Tennessee Board of Pharmacy Advices Pharmacies to Revisit Sterile Compounding Board Rules and that Wholesaler/Manufacturer/Distributor May NOT be Named as to Imply It is A Pharmacy

Pharmacies Advised to Revisit Sterile Compounding 
Board Rules
As discussed in the last two Board meetings, investigators have started
to use a more detailed checklist guide when inspecting sterile compounding
pharmacies. It is advised that according to Tennessee Board of Pharmacy
Rule 1140-07-.03(f), “ . . . Prefilters in laminar flow hoods shall be
changed at least quarterly and a written record of such change shall
be maintained. . .” Pharmacists may believe that they are in compliance
if the semi-annual certification has been satisfied. However, the certifying
technician may only be changing the prefilter every six months as opposed
to the required three-month period.
Moreover, pharmacists are expected to give examples of compliance
with regard to the physical requirements of sterile compounding as stated
in Rule 1140-07-.03, labeling as stated in Rule 1140-07-.05, hazardous
products as stated in Rule 1140-07-.06, attire as stated in 1140-07-.07, and
quality assurance as stated in Rule 1140-07-.08.
As described, pharmacists shall document proper sterile compounding
training and annual continuing education of all compounding personnel.
Updated sterile compounding policies and procedures are expected to be
readily available for investigator review, and should address each item on
the list located in Tennessee Board of Pharmacy Rule 1140-07-.04. The
Board expects for policies and procedures to be complete. Pharmacists are
expected to follow these policies and procedures for the health and safety
of the patient. Refer to Rule 1140-02-.01(11), which states in part “ . . . A
pharmacist shall provide pharmaceutical service: (a) which is as complete
as the public may reasonably expect; (b) without discriminating in any
manner between patients or groups of patients; and (c) without compromising the
kind or extent of services or facilities made available. . .”


A Wholesaler/Manufacturer/Distributor May NOT Be 
Named as to Imply That It is a ‘Pharmacy’
As more pharmacies choose to obtain a Board wholesaler/manufacturer/distributor (W/M/D) license, it is advised to revisit the definition of
“Pharmacy” in the Tennessee Pharmacy Practice Act. As stated in TCA
63-10-204 (32), “ . . . ‘Pharmacy’ means a location licensed by the state
where drugs are compounded or dispensed under the supervision of
a pharmacist, as defined in the rules of the board and where prescription
orders are received or processed . . . ” A W/M/D may distribute, but
not dispense. As an example, the title name “ABC Pharmacy” implies
it is a pharmacy as there is no identifier after the word pharmacy. “ABC
Pharmaceutical Supplies” implies it is a supply company. Therefore,
be advised to avoid using the word “pharmacy” when selecting a name
for the Board W/M/D license.

Source found at Tennessee Board of Pharmacy March 2013 Newsletter

Idaho Board of Pharmacy Notice of Intent to Promulgate Rules Regarding Compounding

Notice of Intent to Promulgate RulesNegotiated Rulemaking
When: April 4, 2013, 8 am MST
Where: Idaho State University (ISU), Pond Student Union,
Pocatello, ID
Descriptive Summary: The public meeting will address at least
the following two topics: compounding and prescription delivery
law.
Method of Participation: Anyone may submit written or verbal
comments regarding this negotiated rulemaking. All written comments may be directed to Mark Johnston at mark.johnston@bop
.idaho.gov on or before March 19, 2013. Written and verbal comments will be heard before the Board in the open, public meeting.

West Virginia Board of Pharmacy Compounding v. Manufacturing

Compounding Versus Manufacturing:
Do You Have a Prescription?
In view of the relatively recent meningitis outbreak due to
the unsanitary conditions at the New England Compounding
Center (NECC), FDA, Congress, and states have been looking
at the practice of compounding in the states to look for ways to
prevent a future issue such as the one at NECC. Therefore, the
Board felt that a review of the compounding rules may be helpful.
As such, the Board looked at its position at the December
2012 Board meeting, and reaffirmed its support for current laws
in this state covering compounding.
First, the Board fully supports compounding for prescriptions,
and distinguishes it from manufacturing when done for
that purpose. The current statutory definition in current West
Virginia Code §30-5-1b(6) is:
(6) “Compounding” means:
(A) The preparation, mixing, assembling, packaging
or labeling of a drug or device:
(I) As the result of a practitioner’s prescription drug
order or initiative based on the practitioner/patient/
pharmacist relationship in the course of professional
practice for sale or dispensing; or
(ii) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing; and
(B) The preparation of drugs or devices in anticipation
of prescription drug orders based on routine, regularly
observed prescribing patterns.

