Thursday, May 31, 2012

List of FDA Warning Letters to Compounding Pharmacies

Although the following website located here has not been updated since 2010, it contains a list of the FDA Warning Letters to Compounding Pharmacies and Suppliers.  The website contains the following information:

FDA Warning Letters to 
Compounding Pharmacies and Suppliers

The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment. Most sellers do what FDA requests. This page indexes warning letters sent to compounding pharmacies and supllier that have prepared or distributed prescription drugs or other drug products that lack FDA approval.
This page was revised on July 19, 2010.

Research Compounding Pharmacies and Pharmacists and Make Informed Decisions Before Doing Business

The following article appeared here in the Edmond Sun on October 8, 2008.  The Oklahoma State Board of Pharmacy has fined or disciplined this pharmacist at least three times..  According to this article and records of the Oklahoma Board of Pharmacy, two of those violations related to compounding violations.  
This real life fact pattern poses numerous questions.  One question is:  Are disciplinary actions by state boards and the FDA sever enough?  Should the fines be stiffer?  How many times should a compounding pharmacy be allowed to violate the rules before it is shut down and the pharmacist's license revoked?  Does death of human life have to result before the pharmacy is closed and the pharmacist's license revoked?  Should more criminal actions be pursued for medical compounding errors?  Should complaints and disciplinary actions against  compounding pharmacies and pharmacists be more readily available to the public?  Is cost the sole reason there are less inspections and disciplinary actions of compounding pharmacies and pharmacists?  Wouldn't imposing more fines for violations cover any cost of  hiring additional inspectors and and conducting additional inspections?
All doctors, veterinarians, and the patients need to research the compounding pharmacy they plan to do business with by checking with the state pharmacy board and by doing an Internet search of the company and the pharmacist.  By doing the necessary research and asking penitent questions, doctors, veterinarians, and consumers can become more educated about compounding pharmacists, pharmacies, and compounded medications and make informed decisions about who to do business with.    Board suspends Edmond pharmacist Owner accused of seeing patients in place of a doctor

Mark Schlachtenhaufen

EDMOND — A state board has suspended the license of an Edmond pharmacist who filled prescription drugs without proper authorization. 

The Oklahoma State Board of Pharmacy has suspended until Dec. 15 the pharmacy license of Sherry Ross, owner of Sherry’s Drug, 220 S. Littler Ave., according to board records. Ross also was fined a total of $5,500. 

During the time Ross’ license is suspended, the board said Ross may not practice pharmacy, including consulting with patients, and Ross may not be present at Sherry’s Drug. Ross will be on probation from Dec. 15 through Aug. 10, 2013.

The board found that Ross was possessing “dangerous drugs” without a valid prescription, and that she dispensed the drugs to patients who did not have a valid patient-doctor relationship. Ross also failed to ensure that the prescription had been issued for a “legitimate medical purpose by an authorized practitioner” and that she submitted “fraudulent” billing reports, according to the board.

A message left for Ross at Sherry’s Drug on Wednesday was not immediately returned.

Pharmacy board compliance officer Gary LaRue said under state rules, patients must have a relationship with a doctor in order to get prescription drugs. Normally, patients take a prescription written by a doctor to the pharmacy to get it filled.

Ross was working with patients who were unhappy with their doctors to obtain their hormone replacement medication, LaRue said. Ross would dispense medication to patients without the patients ever seeing a doctor, he said.

“Ross was more or less acting as their doctor,” LaRue said. 

LaRue said he thinks Ross is a “good” pharmacist, very knowledgeable about what she does and good with patients, but she must abide by the rules. 

LaRue said the board became aware of Ross’ violations after it reprimanded Dr. Paul Edmonds, an obstetrician-gynecologist. LaRue said Edmonds had an agreement with Ross involving seeing patients, and he was not seeing them.

“That was the problem,” LaRue said.

This was not Ross’ first reprimand by the board. 

In February 2005, Ross was cited for 11 counts that included improper substitution on a compounded prescription, record-keeping and filling prescriptions before having a written prescription.

Under an agreed-upon order, Ross was fined and placed on probation. Ross also was listed in board minutes in April 2005 and in July 2005.

This record of violation also appears on the Oklahoma State Pharmacy Board's website:

Ross, Sherry Lynn Covert, R.Ph. LIC. #9815Edmond
Charge: Allowing unlicensed person to compound drugs; manufacturing without a permit.
Action: 3 yr. probation 4/94 and fined.  Click here.

Recall: Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400 used to compound intravascular administration

