As we are seeing there are issues on the front end of compounding with the bulk powders, issues with the actual compounding (sterility and potency) and now with the testing laboratories with blurred or no lines as to who oversees what it. Compounding pharmacists who feared what federal regulation would do to their business now have far greater concerns-lack of trust by the public, liability issues, etc. with potential federal regulation being the least of the worries and potentially a blessing to the good compounders doing it right. With these overwhelming and out-of-control issues in the compounding world, Congress would be doing a grave injustice to the American people if it does not pass some form of federal legislation.
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
Wednesday, August 28, 2013
Question of the Day August 28, 2013 In light of the issues at Front Range Laboratories Inc. and the estimate that it tested compounds for 100 compounding pharmacies in 32 states will Congress act quickly in September to help give the FDA the much needed resources to get this enormous problem with compounding preparations under control?
We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds
on August 27, 2013
The expected backlash to attempts by the FDA to crackdown on compounding pharmacies has begun, threatening public safety.
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.
continue to read here
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.
continue to read here
Tuesday, August 27, 2013
URGENT AND IMPORTANT!! Sterility Concerns at Three More Pharmacies Prompt Recalls
Three more compounding pharmacies are recalling products due to concerns that some of their products may not be sterile, the US Food and Drug Administration (FDA) has announced.
Front Range Laboratories, in Loveland, Colorado, are at the center of 2 of the recalls.
On Monday, JCB Laboratories recalled 6 lots of sterile drug products to the user level because of concerns about sterility assurance following a recent FDA inspection of Front Range Labs, one of the contract testing labs used by JCB. The products, lot numbers and expiration dates are:
Product | Lot # (expiration date) |
Sodium thiosulfate 25% (250 mg/mL) |
130701@9 (12/28/13)
130709@6 (1/5/14)
130717@2 (1/13/14)
|
Sodium citrate 4% solution injection, 30 mL multiple-dose vial | 130710@4 (1/6/14) |
Sodium citrate 4% w/gentamicin, 320 mcg/mL multiple-dose vial | 130620@2 (12/17/13) |
Acetylcysteine, 20% solution for inhalation, 4 mL single-dose vials | 130627@5 (8/26/13) |
The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8 through August 20, 2013.
After an inspection of Front Range Labs, the FDA issued an alert to pharmacies on August 21 stating that "the methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."
"Out of an abundance of caution, JCB has discontinued its relationship with Front Range and is now testing products at a different laboratory," the company said.
JCB has not received any reports of adverse events related to this recall to date, the company said. However, if there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
JCB is notifying its customers by telephone, email, fax, and mail. To return product or request assistance related to this recall, users should contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8 AM. and 5 PM CDT.
Similar Concerns at Second Pharmacy
Concerns at Front Range Labs has also prompted Wellness Pharmacy, Inc, in Birmingham, Alabama, to recall 6 products. They are:
Product | Lot # | Expiration date |
dexpanthenol 250 mg/mL | 130605@52 | 12/2/2013 |
magnesium sulfate 50% | 130613@38 | 12/10/2013 |
methylcobalamin 1 mg/mL | 130612@49 |
12/9/2013
10/19/2013
|
sodium phenylbutyrate 200 mg/mL SDV PF | 130621@28 | 10/19/2013 |
R.L. | 130710@27 | 1/6/2014 |
ascorbic acid (cassava) 500 mg/mL PF SUV | 130711@13 | 1/7/2014 |
The recalled medications were distributed to individual patients and to physician offices nationwide. These liquid medications are in either clear or amber sterile vials ranging in size from 1 mL to 50 mL, the company said. The medications can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size.
Wellness Pharmacy is notifying its customers by telephone and regular mail of this recall. "Patients andphysicians should immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy," the company advises.
To return medication or request assistance related to this recall, patients and physicians should contact Wellness Pharmacy at 205-879-6551 or 800-227-2627, Monday through Friday, between 9 AM and 4 PM CDT.
Testing Issues at Third Pharmacy
On Friday, Park Pharmacy & Compounding, in Irvine, California voluntarily recalled to the consumer level 2 lots of methylcobalamin 5 mg/mL 30 mL amber vials with lot # 06132013@1 and an expiration date of 12/10/2013.
The company also recalled multitrace-5 concentrate 10 mL amber vials for injection with lot # 05212013@20 and an expiration date of 11/17/2013, to the consumer level.
This recall was also prompted by a recent FDA inspection of the laboratory used by this pharmacy, although the laboratory was not named in the company release posted on the FDA Web site.
The prescription preparations were sold during June and July of 2013, in California, Florida, New Mexico, and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).
"To date there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products. We are voluntarily recalling the products as a precautionary measure for the safety of our patients," the company said.
Park Pharmacy & Compounding is notifying its customers by phone and mail and is arranging for return of all recalled product lots. Customers with product being recalled should stop using it and contact Park Pharmacy & Compounding to arrange for return of the unused product. Customers with questions regarding this recall can contact Park Pharmacy & Compounding at 949-551-7195 Monday through Friday, 9 AM to 5 PM PST, or at info@parkrx.com.
Thomas J. Henry Injury Attorneys Investigating 10 deaths linked to IV drugs from Specialty Compounding, LLC National Law Firm Now Representing 59 Individuals Potentially Affected by Tainted IV Meds
CORPUS CHRISTI, TX (August 27, 2013)Thomas J. Henry Injury Attorneys is currently representing 59 individuals and investigating 10 deaths in individuals who may have been exposed to tainted IV drugs at Corpus Christi Medical Center Bay Area and Corpus Christi Medical Center Doctors Regional hospitals.
The calcium gluconate IV medications, which are believed to be tainted by rhodococcus equi bacterium, were recalled by Specialty Compounding, LLC on August 9, 2013.
As more and more victims come forward, the firm continues to uncover new information regarding the infections
“We have seen a tremendous number of people come forward, concerned about their safety and the safety of their loved ones,” lead attorney Thomas J. Henry said. “We are working diligently to get to the truth of how institutional errors resulted in so many patients being affected.”
—10 Deaths Linked to Calcium Gluconate—
The firm is currently investigating 10 deaths in hospital patients who may have received calcium gluconate IV injections manufactured by Specialty Compounding, LLC. The individuals were patients of Corpus Christi Medical Center Bay Area or Corpus Christi Medical Center Doctors Regional hospitals.
While initial investigations into the IV infections centered primarily on Specialty Compounding, LLC, the rise in number of severe injury and death claims has required the firm to broaden its focus to encompass any and all entities with a duty to protect patients from defective or tainted drugs.
