A recent recall by a New Jersey-based specialty pharmacy has reignited congressional criticism that the FDA is not doing enough to protect the public from contaminated compounded drugs.
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
Tuesday, April 2, 2013
SPAARx Issues Industry Letter to Inform Legislators and FDA About the Dissimilarity of Specialty Pharmacy vs. Compounding
FLORHAM PARK, NJ, Apr 02, 2013 (Marketwired via COMTEX) -- The Specialty Pharmacy Association of America (SPAARx), the largest national association representing the broad interests of the specialty pharmacy industry, today announced that it is launching a national advocacy initiative focused on pending federal and state legislation and regulation through agencies including the United States Food and Drug Administration (FDA) related to Compounding. The Association believes that a clear understanding of the differentiation between specialty pharmacy and compounding is critical to avoid unintended consequences.
Numerous media reports over recent weeks, including lead articles by The New York Times, The Wall Street Journal, The Boston Globe, The Washington Post, and others, have used the terms 'Specialty Pharmacy' and 'Compounding' interchangeably, which is inaccurate, misleading to the public and to legislators and regulators as they consider actions that could affect pharmacies that create compounded drugs, but specialty pharmacies as well.
In response, SPAARx is sending a letter to appropriate House and Senate Committees, the FDA Commissioner, and state legislators, that differentiates specialty pharmacy from compounding to help inform decision making. The Association supports the accreditation of compounding pharmacies by nationally recognized agencies with the necessary expertise to assess and confirm ongoing compliance with the highest standards for quality compounding. Most importantly, the Association wishes to inform the public that services provided by compounding pharmacies are poles apart from those services provided by specialty pharmacies.
"SPAARx believes that specialty pharmacy and the art and science of extemporaneous compounding are dissimilar," said Bill Sullivan, Interim Executive Director of the Specialty Pharmacy Association of America. Sullivan continued, "Specialty pharmacies dispense FDA approved and commercially available medications requiring patient-specific prescriptions. By comparison, compounding-only pharmacies prepare medications from FDA approved chemical ingredients and commercially available medications which may not require a patient-specific prescription at the time of formulation. New laws and / or regulations should take into account these significant dissimilarities and focus such actions on compounding as appropriate."
Earlier this year the Specialty Pharmacy Association of America endorsed a comprehensive Definition of Specialty Pharmacy in which no mention is made of the practice of compounding. The definition may be downloaded at: http://www.spaarx.org/documents/SPAARx Specialty Pharmacy - Definition.doc
About Specialty Pharmacy Association of America (SPAARx) SPAARx is the largest national Association solely dedicated to the interests of all individuals in the specialty pharmacy segment of healthcare. SPAARx is managed and governed by a board of directors comprised of executives from a diverse group of specialty pharmacies. This association is vendor-neutral and fully-aligned with the interests of all industry stakeholders. SPAARx is setting the standards, leading in advocacy and promoting the value of specialty pharmacy. The association's goal is to protect and promote common industry interests along with fostering professional growth within specialty pharmacy. To learn more about SPAARX or join today, please visit www.spaarx.org\
Source found here
Monday, April 1, 2013
ASHP Continues Efforts to Address Pharmacy Compounding
4/1/2013
The outbreak of meningitis caused by contaminated methylprednisolone acetate compounded by the New England Compounding Center last fall put the spotlight on sterile products outsourcing. In the aftermath of the incident, ASHP has workedwith policymakers, practitioners, and nationally recognized experts in compounding and manufacturing to develop new approaches to protect patients from preventable harm, and to give practitioners and organizations confidence that compounding outsourcers are appropriately regulated and inspected, and that the products they produce are safe.
Working with Experts
In February, ASHP partnered with The Pew Charitable Trusts, and the American Hospital Association to hold a Summit that explored the scope of pharmacy sterile compounding and the associated risk factors, the differences between sterile production expectations under Current Good Manufacturing Practices and United States Pharmacopeia <Chapter 797>, and oversight roles for states and the federal government. Recommendations from the Summit will be released in April.
Educating PolicymakersASHP has worked to educate policymakers and others about what distinguishes patient-care driven hospital and health-system based IV admixture services from commercial sterile compounding outsourcing. ASHP has also advocated to preserve the important role that credible compounding outsourcers’ play to help supply hospitals and health systems with sterile products that are in short supply, customized dosage forms, high-risk level sterile preparations, and repackaged medications from FDA-approved products.
