CBI's Pharmaceutical Compliance Congress started off both mornings of their two day conference with a matter sure to get industry members' attention: enforcement. A variety of government attorneys offered a glimpse into their approach to healthcare fraud, and shared insights into what they consider to be best practices regarding compliance. Carmen Ortiz, U.S. Attorney for the District of Massachusetts, began by highlighting the high priority areas of 2014. The "enforcement panel" of five government attorneys followed, splitting their time between healthcare fraud on the one hand, and the importance of robust compliance programs on the other. On Wednesday, Assistant Attorney General, Stuart Delery, spoke regarding civil enforcement and non-monetary penalties the Department of Justice (DOJ) has utilized See more here
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, January 30, 2014
MUST READ Interview with Jane Axelrad, CDER's associate director for policy---FDA News FDA to Partner with States on Compounding Oversight
Jane Axelrad, CDER’s associate director for policy, spoke with Drug Daily Bulletin to discuss the FDA’s strategy for regulating compounding pharmacies following the recent passage of the Drug Quality and Security Act.
FDAnews: What is the greatest challenge the FDA faces as it sets out to regulate the compounding industry with its new authorities?
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FDA Provides Additional Information on its Website Regarding Outsourcing Facilities
Notes:
1. The date of registration is the date upon which the required registration information has been determined by FDA to be complete. This table will be updated weekly and will list outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table.
2. Inspections may take place over several days, weeks, or longer. The date of the inspection is the date a Form FDA-483 listing the investigators observations is issued or, if no FDA Form-483 is issued, the last day of the inspection.
3. An FDA Form 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of our relevant regulations.
4. This table includes only FDA actions. It does not include actions, if any, by a State Board of Pharmacy. To determine whether a registered outsourcing facility has been the subject of a State enforcement action, check with the State Board of Pharmacy for the state in which the facility is located. Some states post disciplinary or other actions on their web sites. For more informtion, please see Compounding: Inspections, Recalls, and other Actions14.
5. If the inspection has been closed without further action, the word “closed” will appear. If the inspection has not been closed, the word “open” will appear. Open does not mean that FDA has determined that further action will be taken. It means only that a determination has not yet been made. If an action has been taken, it will be listed. Possible FDA actions may include: warning letter; seizure; or injunction.
6. This column is based on information provided by the registered outsourcing facility at the time of registration and has not been verified by FDA. If this column says “N/A”, it is because the registered outsourcing facility has not provided this information. In the future, FDA intends to provide information about whether the outsourcing facility also intends to compound nonsterile drugs from bulk drug substances, but this information is not currently available to the Agency.
- How does registration as a human drug compounding outsourcing facility under section 503B work?
- What happens after a facility first registers with FDA as an outsourcing facility under section 503B?
- What does it mean to be registered as a human drug compounding outsourcing facility under section 503B?
- If FDA has inspected a human drug compounding outsourcing facility, can I be sure that the drugs I purchase from that facility are safe?
- If I purchase drugs from a company that has multiple facilities, how can I be sure about the quality of the specific compounded drugs I purchase?
- What does an outsourcing facility do?
- Is it safe for me to purchase drugs in shortage from a registered outsourcing facility?
To register as an outsourcing facility, a compounder must send an email or use the electronic registration system to provide the following information: name; place of business; unique facility identifier; point of contact email address; an indication of whether the facility intends to compound products on FDA’s drug shortage list; an indication of whether the facility compounds from bulk drug substances, and if so, whether it compounds sterile drugs from bulk drug substances.
When FDA receives a submission for registration, FDA will review the submission to determine whether the required information has been provided, and if so, the outsourcing facility will be considered registered. If the information is not complete, FDA will contact the registrant and ask that they provide the necessary information. A firm will not be considered registered until the information is complete.
Beginning October 1, 2014, outsourcing facilities will be required to pay a fee at the time of registration. The amount of this fee and directions for paying the fee will be published in the Federal Register in early August 2014. Facilities for which the proper fee has not been received on or after October 1, 2014 will not be considered to be registered and will be removed from this list of registered outsourcing facilities.
2. What happens after a facility first registers with FDA as an outsourcing facility under section 503B?
Once an outsourcing facility is registered, the facility is subject to inspection by FDA and will be added to the list of facilities FDA intends to inspect. Outsourcing facilities are to be inspected according to a risk-based schedule. Depending on the number of outsourcing facility registrants and other inspection priorities, FDA expects to inspect newly registered outsourcing facilities within two months of initial registration, if the facility has not been previously inspected. Subsequent inspections will depend on the findings from the first inspection and other factors including but not limited to: the compliance history of the outsourcing facility; the record, history, and nature of recalls linked to the outsourcing facility; the inherent risk of the drugs compounded at the outsourcing facility; the inspection frequency and history of the outsourcing facility, including whether the outsourcing facility has been inspected within the last 4 years; and whether the outsourcing facility has registered as an entity that intends to compound drugs in shortage.
3. What does it mean to be registered as a human drug compounding outsourcing facility under section 503B?
Registration means only that FDA has received the information required to register the facility. It does not mean that the facility is making FDA-approved drugs and it does not mean it is in compliance with current good manufacturing practice requirements, the other conditions of section 503B, or other requirements in the Act. Approval of a drug requires the submission and approval of a new drug application or an abbreviated new drug application. Facilities registered as human drug compounding outsourcing facilities are required to comply with current good manufacturing practice requirements; report adverse events to FDA; label their products with certain information; and meet certain other requirements if they are to qualify for the exemptions from the new drug approval and adequate directions for use requirements of the Act. Outsourcing facilities that comply with the conditions for exemption under section 503B are not required to obtain new drug approvals. Listing of an outsourcing facility on this list does not mean that FDA has determined that the outsourcing facility is in compliance with these requirements or that it has met the conditions to qualify the exemptions under section 503B.
4. If FDA has inspected a human drug compounding outsourcing facility, can I be sure that the drugs I purchase from that facility are safe?
Drugs made by compounders, including those made at human drug compounding outsourcing facilities, are NOT FDA-approved. This means that they have not undergone the same premarket review as approved drugs. They lack an FDA review of safety and efficacy and of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product.
