Judge Accepts Gary Osborn and Apothecure Pleas of Gulity

The judge in the Northern District of Oklahoma has accepted Gary Osborn and Apothecure plea of guilty.  The orders accepting the plea can be viewed here and here.

Breaking News: Franck's Ceases Sterile Compounding Service

Franck's ceases sterile compounding service

The following appears at Ocala.com:

By Carlos E. Medina
Correspondent

Published: Wednesday, May 23, 2012 at 6:01 p.m.

Last Modified: Wednesday, May 23, 2012 at 6:01 p.m.

Franck's Pharmacy announced Wednesday it will stop producing sterile compounds at its Ocala lab and also confirmed the layoffs of several employees.

The decisions come after the Centers for Disease Control and Prevention warned doctors to avoid sterile products made by the pharmacy. The warning, issued on May 3, came after two ophthalmic products made by Franck's were suspected in causing at least 33 cases of fungal eye infections.

The cases were spread over California, Colorado, Illinois, Indiana, Louisiana, Nevada and New York, and in many cases the patients suffered partial to severe vision loss and required additional eye surgery, according to the CDC report.

The products involved are injected directly into the eye.

Tests on sealed bottles and syringes of the preparations conducted by the CDC confirmed the presence of several bacterial and fungal contaminants.

Initially, Franck's said it would continue to compound sterile products after identifying and fixing the cause of the contamination. The cause was not disclosed.

On Wednesday, Franck's business manager, Stephen Floyd, announced the change in direction via email.

"Franck's has made the difficult but necessary decision to cease production of sterile compound products and is turning our focus to the non-sterile side of the business. This change necessitated a reduction in force," the email stated.

The company did not say how many people were laid off or how many people it employs. In 2007 the company said it had more than 75 employees. It was not clear what portion of Franck's business came from sterile compounding."We greatly value and appreciate our employees and are providing support to them to help bridge the gap during their transition," according to the email.

Specifics of the support were not disclosed.

Franck's will continue to compound non-sterile human and veterinary medicine. The retail pharmacy, home infusion pharmacy and wellness store will continue normal operation.

It is the second time the company has faced claims of improper compounding. In 2009, Franck's veterinary division improperly mixed a nutritional supplement for 21 polo horses that contained far more selenium than required. The horses all died.

That incident prompted the Food and Drug Administration to try to stop Franck's from compounding veterinary medicine and supplements. Franck's eventually prevailed in U.S. District Court.

The FDA as well as the Florida Department of Health are investigating the latest case.

Compound pharmacies make medications and other medical preparations from scratch. They cannot make commercially available medications and can only make medications when they are ordered by a doctor.

These pharmacies fine tune drugs to a patient's need, whether it be for a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.

Franck's and Florida Department of Health Settlement Agreement and Final Order Re: Vitreo Retinal Consultants

A copy of the final order approving the settlement agreement between Franck's and the Florida Department of Health, along with a copy of the settlement agreement dated May 1, 2012, can be viewed here.   This settlement relates to an Medicaid audit on or about July 15, 2008, where a representative of the Florida Department of Health visited Vitreo Retinal Consultants.  During the Medicaid audit inspection, the DOH representative discovered that the Pharmacy was selling and shipping quantities of a non-patient specific prescription drug (Bevacizumab) to Vitreo Retinal Consultants.

Franck's Mentioned in Florida Department of Health Document Showing Verbal Agreement

On the Florida Department of Health, A Best Practice Submission, shows the following with regard to Franck's Pharmacy:

An anonymous donor contacted Dr. Mike Jordan, Executive Director of the Marion County Children’s Alliance, in the summer of 2007 and volunteered to establish a fund of
$4000.00 to assist medically and financially needy children in Marion County. The Marion
County Children’s Alliance is a community organization working toward providing a safe,
healthy and nurturing environment for all children. Dr. Mike Jordan, Marion County
Children’s Alliance Executive Director, contacted Barbara Timmington, RN, Marion County
Health Department School Health Supervisor, to request the assistance of School Nurses
as the referral source for financially and medically needy students. A Marion County
Health Department Standard Operating Procedure was created to determine the method
of implementation of this funding source. No money was transferred or utilized by the
Marion County Health Department staff. A referral request form was created to verify
financial need. The form indicates the medical need and justification of financial need (free
and reduced lunch). The School Nurses complete the form and fax it to the School Health
Supervisor. The School Health Supervisor conducts an investigation into cost, availability
and possible delivery to the student. A verbal agreement with a local pharmacy (Franck’s 
Pharmacy), established a cost effective supply source for medications and durable 
medical supplies with free delivery if needed. The School Health Supervisor obtains the 
lowest quoted price for the requested supply and then contacts the Pharmacy partner to 
advise quote.  The referral form with a prescription copy is faxed to the Pharmacy partner.

Click here to read entire document.

Food and Drug Administrations Compliance Policy Guidance, Section 608.400

Anyway dealing with compounded drugs for use in animals needs to be familiar with not only applicable state laws, but also the Food and Drug Administrations Compliance Policy Guidance, Section 608.400, which address Compounding of Drugs for Use in Animals. Section 608.400 provides:

This compliance policy guidance is intended to provide guidance and instructions to FDA staff, industry, and the public for obtaining information to help fulfill the Agency's plans regarding the compounding of drugs for use in animals. The compliance policy guidance does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. It is intended for FDA personnel, industry, and the public and is available electronically to the public.