Therefore, unless it is for a research, teaching, or other similar
situation that is not for sale or dispensing, pharmacies may
compound only for individual prescriptions, or in anticipation
of their regular and routine prescription-dispensing needs.
Second, looking at the Massachusetts situation as an example,
because of the quantities shipped by the NECC, it appears
they were manufacturing and selling at wholesale, and not for
individual prescriptions. This would be wholly illegal under West
Virginia law unless the pharmacy gets the proper licensures. If
a pharmacy manufactures, it is legal only if the pharmacy gets
licensed as a manufacturer and follows all state and federal
laws governing manufacturing of prescription drugs. Further,
if a pharmacy were to sell its manufactured products, then it
would need to be properly licensed as either a manufacturer
or wholesaler/distributor in the jurisdictions into which it is
sending its product (note, of course, this is different than the
exception to wholesaling drugs where a pharmacy is simply
making distributions that do not exceed 5% of their business,
such that a wholesale license is not required).
Third, in order to protect the safety of the public, naturally,
great scrutiny is put on manufacturers for good manufacturing
practices and standards. Likewise, compounding must be done
in a safe manner to protect the patient. Rule §15-1-18 sets
minimal standards in West Virginia for sanitary regulations in
the pharmacy. Further, Rule §15-1-16 governs compounding
in this state, which, among other things, requires in Subsection
16.3 that “. . . [t]he environment shall facilitate controlled
aseptic conditions and meet all standards of the United States
Pharmacopeial Convention (USP). . .” That is why when
inspecting a compounding pharmacy, the Board looks for USP
Chapters 795 and 797 compliance (flow hoods, donning and
doffing antechambers, sterility, etc).
In summary, if you do compounding, be sure you have a
prescription for each shipment to a patient. Make sure you
are doing it in a clean and safe environment, and are properly
handling the materials and instruments used to serve your
patients. Compounding is at the heart of the practice of pharmacy,
and to keep it there, every person involved in the process must
do his or her best to safeguard the art by keeping the safety of
the patient first and foremost at all times.

Source West Virginia Board of Pharmacy March 2013 Newsletter

North Dakota Board of Pharmacy Compounding Regulations and Compounding of OTC

Compounding Regulations
With the recent tragedy of the meningitis outbreak originating
from the New England Compounding Center in Massachusetts,
the topic of compounding pharmacy practice and regulatory issues has
been brought to the forefront on both a federal and state level. On the
federal level, it remains to be seen what changes or
legislation will be identified in response to this tragedy. The state
boards of pharmacy and Food and Drug Administration (FDA)
have identified a lack of clear definition of what constitutes a
manufacturer versus a compounding pharmacy.
The North Dakota State Board of Pharmacy feels that there
is a need to have this clear definition to ensure there will be the
proper regulatory framework to provide oversight over each of
these industries. Out of this tragedy, the Board wants to provide
a reminder for its licensees of the laws and rules that are specific
to compounding.
♦ Compounding should be done pursuant to a patient-specific prescription.
The Board allows you to make batches of a compounded product but only
pursuant to a likely need.
♦ North Dakota law allows you to compound for “office
use” for practitioners. The Board requires the pharmacist
to ensure the product will only be used within the office
setting and not dispensed by the practitioner to the patient.
♦ The Board recently passed rules that closely mirror United
States Pharmacopeia Chapters 795 and 797 standards. Be
sure that you look at these, which go into effect in January 2015, to
ensure your pharmacy is compliant at that time pursuant to the compounding
activities that your pharmacy is engaged in.
♦ Maintain a compounding log of each of the prescriptions
being formulated. Keep the records for five years.
The Board is not looking to make any changes to the current
laws and rules currently governing compounding pharmacies at
this time. Future inspections at in-state pharmacies who engage in
compounding activities will be more detailed and comprehensive.
The Board will be looking at solutions to address the quality
assurance and inspections of out-of-state compounding pharmacies
to ensure proper procedures and safeguards are consistent
for a high level of patient care for North Dakota residents. The
Board may look to work with the National Association of Boards
of Pharmacy® and their current inspection process for compounding pharmacies
as a potential solution.

Board Discusses OTC Compounding

During the most recent Board meeting, discussion was had on
how to regulate over-the-counter (OTC) compounding in North
Dakota. Board members expressed the desire to continue for the
Board staff to see labels on those OTC drug products that pharmacies
compound to ensure that proper material is contained on
the label so a patient is properly educated on the product. Board
members felt labeling similar to the current structure from the
Federal Trade Commission is necessary

Source North Dakota Board of Pharmacy March 2013 Newsletter

NCPA submits comments to CMS over wide range of issues MARCH 4, 2013 | BY MICHAEL JOHNSEN

ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday submitted written comments urging the Centers for Medicare and Medicaid Services to take action on a wide range of what NCPA characterizes as "anti-patient, anti-pharmacist practices," the association announced. 

***

Preserve beneficiary access to compounded medications. "CMS should omit from the final call letter any prior authorization requirements for compounded medications. Such a mandate would represent a significant federal infringement onto medical practice and doctors’ prescription rights, and would decrease and delay beneficiaries’ access to care";

To read the rest of this article click here

Meningitis outbreak: Saint Thomas clinic blames FDA, state officials

Mar. 4, 2013 5:49 PM

Lawyers for the clinic where dozens of patients were injected with tainted spinal steroids say the FDA and state officials in Tennessee and Massachusetts bear responsibility for the fatal outbreak of fungal meningitis.
In a 55-page answer to a suit pending in Davidson County Circuit Court, lawyers for the Saint Thomas Outpatient Neurosurgery Center say the facility “complied with the acceptable standard of professional practice and acted without wrongdoing” in selecting a Massachusetts firm as the source of drugs.
“The defendants deny that Ms. Reed is entitled to any recovery,” the filing submitted by lawyers with Gideon, Cooper & Essary PLC states.
The filing came in a lawsuit filed by Wayne Reed, whose wife and caregiver, Diana Reed, died from fungal meningitis after treatment at the clinic. Reed died on Oct. 3, 2012, after receiving three injections of methylprednisolone acetate at the Nashville clinic.
In addition to the government agencies, the clinic’s answer charges that the owners and operators of the New England Compounding Center and its sales company bear responsibility. The salesmen were identified as John Notarianni and Mario Giamei of Medical Sales Management, NECC’s sales arm.

continue reading here

An Interview: The Woman in Charge: Margaret Hamburg

FDA Commissioner Margaret Hamburg shares her thoughts on recent health initiatives and the regulatory role of government.

