it Managing Partner, Richard A. Wolpow. Mr Wolpow has been advising and operating small to mid-size private and public companies for over 20 years. He is or has been founder and chief operator of a number of company's primarily in the Healthcare industry. Currently, Mr. Wolpow is on the Board of Directors or three companies, is an operating partner of a healthcare specific private equity firm and is the Trustee for a private charitable trust.
Safe Harbor Statement
Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Pharmagen actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Pharmagen's filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Pharmagen herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Pharmagen disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.
http://online.wsj.com/article/PR-CO-20131217-904085.html?dsk=y
Landmark legislation enacted to improve the safety of drugs distributed and used in the United States
On November 27, President Barack Obama signed the Drug Quality and Security Act (H.R. 3204), a law that makes significant changes that will have a widespread effect on all members of the US prescription drug supply chain – from manufacturers and wholesale distributors to retail pharmacies and large-scale drug compounding operations. The law consists of two distinct parts. First, it requires a 10-year phase-in of a national interoperable electronic track-and-trace system for prescription drugs, a system that ultimately will allow unit level traceability of drugs from the manufacturer to the dispenser. Second, the law creates a new category of drug facilities that can register with and be regulated by the Food and Drug Administration (FDA) when they engage in the compounding of sterile drug products without first obtaining individual prescriptions.
Both parts of the Drug Quality and Security Act (the Act) respond to perceived deficiencies with the existing regulatory system for human pharmaceuticals; the track-and-trace provisions in particular have been the subject of many years of debate and compromise among affected stakeholders and members of Congress. The national track-and-trace system is intended to strengthen the security of the pharmaceutical supply chain by preventing drug diversion, counterfeiting, and other adulteration. The system should enhance patient safety by, among other things, making it much more difficult for counterfeit medications to enter the US drug supply. The law establishes a new federal system and preempts existing and impending state electronic and paper pedigree requirements. Preemption was a critical feature for supply chain members who raised serious concerns about how they would operate within a patchwork of different state laws on the issue.
In a similar vein, following the highly publicized 2012 outbreak of fungal meningitis due to contaminated injectable drug products that were shipped to multiple states by the Massachusetts-based New England Compounding Center (as well as a large number of compounded drug recalls since that time as a result of both states and FDA increasing their inspections of compounding pharmacies), many believed that overlapping federal and state jurisdictions had allowed certain facilities to fall between the cracks.
Pharmacies engaged in “traditional” compounding – in which individual prescriptions are used to make a tailored drug product for a patient, such as a version that omits an allergen or a preservative ingredient – are regulated under state law. However, facilities throughout the country had been compounding drugs in large quantities for distribution across state lines, without receiving practitioner orders in advance of compounding or individual prescriptions for identifiable patients. In essence, historically, those facilities were not viewed as “pharmacies” by the states and were not being adequately overseen at the local level – and they also were not registered with FDA as “drug establishments” engaged drug manufacturing, so they were not being inspected by FDA for compliance with Federal good manufacturing practice regulations. The Act creates a new category of “outsourcing facilities” that will be permitted to compound and distribute large volumes of sterile drugs (meaning parenteral, ophthalmic, or oral inhalation drugs) without first obtaining individual prescriptions.
We outline below some of the more significant aspects of the two parts of the Drug Quality and Security Act.
Drug Supply Chain Security
The provisions of the Act that create a national, interoperable electronic track-and-trace system for prescription drugs establish a stepwise implementation schedule. First, beginning on January 1, 2015, manufacturers must provide (and distributors must receive and pass along to their customers) for each prescription drug product documentation that includes the transaction information, transaction history, and transaction statement for the product.[1] Next, four years after the date of enactment, manufacturers would have to provide the transaction information / history / statement in electronic format only, and they also would be required to affix an electronic product identifier to each package of a particular drug product (also called unit level serialization). The product identifier for a package must be a 2D barcode that consists of the product’s standardized numerical identifier (which follows a defined format established by FDA), its lot number, and its expiration date.
After manufacturers have serialized their products, six years after the date of enactment, wholesale distributors will be prohibited from receiving or selling any products that are not serialized as mandated by the law. Dispensers (i.e., retail pharmacies, hospital pharmacies) would be required to receive and sell only serialized product seven years after the date of enactment. Finally, 10 years after enactment, the requirement to provide transaction information/history/statements will sunset, and drug products’ unit level serialization will be used by all members of the supply chain to trace the product back to the manufacturer using an interoperable electronic system. FDA will issue guidance on unit level product tracing and standards for interoperable data exchange in order to make this system possible.