Although the drugs will not be FDA approved, purchasers of drugs compounded at a registered outsourcing facility that has had a recent satisfactory FDA inspection will have some assurance that the conditions at that facility met applicable current good manufacturing practice standards at the time of the inspection, and the compounded drugs are labeled with the required information. It should be noted, however, that FDA inspections are just a snapshot in time. Conditions at the facility can change at any time. And FDA only reviews a small sample of the records available at a facility during an inspection and must draw conclusions about the conditions and practices at the facility from that small sample of records. Purchasers should look at other available information about the facility that can provide them with additional insight with regard to the facility’s operations.
5. If I purchase drugs from a company that has multiple facilities, how can I be sure about the quality of the specific compounded drugs I purchase?
Registration and inspections are facility specific and do not apply to all facilities under common ownership and control. Before purchasing drugs from a corporate entity, you should determine that the specific facility in which the drugs are compounded is a registered outsourcing facility with a satisfactory inspection.
Under section 503B, outsourcing facilities that compound human drugs may register and meet certain other requirements to qualify for the exemptions from the new drug approval requirements and the requirements for adequate directions for use. Under section 503B, an outsourcing facility is a facility that:
- Is engaged in the compounding of sterile drugs
- Has elected to register as an outsourcing facility
- Complies with all of the requirements of section 503B
- Is not required to be a licensed pharmacy, but compounding must be by or under the direct supervision of a licensed pharmacist
- May or may not obtain prescriptions for identified individual patients
When registering, an outsourcing facility must pay a fee. Registering as an outsourcer means that the compounding pharmacy will be inspected according to a risk-based schedule.
Drugs compounded in registered outsourcing facilities that have had a satisfactory FDA inspection may have more assurance of safety than those made by other non-registered compounders because they are to be made in accordance with current good manufacturing practice standards. However, drugs made by compounders, including those made at human drug compounding outsourcing facilities, are NOT FDA-approved. This means that they have not undergone the same premarket review as approved drugs. They lack an FDA review of safety and efficacy and of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, or an alternative FDA-approved drug can be used, the FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product.
For drugs compounded by registered outsourcing facilities that are on the FDA Drug Shortage List15, the drug must be compounded after the drug is placed on the drug shortage list and may not be dispensed or administered to a patient after it has been removed from the drug shortage list. Therefore, compounders may place shorter beyond use or expiration dates on such products to ensure that they will be used within this period and compounders and purchasers will not be left with inventory of drugs that cannot be used because they are no longer in shortage.
quoted from FDA website found here
Compounding Pharmacy still advertising they are rapidly growing and looking for sales reps--jobs in TX, FL, AL and SC for Houston Compounding Pharmacy
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- Address:Houston, TX 77002 (map)
- Date Posted:01/29/14
- Job Type:Full-time
- Description:
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This is a 1099 commission only position.
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We are presently looking for reps in TX, FL, AL and SC.
We are licensed in many states and are rapidly growing.
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TRICARE has posted a notice on its website indicating it is looking at the safety of compounded drug prescriptions and will be re-examining its policy after the FDA implements key aspects of the new law!!
Compound Drugs
Our primary goal is your safety. TRICARE is looking at the safety of compound drug prescriptions.- Your pharmacist makes compound prescriptions for you specifically.
- These compounds may contain bulk chemicals.
- Many bulk chemicals aren't approved by the Food and Drug Administration (FDA).
- The FDA is currently reviewing a new law concerning the safety of compound drugs Once the FDA implements key aspects of the new law, we will re-examine our policy.
quoted from here
Report: FDA Approved Livestock Drugs That Could Expose Humans to Super-Bacteria
By Napp Nazworth, Christian Post Reporter
January 29, 2014|1:00 pm
The Food and Drug Administration approved the use of 18 drugs for farm animals, even though an internal review found the drugs present a "high risk" of exposing humans to "super-bacteria" that are resistant to antibiotics.The review was not announced to the public but came to light after the Natural Resources Defense Council obtained the information with a Freedom of Information Act request. An NRDC analysis of the obtained documents, "Playing Chicken with Antibiotics: Previously Undisclosed FDA Documents Show Antibiotic Additives Don't meet the Agency's Own Safety Standards," is available on the NRDC website.
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Why is Georgia's corrections department showing up on a Tulsa pharmacy's (and suspected lethal injection supplier) contract?
Why is Georgia's corrections department showing up on a Tulsa pharmacy's (and suspected lethal injection supplier) contract?: DOC: 'The Department legally procures the lethal injection drug that is used in court ordered executions'
Stay of Execution of Smulls Vacated; Compounding Problem Remains
Why was the stay granted initially, and what is so troubling about his execution? The issues are not novel: an all-white jury, plus execution drugs made in secret by a compounding pharmacy. The latter issue, though not dealt with today, is repeating itself across the country and raises important issues of cruel and unusual punishment.
Stay Granted
Smulls' counsel, Cheryl Pilate, filed two last-minute challenges to his execution, after the U.S. District Court in Kansas City and the 8th Circuit Court of Appeals both denied relief. According to the Associated Press, Gov. Jay Nixon denied clemency on Tuesday evening as well.
That left the conservative Justice Samuel Alito as his last hope. A stay was issued last night, about two hours before his scheduled execution at 12:01 a.m., though the stay did not specify the grounds for the temporary relief. The Court's website notes that both challenges were linked on the docket.
Compounded Drugs
As we saw with Warren Lee Hill, thanks to manufacturers' refusals to supply drugs for executions, states are increasingly and controversially turning to compounding pharmacies for execution drugs. And much like Georgia, Missouri refuses to disclose the name of the compounding pharmacy, arguing that the pharmacist is part of the execution team, and its name cannot be released to the public.
The issues with compounding pharmacies are numerous. For one, a mistake in manufacturing can mean a torturous end, and cruel and unusual punishment for a prisoner. These pharmacies produce custom orders of drugs and are not overseen by the Food and Drug Administration. Plus, according to The Associated Press, the state stores the drug at room temperatures, which can reduce the drug's potency.
continue to read here
Smulls' counsel, Cheryl Pilate, filed two last-minute challenges to his execution, after the U.S. District Court in Kansas City and the 8th Circuit Court of Appeals both denied relief. According to the Associated Press, Gov. Jay Nixon denied clemency on Tuesday evening as well.
That left the conservative Justice Samuel Alito as his last hope. A stay was issued last night, about two hours before his scheduled execution at 12:01 a.m., though the stay did not specify the grounds for the temporary relief. The Court's website notes that both challenges were linked on the docket.