By Geng Ngarmboonanant


Dr. Margaret A. Hamburg has served as the 21st commissioner of the U.S. Food and Drug Administration since May 2009. She graduated from Harvard Medical School and previously worked as the assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services.

The Politic: I want to start with a question that you probably receive often – what were the early influences on your career? Why did you decide to go into healthcare, or rather, the intersection between healthcare and public policy?

My interest in medicine evolved very early. I had two parents who were physicians, both professors at Stanford Medical School. I grew up right on the Stanford campus, and the parents of many of my friends were either physicians or scientists or in related fields. It looked like interesting and important work to me. When I started college, I began to realize that there were many other things I could do, but I always found myself coming back to medicine, and ultimately decided that was what I really wanted to do.

But I hadn’t really contemplated a career in public service until medical school, when I was very much influenced by the emergence of the AIDS epidemic. When I started medical school, nobody was aware of this new disease. In fact, when I was a freshman, I was taught that the era of infectious disease threats was over with the advent of antibiotics and vaccines and good sanitation practices–and that the future of medicine was chronic disease–and then watched this initially mysterious and devastating disease emerge, with no one knowing the cause, what to call it or how to treat it.

Continue reading here

 

 

R.I. Health Department shuts down pharmacy that mixed fertility drugs

March 1, 2013 3:24 pm

By Felice Freyer

In a rare move, the Health Department on Friday shut down a specialty pharmacy in Lincoln, R.I., for improperly compounding fertility drugs.

The department also pulled the license of its pharmacist.

The Rhode Island Village Pharmacy, at 1 Commerce St., and pharmacist Elise Varkonyi both received summary suspensions for violations that included mixing drugs without a proper ventilation hood, failure to monitor surfaces and the air for microorganisms and mislabeling drugs made in Massachusetts as having been made in Rhode Island.

Catherine A. Cordy, Pharmacy Board executive director, said that fewer than 100 Rhode Island patients had received drugs from Village Pharmacy and there was no evidence of patient harm. This is the first time in recent memory that the department has shut down a pharmacy, Cordy said.

Sterile Drugs Often Contaminated

Written by Beasley Allen on Monday, March 4, 2013 10:18

As deaths continue to climb in the ongoing outbreak of fungal meningitis infections caused by contaminated pain shots, a new survey of hospital pharmacists shows that they believe it could happen again. About 13% of pharmacists, pharmacy technicians and others who responded to a poll from the Institute for Safe Medication Practices said that they believed contamination had occurred in the compounded sterile drugs made by their shops last year. Those are the same types of drugs that have been blamed for 45 deaths and nearly 700 infections in people who received tainted injectable steroids made by the New England Compounding Center of Framingham, Mass. This outfit has been shut down, according to the Centers for Disease Control and Prevention.

continue reading this report here

FDA Scraps Bar Code Experiment With Compounder

In the wake of the fungal meningitis outbreak that was linked to a compounding pharmacy and has so far caused as many as 45 deaths, the FDA has nixed an experiment proposed several years ago by a different compounding pharmacy that hoped to use bar codes after its medicines were shipped as a way of identifying patient use. The idea, of course, is not the same as compounding specific drugs for individual patients with prescriptions ahead of time.

The proposal, which was made by PharMEDium Services, actually dates to 2005. But in a recent letter to the compounder, the FDA cites two reasons for changing its mind. The first, of course, is the scandal over meningitis, which was traced to the New England Compounding Center. The pharmacy, which recently went bankrupt and is being sued by some patients, had all sorts of cleanliness problems, according to a subsequent FDA inspection (see this and this).

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Tales of competition through regulation III: pharma v. compounding pharmacies by WALTER OLSON on MARCH 4, 2013

Compounding pharmacies, which mix medications to order, are a corner of the drug business that has been much less heavily regulated than mass-manufacturing drug companies. As a result, the compounders began expanding their market presence as against the mass manufacturers, and even get into mass manufacturing methods themselves. The process accelerated in the past few years after tightened FDA control of conventional makers’ production practices (under GMP, or Good Manufacturing Practice, regulation) began to result in widespread production-line suspensions; for hospitals and other users, the availability of compounded alternatives is often the only fallback in the face of shortages.