“These deaths put a greater focus on the hospitals. What the hospitals could or should have done to protect patients and what they should have known about the products they were putting in their patients’ bodies. It also raises questions regarding the timeline of events…specifically when the hospitals suspected a problem and how long it took them to inform patients and the public,” Henry said.
According to a letter sent to several firm clients by Corpus Christi Medical Center, patients at risk for infection from calcium gluconate (produced by Specialty Compounding, LLC) were notified in writing by the hospital onAugust 15, 2013. This was 6 days after Specialty Compounding, LLC issued a nationwide recall on the medication, citing infections at Corpus Christi Medical Center hospitals
“Six days is too long to wait when patients are at risk for serious injury and death,” Henry stated.
—Corpus Christi Medical Center Sends out Letter to Patients—
Click Here to view CCMC Letter to Patients
The letter sent to several of the firm’s clients on August 15, 2013 alerts patients to the possibility that they received an IV solution that has been linked to infections.
The letter warns about unexplained fever and the possibility of infection but makes no mention of Specialty Compounding, LLC, calcium gluconate, the nationwide drug recall, or rhodococcus equi. It also fails to mention the 15 infections reported to the FDA, the severity of reported injuries, or risk of death.
“The ambiguous language leaves many questions unanswered- namely, when the hospital knew about possible infections and how long it took them to relay that information to potentially affected patients,” Henry said. “The answers to these questions and the overall resolution of the case will be important not only to our current clients, but to the safety of future patients as well.”
The letter reads:
“We are writing to let you know that during your recent stay at Corpus Christi Medical Center you may have received an IV solution purchased from a regional pharmacy that isbelieved to have caused some patients to get an infection…”
By this time, both Specialty Compounding, LLC and the U.S. Food and Drug Administration had announced nationwide recalls on the IV solution, citing 15 infections. In their own recall, Specialty Compounding stated “The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area.”
The letter goes on to read:
“…as soon as we became awareof this issue we immediately stopped using this product and all products purchased from this company…”
This raises several questions, including:
Ø When exactly did Corpus Christi Medical Center become “aware” of the “issue?”
Ø Was it on August 9, 2013, when Specialty Compounding recalled the medication citing infections at Corpus Christi Medical Center hospitals?
Ø Or was it prior to that, when a lab technician at Corpus Christi Medical Center discovered rhodococcus equi in patients who had been treated with the IV meds?
What is clear is that Corpus Christi Medical Center did not send out letters informing patients until August 15, 2013.
The letter further states:
“…effects, if any, from this IV solution are usually immediate, so it is unlikely you will have any symptoms, such as unexplained fever, if it has not happened by this time.”
Many families affected simply find themselves asking more questions.
—Incident Spurs Nationwide Recall on IV Drugs—
The injuries reported in Corpus Christi, Texas led to a nationwide recall on all unexpired sterile products from Specialty Compounding, LLC, a compounding pharmacy located in Cedar Park, Texas.
According to the Voluntary Recall Notice issued by Specialty Compounding, LLC:
“Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to individuals located nationwide with the exception of North Carolina.”
—Firm Files TRO, Obtains Temporary Injunction—
Click Here to view the latest Temporary Restraining Order filed by Thomas J. Henry Injury Attorneys
The firm filed two Temporary Restraining Orders (TROs) against Specialty Compounding, LLC in order to preserve evidence related to the cases. The first TRO was filed on August 14, 2013 (Cause No. 2013-CCV-61504-2, Nueces County Court at Law No. 2). A second TRO (Cause No. 2013-CCV-61520-2, Nueces County Court at Law No. 2) was filed August 16, 2013 to include several more individuals potentially affected by the recalled IV drugs from Specialty Compounding, LLC.
Click Here to view the Temporary Injunction Order
On August 26, 2013, Thomas J. Henry Injury Attorneys obtained a Temporary Injunction Order, requiring Specialty Compounding, LLC to preserve evidence relating to the cases until trial, which is anticipated to occur in early 2014.
###
The calcium gluconate IV medications, which are believed to be tainted by rhodococcus equi bacterium, were recalled by Specialty Compounding, LLC on August 9, 2013.
As more and more victims come forward, the firm continues to uncover new information regarding the infections
“We have seen a tremendous number of people come forward, concerned about their safety and the safety of their loved ones,” lead attorney Thomas J. Henry said. “We are working diligently to get to the truth of how institutional errors resulted in so many patients being affected.”
—10 Deaths Linked to Calcium Gluconate—
The firm is currently investigating 10 deaths in hospital patients who may have received calcium gluconate IV injections manufactured by Specialty Compounding, LLC. The individuals were patients of Corpus Christi Medical Center Bay Area or Corpus Christi Medical Center Doctors Regional hospitals.
While initial investigations into the IV infections centered primarily on Specialty Compounding, LLC, the rise in number of severe injury and death claims has required the firm to broaden its focus to encompass any and all entities with a duty to protect patients from defective or tainted drugs.
“These deaths put a greater focus on the hospitals. What the hospitals could or should have done to protect patients and what they should have known about the products they were putting in their patients’ bodies. It also raises questions regarding the timeline of events…specifically when the hospitals suspected a problem and how long it took them to inform patients and the public,” Henry said.
According to a letter sent to several firm clients by Corpus Christi Medical Center, patients at risk for infection from calcium gluconate (produced by Specialty Compounding, LLC) were notified in writing by the hospital onAugust 15, 2013. This was 6 days after Specialty Compounding, LLC issued a nationwide recall on the medication, citing infections at Corpus Christi Medical Center hospitals
“Six days is too long to wait when patients are at risk for serious injury and death,” Henry stated.
—Corpus Christi Medical Center Sends out Letter to Patients—
Click Here to view CCMC Letter to Patients
The letter sent to several of the firm’s clients on August 15, 2013 alerts patients to the possibility that they received an IV solution that has been linked to infections.
The letter warns about unexplained fever and the possibility of infection but makes no mention of Specialty Compounding, LLC, calcium gluconate, the nationwide drug recall, or rhodococcus equi. It also fails to mention the 15 infections reported to the FDA, the severity of reported injuries, or risk of death.
“The ambiguous language leaves many questions unanswered- namely, when the hospital knew about possible infections and how long it took them to relay that information to potentially affected patients,” Henry said. “The answers to these questions and the overall resolution of the case will be important not only to our current clients, but to the safety of future patients as well.”