Compounded Drugs
As we saw with Warren Lee Hill, thanks to manufacturers' refusals to supply drugs for executions, states are increasingly and controversially turning to compounding pharmacies for execution drugs. And much like Georgia, Missouri refuses to disclose the name of the compounding pharmacy, arguing that the pharmacist is part of the execution team, and its name cannot be released to the public.
The issues with compounding pharmacies are numerous. For one, a mistake in manufacturing can mean a torturous end, and cruel and unusual punishment for a prisoner. These pharmacies produce custom orders of drugs and are not overseen by the Food and Drug Administration. Plus, according to The Associated Press, the state stores the drug at room temperatures, which can reduce the drug's potency.
continue to read here
FDA Law Blog Industry Challenges Hydrocodone Combination Reclassification in Citizen Petition January 29, 2014
By Delia A. Deschaine –
Various members of industry recently joined together in filing a citizen petition with FDA. Citizen Petition, Docket No. FDA-2013-P-1711 (hereinafter “Citizen Petition”). The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. in October 2013 that FDA intends to issue a scientific and medical evaluation and recommendation that DEA reschedule all hydrocodone combination products from their current placement in Schedule III to Schedule II. The petitioners argue that reclassifying all combination hydrocodone products is inappropriate for myriad of public policy reasons. Thus they request that FDA instead recommend DEA reclassify only hydrocodone combination products that contain hydrocodone bitartrate in a strength of 5 mg or higher. Citizen Petition at 2. While the petition is brief, it touches on several critical points that FDA and DEA will likely consider in determining whether to move forward with the rescheduling.
Wednesday, January 29, 2014
FDA List of Registered Outsourcing Facilities under 503B is Growing--There are now 23 Compounding Pharmacies on the List
Registered Outsourcing Facilities
Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Updated as of 1/24/14
Firm Name
|
Date of Registration as an Outsourcing Facility1
|
End Date of Last FDA Inspection Related to Compounding2
|
Was a Form FDA-483 issued?3
|
Compounds Sterile Drugs From Bulk Drug Substances6
| |
Allergy Laboratories, Inc., Oklahoma City, OK
| 12/30/2013 | 4/26/2013 | Yes1 | Warning Letter - 9/4/20132 | Yes |
| Banner Health, Chandler, AZ | 12/26/2013 | Not yet inspected | N/A | N/A | No |
| Cantrell Drug Company, Litte Rock, AR | 12/16/2013 | 11/4/2013 | Yes3 | Open | Yes |
| Kings Park Slope, Inc., Brooklyn, NY | 12/23/2013 | Not yet inspected | N/A | N/A | Yes |
| KRS Global Biotechnology, Inc., Boca Raton, FL | 12/15/2013 | Not yet inspected | N/A | N/A | Yes |
| Marlborough Hospital, Marlborough, MA | 12/26/2013 | Not yet inspected | N/A | N/A | Yes |
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
|
12/17/2013
|
1/18/2013
|
Yes4
| Yes | |
PharMedium Services, LLC, Memphis, TN
|
12/11/2013
|
3/22/2013
|
Yes6
|
Open
| No |
PharMedium Services, LLC, Edison, NJ
|
12/11/2013
|
2/28/2013
|
Yes7
| Open | No |
PharMedium Services, LLC, Cleveland, MS
|
12/11/2013
|
2/22/2013
|
Yes8
| Open | No |
PharMedium Services, LLC, Sugarland, TX
|
12/11/2013
|
2/27/2013
|
Yes9
| Open | No |
| Region Care, Inc., Great Neck, NY | 12/24/2013 | Not yet inspected | N/A | N/A | Yes |
SCA Pharmaceuticals, Little Rock, AR
|
12/13/2013
|
Not yet inspected
| N/A | N/A | Yes |
| US Compounding, Inc., Conway, AR | 12/20/2013 | Not yet inspected | N/A | N/A | Yes |
Pharmagen Laboratories Inc., Stamford, CT
| 1/21/2014 | 8/23/2013 | Yes10 | Open | Yes |
JCB Laboratories, North Wichita, KS
| 1/21/2014 | 2/27/2013 | Yes11 | Open | Yes |
Pharmakon Pharmaceuticals, Inc., Carmel, IN
| 1/23/2014 | Not Yet Inspected | N/A | N/A | No |
Edge Pharmacy Services LLC, Colchester, VT
| 1/21/2014 | Not Yet Inspected | N/A | N/A | Yes |
Triangle Compounding Pharmacy Inc., Cary, NC
| 1/24/2014 | 3/1/2013 | Yes12 | Warning Letter - 1/14/201413 | Yes |
Infusion Options, Brooklyn, NY
| 1/24/2014 | Not Yet Inspected | N/A | N/A | No |
| Advanced Pharma, Inc., Houston, TX | 1/22/2014 | 5/3/2006 | No | No | No |
| Unique Pharmaceuticals, Ltd., Temple TX | 1/24/2014 | 5/19/2004 | No | No | Yes |
Supreme Court denies last-minute request to halt Missouri execution
Mary Beth Marklein, USA TODAY 7:12 p.m. EST January 29, 2014
The U.S. Supreme Court has denied last-minute requests to halt the execution of a Missouri man convicted of killing a local jeweler two decades ago.
The high court issued a temporary stay less than three hours before Herbert Smulls was scheduled to be executed at 12:01 a.m. Wednesday.
But the court lifted the stay without explanation late Wednesday afternoon, meaning the execution can move forward.
The ruling could signal how much information states must disclose regarding the drugs they use for lethal injections in death-penalty executions.
Witnesses to the execution were told to report to the Bonne Terre prison by noon Wednesday and await further instruction from the high court.
The execution had been scheduled for 12:01 a.m. Wednesday, but that changed late Tuesday night after his lawyer, Cheryl Pilate, made last-minute pleas to spare his life.
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The high court issued a temporary stay less than three hours before Herbert Smulls was scheduled to be executed at 12:01 a.m. Wednesday.
But the court lifted the stay without explanation late Wednesday afternoon, meaning the execution can move forward.
The ruling could signal how much information states must disclose regarding the drugs they use for lethal injections in death-penalty executions.
Witnesses to the execution were told to report to the Bonne Terre prison by noon Wednesday and await further instruction from the high court.
The execution had been scheduled for 12:01 a.m. Wednesday, but that changed late Tuesday night after his lawyer, Cheryl Pilate, made last-minute pleas to spare his life.