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China plans FDA-like food, drug watchdog: report

China plans FDA-like food, drug watchdog: report

Hamburg: Compounding, Global Regulatory Issues Top Two Upcoming Areas of Regulatory Focus

Hamburg: Compounding, Global Regulatory Issues Top Two Upcoming Areas of Regulatory Focus

Federal legislation hamstrings pharmacy, owner says

Federal legislation hamstrings pharmacy, owner says

Ed Silverman Pharalot Blog: FDA Begins Crackdown On "Risky" Compounders

In the wake of the scandal over the fungal meningitis outbreak, the FDA last month began a new crackdown on compounding pharmacies that is targeting about 30 so-called ‘high risk’ operations in nearly a dozen states and late last week disclosed that inspections reports were issued for four compounders for a variety of serious manufacturing violations.

continue reading Pharalot blog

Area, too, had deadly link to ‘compounding’ pharmacy - The News Desk

Area, too, had deadly link to ‘compounding’ pharmacy - The News Desk

Sequestration Day: FDA Will Manage For Now, But Could Suffer Later If Hiring Deferred By Derrick Gingery / Email the Author / Mar. 1, 2013 Word Count: 1023 / Article # 14130301008 / Posted: March 1 2013 5:55 PM

Sequestration Day: FDA Will Manage For Now, But Could Suffer Later If Hiring Deferred

By Derrick Gingery / Email the Author / Mar. 1, 2013
Word Count: 1023 / Article # 14130301008 / Posted: March 1 2013 5:55 PM

---

Executive Summary

As the across-the-board cuts go into effect, not allowing FDA to add the hundreds of new employees that will be needed to meet the goals of user fee and other programs could damage the agency for years to come; NIH and CMS also will see significant effects.

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Drug makers want crackdown on compounding pharmacies : Stltoday

Drug makers want crackdown on compounding pharmacies : Stltoday

Compounding effort Quality control, costs drive hospitals to mix drugs By Jaimy Lee Posted: March 2, 2013 - 12:01 am ET Read more: Hospitals turn to compound drugs because of quality, cost | Modern Healthcare http://www.modernhealthcare.com/article/20130302/MAGAZINE/303029974#ixzz2MVZZFUiR ?trk=tynt

As public officials and providers fret over the safety and cost of drugs bought from compounding pharmacies, more hospital systems are working on plans to mix and package the drugs themselves.

The multistate meningitis outbreak last year that led to 48 deaths and sickened another 714 people was caused by contaminated steroid injections produced by the New England Compounding Center.

Hundreds of hospitals in the U.S. purchased compounded drugs from NECC and Ameridose, a national compounder that shares ownership with NECC.

The outbreak triggered calls for stronger federal and state oversight of compounding pharmacies, especially for companies such as NECC and Ameridose that were operating more like drug manufacturers than traditional compounders before they closed last year.

“The tipping point for people who were close to making that decision was probably the Ameridose closure,” said Erin Fox, director of the drug information service at the University of Utah Hospitals and Clinics. “It was a wake-up call. They certainly trusted NECC and they trusted Ameridose.”

Read more: Hospitals turn to compound drugs because of quality, cost | Modern Healthcare http://www.modernhealthcare.com/article/20130302/MAGAZINE/303029974#ixzz2MVZmyUCe
?trk=tynt 

FDA springs surprise inspections on specialty pharmacies in targeted action | Concord Monitor

FDA springs surprise inspections on specialty pharmacies in targeted action | Concord Monitor

Lobbyist Efforts Grow for Stricter Regulations of Compounding Pharmacies

Drug companies have ramped up lobbying efforts in Congress to force specialty pharmacies to either stop mass-producing drugs or face stricter regulation.

Commercial drug makers are also trying to prevent these specialty pharmacies, known as compounders, from making “knockoff” drugs for people and their pets that the companies say are costing them millions of dollars in annual profits, records and interviews show.

This rapidly escalating struggle reaches far beyond congressional efforts to rein in reckless compounding pharmacies that began in October after tainted steroids from the Massachusetts-based New England Compounding Center (NECC) were linked to a meningitis outbreak that has killed 48 people.

Amid a public outcry, lawmakers began considering draft legislation to address public safety concerns. With a bill in the works, a range of companies, business associations and health organizations are pressing their interests.

Veterinary groups, for instance, are warning that any legislation requiring patient-specific prescriptions would deprive them of vital drug stockpiles and that pets would die at their clinics.

Hospitals want to ensure that any new oversight of compounders by the Food and Drug Administration does not cripple the firms’ operations, which could worsen drug shortages.

And the compounders, while agreeing that tighter federal enforcement of safety standards is needed for the large firms, are vigorously resisting the drug companies’ bid to limit competition.

The Senate Health, Education, Labor and Pensions Committee is working on draft legislation directed at compounders and is expected to begin circulating it to interested groups as soon as next month. The House Energy and Commerce Committee, meanwhile, is investigating whether lax oversight of NECC by the FDA contributed to illnesses and deaths.

Since Congress and other federal officials began investigating NECC last fall, the number of groups lobbying on issues related to compounding pharmacies has more than doubled, records show.

“Some are making blatant copies of FDA-approved products,” said Ron Phillips, who is lobbying for the Animal Health Institute, which represents drugmakers. “You can go to any trade show or to their websites and they are openly promoting this. A clear line needs to be drawn.”

Over the past two decades, many compounders — who custom-mix medications — have moved from a traditional practice of filling individual prescriptions to mass producing drugs, often without a prescription. Sometimes the drugs are similar to those made by drug manufacturers. Today, compounding is about a $2 billion-a-year industry.