FDA Enforcement Report dated May 20, 2012, found here, includes the following recall.
The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. Pharmacy compounding system for mixing ingredients for intravascular administration. Recall # Z-1371-2012
Units: 30248; 30304; 30577; 30578; 30600; 30321; 30264; 30507; 30256; 30120; 30587; 30778; 30779; 30512; 30218; 30136; 30260; 30549; 30612; 30940; 30268; 30415; 30949; 30300; 30435; 30162; 30269; 30356; 30291;30464; 30915; 30916; 30235; 30136; 30150; 30394; 30704; 30705; 30180; 30134; 30207; 30208; 30376; 30419; 30420; 30510; 30534; 30547; 30548; 30583; 30589; 30590; 30591; 30629; 30630; 30644; 30645; 30654; 30661; 30674; 30686; 30687; 30698; 30699; 30702; 30703; 30707; 30708; 30739; 30752; 30756; 30759; 30765; 30772; 30791; 30793; 30800; 30801; 30816; 30830; 30831; 30836; 30842; 30843; 30869; 30870; 30886; 30899; 30900; 30932; 30935; 30936; 30937; 30938; 30950; 30961; 30962; 30963; 30970; 30981; 30984; 30985; 30997; 31003; 30004; 31027; 31028; 31035; 31036; 31055; 31056; 31074; 31077; 31080; 31081; 31084; 31085; 31097; 31118; 31119; 31120; 31129; 31134; 31142; 31161; 31162; 31163; 31169; 31170; 31171; 31172; 31173; 31174; 31181; 31182; 31194; 31201; 31211; 31212; 31213; 31214; 31215; 31216; 31216; 31217; 31224; 31237; 31238; 31262; 31263; 31264; 31265; 31267; 31268; 31269; 31270; 30918; 30706; 31266; 30943; 30527; 30138; 30323; 30651; 30241; 30515; 30805; 31061; 30440; 30441; 31240; 31006; 30818; 30297; 30798; 30331; 30677; 30579; 30105; 30362; 30287; 30194; 30384; 30489; 30544; 30863; 30203; 30148; 30332; 30978; 30993; 30994; 30360; 30697; 31053; 31054; 31141; 30934; 30137; 31001; 31002; 31029; 31030; 30769; 30770; 30771; 30237; 31104; 31105; 30809; 30810; 31271; 31272; 30727; 31123; 30299; 30341; 30274; 30316; 30141; 30142; 30678; 30679; 30855; 30856; 30490; 30382; 30982; 30983; 30201; 30202; 31179; 31180; 30977; 30799; 30389; 30397; 30465; 30478; 30624; 30443; 30234; 30422; 30242; 30551; 30251; 30781; 30296; 30225; 30638; 30976; 31071; 30722; 30367; 30611; 30819; 30820; 30483; 30484; 30192; 30258; 30974; 30885; 30214; 30290; 30572; 30712; 30787; 30461; 30313; 30523; 30754; 30767; 30682; 30393; 30184; 30343; 30398; 30400; 30616; 30617; 30500; 30574; 30554; 30161; 30567; 30609; 30975; 30280; 31050; 30245; 30806; 30302; 30724; 30294; 30675; 31019; 31020; 30528; 30576; 30462; 30713; 30479; 30480; 30850; 30851; 31015; 31016; 30432; 30780; 30757; 30758; 30584; 30733; 30734; 30605; 30995; 30844; 30231; 30450; 30874; 31116; 31117; 30680; 30117; 30355; 31115; 30346; 30841; 31127; 30627; 30882; 30187; 30349; 30325; 30447; 30580; 30785; 30449; 30491; 30506; 30348; 30598; 30354; 30681; 30919; 31076; 30966; 30967; 30498; 30511; 30466; 30471; 31064; 30575; 30164; 30205; 30838; 31110; 30672; 30725; 30620; 30621; 30613; 30570; 30639; 30944; 30945; 30658; 30660; 31033; 31044; 31057; 30571; 30236; 30906; 30179; 31195; 31196; 30539; 30540; 30334; 30335; 30659; 30939; 30175; 30240; 31051; 30210; 31258; 31259; 30545; 30550; 30320; 30615; 30927; 30928; 30387; 30417; 30959; 30960; 30951; 30952; 30531; 30532; 30622; 30130; 30160; 30255; 30503; 30504; 30846; 30636; 30603; 31025; 31034; 30730; 30633; 30738; 30115; 30156; 30372; 30433; 30606; 30783; 30177; 30493; 31075; 30488; 31017; 30773; 30775; 30525; 30533; 30804; 30135; 30267; 30340; 30463; 30894; 30941; 30889; 30481; 30494; 30709; 30796; 30872; 30381; 30890; 30876; 30198; 30157; 30229; 30526; 30111; 30273; 31072; 31073; 30634; 30723; 30221; 30296; 30676; 31018; 30835; 30803; 30811; 30924; 30905; 30641; 30642; 30149; 30216; 30595; 30128; 30188; 30185; 30524; 30563; 30152; 30270; 30306; 30505; 31207; 31208; 30369; 30254; 30406; 30497; 30784; 31111; 30469; 30826; 30519; 30520; 30541; 30625; 30688; 31151; 30535; 30536; 30986; 30987; 30197; 30247; 30486; 30592; 31112; 31012; 30305; 30475; 30379; 30812; 31239; 30619; 30343; 30223; 30288; 30366; 30217; 30700; 30174; 30263; 30314; 30685; 30308; 30209; 30204; 30412; 30315; 30378; 30345; 30789; 30508; 30653; 31159; 31160; 30908; 30499; 30683; 31065; 30448; 30477; 30807; 30808; 30742; 30139; 30902; 30903; 31274; 31275; 30664; 30648; 31234; 30485; 30743; 30762; 30763; 30439; 31176; 31177; 30423; 31008; 30565; 30250; 30988; 30989; 30607; 30696; 30509; 30181; 30999; 31000; 30113; 30392; 30404; 30582; 30953; 30414; 30614; 30802; 30892; 30893; 30646; 30259; 30338; 30361; 30405; 30409; 30650; 30145; 30119; 30319; 30109; 31125; 31247; 31248; 30454; 30455; 30719; 30168; 31197; 31198; 30102; 30118; 30887; 30888; 30166; 30167; 30942; 30170; 30626; 30839; 31070; 30468; 30735; 30879; 30881; 30410; 30649; 30909; 30425; 60456; 31078; 31079; 31158; 30750; 30751; 30790; 30200; 31058; 30555; 60556; 30792; 30721; 30618; 30640; 30213; 30310; 30979; 30980; 30964; 30965; 30690; 30647; 30637; 30797; 30521; 30522; 30923; 30322; 30327; 30155; 30232; 30363; 30413; 30849; 30744; 30760; 30821; 30822; 31164; 31249; 31250; 30729; 30858; 30513; 30514; 30529; 30530; 30666; 30667; 30823; 30827; 31100; 30276; 30643; 30342; 30428; 30749; 30153; 30178; 30632; 30635; 30837; 30838; 30560; 30561; 30452; 30453; 30552; 30710; 30401; 30459; 31218; 31219; 30593; 30776; 30176; 30817; 30238; 30239; 30399; 30282; 30782; 30910; 30917; 30265; 30954; 31143; 31144; 30222; 30446; 30657; 30460; 31095; 31031; 31191; 31192; 31149; 30476; 30546; 30227; 30228; 30921; 30922; 30968; 30969; 30144; 30581; 31220; 31221; 31222; 31223; 30226; 30227; 31228; 31230; 31251; 31252; 31253; 31254; 31037; 31038; 31039; 31040; 31041; 31042; 31043; 31045; 31046; 31047; 30693; 30764; 31204; 31205; 31206; 30599; 31145; 31146; 31147; 31148; 31150; 31152; 31153; 31154; 30277; 30492; 30873; 31114; 31005; 31007; 31009; 30114; 30129; 30189; 30328; 30768; 30336; 30585; 31260; 31261; 31087; 31088; 31089; 31090; 31091; 31092; 31093; 31094; 31052; 30601; 30602; 30753; 30122; 30233; 30261; 30788; 30487; 30257; 30861; 30815; 30946; 30226; 30411; 30445; 31010; 30929; 30930; 30430; 30692; 30777; 30230l 31165; 31175; 30329; 30652; 30897; 30898; 30196; 30373; 30182; 30673; 30467; 30597; 30746; 30761; 30472; 31026; 30337; 31062; 31063; 30691; 31121; 30852; 30853; 30374; 30990; 30991; 30971; 30972; 31059; 31060; 30326; 30845; 30813; 31032; 30731; 30732; 30121; 30402; 30668; 30669; 30867; 30868; 30913; 30914; 30370; 30371; 30586; 30588; 30252; 30496; 30594; 30711; 30907; 30391; 30665; 30948; 30748; 30862; 30863; 30127; 31094; 30840; 30243; 30364; 30365; 30235; 30755; 30891; 30517; 30518; 31255; 31256; 30542; 30568; 30281; 30747; 30786; 30537; 30538; 30539; 30726; 30718; 30143; 30824; 30825; 30303; 30694; 30631; 30165; 30737; 30925; 30926; 30333; 30429; 30474; 30794; 30795; 31048; 31848; 30470; 30124; 30864; 30357; 30442; 30623; 30295; 30857; 30878; 30716; 30717; 31103; 30502; 30911; 30912; 31183; 31184; 31186; 31187; 31188; 31225; 30955; 30956; 30318; 30957; 30958; 30834; 30847; 31021; 30559; 30286; 30662; 30663; 31209; 31210; 30740; 30741; 30173; 30195; 31123; 30159; 30163; 30655; 30656; 30358; 30684; 30875; 30877; 30998; 30901; 30436; 31199; 31200; 30407; 30610; 30278; 30418; 30896; 30458; 30101; 30317; 30720; 31229; 31231; 31139; 31140; 30116; 30151; 30173; 30865; 30271; 30895; 30828; 30829; 31022; 31023; 30124; 30344; 30421; 31126; 30132; 30133; 30112; 30253; 31067; 31068; 31185; 30206; 30564; 30880; 30569; 31156; 31157; 31113; 30147; 30171; 30301; 30244; 30285; 30604; 30832; 30833; 30883; 30396; 31108; 31166; 31167; 31168; 30390; 30566; 30158; 30884; 30339; 30292; 31106; 31107; 31189; 31190; 31109; 31135; 31136; 31137; 31138; 30562; 30933; 30596; 30211; 30854; 30860; 31241; 31242; 31243; 31244; 31245; 31246; 30871; 30131; 30859; 31130; 31131; 30293; 30243; 30244; 30110; 30191; 30219; 30714; 30996; 31124; 30154; 31013; 31014; 30108; 31132; 31133; 31098; 31099; 30557; 31066; 31122; 31178; 31257; 31233; 30543; 30106; 31102; 30330; 30424; 31082; 31083
Baxa Corp., Englewood, CO, by letter dated June 3, 2008. Firm initiated recall is ongoing.
Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.
1000 units (approximately)
Nationwide, Australia, Canada, China, New Zeland, and UK