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U.S. Supreme Court denies convicted Missouri killer's appeals--Supreme Court Stay Has been Lifted
KANSAS CITY, Mo., Jan 29 (Reuters) - The U.S. Supreme Court on Wednesday lifted a temporary stay of execution for a Missouri man convicted of killing a jewelry store owner during a 1991 robbery, denying last-minute appeals that in part challenged the drug to be used.
But there was no immediate word on whether Herbert Smulls, 56, would be executed before a death warrant expires at midnight, thanks to another stay his lawyer said remained in effect at the Eighth Circuit U.S. Court of Appeals.
Smulls was convicted of shooting jewelry-store owner Stephen Honickman to death while robbing his store in July 1991. Honickman's wife, Florence Honickman, was also shot during the attack and sustained permanent injuries.
Lawyers for Smulls have sought to block his execution on multiple grounds, arguing in part that the compounded pentobarbital Missouri plans to use may not be pure and as potent as it should be and could cause undue suffering.
Missouri and several other states have turned to compounding pharmacies, which are not regulated by the U.S. Food and Drug Administration, to acquire drugs for executions after an increasing number of pharmaceutical manufacturers objected to their drugs being used in capital punishment.
The increasing use of compounded drugs and untested drug mixes has brought renewed debate over the death penalty in the United States.
In Oklahoma, an inmate said he felt burning through his body when the lethal drugs were injected during an execution in early January. Later in the month, an Ohio man gasped and convulsed during his execution with a two-drug mix never before used in the United States.
In the Smulls case, the Eighth Circuit found on Friday that his lawyers did not propose a feasible or more humane alternative than the compounded pentobarbital or show that Missouri sought to cause him unnecessary pain by using the drug.
The Eighth Circuit separately granted a stay until the U.S. Supreme Court decides whether to hear the case. Missouri on Wednesday night asked the Supreme Court to lift that appeals court stay and allow the execution to proceed.
The Supreme Court granted Smulls the temporary stay late Tuesday, hours before his execution was to be carried out, to consider his lawyer's arguments that prosecutors had improperly eliminated a black woman as a possible juror, leaving him with an all-white jury at trial.
On Wednesday afternoon, the Supreme Court vacated the temporary stay and denied the request for a stay or to hear the appeal on the jury selection issue.
If the execution is carried out, Smulls would be the sixth person executed in the United States in 2014 and the third in Missouri since November. (Reporting by Carey Gillam and Kevin Murphy in Kansas City, Lawrence Hurley in Washington and Heide Brandes in Oklahoma City; Writing by David Bailey; Editing by Cynthia Johnston, Prudence Crowther and Mohammad Zargham).
quoted from here
But there was no immediate word on whether Herbert Smulls, 56, would be executed before a death warrant expires at midnight, thanks to another stay his lawyer said remained in effect at the Eighth Circuit U.S. Court of Appeals.
Smulls was convicted of shooting jewelry-store owner Stephen Honickman to death while robbing his store in July 1991. Honickman's wife, Florence Honickman, was also shot during the attack and sustained permanent injuries.
Lawyers for Smulls have sought to block his execution on multiple grounds, arguing in part that the compounded pentobarbital Missouri plans to use may not be pure and as potent as it should be and could cause undue suffering.
Missouri and several other states have turned to compounding pharmacies, which are not regulated by the U.S. Food and Drug Administration, to acquire drugs for executions after an increasing number of pharmaceutical manufacturers objected to their drugs being used in capital punishment.
The increasing use of compounded drugs and untested drug mixes has brought renewed debate over the death penalty in the United States.
In Oklahoma, an inmate said he felt burning through his body when the lethal drugs were injected during an execution in early January. Later in the month, an Ohio man gasped and convulsed during his execution with a two-drug mix never before used in the United States.
In the Smulls case, the Eighth Circuit found on Friday that his lawyers did not propose a feasible or more humane alternative than the compounded pentobarbital or show that Missouri sought to cause him unnecessary pain by using the drug.
The Eighth Circuit separately granted a stay until the U.S. Supreme Court decides whether to hear the case. Missouri on Wednesday night asked the Supreme Court to lift that appeals court stay and allow the execution to proceed.
The Supreme Court granted Smulls the temporary stay late Tuesday, hours before his execution was to be carried out, to consider his lawyer's arguments that prosecutors had improperly eliminated a black woman as a possible juror, leaving him with an all-white jury at trial.
On Wednesday afternoon, the Supreme Court vacated the temporary stay and denied the request for a stay or to hear the appeal on the jury selection issue.
If the execution is carried out, Smulls would be the sixth person executed in the United States in 2014 and the third in Missouri since November. (Reporting by Carey Gillam and Kevin Murphy in Kansas City, Lawrence Hurley in Washington and Heide Brandes in Oklahoma City; Writing by David Bailey; Editing by Cynthia Johnston, Prudence Crowther and Mohammad Zargham).
quoted from here
AVMA Uniform horse-racing rules gaining momentum with 10 jurisdictions signing on to national reform
Uniform horse-racing rules gaining momentum
10 jurisdictions have signed on to national reforms
By Malinda Larkin
Posted Jan. 29, 2014
Odds are good that the horse-racing industry will implement its own uniform medication rules in the near future.
The National Thoroughbred Racing Association sent a letter dated Sept. 30, 2013, to pari-mutuel regulators for the 38 U.S. horse-racing commissions urging them to adopt uniform national reforms involving medication regulation and enforcement, including laboratory testing. The letter was co-signed by more than 50 racetrack and industry organization leaders. The American Association of Equine Practitioners signaled its support on Dec. 6, 2013.
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Clayton, Dubilier & Rice Completes Investment in PharMEDium Healthcare Corporation
PR Newswire
NEW YORK, Jan. 29, 2014
NEW YORK, Jan. 29, 2014 /PRNewswire/ -- Clayton, Dubilier & Rice ("CD&R") today announced the close of an investment in PharMEDium Healthcare Corporation ("PharMEDium" or the "Company"), the leading national provider of hospital pharmacy-outsourced sterile compounding services. Terms of the transaction were not disclosed.