The Society has urged the Food and Drug Administration (FDA) to requirecompounding service providers that operate at the scale and scope of manufacturers to register with the agency, share details about their operations, and submit to routine inspections. Current discussions center on the FDA oversight of a “third category” of vendors—companies that prepare sterile preparations without patient-specific prescriptions and ship them across state lines. FDA is exploring what criteria must be met for these entities to be under the FDA's jurisdiction versus traditional state pharmacy scope of practice laws.
ASHP continues to work with Congress on strategies to address the regulatory gaps with respect to sterile preparations that are mass produced and often shipped to customers across state lines. Much of the discussion thus far has focused on the third category of vendors and how broadly the category needs to be defined. Further, discussion has focused on ensuring there are no unintended consequences that would enable a large sterile preparation entity to bypass the New Drug Application and Abbreviated New Drug Application requirements set forth for manufacturers.
The Society is also collaborating with state affiliates to monitor activity in state legislatures and boards of pharmacy. California, Maryland, Massachusetts, New Jersey, South Carolina, Tennessee, and Virginia are among the numerous states taking action on compounding.
To support ASHP's continued advocacy efforts, a member survey is being conducted to gain information on sterile compounding and the use of outsourcing vendors by health systems.
Resources for Members
Read More• Experts Seek Strategies to Ensure Quality in Sterile Compounding• ASHP Makes Recommendations on Oversight of Pharmacy Compounding• ASHP Testifies to Senate Committee on Compounding• ASHP Provides Tools for Members to Deal with Aftermath of Compounding Incident
Quoted from here
Regulators scrutinize compounding pharmacies in Tennessee, nation (with video) by Kate Harrison
Compounding pharmacies see renewed attention after meningitis outbreak
Chattanooga-area compounding pharmacies have seen renewed attention from both customers and the Tennessee Legislature after a deadly meningitis outbreak that stemmed from a Massachusetts pharmacy. Access Family Pharmacy, which fills about 60 compounding prescriptions per day, has specialized in compounding prescriptions since 1962.
Compounding pharmacies long have been able to fill the gap between mass-produced drugs and highly personal medical needs.
These pharmacies can customize a drug product into a liquid or a gas for patients who can't swallow pills. They can make a medication without specific allergens. They can flavor a medicine with mint or tropical fruit to be more palatable. And they can compound drugs that are on back order -- such as Tamiflu for children.
"Maybe [the patient] can't take something that's commercially made because it's one-size-fits all. Or it's something that's not commercially made and they've got to have it," explains pharmacist Phil Smith at Access Pharmacy, which has been compounding drugs in the Hixson store for more than 50 years.
But over the last few months, state and federal officials have said the gap that compounding pharmacies have filled has been far too unregulated, leading to abuse by certain pharmacies.
"It has been a crazy few months for compounding," said Smith. "We have been letting our customers know that our chemicals are tested, our manufacturers are FDA tested and approved. Things like that let people know what our quality standards are."
A deadly meningitis outbreak prompted heightened scrutiny from both state and federal regulators. Just last month, there were two more recalls of sterile compounded and repackaged drug products, first from a New Jersey compounding pharmacy after fungal contamination was found at a hospital. Days later, a compounding pharmacy in Martinez, Ga., recalled syringes of the drug Avastin after it received reports of eye infections among patients.
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Dr. David F. Chang Reminds Ophthalmologists of Importance of Compounding Pharmacies David F. Chang interviews Charles Leiter regarding the state of compounding and how pharmacies, such as Leiter’s, maintain high standards of quality when compounding medications.
San Jose, CA (PRWEB) April 01, 2013
In the March 2013 issue of EyeWorld magazine, Dr. David F. Chang interviewed CEO of Leiter’sCompounding Pharmacy, Charles Leiter. As compounding pharmacies continue to reel from the devastating Meningitis outbreak caused by the negligence of New England Compounding Center, Dr. David F. Chang reminds the industry of the importance of quality compounding in “Compounding pharmacies: Let’s not throw the baby out with the bathwater.”
In the op-ed and interview, Dr. Chang discusses what happened in Massachusetts, the state of the industry, the results of the Meningitis outbreak, and the utmost need for quality medication from reliable compounding pharmacies such as Leiter’s.