INTRODUCTION

This document provides guidance to drug compounders, veterinarians, and the staff of the Food and Drug Administration (FDA) on how the Agency intends to address compounding of drugs intended for use in animals. This guidance describes FDA's current thinking on what types of compounding might be subject to enforcement action.

BACKGROUND

FDA announced the availability of Compliance Policy Guide (CPG) section 608.400 entitled "Compounding of Drugs for Use in Animals" on July 3, 1996 (61 FR 34849), to provide guidance to FDA's field and headquarters staff with regard to the compounding of animal drugs by veterinarians and pharmacists for use in animals. There is a potential for causing harm to public health and to animals when drug products are compounded, distributed, and used in the absence of adequate and well-controlled safety and effectiveness data or adherence to the principles of contemporary pharmaceutical chemistry and current good manufacturing practices. Use of compounded drugs in animals can result in adverse reactions and animal deaths. Furthermore, because the pharmacokinetics and depletion times for residues from compounded products intended for use in food-producing animals are not known, the assignment of an extemporaneous withdrawal time may result in potentially harmful residues in food. Inactive ingredients, such as excipients and vehicles, from unapproved or unknown origins may also pose additional risk (e.g., Freunds adjuvant, a carcinogen).

FDA is updating this guidance to be consistent, to the extent practicable, with the scope of compounding permitted under regulations implementing the Animal Medicinal Drug Use Clarification Act of 1994, to describe what factors FDA will consider in exercising its enforcement discretion regarding compounding of drugs intended for use in animals, and to ensure the consistency of its policies with regard to compounding of drugs intended for use in humans and in animals.

DISCUSSION

The Federal Food, Drug, and Cosmetic Act (the Act) does not distinguish compounding from manufacturing or other processing of drugs for use in animals. FDA acknowledges the use of compounding within certain areas of veterinary practice. The current state of veterinary medicine requires products to treat many conditions in a number of different species, some of which are known to have unique physiological characteristics. Furthermore, FDA regulations specifically permit the compounding of products from approved animal or human drugs under the conditions set forth in 21 CFR 530.13. This activity is not the subject of this guidance.

However, FDA is greatly concerned about veterinarians and pharmacies that are engaged in manufacturing and distributing unapproved new animal drugs in a manner that is clearly outside the bounds of traditional pharmacy practice and that violates the Act (e.g., compounding that is intended to circumvent the drug approval process and provide for the mass marketing of products that have been produced with little or no quality control or manufacturing standards to ensure the purity, potency, and stability of the product). These activities are the focus of this guidance. Pharmacies and veterinarians who engage in activities analogous to manufacturing and distributing drugs for use in animals may be held to the same provisions of the Act as manufacturers.

With regard to compounding from bulk drug substances, two Federal Appeals Court decisions, United States v. Algon Chemical Inc., 879 F.2d 1154 (3d Cir. 1989) and United States v. 9/1 Kg. Containers, 854 F.2d 173 (7th Cir. 1988), affirmed the FDA position that the Act does not permit veterinarians to compound unapproved finished drug products from bulk drug substances, unless the finished drug is not a new animal drug. The principle established by the court applies equally to compounding by pharmacists.

Neither the Act nor its implementing regulations exempt veterinarians or pharmacists from the approval requirements in the new animal drug provisions of the Act, 21 U.S.C. Section 360b. In the absence of an approved new animal drug application, the compounding of a new animal drug from any unapproved drug or from bulk drug substances results in an adulterated new animal drug in violation of section 21 U.S.C. Section 351(a)(5). The compounding of a new animal drug from an approved human or animal drug also results in an adulterated new animal drug in violation of 21 U.S.C. Section 351(a)(5), unless the conditions set forth in 21 CFR 530.13(b) are met.

DEFINITIONS

1. Bulk drug substance, as defined in 21 CFR 207.3(a)(4), means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.
2. Compounding does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling
3. A valid veterinarian-client-patient relationship (valid VCPR), as defined in 21 CFR 530.3(i), is one in which:
   1. A veterinarian has assumed the responsibility for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;
   2. There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and
   3. The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

POLICY:

Generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal and human drugs that are intended for use in animals. FDA anticipates that, in such cases, cooperative efforts between the states and the Agency will result in coordinated investigations, referrals, and follow-up actions by the states.

However, when the scope and nature of activities of veterinarians and pharmacists raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new animal drug, adulteration, or misbranding provisions of the Act, FDA has determined that it will seriously consider enforcement action. In determining whether to initiate such an action, the Agency will consider whether the veterinarian or pharmacist engages in any of the following acts:

1. Compounding of drugs for use in situations (a) where the health of the animal is not threatened; and (b) where suffering or death of the animal is not likely to result from failure to treat.
2. Compounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving prescriptions issued within the confines of a valid VCPR.
3. Compounding of drugs that are prohibited for extralabel use in food-producing or nonfood-producing animals, under 21 CFR 530.41(a) and (b) respectively, because the drugs present a risk to the public health.
4. Compounding finished drugs from human or animal drugs that are not the subject of an approved application, or from bulk drug substances, other than those specifically addressed for regulatory discretion by the FDA, Center for Veterinary Medicine, e.g., antidotes (see Appendix A). Inquiries about compounding from unapproved drugs or bulk drug substances should be directed to CVM, Division of Compliance, 301-827-1168.
5. Compounding from approved human drugs for which FDA has implemented a restricted distribution system.
6. Using commercial scale manufacturing equipment for compounding drug products.
7. 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.
8. Failing to operate in conformance with applicable state law regulating the practice of pharmacy.
9. Compounding of drugs for use in animals where an approved new animal drug or approved new human drug used as labeled or in conformity with 21 CFR Part 530 will, in the available dosage form and concentration, appropriately treat the condition diagnosed.
10. Compounding from a human drug for use in food-producing animals if an approved animal drug can be used for the compounding.
11. Instances where illegal residues occur in meat, milk, eggs, honey, aquaculture, or other food-producing animal products, and such residues were caused by the use of a compounded drug.
12. Labeling a compounded drug with a withdrawal time established by the pharmacist instead of the prescribing veterinarian.
13. Labeling of compounded drugs without sufficient information, such as withdrawal times for drugs for food-producing animals or other categories of information that are described in 21 CFR 530.12.