Wednesday, May 30, 2012

Doctors using compounding pharmacies to cope with anesthesia drug shortage

Doctors using compounding pharmacies to cope with anesthesia drug shortage
9:05 PM, Mar 8, 2012 by Meredith Mitchell
LITTLE ROCK, Ark. (KTHV) -- Across the country, doctors who use anesthesia drugs are opening up their medicine cabinets to find them nearly empty. The FDA is reporting a shortage of nearly 283 drugs.
Now, many doctors, who perform minor procedures in their offices rely on quick onset and offset anesthesia drugs. But, lately those drugs haven't been readily available.
The anesthesia drug shortage occuring across the country is putting a strain on both doctors and patients.
Little Rock oral surgeon Dr. Joshua Leal says he's having to some fairly big changes.
"When those drugs are not available, it completely alters the way we deliver our anesthetic technique to patients and the way that we deliver our procedure or deliver or treatment to the patient."
Due to the recent shortage, Dr. Leal says he's now using compound pharmacies instead of drug companies for anesthetic.
"Over the past 6 months literally we've had to have compounded at least half of our normal regimen of anesthetic drugs, so that's where not only oral surgeons, but other physicians who administer anesthetics in their office are turning."
Compounding pharmacies purchase chemicals in bulk and formulate prescriptions on-site.
There are just a handful of compounding pharmacies in Arkansas and doctors say they're helping treat their patients even if it is slightly unconventional.
"I would have never even considered using a compounding pharmacy previous to this drug shortage and now essentially everyone I know is using compounding pharmacies to make their anesthetic drugs."

Video and article can be found here.

Sunday, May 27, 2012

California Guidance Regarding Compounding

The state of California has a website that contains specific questions and answers regarding the compounding laws and regulations in that state.  Click here to read that guidance.

Chemical Testing Aspects of USP Chapter 797 for Compounded Sterile Preparations

USP 797 is an important tool in the compounding world.  Sterile Compounding Pharmacies need ot be compliant with 797.  The International Journal of  Pharmaceutical Compounding has a number of helpful articles about 797.  One entitled, Chemical Testing Aspects of USP Chapter 797 for Compounded Sterile Preparations,  discusses quality controls.  To read the article, click here.

13 Vacancies on the FDA Pharmacy Compounding Advisory Committee

As of May 1, 2012, the FDA has 13 vacancies on the Pharmacy Compounding Advisory Committee.  A summary of that committee found here is reproduced below:

Pharmacy Compounding Advisory CommitteeProvides advice on scientific, technical, and medical issues concerning drug compounding by pharmacists and licensed practitioners. 
Knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine and other related specialities.

INCURIN (estriol) Tablets and PROIN (phenylpropanolamine hydrochloride) Chewable Tablets - Veterinarians

On April 20, 2012, the U.S. Food and Drug Administration (FDA) approvedf INCURIN (estriol) Tablets and PROIN (phenylpropanolamine hydrochloride) Chewable Tablets to control urinary incontinence in dogs. The FDA noted:

By prescribing FDA-approved INCURIN and PROIN, you provide your clients and their dogs with the only marketed estriol and phenylpropanolamine products shown to be safe and effective for controlling urinary incontinence in dogs. INCURIN and PROIN are also the only marketed estriol and phenylpropanolamine products that are manufactured to meet FDA’s strict standards for quality, purity, and potency.
Please be aware that estriol and phenylpropanolamine products should not be imported from other countries for use in animals. In addition, bulk estriol and phenylpropanolamine should not be used to compound animal drugs.

The FDA also reminded veterinarians about compounding other strengths or dosages of INCURIN AND PROIN: 

A compounded animal drug is not FDA-approved. This means FDA has not evaluated the safety and effectiveness of the compounded drug or the adequacy of the manufacturing process. 

You may have specific patients that need estriol or phenylpropanolamine in strengths or dosage forms not offered by INCURIN or PROIN. In these limited cases, estriol or phenylpropanolamine can be legally compounded by using FDA-approved INCURIN or PROIN as the source of the active pharmaceutical ingredient. Please find additional requirements for legal animal drug compounding at Title 21, Code of Federal Regulations, Section 530.13.
To read entire FDA notice, click here.

Saturday, May 26, 2012

Article on Federal Regulation of Compounded Drugs

An excellent article, Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split, appears in the 2010 American Society of Law, Medicine & Ethics, Inc., and Boston University (36 Am. J.L. and Med. 220).  The author is Jesse M. Boodoo.  A courtesy copy of the article can be read here.