The letter reads:
“We are writing to let you know that during your recent stay at Corpus Christi Medical Center you may have received an IV solution purchased from a regional pharmacy that isbelieved to have caused some patients to get an infection…”
By this time, both Specialty Compounding, LLC and the U.S. Food and Drug Administration had announced nationwide recalls on the IV solution, citing 15 infections. In their own recall, Specialty Compounding stated “The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area.”
The letter goes on to read:
“…as soon as we became awareof this issue we immediately stopped using this product and all products purchased from this company…”
This raises several questions, including:
Ø When exactly did Corpus Christi Medical Center become “aware” of the “issue?”
Ø Was it on August 9, 2013, when Specialty Compounding recalled the medication citing infections at Corpus Christi Medical Center hospitals?
Ø Or was it prior to that, when a lab technician at Corpus Christi Medical Center discovered rhodococcus equi in patients who had been treated with the IV meds?
What is clear is that Corpus Christi Medical Center did not send out letters informing patients until August 15, 2013.
The letter further states:
“…effects, if any, from this IV solution are usually immediate, so it is unlikely you will have any symptoms, such as unexplained fever, if it has not happened by this time.”
Many families affected simply find themselves asking more questions.
—Incident Spurs Nationwide Recall on IV Drugs—
The injuries reported in Corpus Christi, Texas led to a nationwide recall on all unexpired sterile products from Specialty Compounding, LLC, a compounding pharmacy located in Cedar Park, Texas.
According to the Voluntary Recall Notice issued by Specialty Compounding, LLC:
“Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to individuals located nationwide with the exception of North Carolina.”
—Firm Files TRO, Obtains Temporary Injunction—
Click Here to view the latest Temporary Restraining Order filed by Thomas J. Henry Injury Attorneys
The firm filed two Temporary Restraining Orders (TROs) against Specialty Compounding, LLC in order to preserve evidence related to the cases. The first TRO was filed on August 14, 2013 (Cause No. 2013-CCV-61504-2, Nueces County Court at Law No. 2). A second TRO (Cause No. 2013-CCV-61520-2, Nueces County Court at Law No. 2) was filed August 16, 2013 to include several more individuals potentially affected by the recalled IV drugs from Specialty Compounding, LLC.
Click Here to view the Temporary Injunction Order
On August 26, 2013, Thomas J. Henry Injury Attorneys obtained a Temporary Injunction Order, requiring Specialty Compounding, LLC to preserve evidence relating to the cases until trial, which is anticipated to occur in early 2014.
###
Proposed Law to Regulate Out-Of-State Compounding Pharmacies in California Introduced
August 27, 2013
A bill introduced in the California State Legislature is proposing that pharmacies that sell sterile compounded drugs in the state must meet stricter standards. This proposed legislation comes in the wake of a nationwide fungal meningitis outbreak in 2012 caused by tainted epidural steroid injections manufactured by a Massachusetts-based compounding pharmacy. Some 14,000 patients received injections of the drug, 700 became ill and 63 died.
In reaction to that and several other high-profile incidents concerning compounding pharmacies, the California State Board of Pharmacy threw its weight behind Senate Bill 294, which was introduced by State Sen. Bill Emmerson (R-Redlands). The bill would tighten oversight of compounding pharmacies to “ensure patient safety.” It passed the Senate in May and will now go before the Assembly Appropriations Committee.
The bill would require out-of-state pharmacies that sell or distribute sterile compounded drugs in California to meet the same standards as compounding facilities in California. The legislation would also require that out-of-state compounding pharmacies be subject to annual inspections and that they obtain a license to do business in the state. Those inspections would run about $780 per visit.
“I have introduced SB 294 to strengthen consumer protection and provide consistent oversight of pharmacies that ship or dispense sterile drug products in California so we can do everything we can to prevent another patient injury or death,” Emmerson said.
While some compounding pharmacy owners have lauded the proposed legislation, others have stated that stricter regulations would cause a shortage of sterile medications in California. This would ultimately make sterile compounded drugs more expensive.
continue to read here
NuVision's Response to FDA's Warning Letter August 26, 2013
FDA Response
FDA Response
26AUG
NuVision Pharmacy is a specialty compounding pharmacy committed to patient safety. We adhere to the USP <797>, which is the professional and legal standard for all sterile compounding pharmacies. We follow all state and federal pharmacy laws and our pharmacy license is in good standing with the Texas State Board of Pharmacy.
In response to the warning letter issued by the FDA about our sterile products, we would like to take this opportunity to set the record straight and address their accusations.
There is no evidence to support the FDA’s claim that our products lack sterility assurance. We have sterility tests performed on every lot of sterile products we dispense. We maintain test results documenting a passing sterility test for every product sold by our pharmacy and there is no evidence of any sterile product dispensed by our pharmacy being contaminated.
The FDA did not receive reports about fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product. This is information we voluntarily provided to the FDA. The FDA inspectors had no knowledge of this incident prior to our disclosure. The symptoms were experienced by three individuals and were related to the use of one vial.
Before the FDA was even aware of this issue, NuVision Pharmacy had already proactively recalled the lot in question and contacted everyone who had received it. No one else reported any adverse effects from the use of the product. The vial in question was also used by the same doctor to inject other patients who experienced no adverse effects. The vial associated with these adverse effects was returned to our pharmacy for testing and it passed pyrogen and sterility testing at a third party lab. Neither the FDA nor our pharmacy uncovered any evidence that the symptoms were caused by our product and were not due to an unknown alternative source.
There is currently a debate on which standards should be applied to compounding pharmacies. The FDA has been inspecting compounding pharmacies around the nation and they inspected our pharmacy from March to April 2013. During these inspections the FDA has been inappropriately using the FDA 210 and 211 Manufacturing Guidelines as a basis for their inspections despite the fact sterile compounding pharmacies are not manufacturers and should be instead be judged according to USP <797> regulations.
While we disagree with the FDA’s approach, we do recognize the necessity for continuous quality improvement. Our highest priority is patient safety and we are continuing to make improvements in order to uphold the highest standards for pharmacy compounding.
NuVision Pharmacy continues to improve our facility and incorporate safety measures that would surpass the requirements of current regulation, including changes based on the FDA’s recommendations.
Any of our patients and customers with concerns should contact us . We will be happy to discuss this issue with you and provide you with further information as necessary.
Sincerely,
Thank you,
Dr. Kristi Kubosh, PharmD, RPh
President
Pharmacist in Charge
quoted from here
26AUG
NuVision Pharmacy is a specialty compounding pharmacy committed to patient safety. We adhere to the USP <797>, which is the professional and legal standard for all sterile compounding pharmacies. We follow all state and federal pharmacy laws and our pharmacy license is in good standing with the Texas State Board of Pharmacy.