The foregoing list of factors is not intended to be all inclusive. Other factors may be appropriate for consideration in a particular case.

REGULATORY ACTION GUIDANCE:

District offices are encouraged to consult with state regulatory authorities to assure coherent application of this guidance to establishments that are operating outside of the traditional practice of pharmacy.

Follow FDA's laws and procedures prior to sharing non-public information with the public, or federal, state, local, and foreign government officials.

FDA-initiated regulatory action may include issuing a warning letter, seizure, injunction, and/or prosecution. Charges may include, but need not be limited to, violations of 21 U.S.C. Sections 351(a)(2)(B), 351(a)(5), 352(a), 352(f)(1), and 352(o) of the Act. Tissue residue violations are covered under 21 U.S.C. Section 342(a)(2)(C)(ii) of the Act.

Issued: 6/26/1996 (7/3/1996 Federal Register)
Revised: 7/8/2003 (7/14/2003 FR)

APPENDIX A

LIST OF BULK DRUG SUBSTANCES FOR COMPOUNDING AND SUBSEQUENT USE IN ANIMALS TO WHICH CVM WOULD NOT ORDINARILY OBJECT

• Ammonium molybdate
• Ammonium tetrathiomolybdate
• Ferric ferrocyanide
• Methylene blue
• Picrotoxin
• Pilocarpine
• Sodium nitrite
• Sodium thiosulfate
• Tannic acid

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Page Last Updated: 02/23/2010 

Complaint filed against Santa Clara Drug "The Compounding Shop"

The California Board of Pharmacy filed a complaint against Lionel Francis Jara and Santa Clara Drug “The Compounding Shop”, Administrative Case AC 3990, in March 2012.  The case is still pending.  To read the complaint, click here.

Report on Current Investigative Findings in Case Against Franck's : 33 cases in 7 states: Clinicians warned to avoid use of compounded products labeled as sterile from Franck's

Notes from the Field: Multistate Outbreak of Postprocedural Fungal Endophthalmitis Associated with a Single Compounding Pharmacy — United States, March–April 2012

Morbidity and Mortality Weekly Report (MMWR)

May 4, 2012 / 61(17);310-311
On March 5, 2012, the California Department of Public Health was notified of nine cases of clinically diagnosed fungal endophthalmitis at a single California ambulatory surgical center. The initial investigation, led by the Los Angeles County Department of Public Health, determined that in all cases patients had undergone vitrectomy with epiretinal membrane peeling using a dye called Brilliant Blue-G (BBG) from Franck's Compounding Lab, Ocala, Florida. This investigation has since expanded to involve intravitreal injection of triamcinolone-containing products from Franck's, an overall total of 33 cases in seven states, and collaboration between state and local health departments, CDC, and the Food and Drug Administration (FDA). This report describes the current investigative findings. Clinicians should be aware of the ongoing investigation and should avoid use of compounded products labeled as sterile from Franck's during this ongoing investigation.
A probable case is defined as ophthalmologist-diagnosed fungal endophthalmitis occurring in a patient who underwent an invasive ophthalmic procedure, including but not limited to vitrectomy, corneal surgery, or intravitreal injections on or after August 23, 2011, the production date of the contaminated BBG lot. Confirmed cases meet criteria for probable infection and also have fungi identified from the affected eye by culture, genetic sequencing, or histopathology. Active case-finding in this investigation has included calls for cases through Epi-X postings, FDA MedWatch alerts, ClinMicroNet microbiology laboratories, e-mails sent to all members of two professional ophthalmology societies, and state and local health alerts.
As of April 30, a total of 33 confirmed and probable cases have been identified, with earliest onset of symptoms in November 2011. Of these, 20 cases (13 probable and seven confirmed) are associated with BBG dye use, and 13 (two probable and 11 confirmed) are associated with triamcinolone use. All BBG or triamcinolone products administered to patients reportedly were purchased from Franck's. All available isolates from the seven confirmed cases associated with BBG dye use were identified by culture or genetic sequencing as the mold Fusarium incarnatum-equiseti species complex. All available isolates from the 11 confirmed cases that occurred following intravitreal injection of triamcinolone-containing products have been identified as the mold Bipolaris hawaiiensis. Both Fusarium and Bipolaris are ubiquitous molds present in air, soil, and water. Among the 30 patients for whom data are available, 23 (77%) have suffered some degree of vision loss, ranging from partial to severe, or worsened vision because of infection; 24 (80%) have required repeat ophthalmic surgery.
Culture of unopened bottles and intact (unused, pharmacy-prepared) syringes of BBG dye collected by FDA yielded multiple bacterial and fungal species, including F. incarnatum-equiseti species complex, Rhodotorula, Bullera, Pseudomonas, and Enterobacter species. Microbiologic testing of triamcinolone-containing products from Franck's is ongoing. On March 9, Franck's recalled all BBG dye lots; on March 31, a single lot of triamcinolone was recalled. The investigation to identify the root cause of product contamination is ongoing. The pharmacy has not recalled or halted production of other sterile compounded products, which, in addition to ophthalmic preparations, include chemotherapy and numerous other medications administered by injection (including intrathecal and epidural), inhalation, and intranasal routes.
Postprocedural endophthalmitis is uncommon, complicating 0.04% of either intravitreal injections or pars plana vitrectomies (1,2). The majority of these infections are bacterial; fungal infection is rare and often is diagnosed only after a patient has failed empiric antibacterial therapy. Clinicians are encouraged to be vigilant for postprocedure adverse events, particularly among patients who have received a product labeled as sterile from Franck's, and should consider methods to confirm and treat possible fungal infection.
Compounding pharmacies, which combine or alter medications from standard preparations, provide needed formulations that often are not available from pharmaceutical companies. Compounded sterile preparations must be prepared according to aseptic practices recommended by organizations such as the United States Pharmacopeia, as stated in United States Pharmacopeia-National Formulary (3). However, contamination of compounded sterile preparations has caused outbreaks. Since 1990, FDA has learned of approximately 200 adverse events associated with 71 compounded products (4). A recent outbreak of bacterial endophthalmitis following intravitreal injection of contaminated bevacizumab occurred after breaches in aseptic technique at a different compounding pharmacy (5).
Because of the seriousness of endophthalmitis and because the full extent of the outbreak and root cause of contamination remain unknown, CDC recommends that, at this time, clinicians avoid use of compounded products labeled as sterile from Franck's. Health-care providers should maintain a heightened suspicion for infections among patients who received compounded products labeled as sterile from Franck's and should report suspected infections to their local and state health departments for further investigation. Patients also should avoid use of compounded products labeled as sterile from Franck's and report adverse events or suspected infections promptly to their physician.