In addition to the track-and-trace requirements described above, the provisions in this title of the Act also require all members of the pharmaceutical supply chain to be properly registered or licensed, either by State agencies or the FDA, as appropriate. It also raises Federal licensure standards for wholesale distributors, establishes minimum licensure standards for third-party logistics providers (3PLs), and requires wholesale distributors and 3PLs to report annually to FDA regarding their licensure status.
Drug Compounding
The drug compounding title of the Act defined an “outsourcing facility” as a facility is one geographic location that elects to register with FDA, compounds sterile drug products, and complies with the new statutory provisions governing outsourcing facilities. An outsourcing facility is not required to be licensed as a pharmacy, and it may or may not obtain prescriptions for identifiable individual patients. The law subjects such facilities to FDA regulation and requires them to comply with good manufacturing practice regulations (just as conventional drug manufacturing facilities). However, registered outsourcing facilities would be exempt from the provisions of the Federal Food, Drug, and Cosmetic Act that require (i) approval of a new drug application before a product can be distributed, and (ii) adequate directions for use in the product’s labeling. Outsourcing facilities also would be exempt from the new track-and-trace requirements enacted under the companion title of the Drug Quality and Security Act.
Registering with FDA as an outsourcing facility is voluntary, so facilities that do not register will continue to be regulated as pharmacies at the State level, but registering as an outsourcing facility would allow the site to rely on compliance with Federal law and its inspection history with FDA when shipping sterile compounded products interstate. Otherwise, depending on their specific activities, compounding pharmacies may be required to comply with multiple state laws, hold multiple state licenses, and potentially be inspected by multiple state boards of pharmacy. Registration requires an annual fee of $15,000 to help fund FDA’s risk-based inspections of outsourcing facilities and requires a licensed pharmacist to directly supervise the operations. Each outsourcing facility must report adverse events to FDA and also submit biannually to the agency a list of products that it compounds. In addition to its new inspection mandate, FDA must establish a public database of registered outsourcing facilities on its website.
The Act also places restrictions on the types of drugs that can be compounded – either by state-licensed compounding pharmacies or FDA-registered outsourcing facilities. Consistent with the agency’s long-standing policy, drugs that are essentially copies of commercially available drugs, drugs that have been withdrawn from the market for safety or effectiveness reasons, and drugs identified by FDA though rulemaking as presenting “demonstrable difficulties to compound” may not be compounded.
The intricacies of both parts of the Act make clear that major stakeholders in the pharmaceutical industry, as well as regulators at the FDA and in states, have considerable work ahead of them to realize the shared goal of enhancing the safety and quality of the US drug supply. Arent Fox will continue to monitor these efforts and keep our clients and friends informed of any new developments
http://www.lexology.com/library/detail.aspx?g=b5d9bd75-2705-4678-8d53-c3ed5d3d06db
Both parts of the Drug Quality and Security Act (the Act) respond to perceived deficiencies with the existing regulatory system for human pharmaceuticals; the track-and-trace provisions in particular have been the subject of many years of debate and compromise among affected stakeholders and members of Congress. The national track-and-trace system is intended to strengthen the security of the pharmaceutical supply chain by preventing drug diversion, counterfeiting, and other adulteration. The system should enhance patient safety by, among other things, making it much more difficult for counterfeit medications to enter the US drug supply. The law establishes a new federal system and preempts existing and impending state electronic and paper pedigree requirements. Preemption was a critical feature for supply chain members who raised serious concerns about how they would operate within a patchwork of different state laws on the issue.
In a similar vein, following the highly publicized 2012 outbreak of fungal meningitis due to contaminated injectable drug products that were shipped to multiple states by the Massachusetts-based New England Compounding Center (as well as a large number of compounded drug recalls since that time as a result of both states and FDA increasing their inspections of compounding pharmacies), many believed that overlapping federal and state jurisdictions had allowed certain facilities to fall between the cracks.
Pharmacies engaged in “traditional” compounding – in which individual prescriptions are used to make a tailored drug product for a patient, such as a version that omits an allergen or a preservative ingredient – are regulated under state law. However, facilities throughout the country had been compounding drugs in large quantities for distribution across state lines, without receiving practitioner orders in advance of compounding or individual prescriptions for identifiable patients. In essence, historically, those facilities were not viewed as “pharmacies” by the states and were not being adequately overseen at the local level – and they also were not registered with FDA as “drug establishments” engaged drug manufacturing, so they were not being inspected by FDA for compliance with Federal good manufacturing practice regulations. The Act creates a new category of “outsourcing facilities” that will be permitted to compound and distribute large volumes of sterile drugs (meaning parenteral, ophthalmic, or oral inhalation drugs) without first obtaining individual prescriptions.