In response to the warning letter issued by the FDA about our sterile products, we would like to take this opportunity to set the record straight and address their accusations.
There is no evidence to support the FDA’s claim that our products lack sterility assurance. We have sterility tests performed on every lot of sterile products we dispense. We maintain test results documenting a passing sterility test for every product sold by our pharmacy and there is no evidence of any sterile product dispensed by our pharmacy being contaminated.
The FDA did not receive reports about fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product. This is information we voluntarily provided to the FDA. The FDA inspectors had no knowledge of this incident prior to our disclosure. The symptoms were experienced by three individuals and were related to the use of one vial.
Before the FDA was even aware of this issue, NuVision Pharmacy had already proactively recalled the lot in question and contacted everyone who had received it. No one else reported any adverse effects from the use of the product. The vial in question was also used by the same doctor to inject other patients who experienced no adverse effects. The vial associated with these adverse effects was returned to our pharmacy for testing and it passed pyrogen and sterility testing at a third party lab. Neither the FDA nor our pharmacy uncovered any evidence that the symptoms were caused by our product and were not due to an unknown alternative source.
There is currently a debate on which standards should be applied to compounding pharmacies. The FDA has been inspecting compounding pharmacies around the nation and they inspected our pharmacy from March to April 2013. During these inspections the FDA has been inappropriately using the FDA 210 and 211 Manufacturing Guidelines as a basis for their inspections despite the fact sterile compounding pharmacies are not manufacturers and should be instead be judged according to USP <797> regulations.
While we disagree with the FDA’s approach, we do recognize the necessity for continuous quality improvement. Our highest priority is patient safety and we are continuing to make improvements in order to uphold the highest standards for pharmacy compounding.
NuVision Pharmacy continues to improve our facility and incorporate safety measures that would surpass the requirements of current regulation, including changes based on the FDA’s recommendations.
Any of our patients and customers with concerns should contact us . We will be happy to discuss this issue with you and provide you with further information as necessary.
Sincerely,
Thank you,
Dr. Kristi Kubosh, PharmD, RPh
President
Pharmacist in Charge
President
Pharmacist in Charge
quoted from here
26AUG
The Medicine Store closes up shop---It had already stopped compounding injectables and sterile eye drops-- Will More Compounding Pharmacies Start to Close their Doors With Increased Regulations?
By ROBERT GOLD
rgold@capecodonline.com
August 27, 2013
HYANNIS — Richard "Rick" Gregg celebrated his pharmacy's 30th year in business last Thursday. On Monday, he closed up shop for good.
The Medicine Store, located on West Main Street, closed on Monday. Starting today, customers calling the shop are redirected to the nearby West Main Street Rite Aid, which bought the independent pharmacy.
Gregg, a pharmacist for 40 years, has retired. One of his pharmacists and two technicians will likely be working at the Rite Aid, he said. Three part-time pharmacists will focus on their full-time jobs elsewhere, he said.
Customers can get their prescriptions at the nearby Rite Aid store, Gregg said.
The pharmacist started alerting customers last week about the impending closure.
"It's my time," Gregg said about retiring.
Gregg bought the Medicine Shoppe on Seaboard Lane in 1983 as a franchise. He moved to the current spot on West Main Street in 1992. When his contract as a franchise business ran out 10 years ago, he renamed it the Medicine Store.
The shop's pharmacists would compound drugs for patients on an individual basis. It stopped compounding injectables and sterile eye drops last fall after the state enforced new guidelines for the industry. The increased oversight came after New England Compounding Center in Framingham made medicines linked to the 2012 fatal outbreak of fungal meningitis.
The Medicine Store continued to compound non-sterile products like hormone creams and pediatric products, Gregg said. Many pharmacies in the state take orders online for these compounds.
continue to read here
Find Out the Safety of Compounded Drugs Before You Use Them--great tips in this blog post about questions to ask and things to look for
Are compounded medications safe? Well, it depends. It depends on which pharmacy you choose. It depends on the collaboration between you, your physician and your pharmacist. It also depends on your health condition and how you react to certain components in the medications. This is why it is even more important to plan the use of compounded drugs with your physician and pharmacist before you begin to use it.
Does the Food and Drug Administration (FDA) approve these drugs? The FDA has not approved these drugs but they do acknowledge the usefulness of these alternatives to the regular commercially manufactured drugs. Their website says, “FDA believes that pharmacists engaging in traditional pharmacy compounding provide a valuable medical service that is important to patient health.”
continue to read here
Does the Food and Drug Administration (FDA) approve these drugs? The FDA has not approved these drugs but they do acknowledge the usefulness of these alternatives to the regular commercially manufactured drugs. Their website says, “FDA believes that pharmacists engaging in traditional pharmacy compounding provide a valuable medical service that is important to patient health.”
continue to read here
Compounding Pharmacies Should Not Be Operating as Pharmaceutical Manufacturers
Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC.
On October 26, 2012, the FDA issued a Form 483 with five observations to the New England Compounding Center, the company at the center of the storm of the fungal meningitis outbreak associated with more than 400 cases reported in almost 20 states with 29 deaths. During the inspection, the FDA observed contaminated products and listed a number of deficiencies regarding conditions in the clean rooms, environmental controls, and quality procedures. You can view the complete FDA Form 483 here.
continue to read here
On October 26, 2012, the FDA issued a Form 483 with five observations to the New England Compounding Center, the company at the center of the storm of the fungal meningitis outbreak associated with more than 400 cases reported in almost 20 states with 29 deaths. During the inspection, the FDA observed contaminated products and listed a number of deficiencies regarding conditions in the clean rooms, environmental controls, and quality procedures. You can view the complete FDA Form 483 here.
continue to read here
Another Job in Compounding Pharmacy Sales
Pharmaceutical/Compounding Pharmacy Sales Rep (Orlando)
We are looking for Pharmacy Sales Reps in the South Florida Area. Experience is desired but not required. Offering Both Full Time and Part Time positions. 100% Commission with average Sales Rep making 200K. Please reply with you resume attached or Fax 866-625-1709
- Location: Orlando
- Compensation: Average 200K per year - 100% commission
- This is a contract job.
- Principals only. Recruiters, please don't contact this job poster.
- Please do not contact job poster about other services, products or commercial interests.