Compounders supply about 40 percent of all intravenous medications used in hospitals, up from 16 percent a decade ago, according to industry estimates. Veterinary groups estimate that 20 percent of the medications they prescribe are compounded products.

Read more: http://www.voxxi.com/lobby-stricter-compounder-regulation/#ixzz2MVVPHL00 - See more at: http://www.voxxi.com/lobby-stricter-compounder-regulation/#sthash.3EHWqSVW.dpuf

Niels Erik Hansen: Automation can make compound medicine safer

Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened nearly 700 people in 19 states, and killed more than 40.

Michigan was particularly hard-hit and had the most cases in the nation. One of only two states with more than 100 cases of illness linked to the contaminated injections (the other is Tennessee with 150 cases), Michigan has seen 250 cases to date, and 13 deaths.

Although this outbreak is an egregious example of medication compounding gone awry, it is hardly an isolated incident. In December, the journal American Health & Drug Benefits reported that medication errors from injectable drugs harm more than 1 million patients annually in U.S. hospitals. Adverse drug events (ADEs) due to injectable medications cost U.S. healthcare payers between $2.7 billion to $5.1 billion annually, an average of $600,000 per hospital.

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Sequester: What Will Happen, What Won't Happen and What We Don't Know

Read this ABC Story

FDA Has No Plans To Furlough

FDAnews Drug Daily Bulletin March 1, 2013  | Vol. 10 No. 43   FDA: No Plans to Furlough Employees Under Sequestration The FDA does not anticipate having to furlough employees due to across-the-board spending cuts known as sequestration that are slated to kick in Friday. The agency will take other internal measures to absorb the cuts, including reducing travel and training, FDA spokeswoman Erica Jefferson told DID. She declined to provide specific details on the FDA’s plans to handle the cuts, but said they will have public health consequences. Drug Industry Daily

Compounding effort Quality control, costs drive hospitals to mix drugs Read more: Hospitals turn to compound drugs because of quality, cost

The closure of Ameridose, which controlled an estimated 70% of the compounding market with Pharmedium, worsened a shortage of several drugs already in short supply.

Read more: Hospitals turn to compound drugs because of quality, cost | Modern Healthcare http://www.modernhealthcare.com/article/20130302/MAGAZINE/303029974#ixzz2MOBTslPH
?trk=tynt 

California: CDPH AFL-Impersonation AlertC

February 28, 2013

The California Department of Public Health Licensing and Certification Program has issued an AFL to all health care facilities and providers because several facilities have recently reported visitors who claimed to be representing CDPH and/or the Department of Justice (DOJ) but who were unable to provide identification as such when asked. Do not supply any patient health information, of any kind, to someone who claims to represent either CDPH or DOJ who cannot provide an identifying badge issued by the appropriate department.The entire AFL is available on the CDPH L&C website at http://www.cdph.ca.gov/certlic/facilities/Documents/LNC-AFL-13-01.pdf. The AFL is also available in the Alert Details Section on the CAHAN Home Page.
Although not part of the AFL, occasionally Board of Pharmacy Inspectors are periodically impersonated as well. Please carefully check the credentials of anyone who represents themselves as a state inspector seeking admission into the pharmacy or patient information

- See more at: http://www.cshp.org/post/cdph-afl-impersonation-alert#sthash.Cqhs7OYJ.dpuf

Washington Post: FDA inspects specialty pharmacies in targeted action

By Lena H. Sun and Kimberly Kindy,

Mar 01, 2013 08:46 PM EST

The Washington Post Updated: Friday, March 1, 2:46 PM

Federal regulators found dozens of safety lapses at four large specialty pharmacies during surprise inspections conducted over the past two weeks in response to a deadly meningitis outbreak last fall that was linked to tainted drugs, according to records and interviews.
The inspections were the first targeted enforcement actions against the specialty pharmacies since the U.S. Food and Drug Administration found filthy conditions at a Massachusetts pharmacy that shipped contaminated steroid shots to 23 states. The shots caused the outbreak that has so far killed 48 people and sickened another 666, making it the country’s worst drug disaster in several decades.

Continue reading Washington Post here

ORA FOIA Electronic Reading Room 2013 Pharmacy Inspections

ORA FOIA Electronic Reading Room 2013 Pharmacy Inspections

MUST READ: High-Risk Compounding Pharmacies Targeted for FDA Review

About 30 “high risk” compounding pharmacies are being targeted by U.S. regulators for inspections over the next two months as part of intensified enforcement efforts after last year’s deadly meningitis outbreak.
The companies primarily make sterile drugs and distribute products to health-care providers nationwide, Erica Jefferson, a spokeswoman for the Food and Drug Administration, said today in a phone interview. The visits, which began Feb. 19 and will continue about two months, are the first proactive inspections the agency has conducted of compounding pharmacies, she said.
Facilities in Florida, Chicago, Arkansas and Mississippi were found with conditions that put their drugs at risk of microbiological contamination, the FDA said in four inspection reports today on its website. Drug compounders were thrust into the spotlight when New England Compounding Pharmacy Inc. shut down in October after its contaminated steroid shots were linked to a fungal meningitis outbreak that has killed 48 people.
“The recent tragic fungal meningitis outbreak has shed a harsh and important light on this area for us,” Jefferson said.
Compounding pharmacies traditionally prepare personalized prescriptions and are regulated by state health authorities. The meningitis outbreak revealed some companies go beyond that task by producing larger amounts of medicines, acting more like a drug manufacturer overseen by the FDA.
Typically the FDA waits for complaints against these pharmacies before doing inspections. Jefferson wouldn’t say how many of the businesses targeted have been inspected as of today.