Reported by

Suber Huang, MD, Pravin Dugel, MD, American Society of Retina Specialists, Chicago, Illinois. George Williams, MD, American Academy of Ophthalmology. Moon Kim, MD, Kelsey Oyong, MPH, Clara Tyson, MSN, Laurene Mascola, MD, Los Angeles County Dept of Public Health. Kavita K. Trivedi, MD, California Dept of Public Health. Julie Duran, MPH, Colorado Dept of Public Health and Environment. Shannon Millay, MPH, Indiana State Dept of Health. Stephanie Black, MD, Chicago Dept of Public Health; Judith Conway, Illinois Dept of Public Health. Susanne Straif-Bourgeois, PhD, Louisiana Office of Public Health. Rick Sowadsky, MSPH, Nevada State Health Div. Ellen H. Lee, MD, New York City Dept of Health and Mental Hygiene. Tom Török, MD, Benjamin Sun, DVM, Career Epidemiology Field Officer Program, Office of Public Health Preparedness and Response; Shawn Lockhart, PhD, Julie Harris, PhD, Benjamin J. Park, MD, Div of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases; Rachel Smith, MD, Christina Mikosz, MD, Raymund Dantes, MD, Yoran Grant, PhD, EIS officers, CDC. Corresponding contributors: Christina Mikosz, dex0@cdc.gov, 213-240-7941; Rachel Smith, vih9@cdc.gov, 404-639-7738.

References

1. Chen E, Lin MY, Cox J, Brown DM. Endophthalmitis after intravitreal injection: the importance of viridans streptococci. Retina 2011;31:1525–33.
2. Eifrig CWG, Scott IU, Flynn HW, Smiddy WE, Newton J. Endophthalmitis after pars plana vitrectomy: incidence, causative organisms, and visual acuity outcomes. Am J Ophthalmol 2004;138:799–802.
3. Kastango ES, Bradshaw BD. USP chapter 797: establishing a practice standard for compounding sterile preparations in pharmacy. Am J Health Syst Pharm 2004;6:1928–38.
4. Food and Drug Administration. The special risks of pharmacy compounding. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2007. Available at http://www.fda.gov/forconsumers/consumerupdates/ucm107836.htm. Accessed April 30, 2012.
5. Goldberg RA, Flynn HW, Isom RF, Miller D, Gonzalez S. An outbreak of streptococcus endophthalmitis after intravitreal injection of bevacizumab. Am J Ophthalmol 2012;153:204–8.e1.

U.S. Senators Seek Investigation of State Medical Boards

U.S. Senators Seek Investigation of State Medical Boards

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

Senators have teamed up to request an evaluation of state medical boards. This bipartisan effort was initiated at the end of February 2012 when Senators Charles Grassley R-Iowa , Orrin Hatch R-Utah and Max Baucus D-Mont. sent a letter to the director of the Office of the Inspector General OIG for the Department of Health and Human Services HHS.  Click here to read more.

More News Articles about Franck's and its link to Eye Infections: Is Florida Department of Health Investigating?

The Florida Department of Health (FDOH) has stated that it cannot divulge if Franck’s is being investigated at this time. If an investigation is being done and the pharmacy is believed to pose an immediate threat to patient safety, FDOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license.  FDOH can't confirm whether they are investigating Franck's or any pharmacy until 10 days after the alleged investigation and only if probable cause is found. 
 
To read more about Franck's current issues with its compounding pharmacy, see the following:


Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012), click here.

CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012), click here.

Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012), click here.

WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012), click here.