Posting ID: 4026975739
Posted: 2013-08-26, 1:58PM EDT
Updated: 2013-08-26, 1:58PM EDT
Fungal Meningitis Outbreak: Who Oversees a Compounding Pharmacy?
Since the fungal meningitis outbreak last fall, more than 50 people have died, and roughly 700 are being treated for “persistent fungal infections”
August 26, 2013 -- About 17,000 vials of unregulated injectable corticosteroids were shipped to clinics and hospitals in the fall of 2012 from a pharmacy “clean room” found at the New England Compounding Center (NECC) - a “clean room” that harbored fungal contamination, as reported by CBS News 60 Minutes.
continue to read here
August 26, 2013 -- About 17,000 vials of unregulated injectable corticosteroids were shipped to clinics and hospitals in the fall of 2012 from a pharmacy “clean room” found at the New England Compounding Center (NECC) - a “clean room” that harbored fungal contamination, as reported by CBS News 60 Minutes.
continue to read here
Monday, August 26, 2013
UPDATE! Judge Has Issued An injunction against compounding pharmacy linked to infections in Corpus Christi
By Mark Collette
Corpus Christi Caller Times
Posted August 26, 2013 at 11:46 a.m.,
At least two of the infected patients died, according to state officials, but their deaths have not been linked to the drug from Specialty Compounding in Cedar Park.
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FDA warns 2 Indian companies for manufacturing lapses
In its latest action against Indian drug makers, the US health regulator FDA has red-flagged "significant deviations" from good manufacturing practices at two Indian pharmaceutical companies.
In the case of Hyderabad-based Posh Chemicals, the US Food and Drug Administration said that lapses found at its manufacturing facility may cause the Active Pharmaceutical Ingredients (APIs) manufactured by it to get adulterated.
During an inspection of the company's facilities, FDA found failure to protect computerised data from unauthorised access, failure to ensure that test procedures are scientifically sound and failure to follow and document quality-related activities at the time they are performed.
With regard to the second company, Himachal Pradesh-based Sentiss Pharma (formerly Promed Exports), the FDA said the company failed to establish adequate systems for monitoring environmental conditions and for cleaning and disinfecting the room and equipment in aseptic processing areas.
Besides, Sentiss allegedly failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, FDA has alleged.
In separate warning letters issued to the two companies, the FDA said that their deviation from "good manufacturing practices" could cause their products to be adulterated as per the US regulations.
The FDA said it may withhold approval of any new applications or supplements of the two companies, until they put in place necessary corrective measures and get those corrections approved as per the US regulations.
At least six Indian drug makers have been issued such warning letters so far this year by the FDA, which has also ordered recall of certain drugs manufactured in India.
Wockhardt and Fresenius Kabi received warning letters last month, while Hospira Healthcare India and RPG Life Sciences got such letters in May.
Besides, the FDA recently also clamped down on 15 companies globally, including Gujarat-based Amrutam Life Care, for illegal sale of drugs labelled as dietary supplements and ayurvedic products for treating diabetes.
continue to read here
In the case of Hyderabad-based Posh Chemicals, the US Food and Drug Administration said that lapses found at its manufacturing facility may cause the Active Pharmaceutical Ingredients (APIs) manufactured by it to get adulterated.
During an inspection of the company's facilities, FDA found failure to protect computerised data from unauthorised access, failure to ensure that test procedures are scientifically sound and failure to follow and document quality-related activities at the time they are performed.
With regard to the second company, Himachal Pradesh-based Sentiss Pharma (formerly Promed Exports), the FDA said the company failed to establish adequate systems for monitoring environmental conditions and for cleaning and disinfecting the room and equipment in aseptic processing areas.
Besides, Sentiss allegedly failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, FDA has alleged.
In separate warning letters issued to the two companies, the FDA said that their deviation from "good manufacturing practices" could cause their products to be adulterated as per the US regulations.
The FDA said it may withhold approval of any new applications or supplements of the two companies, until they put in place necessary corrective measures and get those corrections approved as per the US regulations.
At least six Indian drug makers have been issued such warning letters so far this year by the FDA, which has also ordered recall of certain drugs manufactured in India.
Wockhardt and Fresenius Kabi received warning letters last month, while Hospira Healthcare India and RPG Life Sciences got such letters in May.
Besides, the FDA recently also clamped down on 15 companies globally, including Gujarat-based Amrutam Life Care, for illegal sale of drugs labelled as dietary supplements and ayurvedic products for treating diabetes.
continue to read here
A Tonk's Tail... err, Tale...: Update on S. 959 and Vet Compounding
A Tonk's Tail... err, Tale...: Update on S. 959 and Vet Compounding: Back in July we wrote about a proposal coming before the U.S. Senate that, if passed, threatened to ban pharmacies from compounding medica...
Improve scrutiny of tailor-made drugs To ensure FDA oversight of large-scale compounding “pharmacies,” Congress may require some partisan healing of its own.
Monday, August 26, 2013
Southwest Virginians affected by a deadly meningitis outbreak last year wait impatiently for Congress to tighten regulatory control over drug compounding facilities like the one that produced tainted steroid injections linked to the disease.
There is hope — if the House and Senate can pull out of the mire of partisanship long enough to come together on a remedy that will protect the public.
Virginia’s 9th District Rep. Morgan Griffith says he is working on legislation to make it clear the federal Food and Drug Administration has authority to inspect compounding pharmacies like the one in Massachusetts linked to the tainted medicine. He hopes to file the bill next month in the House.
In the Senate, meanwhile, the Health, Education, Labor and Pension Committee unanimously approved a bill late last month to increase the FDA’s regulatory power over compounding pharmacies. It goes next to the full Senate, where it will meet industry opposition.
Compounding pharmacies custom mix drugs for patients in doses or forms generally not available commercially when standard formulations do not fit individual needs. Typically, the facilities fall under the oversight of state pharmacy boards because they turn out small numbers of customized formulas to fill special orders placed by doctors.
Investigators of the fungal meningitis outbreak last year, which killed two people in Southwest Virginia and a total of 63 in 20 states, linked the outbreak to injections of tainted steroids made by the New England Compounding Center. The facility, now closed, was geared up for mass production and nationwide distribution.
Griffith thinks that, under current law, the FDA could have treated NECC as a drug manufacturer and stepped in, but did not; the FDA commissioner says the agency needs a stronger law.
There is hope — if the House and Senate can pull out of the mire of partisanship long enough to come together on a remedy that will protect the public.