A Suggestion from the American Podiatric Medical Association Regarding Compounding Pharmacies and Medication Errors

The following recommendation can be found at this link.

Due to recent medication errors made by compounding pharmacies, APMA recommends that if
you are purchasing medications from compounding pharmacies, you consider obtaining a letter
of attestation from the compounding pharmacy accompanying the deliverance of each drug to
your office. This letter of attestation would contain a statement verifying the content and
concentration of the medication provided.  Due to recent errors, at least one reaction was life
threatening, which involved a patient who received 70 times the correct dose of atropine in
capsule form directly from a compounding pharmacy. APMA is aware that there are
approximately 218 drugs in short supply according to the American Society of Health System
Pharmacists, and this is a crisis for patients, physicians and hospitals.

And yet another example of criminal charges against a compounding pharmacist

Compounding Pharmacist Gains Partial Judicial Relief; Still Guilty on Eight

On April 30, 2010 Judge Marcia S. Krieger, United States District Judge,
District of Colorado dismissed 23 guilty counts against Thomas Bader, a
compounding pharmacist and owner of College Pharmacy in Denver Colorado,
while affirming eight counts and $4.8 million in forfeiture.
The case illustrates many of the nuanced risks involved with compounding
pharmacies, importing and exporting of active pharmaceutical ingredients
(API), compounding and selling high profile drugs such as human growth
hormone (HGH) and anabolic steroids, understanding the subtle distinction
between compounding and manufacturing, and the tenuous interplay between
state compounding laws and the Federal Food, Drug and Cosmetic Act (FDCA).
The case stems back to 2007 when Mr. Bader was charged with illegal
distribution, mail fraud, and conspiracy to facilitate the sale of smuggled
goods. Mr. Bader was importing HGH from China and compounding the API into
finished drug products. As Colorado’s compounding statute is very expansive,
he believed his practice to be protected under state law, and outside the
purview of FDCA.
The federal smuggling charges focused on the fact that imported HGH was from
a non-FDA registered facility and the compounded products thus involved new,
unapproved drugs requiring an NDA under FDCA. Mr. Bader was further charged
with illegal distribution of HGH and testosterone cypionate (a controlled
substance) as both products involved promotion for unapproved uses, illegal
under federal law.
On February 2, 2010 a federal jury found Mr. Bader guilty of 31 counts
including illegal distribution of HGH and controlled substances and unlawful
importation (i.e. smuggling) of HGH. Mr. Bader and counsel then moved to
acquit, or alternatively seek a new trial based on a number of legal
propositions including entrapment by estoppel, violation of due process
rights, erroneous juror instructions, failure to establish a criminal
purpose or intent, and insufficient evidence to support the findings.
Ultimately, on April 29, 2010 Judge Krieger dismissed 23 counts involving
illegal distribution of HGH. The Judge acknowledged a number of Mr. Bader’s
sales were for approved uses of HGH, including some even written for
children. Additionally, Mr. Bader had no way of knowing if the
prescriptions were for permissible uses and thus his actions were protected.
Still, the ruling upheld eight guilty counts. Two smuggling charges were
upheld, as importation of HGH from a non-FDA registered facility was seen as
“contrary to law,” and thus illegal. Simple repackaging or relabeling of a
product may be lawful under state compounding laws; however this
“compounding defense” could not shield Mr. Bader from further provisions of
the FDCA.
Five illegal distribution counts involving HGH were upheld as the use of HGH
as an anti-aging drug is unauthorized and illegal. The lone distribution
charge involving controlled-substances was also upheld, as selling and
promoting testosterone cypionate for muscle building and ant-aging is
illegal. Lastly, the judge affirmed $4.8 million forfeiture in assets based
on the nature of the guilty counts. Sentencing in this matter is scheduled
for June 10, 2010.
To read the remainder of the article click here.

This entry was posted on Monday, May 10th, 2010 at 3:06 pm and is filed under General.      

Another Example of Pharmacist Being Criminally Charged for Death Resulting from Compounding Error.

Here is an article about a case where the death from compounding error occurred in 2006 that shows a pharmacist who plead no contest to involuntary manslaughter of a 2-year old child.

Article appears here.

Failed check system for chemotherapy leads to pharmacist's no contest plea for involuntary manslaughter

From the April 23, 2009 issue
The April 19, 2009, Cleveland Plain Dealer covered another disconcerting report about a healthcare professional who is facing criminal charges for his role in a fatal medication error.(1) According to the news report, a former Ohio pharmacist will plead no contest next month to involuntary manslaughter of a 2-year-old child who died in 2006 as a result of a chemotherapy compounding error. We first wrote about this tragic error in our March 8, 2007 newsletter, when criminal investigation of the event was being considered.(2) Since then, the pharmacy board revoked the pharmacist’s license, and a grand jury indicted him on charges of reckless homicide and involuntary manslaughter. The pharmacist faces up to 5 years in prison.
Prosecutors hold the pharmacist responsible for the toddler’s death because he oversaw the preparation of her chemotherapy. The child had undergone surgeries and four rounds of chemotherapy to treat a curable malignant tumor at the base of her spine. She was supposed to receive her last dose of chemotherapy on the day of the error. A pharmacy technician mistakenly prepared the infusion using too much 23.4% sodium chloride. According to a news report,(3) the technician mentioned to the pharmacist that the final preparation didn’t seem right, but the error went unnoticed. The infusion was administered to the child, who died 3 days later.
Though we cannot shed more light on the root causes of the error, our experiences with analyzing other errors strongly suggest that underlying system vulnerabilities played a role. For example, some pharmacies remove fluid from a bag when they have to add a large volume of medication to infuse, and then add additional fluid to the bag and titrate with 23.4% sodium chloride injection to bring the final concentration of the infusion to whatever was prescribed. Or they start with an empty bag and follow a similar process. Compounding the solution from scratch is error-prone. Such exactness of base solutions is most often unnecessary from a clinical standpoint. Communication failures between technicians and pharmacists, IV compounder-related failures, inadequate documentation of the exact products and amounts of additives, and other system issues have contributed to numerous fatal errors. We have also seen compounding errors and subsequent failed double-checks due to adverse performance shaping factors such as poor lighting, clutter, noise, and interruptions. In fact, in this particular case, news reports suggest that the pharmacist felt rushed, causing him to miss any flags that may have signaled an error.(3)
Without minimizing the loss of life in this case, we continue to be deeply concerned about the criminalization of human errors in healthcare. Ever since the advent of powerful machines like automobiles, the law allows for the criminal indictment of people who make errors that harm others, despite no intent to cause harm. To cite one instance, drivers who have been involved in an accident that caused the death of another person might be prosecuted in most states for vehicular homicide, even if the accident resulted from human error. The reality is, mere human errors that randomly occur in well-meaning people are considered “criminal” in a number of circumstances where public safety is at issue.
Safety experts including ISMP advocate for a fair and just path for individuals involved in adverse events, arguing that punishment simply because the patient was harmed does not serve the public interest. Its potential impact on patient safety is enormous, sending the wrong message to healthcare professionals about the importance of reporting and analyzing errors. It could also have a chilling effect on the recruitment and retention of an already depleted healthcare workforce. All professionals are fallible human beings destined to make mistakes along the way and drift away from safe behaviors as perceptions of risk fade when trying to do more in resource-strapped professions. Who would knowingly put themselves at risk for criminal indictments by entering the medical profession? If warranted, licensing boards can protect patients from reckless or incompetent actions of healthcare practitioners by limiting or revoking licenses.
While the law clearly allows for the criminal indictment of healthcare professionals who make harmful errors, despite no intent to cause harm, it will long be debated whether this course of action is fair, required, or even beneficial. The fact remains that the greater good is served by focusing on system issues that allow tragedies like this to happen. By focusing instead on those involved—the easy targets—one can easily avoid addressing the systems issues. Focus on the easy target in this case makes us wonder whether any regulatory or accreditation agency is assuring that all hospitals learn from this event and adjust their systems to prevent the same type of error. If not, the death of this little girl is a heartbreaking commentary on healthcare’s inability to truly learn from mistakes so they are not destined to repeat.
Some good has come from this tragic error. In Ohio, Senate Bill 203, called Emily’s Law after the child that died, requires pharmacy technicians to be 18 years or older, possess a high-school diploma, pass a criminal background check, and pass a competency exam approved by the Ohio State Board of Pharmacy. A similar House bill did not pass in the federal legislature.
References: 1) McCarty J. Eric Cropp, ex-pharmacist in case in which Emily Jerry died, is ready to plead no contest. Cleveland Plain Dealer. April 19, 2009. Available at: 2) ISMP Medication Safety Alert! Criminal prosecution of human error will likely have dangerous long-term consequences. 2007;12(5):1-2. 3) McCoy K, Brady E. Drug error killed their little girl. USA Today. February 25, 2008. Available at:

Know the Truth About Compounding Drugs website, found here, contains helpful information for both patients and practitioners.  Some of the very useful information, including whether malpractice insurance covers an error in compounding and when the use of compounded drugs is appropriate,  from the website is as follows:

What is drug compounding?Pharmacist compounding is an age-old process used to make non-FDA-approved medications by mixing available ingredients that result in a medication that is unavailable from an approved commercial pharmaceutical manufacturer. Pharmacy compounding is ONLY appropriate when there is no FDA approved alternative to meet a specific patient need (e.g., when a patient is allergic to an ingredient in the FDA approved alternative).
What is the FDA’s position on the use of compounded (non-FDA-approved) drugs?
State and Federal laws govern the availability of compounded unapproved drugs. While the FDA reserves the right to inspect compounding pharmacies; restricted resources limit the FDA’s ability to inspect most compounding pharmacies. When FDA receives a complaint about a compounded medication it typically refers the complaint to the appropriate state’s board of pharmacy.
Compounding is ONLY appropriate when:
  • There is no FDA-approved drug for a patient’s ailment.
  • An individual patient has an allergy to an ingredient used
    in an FDA-approved medication.
  • A pediatric patient requires a medication for which there is
    no suitable formulation.
  • The FDA-approved drug is not currently available
If there is an FDA-approved product that can be used, it should be used. Compounding is intended to address the needs of individual patients; in other words, compounded (non-FDA-approved) drugs should only be produced on a patient-by-patient basis. It is illegal for a compounding pharmacy to make bulk quantities of a medication and sell it.
Have there ever been safety issues with compounded (non-FDA-approved)

Drug safety is important to both drug compounders and FDA-approved manufacturers. The FDA document titled, The Special Risks of Pharmacy Compounding (link), the FDA provides examples of situations where patients have been injured by compounded drugs. More examples are provided on a page of this website titled, Helpful Links. The FDA asks that adverse events experienced with FDA-approved and compounded medications be reported to FDA MedWatch (link).
Does malpractice insurance cover the potential liabilities associated with prescribing compounded drugs?The liability for physicians using a compounded drug (non-FDA–approved) is significant, with several negative consequences. A major liability for a physician who uses a compounded drug (non-FDA-approved), is the possible invalidation of their malpractice insurance. Malpractice insurance typically excludes coverage of procedures that involve the use of non FDA approved drugs. Unlike pharmaceutical companies, compounders do not carry liability insurance that is sufficient to protect physicians from catastrophic damages. The use of a compounded or imported drug could leave a physician with tremendous personal liability and possible criminal prosecution.
Are compounded (non-FDA-approved) medications reimbursed?
The FDA and Medicare can impose criminal charges and significant fines against a physician who is convicted of using illegally imported or illegally compounded drugs. Medicare Part B will pay for compounded (non-FDA-approved) drugs when they meet the criteria for coverage. However, it is considered Medicare fraud to bill for a drug that is non-approved or illegal. The Centers for Medicare and Medicaid Services (CMS) have taken an aggressive position in recent years to prevent fraud. Under the Federal False Claims Act (FCA), any person who knowingly submits a false or fraudulent claim to Medicare or Medicaid is liable to the Federal Government for three times the amount of the Federal Government's damages plus penalties of $5,000 to $10,000 for each claim. This is evidenced by the aforementioned 2005 case where the penalized physician was mandated to pay $150,000 restitution under the False Claims Act. In the case, the physician billed Medicare for 62 procedures, all of which Medicare refused payment because the drug utilized was non-approved. Under the Federal False Claims Act, persons who report fraudulent claims to the U.S. Government are entitled to a reward equal to 15% to 25% of the recovery of Federal damages. This provides tremendous incentive to persons who have exposure to Medicare or Medicaid billing to report any activity that may be deemed as false. A fraud conviction can be very costly for a physician, as the penalties are paid out-of-pocket unless the physician has supplemental insurance specifically for Medicare fraud.

Has the US government performed hearings about the issues associated with drug compounding?
Yes, in 2003 hearings were held. The link below will take you to a review of those hearings:

Has the FDA ever quantified quality control issues related to compounded drugs?
There are many significant issues associated with compounded medications. These issues can affect unapproved drug efficacy and patient safety.
  • A sterile compounding environment - The lack of a sterile manufacturing area can compromise the ingredients used to make medicine.
  • Unknown drug stability - It is common for compounded drugs
    (non-FDA-approved) to come without an expiration date and after potency has diminished.
  • Supra-potency - The strength of the compounded medication is higher than the labeling indicates.
  • Low-potency - The strength of the compounded medication is lower than the labeling indicates.