Why We Need and Must Have Compounded Medications

In the wake of the tragic deaths in Franck's (Florida), Apothecure (Texas) and Meds IV (Alabama), it is important to not lose sight of the fact that we need and must have compounded medications.    If these medications were not available, some patients  (both humans and animals) would suffer and some could die. This was explained by Loyd V. Allen, Jr., Ph.D., R.Ph., Editor-in-Chief, International Journal of Pharmaceutical Compounding, when he testified on April 19, 2007, before the U.S. Senate Special Committee on Aging in Washington, DC.  During his testimony he explained:

Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For many of them a customized, compounded medication prescribed by licensed physicians or veterinarians and mixed by trained, licensed compounding pharmacists are the only way to better health. If customized medicines were not available, some of our most at-risk patients would needlessly suffer and some would die.

Allen also gave excellent examples of those who rely on compounded medications:

• Infants and children: Compounding pharmacists can transform medicines from
hard-to-swallow pills intended for adults into syrups, elixirs, suspensions, and
emulsions for children, at the request of physicians. Flavors offered by
compounding pharmacists can make drugs more palatable to children. In
addition, premature infants often rely on lifesaving and life-sustaining drugs made
only in compounding pharmacies.
• Hospital patients: Many, if not most, of the lifesaving intravenous drugs given in
hospitals and clinics are compounded. Because hospital patients are often on
multiple medications, compounding them into one treatment saves the hospital
personnel time and the patient multiple injections or administrations.
• Cancer patients: Cancer treatment often involves special mixtures of cancer drugs
that are compounded pursuant to a doctor’s prescription. Pharmacists can
combine multiple drugs into one treatment, leading to shorter administration times
for cancer patients.
• Senior citizens: Elderly patients often have difficulty with traditional dosage
forms, such as pills taken orally. Compounding pharmacists create alternate
methods of delivery, like transdermal gels, to make it easier for the elderly to take
their medicine.
• Pets: Animals come in all shapes and sizes, so one-size-fits-all pharmaceuticals do
not always meet their needs. In many cases, a compounded medication may be
necessary for a non-food animal to be satisfactorily treated.
• Patients with allergies: Patients who are allergic to a preservative, dye, flavor or
other ingredient in commercial products can have their doctor write a prescription
for a compounding pharmacist to customize the same medication without the
offending ingredient.
• Menopausal women: Many women experience significant pain and discomfort as
their bodies’ progress through menopause. Doctors prescribe bioidentical
hormones for patients for whom synthetic hormone treatments may be ineffective
or produce undesired side effects. Several bioidentical hormone products are
available in FDA-approved, one-size-fits-all formulations from pharmaceutical
companies. However, physicians may determine that their patients have unique
needs that warrant prescribing a different compounded hormone treatment. This
often allows patients to take the smallest amount of a given hormone preparation
to treat their symptoms, in conjunction with the recommendation provided by the
Women’s Health Initiative study.
• Patients who require non-traditional dosage forms: Many patients are unable to
take medications orally or as injections – the traditional dosage forms for
manufactured drugs. Compounding pharmacists can create alternate methods of
delivery, like ointments, solutions or suppositories, to fit these patients’ unique
health needs. The pharmaceutical industry supplies only limited strengths of
drugs, which some patients cannot tolerate. It is often necessary for a doctor to
request a different strength of a drug for a patient through compounding.
• Patients who rely on discontinued drugs: Pharmaceutical manufacturers have
discontinued thousands of drug products over the years, due to low profitability.
For certain groups of patients, these were very effective, important, and
sometimes life-saving medications. Such medications are now only available if a
doctor prescribes them to be compounded.
• Hospice patients: End-of-life therapy involves the compounding of many different
and unique dosage forms to allow patients to live out their lives free of pain and
discomfort. Many combinations of drugs are prescribed by doctors and used for
these patients who cannot swallow medications and who don’t have the muscle
mass that is required to receive multiple injections each day. Compounding
pharmacists can provide alternate delivery methods such as oral inhalation, nasal
administration, topical, transdermal or rectal use.

These are important examples of why we need and must have compounded medications in the United States.  The problems in the tragic cases do not suggested that the practice of compounded medications must be stopped; instead, the tragedies shows that the rules and regulations relating to compounding need to be complied with by pharmacies, doctors, veterinarians and enforced by state boards of pharmacy, state boards of medicine, state veterinary boards and the United States Food and Drug Administration.   To read the entire transcript of Dr. Allen's testimony, click here.

Franck's had to Answer Why It had Not Paid Penalties

A recent article entitled Trouble ahead for Franck's, Second Drug Controversy in Three Years could Spell Problems for Ocala Compounding Law, written by Carlos E. Medina and published on May 4, 2012, points out that Franck's has not satisfied state penalties handed down in the settlement after the 2009 incident that killed the 21 horses and Franck's recently had to appear before the Florida State Board of Pharmacy to answer why it had not paid the penalties.  The articles states: 

But even as the company deals with the latest investigation, it still has not satisfied state penalties handed down in a settlement after the 2009 incident that killed the 21 horses.The Florida State Board of Pharmacy recently brought Franck's before them to answer for not paying the penalties.
On May 1, the board ordered the lab to pay more than $14,387.21 in original penalties, plus another $2,000 fine and $1,000 in administrative costs for not abiding by the first settlement. The company has 90 days to pay the fines.

In the 2009 case, Franck's was cited by the state Department of Health for numerous violations of Florida law covering pharmacies. 

To read the entire article, click here.