PharMEDium's outsourced sterile compounding services are used by hospitals primarily to facilitate ready-to-use intravenous drug therapy to patients; it is one of the first companies to voluntarily register with the U.S. Food and Drug Administration's (FDA) as an Outsourcing Facility and to comply with guidelines under the newly created section 503B of the Drug Quality and Security Act. Using only FDA-approved drugs, diluents and containers, the Company creates compounded sterile preparations ("CSPs"), which are not otherwise commercially available in the marketplace. PharMEDium provides CSPs in ready-to-use presentation with enhanced safety, labeling, sterility and shelf life, typically exceeding what hospital pharmacies can produce themselves. The Company's CSPs are primarily used in: (i) intravenous pain management and anesthesia associated with surgical procedures and post-operative care, (ii) the intensive care unit (CSPs including analgesics, antibiotics, anticoagulants and electrolytes), and (iii) labor and delivery (epidurals and oxytocin).
Based in Lake Forest, Illinois, PharMEDium serves more than 2,600 acute-care hospitals, including integrated delivery systems, academic medical centers, hospital groups, and standalone urban, suburban and rural hospitals.
About Clayton, Dubilier & RiceFounded in 1978, Clayton, Dubilier & Rice is a private equity firm with an investment strategy predicated on producing financial returns through building stronger, more profitable businesses. Since inception, CD&R has managed the investment of $19 billion in 59 businesses representing a broad range of industries with an aggregate transaction value of approximately $90 billion. The Firm has offices in New York and London. For more information, please visit www.cdr-inc.com.
FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.
Compounding Warning Letter Format Unchanged Since Legislation
By Derrick Gingery / Email the Author / View Full Issue
Word Count: 828 / Article # 14140128005 / Posted: January 29 2014 5:00 PM
Word Count: 828 / Article # 14140128005 / Posted: January 29 2014 5:00 PM
Executive Summary
FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.
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Unique Pharmaceuticals Registers As Drug Outsourcing Facility Under The Drug Quality And Security Act
By Cyndi Root
Unique Pharmaceuticals, Ltd. (UPI) registered voluntarily with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility. The company announced the move in a press release last week. UPI is a pharmacy outsourcing facility for hospitals, medical clinics, and surgery centers in the U.S. UPI has been in the business for over 15 years and has certifications, accreditations, and quality assurance practices.
Travis A. Leeah, RPh, MBA, the President of UPI said, "At Unique Pharmaceuticals we have always been and will remain firmly committed to the quality and safety of our compounded preparations.” He said that the company works closely with regulators at federal and state levels. Leeah added that the company is committed to transparency and oversight as part of its mission to provide sterile and reliable medication to patients.
UPI sought the registration under the Drug Quality and Security Act, passed in late 2013. The company stated that passage of the Act helped bring definition to the compounding industry, as it includes FDA oversight. The Act (H.R. 3204) amends the Federal Food, Drug, and Cosmetic Act under Section 503B. It allows specific provisions for the human drug compounding and drug supply chain. Compounding facilities can voluntarily register, but can expect FDA inspections and strict requirements.
In a recent media briefing, the FDA explained some of its efforts and intended actions to enforce the new Act. The agency sent letters to hospitals urging them to do business with compounding facilities that are registered with the FDA. FDA Commissioner Margaret Hamburg, M.D. said, “Congress has worked to develop a framework that would enhance the security of the drug supply chain, so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.”
The Commissioner pointed out that last year, a compounding facility caused fungal meningitis in a contaminated product, sickening 750 people and killing 64 people. The New England Compounding Center in Framingham, Mass., shut down operations due to the tragedy.
Unique Pharmaceuticals, seeking to avoid the same fate, registered with the FDA and embraces oversight and accountability. Additionally, the company has invested in technological improvements like Chemunex ScanRDI, which can discover sterility issues and contamination as it identifies microorganisms down to the microbial cell.
Source:
http://www.upisolutions.com/upinews.php?id=18
Unique Pharmaceuticals, Ltd. (UPI) registered voluntarily with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility. The company announced the move in a press release last week. UPI is a pharmacy outsourcing facility for hospitals, medical clinics, and surgery centers in the U.S. UPI has been in the business for over 15 years and has certifications, accreditations, and quality assurance practices.
Travis A. Leeah, RPh, MBA, the President of UPI said, "At Unique Pharmaceuticals we have always been and will remain firmly committed to the quality and safety of our compounded preparations.” He said that the company works closely with regulators at federal and state levels. Leeah added that the company is committed to transparency and oversight as part of its mission to provide sterile and reliable medication to patients.
UPI sought the registration under the Drug Quality and Security Act, passed in late 2013. The company stated that passage of the Act helped bring definition to the compounding industry, as it includes FDA oversight. The Act (H.R. 3204) amends the Federal Food, Drug, and Cosmetic Act under Section 503B. It allows specific provisions for the human drug compounding and drug supply chain. Compounding facilities can voluntarily register, but can expect FDA inspections and strict requirements.
In a recent media briefing, the FDA explained some of its efforts and intended actions to enforce the new Act. The agency sent letters to hospitals urging them to do business with compounding facilities that are registered with the FDA. FDA Commissioner Margaret Hamburg, M.D. said, “Congress has worked to develop a framework that would enhance the security of the drug supply chain, so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.”
The Commissioner pointed out that last year, a compounding facility caused fungal meningitis in a contaminated product, sickening 750 people and killing 64 people. The New England Compounding Center in Framingham, Mass., shut down operations due to the tragedy.
Unique Pharmaceuticals, seeking to avoid the same fate, registered with the FDA and embraces oversight and accountability. Additionally, the company has invested in technological improvements like Chemunex ScanRDI, which can discover sterility issues and contamination as it identifies microorganisms down to the microbial cell.
Source:
http://www.upisolutions.com/upinews.php?id=18
Number of Publi Notifications from FDA of supplements with Hidden Drug Ingredients!!
What's New on the FDA Drugs Site
January 28, 2014
January 28, 2014
- Public Notification: JINQIANGBUDOR Red Dragon Contains Hidden Drug Ingredient
- Public Notification: Bali Mojo Contains Hidden Drug Ingredient
- Public Notification: Citrus Fit Gold Contains Hidden Drug Ingredient
- Public Notification: Tonic Life BP Contains Hidden Drug Ingredient
- Public Notification: Hot Detox Contains Hidden Drug Ingredient
- Public Notification: Thinogenics Contains Hidden Drug Ingredient
- Public Notification: Vimax Contains Hidden Drug Ingredient
- Public Notification: Tiger King Contains Hidden Drug Ingredient
- Public Notification: SexRx Contains Hidden Drug Ingredients
Corrective Action stated in recent FDA warning letters to compounding pharmacies is very informative about the FDA's future application of the DQSA.