In 2002 and 2006 the FDA evaluated medications supplied by compounding pharmacies.
An overview of the FDA’s 2006 finding can be found here.

What did the US FDA find in their review of compounded (non-FDA-approved)
Among 198 samples gathered during 2006, 125 were active pharmaceutical ingredient (API) and 73 were compounded (non-FDA-approved) finished drug products. All 125 API samples passed analysis. Of the 73 compounded (non-FDA-approved) finished drug products, two-thirds (66%) either couldn’t be tested or failed analytical testing.
Most of the products that failed analysis did so due to sub or super-potency, called assay, or a lack of uniformity of individual dosage units, called content uniformity. Potency ranged from 67.5% (one-third less potent than intended) to 268.4% (2.5 times more potent than intended) of the amount of drug declared on the product labeling. For content uniformity analysis of products containing multiple active components, both sub- and super-potent active components were found within the same product samples. Such variability can lead to uncertainty in dosing and raises concern for patient therapy.
The results of the survey suggest that problems with the quality of compounded drugs occur throughout the country. Of note is that all APIs passed analytical testing, supporting the notion that the observed failures of the finished drug products may be causally related to the compounding processes at pharmacies.
Has the FDA described unacceptable drug compounding?
Yes, in 2002 the FDA re-issued guidance on pharmacy compounding. The following are unacceptable criteria:
  • Compounding drug products that are commercially available
    in the marketplace or that are essentially copies of commercially
    available FDA-approved drug products. In certain circumstances,
    it may be appropriate for a pharmacist to compound a small quantity
    of a drug that is only slightly different than an FDA-approved drug
    that is commercially available. In these circumstances, FDA will
    consider whether there is documentation of the medical need
    for the particular variation of the compound for the particular patient.
  • Compounding of drugs in anticipation of receiving prescriptions,
    except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.
  • Using commercial scale manufacturing or testing equipment for compounding drug products.
  • Compounding drugs that were withdrawn or removed from
    the market for safety reasons.
  • Compounding finished drugs from bulk active ingredients that
    are not components of FDA approved drugs without an FDA
    sanctioned investigational new drug application (IND) in accordance
    with 21 U.S.C. § 355(i) and 21 CFR 312.
  • Receiving, storing, or using drug substances without first obtaining
    written assurance from the supplier that each lot of the drug substance
    has been made in an FDA-registered facility.
  • Receiving, storing, or using drug components not guaranteed
    or otherwise determined to meet official compendia requirements.
  • Compounding drugs for third parties who resell to individual
    patients or offering compounded drug products at wholesale to
    other state licensed persons or commercial entities for resale.
  • Failing to operate in conformance with applicable state law regulating the practice of pharmacy.
Are compounded (non-FDA-approved) medications less expensive than FDA-approved medications?
You may hear that compounded (non-FDA-approved) medications are less expensive than FDA-approved medications. This may not always be true. The expense of any given medication can be measured numerous ways. It is important that physicians know if there is a suitable FDA-approved drug available before prescribing or using a compounded (non-FDA-approved) drug. Physicians may also want to determine if a patient’s insurance company will pay for compounded medications before touting a compounded (non-FDA-approved) medication as less expensive than an FDA-approved drug and insurance carriers frequently do not reimburse the cost of compounded (non-FDA approved) medication.
Why is it illegal for drug compounding pharmacies to make a large quantity
of medication and sell it?

The manufacturing standards applied to compounding pharmacies and FDA-approved drug manufacturers are different. All FDA-approved medications are required to show quality control analyses, while compounding pharmacies are not held to the same, if any, standards. Many drug compounding pharmacies may make medications in a clean environment, there are no controls enforced regarding drug stability and sterility. It is impossible for a physician or patient to know the duration of stability for a compounded product, whereas, all FDA-approved drugs are supplied with an expiration date and lot number. An FDA-approved drug’s expiration date helps ensure that the product is used at a time when it’s known to contain the desired amount of medication. Having a lot number helps ensure the medication is always traceable if a recall was ever required. Since it is illegal for compounding pharmacies to make large (bulk) quantities of drug lot numbers are not used thus it may not be traceable. Additionally, the stability profile of compounded (non-FDA-approved) drugs is unknown.
In a document titled, The Special Risks of Pharmacy Compounding (link), the FDA provides consumers with guidance related to the use of compounded unapproved  

Medisca, Inc. and Signature Compounding Pharmacy: Overview of Criminal Case

Here is another example of a compounding pharmacy, Signature Compounding Pharmacy, charged in a criminal case.  Signature was located in Orlando, Florida but the criminal case was brought in Albany, New York.  The Florida Department of Health filed administrative complaints against the pharmacy for improper distribution of human growth hormone but never pursued the charges.  Signature closed down after the indictment.  A Plattsburgh pharmaceutical company, Medisca Inc., and its president, a Canadian citizen, both pleaded guilty to misdemeanor federal drug charges for mislabeling more than $1 million worth of human growth hormone that was imported from China and distributed to pharmacies around the country.  Signature Compounding Pharmacy was among the customers of  Medisca, Inc, which had corporate offices in St. Laurent, Quebec.  This case has led to 17 convictions. The remaining case is against Naomi Loomis; her husband, Robert "Stan" Loomis; his brother, Kenneth Michael Loomis; Kirk Calvert; and Anthony Palladino.

Soares defends steroids case
Albany prosecutor cites factual errors in federal ruling; rejects bias claim
By BRENDAN J. LYONS Senior writer
Published 05:00 a.m., Monday, September 13, 2010

ALBANY -- Prosecutors have asked an Albany judge to forge ahead with a criminal trial for five Florida pharmacy operators accused of being at the center of an alleged illegal steroids business. It's a part of a case that drew national interest in 2007, but that has since brought attacks on the Albany County district attorney's office.
The remaining criminal case, which targets the pharmacist-owners of Orlando's former Signature Compounding Pharmacy, has languished for three years following an interstate law enforcement raid in February 2007 -- spearheaded by Albany County prosecutors -- that exposed illicit steroid use by professional athletes and others.