Dr Chang said, “The disastrous fungal infections caused by contaminated medications from the New England Compounding Center(NECC) have rocked the pharmaceutical compounding industry. As a result of this horrible outbreak, the confidence of many physicians and their patients in compounded medications has been shaken.” Leiter expands, “What happened at NECC was a disaster. They were operating under horrific, unsafe conditions, and they never should have been in business. They’ve unfairly tarnished our entire industry. No responsible doctor should have ever ordered from NECC. The FDA and pharmacy boards should have shut them down years ago, and the owners should never have allowed product to ship.”
Dr. Chang follows by explaining the continued need for high quality medication from compounding pharmacies. He said, “Of course, drug compounding has always filled important and otherwise unmet pharmaceutical needs.” Leiter reiterates this point, saying “The role of compounding drugs is paramount in the U.S. because compounding meets very tangible and very serious medical needs that cannot be met anywhere else.”
As scrutiny intensifies on compounding pharmacies, Chang reminds industry professionals of the compounding pharmacies that are producing quality medications and the distinction of a PCAB accredited pharmacy. “As you will see, there is only a small minority of compounding pharmacies that are accredited, and this is a very important distinction.” Leiter expands on the accreditation and the importance of not distinguishing based on cost. “NECC was not PCAB accredited. The number one rule for doctors when ordering a compounded medication is to verify that the pharmacy is PCAB accredited. Doctors or buyers at their clinics or ASCs should know and trust who they are doing business with and should not procure on the basis of selecting the lowest cost provider.”
Dr. Chang summarizes, “With the increased scrutiny and regulation that are sure to follow in the wake of the fungal meningitis outbreak, we must heed the idiom in this column’s title and preserve patient access to appropriate and properly compounded medications.”
About Dr. David F. Chang:
David F. Chang, MD is clinical professor at the University of California, San Francisco, and the current president of the American Society of Cataract and Refractive Surgery. He is also Chairman of the American Academy of Ophthalmology’s Cataract Preferred Practice Pattern Committee, and is considered a leading expert in cataract surgery. Dr. Chang is the chief medical editor of EyeWorld and was previously co-chief medical editor for Cataract and Refractive Surgery Today.
State Weighs New Regulations for Compounding Pharmacies April 1st, 2013
BOSTON (AP) — Lawmakers are considering changes in how sterile compounding pharmacies are regulated after a deadly nationwide fungal meningitis outbreak that was linked to a steroid distributed by a Massachusetts firm.
The Legislature’s public health committee has scheduled a hearing for Tuesday on several proposals that call for strengthening oversight and licensing of the pharmacies.
Among them is a bill filed by Gov. Deval Patrick that would require compounding pharmacies to obtain a special state license. The bill would also create whistleblower protections for pharmacy workers and enforce new fines and penalties for compounding pharmacies that break the rules.
More than 50 deaths and hundreds of illnesses have been tied to the meningitis outbreak. New England Compounding Center of Framingham shut down operations last fall.
Source found here
Meningitis outbreak sparks investigations, lawsuits, fears
Second of two parts
In September, Milda Mattila became unsteady on her legs. Soon, she was unable to walk.
The 87-year-old South Lyon woman had been infected with fungal meningitis through a tainted steroid shot meant to relieve back pain.
"Why did I have to get this?" she asked her family.
That question fills households and hospital rooms as hundreds of people struggle with the physical, emotional and financial scars left in the wake of the national fungal meningitis outbreak that has killed at least 51 people, including 17 Michigan residents. Nationwide, 730 people have fallen ill, including 259 in Michigan.
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California State Board of Pharmacy LEGISLATION AND REGULATION COMMITTEE April 11, 2012
California State Board of Pharmacy
1625 N. Market Blvd, N219, Sacramento, CA 95834 Phone: (916) 574-7900
Fax: (916) 574-8618
www.pharmacy.ca.gov
NOTICE OF MEETING AND AGENDA
1625 N. Market Blvd, N219, Sacramento, CA 95834 Phone: (916) 574-7900
Fax: (916) 574-8618
www.pharmacy.ca.gov
NOTICE OF MEETING AND AGENDA
STATE AND CONSUMER SERVICES AGENCY
DEPARTMENT OF CONSUMER AFFAIRS
GOVERNOR EDMUND G. BROWN JR.