Settlement Agreement Between Franck's and Florida State Department of Health

A draft of the Florida State Department of Health board meeting minutes for April shows more trouble for Paul Franck and Franck Pharmacy.  To read the entire draft of the minutes, click here.  Here are the disciplinary actions against Franck.

TAB 3 DISCIPLINARY CASES – John Truitt, Assistant General Counsel
A. SETTLEMENT AGREEMENT– APPEARANCE REQUIRED CASES
A-1  Paul Wayne Franck, PS 17342, Ocala, FL
  Case No. 2008-17152 – PCP Powers/Jones
Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $427.17. Respondent shall complete a 12 hour Laws and Rules CE course.
Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
Motion: by Weizer, seconded by Fallon, to accept the Settlement Agreement. Motion carried.
A-2  Francks Lab, Inc, PH 19761, Ocala, FL
Case No. 2008-16979, 2010-16555 – PCP Powers/Jones, Garcia/Weizer
(2008-16979) Respondent violated:
Count One:  Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two:  Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
(2008-16979) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $750.97.

Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
For the first Settlement Agreement:
Motion: by Ms. Mullins, seconded by Dr. Fallon, to dismiss the case. Motion carried with Dr. Griffin opposed.
(2010-16555) Respondent violated Section 456.072(1)(k), F.S., by failing to perform any statutory or legal obligation placed upon a licensee.
(2010-16555) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $80.67.
For the second Settlement Agreement:
Motion: by Dr. Fallon, seconded by Ms. Glass, to accept the Settlement Agreement. Motion carried.

Article: Liability of Veterinarians When Using Compounded Drugs

The following article appearing in the November 3, 2011, edition of Veterinary Practice addresses the liability issues a veterinarian may be exposed to when violating the law regarding compounded medications.

Legal Exposure Might Not be Worth the Savings

Using a compounded drug instead of an FDA-approved animal medication could open a veterinarian to legal exposure if the animal has a bad outcome.

By Marie Rosenthal, MS

For Veterinary Practice News

Posted: Nov. 3, 2011, 2:35 p.m. EDT

Some veterinarians believe they are helping clients reduce costs by ordering compounded drugs instead of medications approved by the U.S. Food and Drug Administration.

But there’s a reason compounded drugs are cheaper than FDA-approved medications, pharmaceutical companies say. Compounding pharmacies’ quality-control procedures are rarely as stringent or comprehensive as the good manufacturing practices required by the FDA for approved products. Therefore, the safety and efficacy of compounded drugs are not guaranteed.

In a case of therapeutic failure of a compounded product when an FDA-approved medication is available, the amount the veterinarian saves the client might turn a competitive advantage into a serious disadvantage. That prescription could leave the veterinarian exposed to legal liabilities because the FDA does not test or approve compounded drugs. 

Liability Dangers

“Many times veterinarians don’t understand that they are the first in line in liability in the event that a compounded product goes bad,” says Denise E. Farris, Esq., owner of Farris Law Firm LLC in Kansas City, Mo.

“If there is an adverse reaction, he or she is liable to the client for veterinary malpractice. The liability coverage may not cover that activity because most policies do not cover ‘gross negligence’ or ‘intentional acts.’

“If a veterinarian is prescribing a compounded product, the veterinarian could be charged with negligence because he or she knew or should have known that the product was untested and its efficacy was not proven,” she says.

She adds that there can be further liability if a client is not fully informed about the risk of using the compounded substitute.

Several studies have reported quality problems with compounded drugs, including subpotency, superpotency and contamination. In 2006, 33 percent of active pharmaceutical ingredients for human drugs used by compounding pharmacists or finished compounded human drugs failed an FDA test, primarily because of sub- or super-potency or a lack of uniformity. Potency ranged from 67.5 percent to 268.4 percent of the amount of drug declared on the product labeling, according to the FDA.

In its report, the FDA says, “The results of the survey suggest that problems with the quality of compounded drugs occur throughout the country.”

Finding a Place

This is not to say that compounded products do not have a legitimate place in equine medicine. They do, the FDA acknowledges, but it says that place is narrow.

In a 2006 warning letter to a veterinary compounding pharmacy, the FDA wrote: “The drugs that pharmacists compound are rarely FDA-approved and thus lack an FDA finding of safety and efficacy.”

The FDA regards traditional compounding as the extemporaneous combining, mixing or altering of ingredients by a veterinarian or a pharmacist as ordered by a veterinarian (or physician) to create medication tailored to the specialized needs of an individual patient.

“Compounding is a very narrow, specific field,” says Jeffrey T. Berk, VMD, who practices equine medicine at Equine Medical Associates in Lexington, Ky. “A compounded product is supposed to be produced for a particular patient, for a particular condition, at a particular time and is obviously tailored for a unique need for which there is no approved product.”

Many clients think that compounded drugs are generic substitutions of a name-brand medication, but they are not. By law, compounding pharmacies are not allowed to make large quantities of medications using commercial-scale equipment—that could be construed as manufacturing drugs without a license.

Although the compounding pharmacist is supposed to use FDA-approved active ingredients when compounding a drug, the final compounded drug formulation is not an FDA-approved medication because it has not been tested for efficacy, safety, potency, sterility, dosage or even stability.

Approvals

Generic drugs are subject to FDA oversight just as brand-name medications are, but compounded drugs are not. A pharmaceutical company that wants to make a generic version of a brand-name medication must prove to the FDA that the generic is equivalent in all characteristics to the brand-name medication. The generic drug must also meet the same manufacturing quality control requirements as the brand-name product.