Virginia’s 9th District Rep. Morgan Griffith says he is working on legislation to make it clear the federal Food and Drug Administration has authority to inspect compounding pharmacies like the one in Massachusetts linked to the tainted medicine. He hopes to file the bill next month in the House.
In the Senate, meanwhile, the Health, Education, Labor and Pension Committee unanimously approved a bill late last month to increase the FDA’s regulatory power over compounding pharmacies. It goes next to the full Senate, where it will meet industry opposition.
Compounding pharmacies custom mix drugs for patients in doses or forms generally not available commercially when standard formulations do not fit individual needs. Typically, the facilities fall under the oversight of state pharmacy boards because they turn out small numbers of customized formulas to fill special orders placed by doctors.
Investigators of the fungal meningitis outbreak last year, which killed two people in Southwest Virginia and a total of 63 in 20 states, linked the outbreak to injections of tainted steroids made by the New England Compounding Center. The facility, now closed, was geared up for mass production and nationwide distribution.
Griffith thinks that, under current law, the FDA could have treated NECC as a drug manufacturer and stepped in, but did not; the FDA commissioner says the agency needs a stronger law.
The District of Columbia Board of Pharmacy has a chart of Inspection Fines--What a Great Idea
Pharmacy Inspection Fine Schedule
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California State Board of Pharmacy Disciplinary Actions Filed in July 2013--Santa Clara Drug "The Compounding Shop" is on the List Again and Accusations Against Six-Twelve Pharmacy
Individual Licenses
Ahrenholtz, James P., TCH 99246, Administrative Case AC 4374
Modesto, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Bader, Jr., Larry D., TCH 114230, Administrative Case AC 4632
Fallbrook, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Cabugos, Manuel M., TCH 59049, Administrative Case AC 4618
Garden Grove, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Carlson, Lindsey N., TCH 94160, Administrative Case AC 4410
San Diego, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Castillo, Nadine C., TCH 76096, Administrative Case AC 4351
Santa Maria, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Castro, Melinda, Applicant, Administrative Case SI 4508
Oxnard, CA
Statement of Issues Filed 7/22/2013; Case Pending.
View the accusation
Chau, Mike D., TCH 89969, Administrative Case AC 4541
Alhambra, CA
Petition to Revoke Probation Filed 7/18/2013; Case Pending.
View the accusation
Cornelio, Jose L., TCH 115350, Administrative Case AC 4504
Lynwood, CA
Accusation Filed 7/12/2013; Case Pending.
View the accusation
Devlin, Brandon, TCH 91611, Administrative Case AC 4684
Clovis, CA
Accusation Filed 7/19/2013; Case Pending.
View the accusation
Dobin, Brenda M., TCH 99068, Administrative Case AC 4390
Simi Valley, CA
Accusation Filed 7/18/2013; Case Pending.
View the accusation
Edwards, Amber B., TCH 112583, Administrative Case AC 4387
Baldwin Park, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Gutierrez, Brandi, TCH 81632, Administrative Case AC4376
San Bernardino, CA
Accusation filed 7/23/2013; Case Pending.
View the accusation
Gutierrez, Frank A., TCH 64204, Administrative Case AC 4544
Madera, CA
Petition to Revoke Probation Filed 7/11/2013; Case Pending.
View the accusation
Hall, Jacqueline M., TCH 63581, Administrative Case AC 4538
Bakersfield, CA
Petition to Revoke Probation Filed 7/2013; Case Pending.
View the accusation
Hibbs, Terry L., RPH 41315, Administrative Case AC 4616
Downey, CA
Accusation Filed 7/18/2013; Case Pending.
View the accusation
Ho, Michael Q.B., TCH 20393, Administrative Case AC 4659
San Jose, CA
Accusation Filed 7/2013; Case Pending.
View the accusation
LaFlower, Christina M., TCH 119491, Administrative Case AC 4634
Wildomar, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Madrid, Antonio, TCH 79877, Administrative Case AC 4400
Redlands, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Montano, Hugo, Applicant, Administrative Case SI 4044
Pacoima, CA
Statement of Issues Filed 7/22/2013; Case Pending.
View the accusation
Montero, Andrew D., TCH 114540, Administrative Case AC 4651
Stockton, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Moore, Lindsey N., Applicant, Administrative Case SI 4595
Oceanside, CA
Statement of Issues Filed 7/22/2013; Case Pending.
View the accusation
Mulala-Simpson, Liseli, RPH 54290, Administrative Case AC 4649
San Francisco, CA
Accusation Filed 7/18/2013; Case Pending.
View the accusation
O’Connor, Kelly J., TCH 37039, Administrative Case AC 4283
Palmdale, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Oduyale, Olugbenga, RPH 42719, Administrative Case AC 4724
Woodland Hills, CA
Accusation Filed 7/2013; Case Pending.
View the accusation
Park, Sung Hoon, RPH 56937, Administrative Case AC 4683
La Quinta, CA
Accusation Filed 7/20/2013; Case Pending.
View the accusation
Perkins, Courtney J., TCH 109414, Administrative Case AC 4262
Fillmore, CA
Accusation Filed 7/18/2013; Case Pending.
View the accusation
Purohit, Vishal, RPH 62617, Administrative Case AC 4842
San Jose, CA
Accusation filed 7/26/2013; Case pending.
View the accusation
Ramirez, Jolynn A., TCH 84739, Administrative Case AC 3862
Bloomington, CA
Accusation Filed 7/1/2013; Case Pending.
View the accusation
Ramirez, Marlene R., TCH 52404, Administrative Case AC 4517
Riverside, CA
Petition to Revoke Probation Filed 7/18/2013; Case Pending.
View the accusation
Rangel, Neiva N., TCH 99226, Administrative Case AC 4601
Corona, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Rendon,Lizette, TCH 110862, Administrative Case AC 4536
San Bernardino, CA
Petition to Revoke Probation Filed 7/22/2013; Case Pending.
View the accusation
Robinson, Dominik A., TCH 64982, Administrative Case AC 4631
Petaluma, CA
Accusation Filed 7/2013; Case Pending.
View the accusation
Romero, Jessica Y., TCH 116513, Administrative Case AC 4563
Downey, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Saechao, Cheng Chiew., TCH 93464, Administrative Case AC 4706
Sacramento, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Sandoval, Jesse, TCH 32059, Administrative Case AC 4403
Sylmar, CA
Accusation Filed 7/12/2013; Case Pending.
View the accusation
Schmidthues, Julia, Applicant, Administrative Case SI 4430
San Luis Obispo, CA
Statement of Issues Filed 7/22/2013; Case Pending.