California State Board of Pharmacy
LEGISLATION AND REGULATION COMMITTEE
April 11, 2012
DATE: April 11, 2013
PLACE: Department of Consumer Affairs Headquarters Building II
1747 North Market Blvd., Room 186 Sacramento, CA 95834
PLACE: Department of Consumer Affairs Headquarters Building II
1747 North Market Blvd., Room 186 Sacramento, CA 95834
This committee meeting is open to the public and is accessible to the physically disabled. A person who needs a
disability‐related accommodation or modification in order to participate in the meeting may make a request by
contacting Laura Hendricks at (916) 574‐7918, by emailing laura.hendricks@dca.ca.gov or sending a written
request to the Board of Pharmacy, 1625 N. Market Blvd., Suite N‐219, Sacramento, CA 95834. Providing your
request at least five business days before the meeting will help to ensure availability of the requested
accommodation.
Opportunities are provided to the public to address the committee on each open agenda item. Board members who are not on the committee may attend the meeting as observers. Action may be taken on any item on the agenda.
CONTINUING EDUCATION: Pharmacists and pharmacy technicians who attend the full committee meeting in person may be awarded two hours of Continuing Education (CE) in accordance with the Board’s CE policy. Sign‐in and sign‐out that day is required for the CE credit.
Opportunities are provided to the public to address the committee on each open agenda item. Board members who are not on the committee may attend the meeting as observers. Action may be taken on any item on the agenda.
CONTINUING EDUCATION: Pharmacists and pharmacy technicians who attend the full committee meeting in person may be awarded two hours of Continuing Education (CE) in accordance with the Board’s CE policy. Sign‐in and sign‐out that day is required for the CE credit.
Contact Person: Virginia Herold
(916) 574‐7911
Call to Order
A. LEGISLATION REPORT
A. LEGISLATION REPORT
9:00 a.m.
1.
Board‐Sponsored Legislation for 2013
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SB 294 (Emmerson) – Compounded Sterile Drug Products
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Board‐Approved Proposals for 2013‐2014
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Board Proposal – Section 4046 “Correctional Pharmacy” Defined
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Omnibus – SB 822, SB 821
Agenda
Page 1 of 3
Meeting Materials will be available on the board’s Web site at www.pharmacy.ca.gov by April 9, 2013.
Continue reading here
Meeting Materials will be available on the board’s Web site at www.pharmacy.ca.gov by April 9, 2013.
Continue reading here
AMCP, Pharmacy Stakeholders Discuss Compounding Issues at FDA Meeting
The Academy joined other pharmacy stakeholders last month in an invitation-only meeting on pharmacy compounding issues. The Dec. 14 meeting was convened by the Food and Drug Administration (FDA) in the wake of the deadly fungal meningitis outbreak linked the New England Compounding Center’s (NECC) production of tainted drugs.
The pharmacy groups were generally in agreement that the recent actions of NECC constitute illegal manufacturing and not pharmacy compounding. While the participants indicated that distinctions are necessary to delineate traditional compounding from larger-scale activities, no specific recommendations were offered.
The pharmacy groups focused on the need to ensure that pharmacies that compound conform to the standards in USP Chapters 795, non-sterile preparations and 797, sterile preparations. State boards must be given resources and training to understand issues associated with compounding practices. Accreditation of compounding pharmacies should be highly encouraged but not required.
The FDA noted that eliminating the ability to conduct larger-scale compounding activities would disrupt hospitals and cause unnecessary financial implications.
The FDA further indicated that the traditional distinctions between compounding and manufacturing may not be suited for the needs of modern medicine, particularly as personalized medicine will require more customized preparations.
To meet these needs, FDA has offered recommendations for a two-tiered approach giving FDA oversight for large scale compounding and allowing the states to maintain oversight of traditional pharmacy compounding. Some members of Congress and various pharmacy groups reject this approach and prefer oversight be maintained by state boards with a default to FDA only if states fail in their responsibilities.
This meeting was one of many ongoing meetings between FDA and health care professionals, consumer groups, state boards, hospitals, and other entities affected by compounding.