C. Corrective Actions
In your response to the Form FDA 483 dated March 7, 2013, you referenced your purported compliance with United States Pharmacopeia (USP)-National Formulary (NF) General Chapter <797>, “Pharmaceutical Compounding - Sterile Preparations.” As noted above, your firm has manufactured and distributed drugs without valid prescriptions for individually-identified patients, and the manufacture of such drugs is subject to FDA’s drug CGMP regulations, 21 CFR Parts 210 and 211. Your firm’s planned corrections do not meet the minimum requirements of 21 CFR part 211, and there is no assurance that the drug product(s) produced by your firm without valid prescriptions for individually-identified patients conform to these basic quality standards that ensure safety, identity, strength, quality, and purity.
FDA strongly recommends that your management immediately undertake a comprehensive assessment of your manufacturing operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.
quoted from Warning Letter to Avella Deer Valley, Inc. 1/17/14. See also Warning Letter to Triangle Compound 1/14/14 for additional indications of the FDA's future application of the DQSA.
2013’s Top Pharmacies by Rx Revenues: The Big Get Bigger
Next week, Drug Channels Institute will release our updated and expanded 2013-14 Economic Report on Retail, Mail, and Specialty Pharmacies. Here's a sneak peek at 2013's top pharmacies.
The exhibit below, one of 98 in our new report, shows each company's market share of total U.S. prescription revenues for calendar year 2013. Highlights:
Here’s Exhibit 9 from the new report. Click here to download this chart as a PDF file.
continue to read here
The exhibit below, one of 98 in our new report, shows each company's market share of total U.S. prescription revenues for calendar year 2013. Highlights:
- The top five dispensing pharmacies—CVS Caremark, Walgreens, Express Scripts, Rite Aid, and Walmart—accounted for about 65% of U.S. prescription dispensing revenues in 2013.
- Market share concentration in 2013 was slightly greater than that of 2012.
- We project total 2013 retail, mail, and specialty pharmacy revenues of $287.0 billion, up 1.6% from 2012.
Here’s Exhibit 9 from the new report. Click here to download this chart as a PDF file.
continue to read here
More Information on Imprimis Pharmaceuticals formerly known as Transdel Pharmaceuticals, Inc.
Imprimis Pharmaceuticals, Inc. operates as a specialty pharmaceutical company focusing on the commercial development of compounded drug formulations. The company, through a strategic relationship with Professional Compounding Centers of America, Inc., expects to use its proprietary Accudel drug delivery technology, coupled with licensed technologies, and proprietary formulations and market data, to facilitate its future selection, formulation, and development of potential product candidates. The company is also internally developing non-invasive, topically delivered products. Its patented Accudel cream formulation technology is designed to enable highly targeted site-specific treatment. The companys lead Phase III pain product candidate, Impracor, utilizes the Accudel platform technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug, through the skin directly into the underlying tissues where the drug exerts its localized anti-inflammatory and analgesic effects. It intends to leverage the Accudel platform technology to expand and create a portfolio of topical products for various indications. The company was formerly known as Transdel Pharmaceuticals, Inc. and changed its name to Imprimis Pharmaceuticals, Inc. in February 2012. Imprimis Pharmaceuticals, Inc. was founded in 1998 and is headquartered in San Diego, California.
read here
read here
Breaking News! Very Important! United States Supreme Court orders stay of execution in case involving compounded preparations!! Justice Alito signs order
January 28, 2014 5:58PM ET
Missouri may be breaking its own laws to procure lethal injection drug, according to legal rights charity
The Supreme Court granted a temporary stay of execution for Missouri death row inmate Herbert Smulls Tuesday night.
Justice Samuel Alito signed the order that was sent out after President Barack Obama's State of the Union speech, about two-and-a-half hours before Smulls was scheduled to die at 12:01 a.m. Wednesday.
Smulls' lawyer, Cheryl Pilate, had made last-minute pleas Tuesday to spare his life, focusing on the state's refusal to disclose from which compounding pharmacy they obtained the lethal-injection drug, pentobarbital. Missouri has argued the compounding pharmacy is part of the execution team — and therefore its name cannot be released to the public.
Smull's attorney said that makes it impossible for Smulls' advocates to know whether the drug could cause pain and suffering.
Pilate said that she used open records requests and publicly available documents to determine the name of the compounding pharmacy she believes manufactures Missouri's lethal injection drug.
Pilate told The Associated Press on Tuesday that her research indicates the drug is made by The Apothecary Shoppe, based in Tulsa, Okla.
Smulls, 56, was convicted and sentenced to death for killing a St. Louis County jeweler and badly injuring his wife during a 1991 robbery.
Pilate says the stay is temporary while the high court reviews the case, but she is hopeful the stay will become permanent.
"We're happy to get the stay and we're glad the court is reviewing it," she said.
Maya Foa of the legal rights charity Reprieve told Al Jazeera that crossing state lines to procure a lethal injection drug may be unlawful because the pharmacy is unlicensed in Missouri to dispense or distribute controlled substances.
"You see states like Missouri becoming more and more underhanded and shady in procuring these drugs, which is dangerous and raises serious constitutional concerns," Foa said.
Just as troubling, she said, is that Apothecary is the same pharmacy that is attempting to supply a number of other states with lethal injection drugs. "That’s not the job of a compounding pharmacy," she said. "We're seeing traditional compounding pharmacies now entering the domain of the execution drug industry. That's troubling and raises serious legal concerns."
A spokeswoman for The Apothecary Shoppe on Tuesday would neither confirm nor deny providing the drug.
The prospect of being put to death with a drug whose origin remains sealed "terrifies" Smulls, his attorney said. Pilate also said her client changed in prison, becoming a man who gets along well with other inmates and guards and who has learned to write despite a low level of intelligence.
"I frankly cannot begin to tell you how distressing this situation is, that the state is going to execute a prisoner in his mid-50s who made one series of colossal mistakes that were in many ways out of character, because he is not a violent person," Pilate said.
St. Louis County prosecutor Bob McCulloch said talk about the drug is a smoke screen aimed at sparing the life of a cold-blooded killer. He noted that several courts have already ruled against Smulls, including U.S. District Court in Kansas City and the 8th U.S. Circuit Court of Appeals. Gov. Jay Nixon denied clemency Tuesday evening.