Pharmacy Selection

The agency chose the pharmacies to inspect based on a potential for risk using adverse event reports turned in to the FDA, historical inspection data, reports of quality problems and public information. The FDA is working with state regulators to conduct the inspections
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Compounded Formulations From Retail Pharmacies Are Inaccurate in Respect to Potency Approximately 50% of the Time and Lack Content Uniformity Approximately 40% of the Time

NEW YORK, March 1, 2013 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc. (Nasdaq: VTUS) today announced the poster presentation of the results from its study investigating the quality of compounded topical 2% diltiazem hydrochloride formulations for anal fissures at the American Pharmacists Association Meeting currently underway in Los Angeles.
The use of topical 2% diltiazem hydrochloride for treating anal fissures has been explored in multiple clinical trials since 2000. In 2004, the Standard Practice Task Force of the American Society of Colon and Rectal Surgeons (ASCRS) published revised practice parameters for managing anal fissure and stated that topical formulations of calcium channel blockers may be appropriately used to treat anal fissure and accorded this practice parameter the highest level of evidence and highest grade of recommendation. Because no commercially manufactured version of topical 2% diltiazem has been approved by the US Food and Drug Administration (FDA) for treatment of anal fissure, colon and rectal surgeons, gastroenterologists, and other physicians who want to follow ASCRS practice parameters have to write prescriptions for a product that will be extemporaneously compounded by retail pharmacies. To examine the quality of compounded formulations of topical 2% diltiazem, Ventrus undertook a high-performance liquid chromatography (HPLC) analysis of preparations gathered from retail pharmacies in a metropolitan region.
A participating healthcare professional wrote 12 prescriptions, with 2 refills allowed per prescription, so that 3 prescriptions could be filled at each of 12 pharmacies (36 total refills) for compounded 2% diltiazem cream. The analysis included an assessment of potency (percentage of claim) and content uniformity, with sampling from 8 different pre-specified locations within the compounded formulation containers.
The United States Pharmacopoeia (USP) standard for potency is 90% to 115% of claim. Of the 36 preparations, 5 (13.89%) were supra-potent and 13 (36.11%) were sub-potent. The supra-potent prescriptions ranged in potency from 117.2% to 128.5% of claim, and the sub-potent prescriptions ranged in potency from 34.8% to 89.8% of claim. Fourteen (38.9%) preparations lacked content uniformity according to the USP standard.

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Florida’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company: Healthpoint Ltd for ointment Xenaderm

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement is in response to allegations of misrepresenting the regulatory status of an ointment used to treat skin conditions and submitting false Medicaid claims. Florida’s Medicaid program will receive almost $900,000 of the settlement.

Click here to see the press release from the AG’s office.

Pharmaceutical Company Allegedly Submitted False Claims to Medicaid.
According to the Department of Justice (DOJ), Healthpoint launched the ointment for the treatment of nursing home patients with bed sores. The settlement resolves allegations that Healthpoint marketed the ointment, Xenaderm, without the approval of the Food and Drug Administration (FDA) by modeling it on a pre-1962 drug that the FDA never reviewed. The DOJ states that the main ingredient in Xenaderm was determined by the FDA to be less-than-effective for its intended use. The government contends those determinations render the ointment ineligible for Medicaid reimbursements. Healthpoint is accused of knowingly submitting false claims to Medicaid programs.

To read the press release on the settlement from the DOJ, click here.

The settlement is th result of litigation by the United States Attorney’s Office for the District of Massachusetts, the DOJ and fifteen (15) states, including Florida.
Responding to a Medicaid Audit.
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Pharmacist sentenced to 2 years Pa. steroids case

AP
PITTSBURGH — A pharmacist has been sentenced to 2½ years in federal prison after pleading guilty to helping a former Pittsburgh Steelers team doctor illegally distribute anabolic steroids in an investigation spun off from a national crackdown on the performance enhancing drugs.
William Sadowski, 47, of Robinson Township, pleaded guilty in November to conspiracy to possess with intent to distribute anabolic steroids and human growth hormones, or HGH, and was sentenced Tuesday by Senior U.S. District Judge Maurice Cohill Jr.
Sadowski has acknowledged helping Dr. Richard Rydze illegally distribute the body-building substances and other drugs used to prevent their negative side effects or, at least, mask their use. On Tuesday, the married father of two told the judge he let greed and profit cloud his judgment.
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After failures, DPH seeks 30 new staffers to boost inspection ability By Andy Metzger | State House News Service March 01, 2013