Other pharmacy stakeholders at the meeting included: American Association of Colleges of Pharmacy; American Pharmacists Association; American Society of Health-System Pharmacists; International Academy of Compounding Pharmacy; Institute of Safe Medication Practices; National Association of Chain Drug Stores; National Community Pharmacists Association; Pharmacy Compounding Accreditation Board; Society of Veterinary Hospital Pharmacists; and, Express Scripts, Inc. Participants from FDA included representatives from the Administrator's office and key pharmacists and others with pharmacy expertise from various sections of the Agency.
Of 40 pharmacies inspected by FDA 11 ordered to halt all or part of componding
Web Exclusives
NECC Crisis Shifts Focus to Hospital Sterile PreparationCompounding Update
Three out of four (74%) of 412 survey respondents—most of them pharmacists—reported that contamination could be a risk for their facilities, and 13% said that contamination actually had occurred during the past year.
Those findings came as no surprise to Darryl S. Rich, PharmD, MBA, FASHP, a medication safety specialist at ISMP. Based on hospital visits he has made, Dr. Rich told Pain Medicine News, hospital pharmacies are “not quite there yet” in complying with U.S. Pharmacopeia (USP) Chapter <797> standards.
For hospital pharmacies trying to upgrade their facilities to comply with USP standards, it is “mostly the facility-based issues that are the toughest” to contend with, said Dr. Rich, noting that cramped pharmacy space was often the biggest obstacle. “When hospitals do it successfully,” he added, “it’s either because the pharmacy has moved or they were able to get space next door. In some cases, it is just not a priority to improve the pharmacy’s IV room.”
As a result, he continued, “a lot of pharmacies have gone to outsource vendors because they figured they couldn’t do it themselves, particularly with regard to higher-risk compounded products.” The problem, he said, was their “level of trust” that there were “regulatory bodies out there” that were evaluating the outsourcers and making sure they remained compliant. “That obviously turned out not to be true,” he said.
More Stringent Inspections
In the wake of the fungal meningitis outbreak, the inspections carried out during the resultant crackdown in Massachusetts were extremely rigorous. Of the 40 sterile compounding pharmacies that received unannounced visits by teams of internal investigators and outside consultant experts hired by the Department of Public Health (DPH), 11 were ordered to halt all or part of their compounding activities, and 21 were cited for minor infractions that since have been corrected. The serious violations included noncompliance with required USP standards for preparation, storage and dispensing of sterile products, including some hazardous medications. Several pharmacies were cited for faulty facility design and controls.
The thoroughness of the inspections contrasted sharply with the regulatory laxity that existed prior to the multistate meningitis outbreak, attributed to contaminated methylprednisolone shipped by the now-shuttered New England Compounding Center (NECC), of Framingham, Mass.
“When you’re under the microscope, you don’t just get the walk-through, you get the fine-toothed comb,” said Michael Cotugno, RPh, the director of pharmacy patient services at Brigham and Women’s Hospital, in Boston. Mr. Cotugno was a member of the pharmacy compounding oversight commission appointed by Gov. Deval Patrick to recommend actions to strengthen the state’s regulatory surveillance in the wake of the NECC-linked public health disaster.
The oversight commission’s chairman, Christian Hartman, PharmD, MBA, the director of clinical quality and patient safety at Wolters Kluwer, said that before the meningitis outbreak, the annual budget for the volunteer state Board of Registration in Pharmacy and inspection staff was insufficient to provide comprehensive inspections. The new FY 2014 budget submitted by Gov. Patrick is for $1.3 million. “The new funding is intended to support increased inspections of compounding pharmacies and increased training of inspectors,” according to the Massachusetts Budget and Policy Center. Under the current, FY2013 budget the board received $182,600.
Additionally, the DPH hired the pharmacy consulting firm Comprehensive Pharmacy Services (CPS) to help carry out the inspections. “We were able to provide the resources needed to establish a comprehensive checklist for the pharmacy inspections,” said Edward Choy, PharmD, a divisional vice president for CPS.
“They’re using pharmacists” for inspections now, Dr. Hartman said, “and that’s a good thing. The unfortunate piece,” he added, is that there are “a lot more pharmacies that are doing medium- to high-risk compounding.” He said that it was time that all compounding pharmacies, including those operating within the state’s hospital systems, receive the same level of scrutiny as the smaller outsource pharmacies targeted in the initial inspection wave. “Raising the bar for providing high-quality and safe compounding services is something pharmacists welcome,” said Dr. Hartman.