"It was a horrific crime," McCulloch said. "With all the other arguments that the opponents of the death penalty are making, it's simply to try to divert the attention from what this guy did and why he deserves to be executed."
Justice Samuel Alito signed the order that was sent out after President Barack Obama's State of the Union speech, about two-and-a-half hours before Smulls was scheduled to die at 12:01 a.m. Wednesday.
Smulls' lawyer, Cheryl Pilate, had made last-minute pleas Tuesday to spare his life, focusing on the state's refusal to disclose from which compounding pharmacy they obtained the lethal-injection drug, pentobarbital. Missouri has argued the compounding pharmacy is part of the execution team — and therefore its name cannot be released to the public.
Smull's attorney said that makes it impossible for Smulls' advocates to know whether the drug could cause pain and suffering.
Pilate said that she used open records requests and publicly available documents to determine the name of the compounding pharmacy she believes manufactures Missouri's lethal injection drug.
Pilate told The Associated Press on Tuesday that her research indicates the drug is made by The Apothecary Shoppe, based in Tulsa, Okla.
Smulls, 56, was convicted and sentenced to death for killing a St. Louis County jeweler and badly injuring his wife during a 1991 robbery.
Pilate says the stay is temporary while the high court reviews the case, but she is hopeful the stay will become permanent.
"We're happy to get the stay and we're glad the court is reviewing it," she said.
Maya Foa of the legal rights charity Reprieve told Al Jazeera that crossing state lines to procure a lethal injection drug may be unlawful because the pharmacy is unlicensed in Missouri to dispense or distribute controlled substances.
"You see states like Missouri becoming more and more underhanded and shady in procuring these drugs, which is dangerous and raises serious constitutional concerns," Foa said.
Just as troubling, she said, is that Apothecary is the same pharmacy that is attempting to supply a number of other states with lethal injection drugs. "That’s not the job of a compounding pharmacy," she said. "We're seeing traditional compounding pharmacies now entering the domain of the execution drug industry. That's troubling and raises serious legal concerns."
A spokeswoman for The Apothecary Shoppe on Tuesday would neither confirm nor deny providing the drug.
The prospect of being put to death with a drug whose origin remains sealed "terrifies" Smulls, his attorney said. Pilate also said her client changed in prison, becoming a man who gets along well with other inmates and guards and who has learned to write despite a low level of intelligence.
"I frankly cannot begin to tell you how distressing this situation is, that the state is going to execute a prisoner in his mid-50s who made one series of colossal mistakes that were in many ways out of character, because he is not a violent person," Pilate said.
St. Louis County prosecutor Bob McCulloch said talk about the drug is a smoke screen aimed at sparing the life of a cold-blooded killer. He noted that several courts have already ruled against Smulls, including U.S. District Court in Kansas City and the 8th U.S. Circuit Court of Appeals. Gov. Jay Nixon denied clemency Tuesday evening.
"It was a horrific crime," McCulloch said. "With all the other arguments that the opponents of the death penalty are making, it's simply to try to divert the attention from what this guy did and why he deserves to be executed."
Eighth circuit weighs in
The Supreme Court's decision comes just three days after the Eighth Circuit Court of Appeals ruled that states have no obligation to release material information about execution drugs unless death row inmates can show that "a readily available alternative method of execution" exists that would significantly reduce a substantial risk of severe pain. Only in those circumstances can a state’s refusal to change its method be viewed as "cruel and unusual punishment" under the Eighth Amendment.
Richard Dieter, executive director at the Death Penalty Information Center, told Al Jazeera that the ruling's circular logic makes it difficult for inmates, because they can't learn the basic information about the drug necessary to mount a challenge. "It's very difficult for lawyers to come up with an alternative if they don't know what's happening in the first place."
The Associated Press. Amel Ahmed contributed to this report.
quoted from here
Richard Dieter, executive director at the Death Penalty Information Center, told Al Jazeera that the ruling's circular logic makes it difficult for inmates, because they can't learn the basic information about the drug necessary to mount a challenge. "It's very difficult for lawyers to come up with an alternative if they don't know what's happening in the first place."
The Associated Press. Amel Ahmed contributed to this report.
quoted from here
FDA Law Blog Reminder from Tenth Circuit Regarding Making False Statements to the Government
Tenth Circuit Affirms False Statement Conviction: Lesson Learned
By Anne K. Walsh –
While the mid-Atlantic region was paralyzed under 4 to 8 inches of snow, it was business as usual for the Tenth Circuit Court of Appeals in Colorado. On January 21, 2014, the court issued an opinion affirming the felony conviction of John Schulte, former CEO of The Spectranetics Corporation, for making a false statement to the government.
The woes of the company date back to 2008, when a former employee alleged that it was marketing unapproved devices brought into the country illegally. The company’s Board of Directors ordered an internal investigation, but the investigation did not result in any finding of wrongdoing. Later that year, the government learned of the same allegations brought to the Board, and quickly executed a search warrant. It was during this search that Schulte voluntarily agreed to provide an interview to federal law enforcement agents. The statements he made during that interview five and a half years ago continue to haunt him today.
As readers may recall (see our previous post here), the company entered into a settlement with the government in 2009 in which it agreed to pay a $5 million civil penalty. The government decided not to criminally prosecute the company, and instead allowed the company to enter into a non-prosecution agreement that required cooperation in the government’s ongoing criminal investigation of certain individuals, including Schulte.
In 2010, the government indicted Schulte on twelve separate counts, but after a four-week jury trial in 2012, a jury acquitted him of all but one of those counts: making false statements under 18 U.S.C. § 1001. The court’s sentence was lenient, requiring only one year of probation, a $5000 fine, and 100 hours of community service. (The court rejected the government’s sentencing request for two years of prison and three years of probation.)
continue to read here
While the mid-Atlantic region was paralyzed under 4 to 8 inches of snow, it was business as usual for the Tenth Circuit Court of Appeals in Colorado. On January 21, 2014, the court issued an opinion affirming the felony conviction of John Schulte, former CEO of The Spectranetics Corporation, for making a false statement to the government.