More than 15 people, including doctors and business owners, pleaded guilty to related drug charges in a case that exposed systemic abuse of prescription drug laws. But the case against the pharmacists and their managers, who were also targets of a related federal criminal investigation, has thrust a spotlight on District Attorney David Soares' decision to indict operators of a faraway company that did a small percentage of its multi-million-dollar business in New York state and Albany County.
Two years ago an Albany County judge threw out the first indictment against the pharmacy's operators, citing prosecutorial missteps in the grand jury proceedings. A month later, the pharmacists fought back with a federal civil rights lawsuit in Florida seeking millions of dollars in damages for false arrest and malicious prosecution. They sued Soares, an assistant district attorney, the Orlando Police Department and other law enforcement officials.
But their criminal case in New York was not over. Earlier this year a state appellate court reversed a portion of the county judge's dismissal order that barred prosecutors from bringing a new indictment, which they did in June.
Last month defense attorneys for the five Signature defendants asked the same judge who dismissed the first case, County Judge Stephen W. Herrick, to do it again. This time, they claimed similar grand jury problems and also pointed repeatedly to a scathing analysis of the investigation last June by a federal judge in Florida, whose ruling has the civil rights lawsuit on course for a jury trial in Florida
"Soares not only participated in, but directed (assistant District Attorney Christopher) Baynes and others to violate plaintiffs' Fourth Amendment right to be free from unlawful arrests," wrote the federal judge, Gregory A. Presnell. "Rather than wait for any documentary evidence that plaintiffs had committed a crime in New York and comply with the very limited requirements of federal and state extradition statutes, Soares decided to orchestrate Plaintiffs' arrests without valid New York warrants and, in the process, garner significant media attention."
Last week, Christopher D. Horn, special counsel to the Albany County district attorney, filed a 34-page motion that seeks to uphold the latest 33-count indictment. It also accuses the federal judge of making numerous factual errors. Horn's written statement marks the first detailed response to Presnell's searing criticism of the Albany district attorney's investigation.
Lawyers in the criminal case are subject to a gag order and were unable to comment for this report.

Prosecutors and investigators have previously characterized Signature pharmacy as a prescription mill that manufactured many of its own drugs, including steroids, that were marketed to people through "wellness clinics" that did a large volume of business through the Internet. Several people convicted in the case admitted they set up the wellness clinics that funneled prescriptions to Signature, which mailed drugs to people around the country. Some of the clinic operators said they paid doctors to write prescriptions for people who were never evaluated in person, and who had no legitimate medical need for the controlled substances, including steroids and human growth hormone.
The case, especially the fallout of its exposure of illicit drug use by athletes, shook up the pro sports world. It also was cited by former Sen. George L. Mitchell in his 2007 report on illegal steroid use in Major League Baseball.
While Signature's defense team has characterized their clients as law-abiding pharmacists who were victims of a zealous prosecutor, others convicted of dealing with them have cast doubt on that assertion.
Last year in Rhode Island, Orlando businessman Victor Martin Effron pleaded guilty to federal charges related to the illegal importation of human growth hormone from China. Federal authorities said the product was being sold to Signature pharmacy, which had contracted Effron to smuggle the drug into Florida, and marketed as approved for use by the Food and Drug Administration.
Orlando police, who were an integral part of the Signature case, asked Albany's prosecutors four years ago to join their investigation after building a criminal case from wiretaps, cooperating witnesses and evidence collected from trash bins outside Signature's pharmacy. They solicited the interest of Soares, according to court records, because the company dispensed prescriptions in New York, which has some of the strictest prescription drug laws in the nation.
Still, defense attorneys have countered that Soares, known from his position as district attorney for the state capital, only became involved in the case to thrust himself into a national spotlight. They said the new charges should be dismissed, or a special prosecutor appointed, because Soares' office has a conflict due to the related federal civil rights lawsuit that has gained traction in Orlando.
Horn, who also handles appeals for the office, countered last week that appointing a special prosecutor would set a precedent for criminal defendants to disqualify prosecutors from pursuing cases by suing them, then claiming there is a conflict.
"The defendants had been being prosecuted for the same criminal conduct for well over a year prior to the filing of their federal civil lawsuit," Horn wrote in the motion to Herrick. "Now the defendants argue that the filing of a fifth indictment is evidence of bias born of the 'conflict' which the defendants themselves manufactured. They are in no different position than they were before they filed their lawsuit. They were being prosecuted then and they are being prosecuted now."
The defendants, three of whom are licensed pharmacists in the state of Florida, are: Naomi Loomis, 37, her husband, Robert "Stan" Loomis, 59; Kenneth Michael Loomis, 62, who is Robert's brother; former business manager Kirk Calvert, 40; and former business manager Tony Palladino, 34.
Horn's motion also attacks key sections of the federal court order, and notes that days after Presnell ordered the civil case to proceed, the judge abruptly issued a corrective order dismissing the claim against a former state Health Department investigator, Mark Haskins, who had played a key role in the Signature investigation.

To read the remainder of this article, click here.
To read more about this case, click here, here, here, and here.

Friday, May 25, 2012

Successful Lawsuit Based on IV Compounding Error in Hospital Pharmacy; settled for 8.25 Million

Advocate Lutheran General Hospital (IL), which admitted that a pharmacy technician’s IV machine data entry error in 2010 killed a baby, settled the family’s lawsuit for $8.25 million. 

The wrongful death suit alleged an IV bag was incorrectly filled with 60 times the amount of sodium. In a statement in 2011, a hospital spokeswoman said, ""It was determined that a data entry error was made in the formulation of the IV solution. The dosage of sodium for an IV bag from an order had been incorrectly entered into the machine that mixes IV solutions."  Read about this story here.  Another article points out:

Hospitals across the country rely extensively on pharmacy compounding, for products ranging from simple oral capsules and liquids, to sterile products intended for intravenous, intramuscular and intrathecal use. Though the practice of compounding is regulated by state law, with oversight by state boards of pharmacy, the federal Food and Drug Administration has for years taken the position that while “traditional” pharmacy compounding is not of concern, certain types of compounding practices could fall within FDA’s jurisdiction.

To read this article, click here.

Pathway Pharmacy on Probation for Three Years; Pharmacist Crowley can no Longer Practice; Other Pharmacist Disciplined

Pharmacist with criminal history can no longer practice in Nevada By Krista Hostetler CREATED APR. 25, 2012 Las Vegas, NV (KTNV) -- A pharmacist, with a history of DUI convictions and drug abuse, can no longer practice in Nevada after nine patients became seriously ill. Dr. Kenton Lance Crowley, whose record includes dispensing the wrong medication and working while under the influence, has surrendered his license. In January, Action News Chief Investigator Darcy Spears exposed how nine people got Sepsis, a dangerous bacterial blood infection, after being injected with calcium gluconate. The Nevada State Board of Pharmacy says Crowley prepared the tainted substance while working at Pathway Pharmacy. Crowley can reapply for a Nevada license in five years. He permanently lost his California pharmacy license in 2008 after officials there determined he was a threat to public safety. The Nevada Pharmacy Board also disciplined two other pharmacists involving in the tainted calcium mixture: Tim Brown was fined $1,000 and Michelle Badten faces one year on probation. Pathway Pharmacy remains open, but will be on probation for three years.