View the accusation
Smith, Rina L., TCH 107236, Administrative Case AC 4129
Gardena, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Tango, Chauntay L., TCH 10213, Administrative Case AC 4607
Lancaster, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Tong, John H., TCH 82932, Administrative Case AC 4583
Westminster, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Vinatieri, Gina A., TCH 121899, Administrative Case AC 4476
Canyon Country, CA
Accusation Filed 7/19/2013; Case Pending.
View the accusation
Walton, Latrice R., TCH 76453, Administrative Case AC 4648
Banning, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Wilcox, Wendy L., TCH 18877, Administrative Case AC 4575
Riverside, CA
Accusation Filed 7/2013; Case Pending.
View the accusation
Wilson, James A., RPH 23617, Administrative Case AC 4389
Woodland Hills, CA
Accusation Filed 7/22/2013; Case Pending
View the accusation
Yepiz, Dulce J., TCH 6601, Administrative Case AC 4452
Escondido, CA
Accusation Filed 7/12/2013; Case Pending.
View the accusation
Zuniga, Brittney, TCH 126842, Administrative Case AC 4620
Norco, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Site Licenses
Cal-Mex Pharmacy, PHY 50374, Administrative Case AC 4724
Calexico, CA
Accusation Filed 7/3/2013; Case Pending
View the accusation
Medicine Shoppe #565, PHY 48719, Administrative Case AC 4683
Palm Springs, CA
Accusation Filed 7/20/2013; Case Pending
View the accusation
Rite Aid 5945, PHY 42814, Administrative Case AC 4397
San Jose, CA
Accusation Filed 7/20/2013; Case Pending
View the accusation
Rite Aid 5985, PHY 42795, Administrative Case AC 4397
San Jose, CA
Accusation Filed 7/20/2013; Case Pending
View the accusation
Santa Clara Drug “The Compounding Shop”, PHY 51229, Administrative Case AC 4842
San Jose, CA
Accusation filed 7/26/2013; Case pending.
View the accusation
Six-Twelve Pharmacy, PHY 36222 and LSC 99618, Administrative Case AC 4389
Arcadia, CA
Accusation Filed 7/14/2013; Case Pending
View the accusation
Ahrenholtz, James P., TCH 99246, Administrative Case AC 4374
Modesto, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Bader, Jr., Larry D., TCH 114230, Administrative Case AC 4632
Fallbrook, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Cabugos, Manuel M., TCH 59049, Administrative Case AC 4618
Garden Grove, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Carlson, Lindsey N., TCH 94160, Administrative Case AC 4410
San Diego, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Castillo, Nadine C., TCH 76096, Administrative Case AC 4351
Santa Maria, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Castro, Melinda, Applicant, Administrative Case SI 4508
Oxnard, CA
Statement of Issues Filed 7/22/2013; Case Pending.
View the accusation
Chau, Mike D., TCH 89969, Administrative Case AC 4541
Alhambra, CA
Petition to Revoke Probation Filed 7/18/2013; Case Pending.
View the accusation
Cornelio, Jose L., TCH 115350, Administrative Case AC 4504
Lynwood, CA
Accusation Filed 7/12/2013; Case Pending.
View the accusation
Devlin, Brandon, TCH 91611, Administrative Case AC 4684
Clovis, CA
Accusation Filed 7/19/2013; Case Pending.
View the accusation
Dobin, Brenda M., TCH 99068, Administrative Case AC 4390
Simi Valley, CA
Accusation Filed 7/18/2013; Case Pending.
View the accusation
Edwards, Amber B., TCH 112583, Administrative Case AC 4387
Baldwin Park, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Gutierrez, Brandi, TCH 81632, Administrative Case AC4376
San Bernardino, CA
Accusation filed 7/23/2013; Case Pending.
View the accusation
Gutierrez, Frank A., TCH 64204, Administrative Case AC 4544
Madera, CA
Petition to Revoke Probation Filed 7/11/2013; Case Pending.
View the accusation
Hall, Jacqueline M., TCH 63581, Administrative Case AC 4538
Bakersfield, CA
Petition to Revoke Probation Filed 7/2013; Case Pending.
View the accusation
Hibbs, Terry L., RPH 41315, Administrative Case AC 4616
Downey, CA
Accusation Filed 7/18/2013; Case Pending.
View the accusation
Ho, Michael Q.B., TCH 20393, Administrative Case AC 4659
San Jose, CA
Accusation Filed 7/2013; Case Pending.
View the accusation
LaFlower, Christina M., TCH 119491, Administrative Case AC 4634
Wildomar, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Madrid, Antonio, TCH 79877, Administrative Case AC 4400
Redlands, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Montano, Hugo, Applicant, Administrative Case SI 4044
Pacoima, CA
Statement of Issues Filed 7/22/2013; Case Pending.
View the accusation
Montero, Andrew D., TCH 114540, Administrative Case AC 4651
Stockton, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Moore, Lindsey N., Applicant, Administrative Case SI 4595
Oceanside, CA
Statement of Issues Filed 7/22/2013; Case Pending.
View the accusation
Mulala-Simpson, Liseli, RPH 54290, Administrative Case AC 4649
San Francisco, CA
Accusation Filed 7/18/2013; Case Pending.
View the accusation
O’Connor, Kelly J., TCH 37039, Administrative Case AC 4283
Palmdale, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Oduyale, Olugbenga, RPH 42719, Administrative Case AC 4724
Woodland Hills, CA
Accusation Filed 7/2013; Case Pending.
View the accusation
Park, Sung Hoon, RPH 56937, Administrative Case AC 4683
La Quinta, CA
Accusation Filed 7/20/2013; Case Pending.
View the accusation
Perkins, Courtney J., TCH 109414, Administrative Case AC 4262
Fillmore, CA
Accusation Filed 7/18/2013; Case Pending.
View the accusation
Purohit, Vishal, RPH 62617, Administrative Case AC 4842
San Jose, CA
Accusation filed 7/26/2013; Case pending.
View the accusation
Ramirez, Jolynn A., TCH 84739, Administrative Case AC 3862
Bloomington, CA
Accusation Filed 7/1/2013; Case Pending.
View the accusation
Ramirez, Marlene R., TCH 52404, Administrative Case AC 4517
Riverside, CA
Petition to Revoke Probation Filed 7/18/2013; Case Pending.
View the accusation
Rangel, Neiva N., TCH 99226, Administrative Case AC 4601
Corona, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Rendon,Lizette, TCH 110862, Administrative Case AC 4536
San Bernardino, CA
Petition to Revoke Probation Filed 7/22/2013; Case Pending.