“There are appropriate times and ways to compound, and there are inappropriate ways to compound,” says Lynne White-Shim, MS, DVM, an assistant director in the American Veterinary Medical Association’s Scientific Activities Division. “When a veterinarian is deciding how to treat his or her patient that has a medical condition, the veterinarian needs to follow federal rules if he or she decides on an extralabel use of a product, and compounding rules are a component of extralabel drug-use rules.”

The experts say there is a hierarchy to prescribing medications, especially when it comes to food animals. The rules allow for greater flexibility when treating non-food animals, says Dr. White-Shim:

* The first choice should be an FDA-approved veterinary medication indicated for that species and marketed for that condition;

* The second choice should be an FDA-approved veterinary medication which might be indicated for another species;

* The third choice would be an FDA-approved human medication indicated for that condition; and

* Fourth, if there are no FDA-approved medications, a compounded drug.

“If a veterinarian is prescribing a compounded product knowing that there is an equivalent FDA-approved medication on the market, then that is an FDA violation,” says Farris, the attorney. “If there is an FDA-approved medication, FDA regulations prohibit veterinarians from prescribing a compounded equivalent, and prohibit a compounding pharmacy from producing it.”

Limitations

Generally speaking, compounding pharmacies are restricted from promoting or advertising unapproved new animal drugs, creating and marketing compounded preparations that mimic FDA-approved medications, and manufacturing large quantities of drugs under the guise of compounding or distributing these preparations wholesale.

They are permitted to advertise in certain instances, such as when the compounded product serves many patients that do not have access to an FDA-approved product.

Some compounding pharmacies skirt the law, veterinarians and pharmaceutical companies contend, and the FDA lacks the resources to prosecute every violation.

Berk notes that the American Association of Equine Practitioners and the AVMA, which have issued guidance for veterinarians about the appropriate use of compounded products in veterinary medicine, encourage the FDA to become more involved in enforcing compounding regulations.

“Veterinarians are under additional legal exposure when they use compounded drugs,” Berk says.

The experts provide these tips to limit that exposure:

* Make sure you have a valid veterinarian-client-patient relationship and provide full disclosure about the compounded drug, its risks and why it is being prescribed.

* Use compounded drugs only if an FDA-approved medication (indicated for either animals or human use) is not available or cannot adequately treat the medical condition at hand, and the health of the animal is threatened, or if suffering or death may result from failure to treat.

* Check whether the pharmacy is certified by an independent body, such as the Pharmacy Compounding Accreditation Board.

* Contact the state board of pharmacy to find out the status of the pharmacy within the state and assure that it is licensed to compound in that state.

“Veterinarians often believe they are providing a cost savings to the client, but their clients may not understand that the cost of the legitimate FDA-approved products include long-term testing for efficacy, safety, consistency and purity. There might also be a lack of understanding of the legal ramifications the veterinarian faces,” says Farris.

“In addition,” Farris continues, “the owner relies on the veterinarian to provide the appropriate standard of care. Using untested, unproven compounded products when there is an FDA-approved medication available not only violates FDA regulations, but increases the veterinarian’s liability exposure in circumstances not typically covered by insurance.”

Texas State Board of Pharmacy's Ability to Impose Discipline for Violations of Other States' Law

An excellent blog post entitled, Texas State Board of Pharmacy's Ability to Impose Discipline for Violations of Other States' Law, posted on on February 3, 2011,and written by Louis Leichter, explains how Texas Board of Pharmacy, pursuant to Texas law, is authorized to discipline pharmacists for violating another state's law pertaining to drugs or the practice of pharmacy. Leichter notes that this grant of jurisdiction is expansive and raises unique regulatory pitfalls for Texas pharmacists whose practice reaches into other states or who hold licenses in multiple jurisdictions.  With regard to the law relating to compounding medications, this is another example where a pharmacist needs to not only check federal law and the law of the state where licensed, but the pharmacist also needs to check the law of any other state where business is being conduct.  For example, if the pharmacist is licensed in Texas, but delivering or shipping compounded medications to Oklahoma, the pharmacist would need to comply with applicable Texas and Oklahoma state law and any applicable federal laws.
Click here to view the post.

United States General Accounting Office Report on State and Federal Oversight of Drug Compounding by Pharmacies

In 2003, Janet Heirich, who was then the Director of Health Care--Public Health Issues, testified before Congress regarding State and Federal Oversight of Drug Compounding by Pharmacies.  Her testimony was based on a very interesting study conducted by the United States General Accounting Office.  To review that report click here.

Compliance Study on Sterile Compounding Practices Calls for Participants

From the National Association of Boards of Pharmacy website dated May 16, 2012:

Compliance Study on Sterile Compounding Practices Calls for Participants

May 16, 2012 03:00 PMTopics: Compounding, Patient Safety

Sterile compounding facilities are invited to participate in the 2012 USP 797 Compliance Study, a National Study of Sterile Compounding Practices, co-directed by sterile compounding experts, Eric Kastango, RPh, MBA, FASHP, and Kate Douglass, MS, RN, APN,C, CRNI. The study is now open and will remain open through June 30, 2012. The study, first conducted in 2011, is the largest and most comprehensive study of 797 compliance ever undertaken in the US, as noted in an announcement from CriticalPoint. After this year, the study team plans to repeat the study again one year after the US Pharmacopeial Convention (USP) Expert Committee makes final the newest changes to the chapter, expected in late 2013. It is hoped that the information and insights gained from this study will assist in benchmarking progress and identifying where additional resources and focus are required to continue to improve sterile compounding practice and patient safety. More information and a link to participate in the study are available at www.797study.com (Survey Code B797A). Questions may also be directed to the study team by calling 240/238-4352. The results of the study will be published this fall in Pharmacy Purchasing & Products Magazine.