The woes of the company date back to 2008, when a former employee alleged that it was marketing unapproved devices brought into the country illegally. The company’s Board of Directors ordered an internal investigation, but the investigation did not result in any finding of wrongdoing. Later that year, the government learned of the same allegations brought to the Board, and quickly executed a search warrant. It was during this search that Schulte voluntarily agreed to provide an interview to federal law enforcement agents. The statements he made during that interview five and a half years ago continue to haunt him today.
As readers may recall (see our previous post here), the company entered into a settlement with the government in 2009 in which it agreed to pay a $5 million civil penalty. The government decided not to criminally prosecute the company, and instead allowed the company to enter into a non-prosecution agreement that required cooperation in the government’s ongoing criminal investigation of certain individuals, including Schulte.
In 2010, the government indicted Schulte on twelve separate counts, but after a four-week jury trial in 2012, a jury acquitted him of all but one of those counts: making false statements under 18 U.S.C. § 1001. The court’s sentence was lenient, requiring only one year of probation, a $5000 fine, and 100 hours of community service. (The court rejected the government’s sentencing request for two years of prison and three years of probation.)
continue to read here
FDA LAW Blog: FDA Sends Two Warning Letters Regarding Medical Food
January 28, 2014
Increase in Enforcement Actions against Medical Foods; FDA Sends Two Warning Letters
By Riëtte van Laack –
On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease,” whereas NVN Therapeutics markets GlucoreinTM PCOS as a medical food for the “dietary management of Polycystic Ovarian Syndrome ("PCOS") by reducing the incidence of metabolic syndrome and insulin resistance.” FDA alleges that these products are misbranded as medical foods because, according to FDA, there are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer’s disease and for PCOS.
continue to read here
On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease,” whereas NVN Therapeutics markets GlucoreinTM PCOS as a medical food for the “dietary management of Polycystic Ovarian Syndrome ("PCOS") by reducing the incidence of metabolic syndrome and insulin resistance.” FDA alleges that these products are misbranded as medical foods because, according to FDA, there are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer’s disease and for PCOS.
continue to read here
Tuesday, January 28, 2014
Ranbaxy has had so much regulatory action by FDA it has its own FDA page--
Regulatory Action Against Ranbaxy
Consent Decree for Toansa, India, Facility
- FDA Press Release1: FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market (1/23/2014)
- FDA Form 483 (PDF - 8.44MB)2 (1/11/2014)
Import Alert and Consent Decree for Mohali, India, Facility
- FDA Press Release3: FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert (9/16/2013)
- FDA Form 483 (PDF – 2MB)4 (9/11/2012)
- FDA Form 483 (PDF – 785KB)5 (12/7/2012)
- DOJ News Release6: Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, CGMP Violations and False Statements to the FDA (5/13/2013)
Consent Decree for Paonta Sahib, Batamandi, and Dewas, India, Facilities and Ohm Laboratories in Gloversville, N.Y.
- FDA News Release7: Department of Justice files consent decree of permanent injunction against Ranbaxy (1/25/2012)
Application Integrity Policy Action for Paonta Sahib, India, Facility
- FDA AIP Letter to Ranbaxy Laboratories8 (updated 3/2/2009)
- FDA News Release9: FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India (2/25/2009)
Import Alert for Dewas and Paonta Sahib, India, Facilities
- FDA News Release11: FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India (9/16/2008)
- List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd. 12
- Questions and Answers 13
- Warning Letter Dewas, India 14
- Warning Letter Batamandi (Unit II), in Paonta Sahib, India 15
Additional Warning Letters
- Ohm Laboratories, Inc.16 (12/21/2009)
- Paonta Sahib, India17 (6/15/2006)
- Princeton, NJ18 (10/11/2002)
Report: FDA Turning a Blind Eye to Growing Superbug Threat
A new report from the NRDC claims that the FDA effectively turned a blind eye to the risks associated with antibiotics it approved for agricultural use. These antibiotics were allowed to be used in livestock despite posing a “high risk” to human antibiotic resistance.
According to the NRDC these drugs were allowed to remain on the market as additives in animal feed and water “despite an internal review that raised significant red flags…” and allowing the drugs to be distributed “likely exposed humans to antibiotic resistant bacteria through the food supply.”
Beyond this, 30 antibiotics, currently in use, would not be likely to gain FDA approval under current FDA guidelines, as “drugmakers have not submitted sufficient information to establish their safety.
“This discovery is disturbing but not surprising given the FDA’s poor track record with dealing this issue. It’s just more overwhelming evidence that FDA – In the face of a mounting antibiotic resistance health crisis – is turning a blind eye to industry’s misuse of these miracle drugs,” said Carmen Cordova, NRDC microbiologist and lead author of the new NRDC analysis.
quoted from here
Urine spills stain Wockhardt’s image during FDA inspection
Mumbai: The Wockhardt Ltd plant that makes copies of a popular heart pill sold in the US turns out to be a jumble of dilapidated buildings with blighted windows connected by flaking pipes and capped by a rusty roof.
When US Food and Drug Administration (FDA) inspectors visited the factory that produces generic copies of the heart tablet Toprol-XL in July, they found urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area. They summarized their findings in a filing obtained by Bloomberg via a Freedom of Information Act request.
The document, known as an FDA Form 483, listed 16 so-called observations about Wockhardt’s factory in Chikalthana, 200 miles east of Mumbai, including concerns about quality control. While the FDA isn’t commenting on the possibility of enforcement action, such forms can be a prelude to export restrictions. A typical one contains only four to eight entries, said John Avellanet, managing director of Cerulean Associates Llc, an FDA compliance consultancy in Williamsburg, Virginia.
“This is very serious,” Avellanet said in an e-mail after reviewing the document. “Think of it as a giant vote of ‘no confidence’ from the FDA.”
As US regulators step up inspections, they’re finding more examples like Wockardt’s. The FDA has filed reports on four Indian facilities in the past six months and curbed exports at two drugmakers, including Ranbaxy Laboratories Ltd, the country’s largest. The findings highlight the contrast between immaculate headquarters like Wockhardt’s in Mumbai and working conditions at remote locations in India, where one-fifth of the world’s generics are made.
continue to read here
Ranbaxy's repeat violation elicits swift FDA action--API Cut Off From US
Its key API plant is cut off from the U.S., joining three banned drug formulation plants
January 27, 2014 | By Eric Palmer
Read more: Ranbaxy's repeat violation elicits swift FDA action - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/ranbaxys-repeat-violation-elicits-swift-fda-action/2014-01-27#ixzz2rkhuimOp
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