FITCHBURG — Interim Commissioner of Public Health Lauren Smith said Thursday that when she took over the depart­ment, following a deadly meningitis outbreak and the closure of a crime lab that shook confidence in the regulators, she engaged in a “frank and brutally honest introspection” with her staff.
One result of that introspection is a proposed $32 million budget increase at DPH, bringing the total amount to $549 million, which would allow for increased inspections and oversight of health care, hazardous material, and substance abuse facilities. That would fund 30 new ­positions and send $1 million to the Board of Registration in Pharmacy, Smith said.
“The public in general goes through its business, its daily life and appropriately assumes that the services, the restaurants, the beaches, the mammography machines, or everywhere it goes, that someone has looked at that, and someone has made sure that it’s OK,” said Smith. “Our role, as I see it, is to make sure that the public’s assumption that those things are well taken care of is actually true.”
The public’s confidence in pharmacies was shaken last year as hundreds fell ill around the country with ailments, includ­ing fungal meningitis, from tainted steroids produced at the New England Compounding Center in Framingham. That outbreak, which has sickened 714 and killed 48 by this week, led to changes within DPH, including unannounced inspections at the state’s 40 sterile compounding pharmacies. Many of those ­revealed that the alleged lack of proper protocols at the Framingham pharmacy was not unique.
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Obstetrics & Gynecology News - Qualitative and quantitative measures of various compounded formulations of 17-hydroxyprogesterone caproate |4471506

Obstetrics & Gynecology News - Qualitative and quantitative measures of various compounded formulations of 17-hydroxyprogesterone caproate |4471506

Government Regulations Hinder Quality Control and Harm Consumers

The tragic case of the tainted medication produced by New England Compounding Center, which resulted in at least twenty-five deaths and hundreds sickened, highlights a little-recognized danger inherent in government regulation. As David Brown reported:

“[Purchasing pharmaceuticals from compounding pharmacies is] like buying your electricity from a different supplier. It looks like you’re getting the same stuff, but evidently you’re not,” says a physician at one of the seven outpatient treatment centers in Maryland that received methylprednisolone from a contaminated lot from the New England Compounding Center. A pain specialist, he’s been using compounding pharmacies [which produce customized drugs] “for at least five years, closer to 10.” He spoke on the condition of anonymity on the advice of his lawyer.

He’s never really thought of compounding pharmacies as different, less regulated, under-the-radar enterprises.

“From our perspective, they look like any of our other vendors,” he said. “They’re licensed and inspected; they have nice, pretty Web sites and sales teams and inspections. They look no different from Upjohn.”

This doctor operated under the assumption that government regulators assured all product integrity, creating in his mind a false sense of security. If there were no government regulation, how would his thinking have differed? Where would physicians and patients turn for information on medications and drug manufacturers? As Stella Daily Zawistowski explains in “How the FDA Violates rights and Hinders Health”:

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FDA sends warning letter to Philly dye company, Abbey Color, about water problems in drug products POSTED: Wednesday, February 27, 2013, 11:47 AM

David Sell

Abbey Color, Inc., an industrial dye manufacturer in the Kensington section of Philadelphia, was sent a warning letter by the U.S. Food and Drug Administration that said the company failed to ensure adequate purity of the water used in drug products including those for eye exams.

Fluorescein is a sterile liquid dye used in eye exams that look at blood flow in the retina and choroid, the two layers in the back of the eye.

Eye drops are put directly in the eye to dilate pupils. With the patient's chin resting in the camera's chin rest, pictures are taken of the eye. Then the fluorescein dye is injected into a vein, usually near the elbow. A second set of pictures is taken as the dye moves through the blood vessels in the back of the eye.

The warning letter said the FDA inspected the facility on East Tioga Street from March 13-23, 2012. The company's reply to the FDA observations was not acceptable, the agency said.

"Your firm uses water in the final purification step of Fluorescein USP, an API [active pharmaceutical ingredient] intended for use in sterile drug products," the letter said. "However, your firm failed to demonstrate that your purified water system can consistently produce water that is suitable for use in the manufacture of this API.

"This is a repeat observation from the July 21-August 8, 2010 inspection. In your response to observations made at the 2010 inspection, your firm promised actions it would take to assure reliable water quality. However, those changes were inadequate, as you continued to get periodic out-of-specification (OOS) endotoxin and total organic carbon (TOC) test results."

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Kansas Adopting New Rules and Regulations, Hiring and Training Inspector, Additional Inspections for Holders of Nonresident Permit in Another State

Compounding Issues
Last year’s deadly outbreak of fungal meningitis linked to
spinal injections of a pain-relieving steroid product produced
by the New England Compounding Center in Massachusetts
raised serious questions about the oversight of compounding
pharmacies and the appropriate role for federal and state
regulators. The Kansas State Board of Pharmacy and Kansas
Department of Health and Environment participated in a Food
and Drug Administration (FDA) intergovernmental meeting on
December 19, 2012. There was discussion on whether the states
had the resources to provide oversight of pharmacy compounding
and whether there was a way to rebalance federal and state
participation in the regulation of pharmacy compounding that
would better protect the public health.
The Board is very concerned about whether federal preemptions
will be enacted that could possibly undermine the
Board’s authority by removing its oversight in this area. The
Board has implemented a plan that includes the adoption of
rules and regulations for compounding. The regulations have
been approved by the Department of Administration and are
currently at the Office of the Attorney General for review. The
Board has asked the Office of the Attorney General to expedite
these regulations. The inspectors are going to receive additional
training related to compounding, and the Board is going to
work with the National Association of Boards of Pharmacy®
and other states to share its limited resources. The Board has
also requested that Board staff seek approval for hiring an
additional pharmacist inspector.
If you hold a nonresident permit in another state, be advised
that your pharmacy may get an additional inspection from the
state in which you are licensed. Make sure that you know the
laws of each state that you are registered in related to office use
because many states do not allow this practice. The Board will
cooperate with any state that wants an additional inspection of
your premises.
It is the Board’s goal to address the compounding issues in
order to adequately protect the public’s health, welfare, and
safety.
Source Kansas Board of Pharmacy March 2013 Newsletter