Drug Compounding for Veterinary Patients

In 2005, the AAPS Journal published an article entitled Drug Compounding for Veterinary Patients

written by Mark G. Papich.  Although this article was written several years ago it is still a good resource.  The article contains the following topics: 

Current Regulations on Compounded Veterinary Drugs   

The Need for Compounded Drugs in Veterinary Medicine   

Potential Problems Caused by Compounded Formulations   

Examples of Potential Problems   

The Interspecies Problem   

Transdermal Drugs   

Current Guidelines for Veterinarians  

Future of Veterinary Drug Compounding  

To read the article click here

Oral Arguments Set in Franck's case for week of October 29, 2012

The 11th Circuit Court of Appeals has set the Franck's case on the oral argument tentative calendar to be held in Atlanta during the week of October 29, 2012.  The actual date and time of the oral argument will be announced later.  As previously, discussed on this blog, here is an overview of the appellate process:

Jurisdiction of 11th Circuit Court of Appeals The Franck's case is currently pending at the 11th Circuit Court of Appeals.  I thought a short discussion of federal appellate procedure might be helpful.  The 11th Circuit Court of Appeals is a federal court with appellate jurisdiction over the district courts in the following districts: 1.  Middle District of Alabama 2.  Northern District of Alabama 3.  Southern District of Alabama 4.  Middle District of Florida 5.  Northern District of Florida 6.  Southern District of Florida 7.  Middle District of Georgia 8.  Northern District of Georgia 9.  Southern District of Georgia What the 11th Circuit Can Consider A federal appellate court is generally only allowed to consider the record that was established in the district court.  There are some exceptions, but for the most part if the evidence or information was not presented in the district court then the 11th Circuit will not be allowed to consider it on appeal.  The same principle generally applies to legal arguments made on appeal.  If the argument was not made in the district court, there is a strong chance it will be considered waived or forfeited on appeal.  Again there are exceptions. Oral Argument Once briefing is done in Francks, the case will be submitted to a panel of three judges to review the district court decision. Approximately three-fourths of the court's cases are decided on the briefs submitted by the parties, while the remaining cases include oral argument. Oral arguments are held in the Elbert P. Tuttle United States Court of Appeals Building in Atlanta, Georgia and are open to the public. Oral arguments are also held in Florida (Jacksonville and Miami) and Alabama (Montgomery). Most likely in Franck's the judges will set the case for oral argument because the parties have requested oral argument.  Each side's attorneys will get 15 minutes to argue the position of the party represented.  The amicus curiae who filed briefs in the Franck's case may participate in oral argument only with the court's permission. Timing of Decision After oral argument, the appellate court will issue a decision.  There is no time limit on when the decision has to be issued.  Some cases can take over a year before an appellate court issues its opinion. The Written Opinion The opinion will consist of a written analysis that reviews the district court's decision.  The appellate court can (1) affirm the district court decision; (2) reverse the district court decision; (3) modify the district court decision or (4) remand the case for further the district court to make further factual findings.  This decision will be binding only in the states listed above that make up the 11th Circuit Court of Appeals.  It will be persuasive authority in all other states, but those federal courts will not be bound by the decision and can reach a totally contrary result if presented with the issue.  Only if the issue is decided by the United States Supreme Court will the decision be binding in all federal courts. Options of Losing Party At that point, the losing party can file a (1) petition for rehearing before the three judge panel, (2) file a petition for rehearing en banc before the full 11th Circuit Court of Appeals (3) petition for certiorari to the United States Supreme Court or (4) accept the decision and implement whatever it says.  A court of appeals is not required to grant a petition for rehearing before the three judge panel or before the full court.  Furthermore, the United States Supreme Court would not be required to grant certiorari.  Each of the first three options has different legal standards that must be met.

JUDGE IN NORTHERN DISTRICT OF TEXAS SETS SCHEDULING ORDER FOR SENTENCING as to Gary D Osborn, Apothecure Inc

SCHEDULING ORDER FOR SENTENCING as to Gary D Osborn, Apothecure Inc:

Presentence Investigation Report due by 7/6/2012.
Objections to Presentence Investigation Report due by 7/20/2012.
Presentence Investigation Addendum due by 7/27/2012.
Objections to Presentence Investigation Addendum due by 8/3/2012.
Sentencing set for 9/21/2012 01:30 PM before Judge Barbara M.G. Lynn.
Motions for Downward Departure due by 9/12/2012.
Sentencing Memoranda and Character Letters due by 9/12/12.

Franck's Compounding Lab: Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml

These recalls relating to Franck's Compounding Lab were issued on March 31, 2012, and May 1, 2012

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml

Contact:
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

May 2, 2012

Dear Physician,

Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and on March 29, 2011 instituted a recall. The recall involved five physicians and eight prescriptions. The physicians have been contacted and all prescriptions accounted. As a precaution Franck’s Lab has recalled one additional lot of triamcinolone acetonide P.F. 80mg/ml. No adverse events have been reported related to this lot. The recall involved four physicians and five prescriptions. All offices have been contacted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

NOTICE OF RECALL

Contact:
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

March 31, 2012

Dear Physician
Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and instituted a recall. The recall involved five physicians and seven prescriptions. The physicians have been contacted and all prescriptions accounted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

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