We outline below some of the more significant aspects of the two parts of the Drug Quality and Security Act.
Drug Supply Chain Security
The provisions of the Act that create a national, interoperable electronic track-and-trace system for prescription drugs establish a stepwise implementation schedule. First, beginning on January 1, 2015, manufacturers must provide (and distributors must receive and pass along to their customers) for each prescription drug product documentation that includes the transaction information, transaction history, and transaction statement for the product.[1] Next, four years after the date of enactment, manufacturers would have to provide the transaction information / history / statement in electronic format only, and they also would be required to affix an electronic product identifier to each package of a particular drug product (also called unit level serialization). The product identifier for a package must be a 2D barcode that consists of the product’s standardized numerical identifier (which follows a defined format established by FDA), its lot number, and its expiration date.
After manufacturers have serialized their products, six years after the date of enactment, wholesale distributors will be prohibited from receiving or selling any products that are not serialized as mandated by the law. Dispensers (i.e., retail pharmacies, hospital pharmacies) would be required to receive and sell only serialized product seven years after the date of enactment. Finally, 10 years after enactment, the requirement to provide transaction information/history/statements will sunset, and drug products’ unit level serialization will be used by all members of the supply chain to trace the product back to the manufacturer using an interoperable electronic system. FDA will issue guidance on unit level product tracing and standards for interoperable data exchange in order to make this system possible.
In addition to the track-and-trace requirements described above, the provisions in this title of the Act also require all members of the pharmaceutical supply chain to be properly registered or licensed, either by State agencies or the FDA, as appropriate. It also raises Federal licensure standards for wholesale distributors, establishes minimum licensure standards for third-party logistics providers (3PLs), and requires wholesale distributors and 3PLs to report annually to FDA regarding their licensure status.
Drug Compounding
The drug compounding title of the Act defined an “outsourcing facility” as a facility is one geographic location that elects to register with FDA, compounds sterile drug products, and complies with the new statutory provisions governing outsourcing facilities. An outsourcing facility is not required to be licensed as a pharmacy, and it may or may not obtain prescriptions for identifiable individual patients. The law subjects such facilities to FDA regulation and requires them to comply with good manufacturing practice regulations (just as conventional drug manufacturing facilities). However, registered outsourcing facilities would be exempt from the provisions of the Federal Food, Drug, and Cosmetic Act that require (i) approval of a new drug application before a product can be distributed, and (ii) adequate directions for use in the product’s labeling. Outsourcing facilities also would be exempt from the new track-and-trace requirements enacted under the companion title of the Drug Quality and Security Act.
Registering with FDA as an outsourcing facility is voluntary, so facilities that do not register will continue to be regulated as pharmacies at the State level, but registering as an outsourcing facility would allow the site to rely on compliance with Federal law and its inspection history with FDA when shipping sterile compounded products interstate. Otherwise, depending on their specific activities, compounding pharmacies may be required to comply with multiple state laws, hold multiple state licenses, and potentially be inspected by multiple state boards of pharmacy. Registration requires an annual fee of $15,000 to help fund FDA’s risk-based inspections of outsourcing facilities and requires a licensed pharmacist to directly supervise the operations. Each outsourcing facility must report adverse events to FDA and also submit biannually to the agency a list of products that it compounds. In addition to its new inspection mandate, FDA must establish a public database of registered outsourcing facilities on its website.
The Act also places restrictions on the types of drugs that can be compounded – either by state-licensed compounding pharmacies or FDA-registered outsourcing facilities. Consistent with the agency’s long-standing policy, drugs that are essentially copies of commercially available drugs, drugs that have been withdrawn from the market for safety or effectiveness reasons, and drugs identified by FDA though rulemaking as presenting “demonstrable difficulties to compound” may not be compounded.
The intricacies of both parts of the Act make clear that major stakeholders in the pharmaceutical industry, as well as regulators at the FDA and in states, have considerable work ahead of them to realize the shared goal of enhancing the safety and quality of the US drug supply. Arent Fox will continue to monitor these efforts and keep our clients and friends informed of any new developments
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