Disciplinary Action in Nevada Against Pathway Specialty Compounds

The Nevada State Board of Pharmacy recently filed a disciplinary action against:

Michelle Badten, R.Ph (11-092A-RPH-S)
Kenton Crowley, R.Ph (11-092B-RPH-S)
Timothy Brown, R.Ph (11-092C-RPH-S)
Pathway Specialty Compounds (11-092-PH-S)

In 2011, Pathway Specialty Compounds compounded calcium gluconate The calcium gluconate was contaminated and made several individuals sick.  The complaint also contains additional allegations. To view that complaint, click here

The following news article about Pathway appears here.

Pharmacy accused of sickening nine patients

CREATED Jan. 6, 2012
Las Vegas, NV (KTNV) -- A pharmacist whose name surfaced in the Michael Jackson death investigation is once again under scrutiny.
This time, after nine people became dangerously ill.
Contact 13 Chief Investigator Darcy Spears has the exclusive story.
"It just seems like the standard of practice was not followed in this case," says Dr. Paul Oesterman, Associate Professor of Pharmacy at Roseman University of Health Sciences.
Dr. Oesterman was appalled when he learned what happened at Pathway Pharmacy on Sunset Road and Eastern Avenue.
"It was an inappropriate product to use, they recognized this and labeled it themselves but then they still went ahead and used it."
Darcy: "Is that unconscionable in your mind?"
Dr. Oesterman: "In my mind, it is, yes. They should have never used it."
In a complaint recently filed by the State Board of Pharmacy, Pathway is accused of multiple violations of state laws involving a substance called calcium gluconate.
It's a specially-prepared compound used to treat calcium deficiencies due to hormone imbalance, some skin conditions, even to relieve muscle cramps from black widow spider bites.
The complaint says the calcium gluconate from Pathway caused nine cases of sepsis -- a dangerous bacterial blood infection that resulted in people being hospitalized.
All nine people who got sick were patients of Dr. Fuller Royal, who runs the Nevada clinic.
He's the one who originally diagnosed them with sepsis and reported those cases to the Southern Nevada Health District, who passed the complaint on to the Nevada Board of Pharmacy.
We've called Dr. Royal multiple times for comment, but he hasn't returned any of those calls.
We wanted to ask him why he used a single-use vial to inject multiple patients.
"It was not appropriate to be dispensed to multiple patients," says Tim Brown, one of three pharmacists named in the state Complaint, and the only one who would talk to us.
He explained that the calcium gluconate was labeled for oral use only, but because of a shortage of the injectable formula, his colleagues devised a workaround.
As he told the State Board in answer to their accusations, he blames the whole thing on "the reckless behavior of an individual, basically a rogue pharmacist."
He identifies that pharmacist as Dr. Kenton Lance Crowley who we found posing, seemingly shirtless, in his Facebook profile picture.
His name made national news in 2009 when the pharmacy where he had worked was raided in connection with the Michael Jackson death investigation. It's unclear when Crowley left Applied Pharmacy and he was never charged in that case.
In 2008, he permanently lost his on-again off-again license to practice in California after the state board there determined he was a threat to public safety.
Board records show he's got a history of DUI convictions, drug abuse including a near-fatal overdose, dispensing the wrong medication, working while under the influence, sending dangerous drugs out of state without a prescription and providing drugs to an addict.
He did significant jail and prison time on multiple convictions.
Despite all that, he got licensed here in Nevada on a probationary basis.
"I am concerned that this person did get a license," says Dr. Oesterman, who hopes this case will force the Nevada Pharmacy Board to look more closely at applicants from out of state.
No one from the board would talk to us because of the pending complaint, which also names Michelle Badten -- another pharmacist with a history of prescription drug abuse.
The state accuses her, Tim Brown and Pathway with failing to provide the checks and balances that should have prevented Crowley from delivering the tainted calcium gluconate to Dr. Royal.
"We're in business for the public, to help the public, for the public good, for health, not anything like this. This is not a situation where we would ever want to find ourselves in and want to be in any way responsible for," Brown says.
He blames Crowley for coercing other Pathway staff members into behaving recklessly by threatening their jobs.
"And in this market, that's a valid threat. So does it justify what happened? No," Brown says. " We terminated him upon this last incident and so from our standpoint, problem solved."
We tried to track down Kenton Crowley but colleagues say he disappeared after he was fired.
He did not respond to any of our calls or emails.
The Pharmacy Board will hear this case on January 18 and we'll let you know what disciplinary action they take.  

Apothecare Compounding Solutions in Rhode Island

On May 17, 2012, the State of Rhode Island Department of Health reprimanded Apothecare Compounding Solutions in Rhode Island for various violations, one of which includes permitting drugs to be compounded in a manner inconsistent to the USP 795 standards.  Apothecare Compounding Solutions has admitted these allegations.  To view the consent order, click here

Thursday, May 24, 2012

Royal Palm Compounding Pharmacy Disciplined by North Carolina Board of Pharmacy

THE NORTH CAROLINA BOARD OF PHARMACY recently entered a consent order of discipline against
Royal Palm Compounding Pharmacy.  To view the consent order, click here.

Urgent: Franck's Compounded Prescription Recall

Urgent: Compounded Prescription Recall


FOR IMMEDIATE RELEASE - May 25, 2012 - This is to inform you of a product recall involving:
All Sterile Human and Veterinary Prescriptions Distributed by Franck’s Pharmacy From November 21, 2011 to May 21, 2012.
This recall is being initiated after the U.S. Food and Drug Administration ("FDA") notified us that environmental sampling of our clean room revealed the presence of microorganisms and fungal growth. In light of the FDA’s findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control. Accordingly, we are extending the recall to all sterile preparations we have provided to you since November 21, 2011.
If any of these sterile preparations remains under your control, it is essential that you do not use them and that employing appropriate practices, you destroy all such sterile preparations and all remaining portions of such sterile preparations.
This recall should be carried out to the User/Physician level. Your assistance is appreciated and necessary to prevent patient illness. Physicians should be advised to review and evaluate their patient records to determine if any adverse events may have resulted from use of the recalled products. Please report any adverse events to Franck’s Compounding Pharmacy and FDA’s MedWatch program.
FDA will expect us to be able to account for all of the sterile preparations subject to this recall. As a result, it is critically important that you read, complete, and return the enclosed response form as soon as possible.
We will update you with any relevant details as they become available to us. If you have any questions please call us at 352-690-6773, Monday through Friday from 9AM to 5 PM, EST.
This recall is being made with the knowledge of the Food and Drug Administration.