View the accusation
Robinson, Dominik A., TCH 64982, Administrative Case AC 4631
Petaluma, CA
Accusation Filed 7/2013; Case Pending.
View the accusation
Romero, Jessica Y., TCH 116513, Administrative Case AC 4563
Downey, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Saechao, Cheng Chiew., TCH 93464, Administrative Case AC 4706
Sacramento, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Sandoval, Jesse, TCH 32059, Administrative Case AC 4403
Sylmar, CA
Accusation Filed 7/12/2013; Case Pending.
View the accusation
Schmidthues, Julia, Applicant, Administrative Case SI 4430
San Luis Obispo, CA
Statement of Issues Filed 7/22/2013; Case Pending.
View the accusation
Smith, Rina L., TCH 107236, Administrative Case AC 4129
Gardena, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Tango, Chauntay L., TCH 10213, Administrative Case AC 4607
Lancaster, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Tong, John H., TCH 82932, Administrative Case AC 4583
Westminster, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Vinatieri, Gina A., TCH 121899, Administrative Case AC 4476
Canyon Country, CA
Accusation Filed 7/19/2013; Case Pending.
View the accusation
Walton, Latrice R., TCH 76453, Administrative Case AC 4648
Banning, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Wilcox, Wendy L., TCH 18877, Administrative Case AC 4575
Riverside, CA
Accusation Filed 7/2013; Case Pending.
View the accusation
Wilson, James A., RPH 23617, Administrative Case AC 4389
Woodland Hills, CA
Accusation Filed 7/22/2013; Case Pending
View the accusation
Yepiz, Dulce J., TCH 6601, Administrative Case AC 4452
Escondido, CA
Accusation Filed 7/12/2013; Case Pending.
View the accusation
Zuniga, Brittney, TCH 126842, Administrative Case AC 4620
Norco, CA
Accusation Filed 7/22/2013; Case Pending.
View the accusation
Site Licenses
Cal-Mex Pharmacy, PHY 50374, Administrative Case AC 4724
Calexico, CA
Accusation Filed 7/3/2013; Case Pending
View the accusation
Medicine Shoppe #565, PHY 48719, Administrative Case AC 4683
Palm Springs, CA
Accusation Filed 7/20/2013; Case Pending
View the accusation
Rite Aid 5945, PHY 42814, Administrative Case AC 4397
San Jose, CA
Accusation Filed 7/20/2013; Case Pending
View the accusation
Rite Aid 5985, PHY 42795, Administrative Case AC 4397
San Jose, CA
Accusation Filed 7/20/2013; Case Pending
View the accusation
Santa Clara Drug “The Compounding Shop”, PHY 51229, Administrative Case AC 4842
San Jose, CA
Accusation filed 7/26/2013; Case pending.
View the accusation
Six-Twelve Pharmacy, PHY 36222 and LSC 99618, Administrative Case AC 4389
Arcadia, CA
Accusation Filed 7/14/2013; Case Pending
View the accusation
Sunday, August 25, 2013
Special Note: One Question to Ask Before Doing Business With a Compounding Pharmacy Is What Special Training or Creditials Does the Compounding Pharmacist Have in the Specific Area of Compounding? For example, if they are compounding Hormone Replacement Dugs What qualifies them to do this? If they are compounding veterinary medications, what qualifies them to do this type of compounding?
American College of Apothecaries Offers Training in Pharmacy Compounding
Contemporary Prescription Compounding
Women's Health Compounding
Aseptic Technique Compounding
November 21-22
Women's Health Compounding
September 27-28
Aseptic Technique Compounding
November 21-22
Kennedy Center Lecture Series: An Overview of Pharmacy Compounding
Enroll | Kennedy Center Lecture Series: An Overview of Pharmacy Compounding
Price: $25.00 |
Product Volume & API Process Optimization: Connecting the Dots
To the uninitiated, active pharmaceutical ingredients (APIs) look like wiggly, leafless branches, but they can treat diseases. Selected chemicals are reacted to produce the desired effect. The manufacturing processes can be complex. Our job is to create processes that are as simple and environmentally friendly as possible and result in products that meet quality specifications all the time without much interference.
The most important factor in any API business process is the volume of product required to meet global demand. It determines manufacturing process design, equipment selection, and asset utilization, and it influences the overall supply chain.
Traditionally in the chemical industry, product volumes are large enough to warrant producing large quantities at multiple plants. However, pharmaceutical APIs present a different scenario. This needs to be understood and explained.
continue to read here
Why is FDA at my facility, and what do I do during an inspection? Seminar
26th - 27th September 2013 at the Courtyard Marriott Boston - Cambridge in Cambridge, United States [5984]
Why is FDA at my facility, and what do I do during an inspection?
This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.
Contact: Referral
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: referral@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/seminar?product_id=80075SEM&?channel=pharmaorg
Why is FDA at my facility, and what do I do during an inspection?
This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.
Contact: Referral
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: referral@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/seminar?product_id=80075SEM&?channel=pharmaorg
Are You HIPAA Compliance Audit Ready? Strategies to Avoid Civil and Criminal Penalties Webinar
19th September 2013 at the Online Event in Fremont, United States [6039]
Are You HIPAA Compliance Audit Ready? Strategies to Avoid Civil and Criminal Penalties
Did you know that failure to comply with HIPAA, the DHHS Privacy and Security regulations, and the HITECH Act can result in hefty fines and even imprisonment? DHHS has said that it will also focus on board members, CEOs, and management, not just "worker bees." You are responsible for compliance. How can you ensure that you are meeting federal and state statutes and regulations to protect patients' privacy of health information?
Contact: Roger Steven
Telephone: 8003851607; Fax: 302-288-6884
Email: webinars@mentorhealth.com
Website: http://bit.ly/18Y2in8
Are You HIPAA Compliance Audit Ready? Strategies to Avoid Civil and Criminal Penalties
Did you know that failure to comply with HIPAA, the DHHS Privacy and Security regulations, and the HITECH Act can result in hefty fines and even imprisonment? DHHS has said that it will also focus on board members, CEOs, and management, not just "worker bees." You are responsible for compliance. How can you ensure that you are meeting federal and state statutes and regulations to protect patients' privacy of health information?
Contact: Roger Steven
Telephone: 8003851607; Fax: 302-288-6884
Email: webinars@mentorhealth.com
Website: http://bit.ly/18Y2in8
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