Treat a Veterinarian Prescription Exactly as You Would a Physician Prescription in Kansas

If you are filling veterinary prescriptions and you have questions or concerns about the drug prescribed, it is important to contact the veterinarian for clarification. Lowering or raising the dosage or substituting medication may seriously compromise an animal’s health. Do not make changes to veterinary prescriptions without first contacting the prescriber because drugs affect animals much differently than humans. After contacting the veterinarian, clarification or any changes made to the original prescription should be documented on the back of the original prescription.

Source found at Kansas Board of Pharmacy March 2013 Newsletter

Survey Investigates Attitudes on High-Risk CSPs Daniel Weiss, Senior Editor Published Online: Friday, March 1, 2013

The Institute for Safe Medication Practices surveyed hospital pharmacists and other practitioners about issues including who should be responsible for ensuring the safety of high-risk compounded sterile preparations.

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A survey carried out by the Institute for Safe Medication Practices in November and December 2012 addressed a range of issues regarding the preparation, oversight, and use of high-risk compounded sterile preparations (CSPs). The survey yielded responses from 412 hospital practitioners, primarily pharmacists but also including pharmacy technicians, nurses, and physicians. In the wake of the recent fungal meningitis outbreak caused by contaminated steroids, there is a great deal of concern over how to ensure compliance with sterility standards in pharmacies.
 
High-risk CSPs were defined as preparations in which non-sterile ingredients or devices play a role in preparation, necessitating sterilization before use. More than 1 in 10 respondents reported that contamination of CSPs had occurred in their facility in the last year, although there was some disparity in this regard between pharmacist respondents (11%) and pharmacy technicians (29%).  Just 50% of pharmacists and 38% of technicians expressed confidence that contamination had not occurred in their facility in the last year. In addition, almost 74% of all respondents said that contamination could occur in their facility.
 
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BREAKING NEWS: Contaminants in fertility drug called harmless

By Kay Lazar

 |  GLOBE STAFF   

  MARCH 01, 2013

Particles found floating in ­vials of a fertility drug that was recalled last week by a Waltham speciality pharmacy have been identified as apparently harmless pieces of the vial’s rubber stopper.

Laboratory results given to the Globe late Thursday by ­Village Fertility Pharmacy, which commissioned the ­report, concluded: “The ­vials contained numerous particles that contain polyisobutene with substantial amounts of talc and silica. This composition is typical of rubber stopper formulations.

Continue reading the Boston Globe article

Tufts Center for the Study of Drug Development: Study on the Structural Roots of Drug Shortages and The Shortages Effects on Kids

Pharm Exec recently asked the Tufts Center for the Study of Drug Development (TCSDD) to summarize new survey research—partly commissioned by a grant from Amgen—that documents the scope of the threat and identifies the structural roots of the shortages. In a larger sense, the study underscores how effective management of the drug supply chain is emerging as something much more than an engineering feat: instead it’s a societal obligation.

TCSDD developed a two-part methodology that entailed building a database of current drug shortages and conducting interviews with experience hospital pharmacists to gather first-hand knowledge of how drug shortages are managed and the challenges that they pose. Tufts CSDD staff gathered publicly available data on 240 drug shortages occurring between 2001 and February 2012, from lists maintained by the ASHP and the FDA.

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Rebuttal to "Just Say No To (Unapproved) Drugs for Horses"--Why You Can't Just Say No to Compounded Preparations

by Sue Tuck Richmond

Last night I posted an article entitled " Just Say Not to (Unapproved) Drugs for Horses."  Some might questions why I would post this, but as I have stated before I try to present all views on the blog and not just advocate one position.  After thinking about this article overnight, I felt the need to post a response to it. In the legal world we call this playing devil's advocate--presenting or arguing the other side.  And, I woke  up feeling the need to present  the other side of the argument.  First, I must state a disclaimer.  I am not an expert at all on drugs for horses nor do I pretend to be.  However, I feel certain that there are drugs or medicines that must be compounded for the treatment of horses, thus again making compounding essential and necessary in the veterinary world.  I will leave it to the readers who are experts about horse medications to tell the readers when the essential and necessary times are.  It is true that animals have died from bad compounds.  This can be blamed on a lack of enforcement of the rules and regulations, a lack of proper testing, lack of stopping those who cut corners and use substandard powders, don't have sterile rooms, and really don't care whether their preparations are any good or not.  Ultimately it is about allowing bad compounders to remain in business and compete against the good compounders, who are following the rules and regulations--who are doing the testing, who do have clean, sterile rooms, who don't cut corners or use substandard powders, who do care and take ever step to make sure their preparations are what they say they are.  It is easy for a manufacturer of FDA approved drugs to say "just say no." However, just saying no to unapproved drugs for horses or any animals cannot be the answer as this article suggests.