Hospital compounding practices may be among the next in line to undergo DPH scrutiny. “We expect that to be the case,” Mr. Cotugno said. “Obviously they started with where the problem came from. But when this broke in Massachusetts, the DPH contacted all the hospitals and said we want to make sure you’re doing all you can to be compliant with USP <797>.”
Constant Monitoring Required
That requires constant vigilance, Mr. Cotugno noted. “Just because you look good today, doesn’t mean that you’re going to look good tomorrow. That’s why you have to keep monitoring because you never know when someone is going to cut a corner. All it takes is one day for a break in technique” to occur, he said.
So far eight of the 11 Massachusetts pharmacies whose compounding activities were halted have submitted corrective plans. But the DPH said that cease-and-desist orders would remain in place until pharmacies come into compliance with USP <795> and <797>.
“That is all for the greater good of patients,” Mr. Cotugno said. “We will get a better quality compounding pharmacy, and maybe we’ll have fewer of them. Some of them are behind the times and won’t want to invest the resources” needed to upgrade to the new standards. “If that’s the case, they need to get out,” he said.
In the ISMP survey, most respondents (74%) said that accrediting agencies, such as the Joint Commission, should be responsible for monitoring external compounding pharmacies’ compliance with USP <797>.
“I think that’s great,” Dr. Rich said, “but it’s just that it’s not what the accrediting agencies are doing.” He added that most accrediting agencies’ surveys cover only their own standards, and in the case of the Joint Commission, although compliance with state law and regulation is required, USP <797> compliance is neither part of its standards nor surveyed.
One answer, he said, might be for regulatory bodies to mandate accreditation for external compounding pharmacies, just as the Centers for Medicare & Medicaid Services (CMS) requires Joint Commission accreditation for hospitals. The regulatory bodies then could mandate compliance with <797> and the accrediting agencies would have to survey for that. Also, if CMS mandated that the agencies that accredit hospitals comply with USP <797>, then those agencies would have to survey for it.
However, he said, “right now if it is just going to be left up to the accrediting agencies and the states, it doesn’t become mandatory unless it becomes law.”
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3/31/2013 Question of the Day: Do Unsafe Compounded Veterinary Drugs Poses Just As Great A Public Health Risk As Contaminated Compounded Human Drugs?
If so, why does the FDA and state boards of pharmacy and others not seem to pay any attention to this area?
Pols may doctor Gov. Deval Patrick’s pharmacy bill
By:
Lawmakers will examine Gov. Deval Patrick’s compounding pharmacy bill and may add their own measures as they try to plug regulatory loopholes revealed by the deadly nationwide fungal meningitis outbreak tied to Framingham-based New England Compounding Center.
“There are a number of sections that absolutely make a lot of sense, but we’re going to come up with some ideas as well,” said state Rep. Jeffrey Sanchez (D-Jamaica Plain), the chairman of the Joint Committee on Public Health. “We’re doing this in as thoughtful a manner ... so that this never happens again.”
The meningitis outbreak has led to at least 730
cases and killed 51 patients in 20 states, according to the Centers for Disease Control and Prevention.
Patrick’s bill, which one former federal official labeled “a great first step,” would tighten restrictions on Bay State compounding pharmacies by requiring that they obtain special licenses and by reducing the mandated number of pharmacists that sit on the 11-member Board of Pharmacy. The state also would hire more inspectors and install whistle-blower protections for employees.
“The Department of Public Health has made great strides to increase regulation of pharmacies over the past six months, and the governor’s legislation would further enhance our oversight of this industry,” said Department of Public Health spokesman Dave Kibbe in a statement.
Interim Department of Public Health Commissioner Lauren Smith, compounding pharmacists and a representative from the Massachusetts Hospital
Association are all expected to testify as the committee looks at a dozen pharmacy-related bills in tomorrow’s hearing.
Last week, Woburn-based Pallimed Pharmacy recalled its sterile compounding products after a joint inspection by the state pharmacy board and the FDA revealed vials contaminated with unidentified “visible particulates.”
That news surprised Sanchez, who told the Herald a trade group had showed him around Pallimed in November, citing it as a standard-bearer for the industry.
“I’m blown away. Flabbergasted,” Sanchez said. “I’m speechless at this point.”
Pallimed spokesman Scott Farmelant said, “Pallimed has always embraced the best practices in its procedures in terms of providing the highest possible level of patient safety.”
Source found here
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