Tuesday, December 31, 2013

Policy and Medicine: Current Healthcare Landscape and Predictions for 2014

December 31, 2013 Law regulating compounding pharmacies falls short

HealthDay News -- Additional steps are needed for regulating compounding pharmacies beyond those outlined in the Drug Quality and Security Act of 2013, some are warning.
Kevin Outterson, JD, LLM, from the Boston University School of Law, discusses limitations of the Act, passed after a 2012 fungal meningitis outbreak originated at a New England compounding pharmacy.
His insights were recently published online in the New England Journal of Medicine.
Although the new Act goes some way to improve regulation, including reenactment of Section 503A, additional legislation is needed at the state level to avoid similar tragedies as the one that originated at the New England Compounding Center (NECC) in Framingham, Mass.
Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies, according to Outterson. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering drug shortages.
continue to read here

Another Compounding Sales Opening in Georgia

Sales Representative Compounding Pharmacy

Towne Lake Family Pharmacy  - Greater Atlanta Area

We are looking for independent sales professionals with experience calling into physician practices  in Orthopedics, Pain Management, Sports Medicine, Podiatry, Rheumatology, Neurology, Family Practice, Internal Medicine.

A history of close personal relationships with physicians and their staff is a must in order to drive brand preference and referrals.
Job requires enthusiastic, self-motivated, self-directed individual to effectively manage the territory and work independently. 

We offer a 20% share of the reimbursement with annual income potential of $250K+. 

We welcome people seeking full-time or part-time positions.   

Desired Skills and Experience

Professional and ethical character is of the utmost importance, while displaying a positive, can-do, team-oriented attitude.
Know the pain therapy market well and have represented pain products and /or have a solid list of physicians who treat acute and chronic pain.
Can demonstrate strong track record of success. 
Excellent organizational, analytical and follow-up skills.
Must have a valid driver’s license in good standing.

quoted from here

About this company

Towne Lake Family Pharmacy

We specialize in formulating topical transdermal pain cream compounds used to treat both acute and chronic neuropathic and inflammatory pain.
Topical treatment is used as a replacement or adjunct to oral opioid pain management therapy eliminating most major side effects as well as avoiding addiction.
Many patients are unable to take oral medications due to gastrointestinal  (stomach, liver, kidneys), issues, which can significantly affect the patient’s quality of life. 
Towne Lake Family Pharmacy is locally owned and offers superior customer service which includes facilitating prescription medication and expediting home medication delivery for patients WITHIN 24 HOURS BY LICENSED PHARMACISTS. We manage the claims process for patients, our experienced and devoted staff has worked closely with physicians and has extensive experience dealing with insurance companies AND coordinating

California Board of Pharmacy Enforcement and Compounding Committee Agenda for January 10, 2014

January 10, 2014Department of Consumer Affairs
1625 N. Market Blvd.
1st Floor Hearing Room
Sacramento, CA 95834

Answer to my Fourth Question of the Day on December 31, 2013 Regarding the cost of compounded pain medications: Thank you Dr. Kenneth Woliner for the comment


Yes. The compounded pain creams may be useful for patients (or not), and are EXTREMELY LUCRATIVE FOR COMPOUNDING PHARMACIES and the sales reps they employ to get prescriptions from doctors all around the country (not just locally). Sometimes they are also lucrative to the prescribing physician through illegal kickbacks and split-fee relationships (e.g. Florida Board of Medicine v. David R. Balding, M.D. DOH 93-02958 - where the doctor was getting a 25% kickback on all compounded ketoprofen creme prescriptions - ALL IN CASH, as to not have a paper trail - http://ww2.doh.state.fl.us/FinalOrderNet/folistbrowse.aspx?LicId=42705&ProCde=1501&discpln=DISCPLN)

The way the SCAM part of this works is that:

- Active Pharmaceutical Ingredient (API) suppliers "artificially inflate" the "Average Wholesale Price (AWP) of the raw material drugs used in these creams by 1,000%, but will sell the API's to compounding pharmacies for a tenth of the AWP.

- Compounding Pharmacies bill insurance at the AWP (often $2,000 - $3,000 for a month's supply of transdermal cream), but get reimbursed by the insurance company at about 80% of billed charges. The insurance company may think they "negotiated a good deal", but in reality, they got scammed.

- The compounding pharmacy makes so much profit ($1,000 - $1,500 per prescription per month) that they can afford to pay outrageous commissions tomtheir sales reps (and sometimes, kickbacks to the prescriber).

Kenneth N. Woliner, M.D.

Recalls of both manufactured and compounded drugs were common frustrations for vets, and may have caused significant health hazards for pets made top 12 veterinary news stories of 2013

The Top 12 Veterinary News Stories of 2013

You may not know it, but 2013 was a tumultuous year for the vet world, from drug shortages and recalls to revolt in the American Veterinary Medical Association.
 |  Dec 31st 2013

read here

Ohio plans to use compounded preparation in execution

Fourth Question of the Day December 31, 2013 What is the average price for a compounded pain preparation script? Is it really $2200 as stated on cafepharma board? Are insurance companies covering this type of cost?

AVMA announces that American Association of Bovine Practitioners have developed guide for proper oversight of drugs use in cattle

Cattle veterinarians develop guide on drug oversight
Posted Dec. 30, 2013
A guide from the American Association of Bovine Practitioners is intended to help veterinarians ensure they establish proper oversight for drug use in cattle.

The AABP published in November 2013 the two-page guide on veterinarian-client-patient relationship practices that the organization endorses and that exceed regulatory requirements.

For example, the guide indicates veterinarians or veterinary practices should have written agreements that identify the veterinarian who is accountable for drug administration on a farm as well as who is responsible for duties such as drug inventory maintenance.

The guide, “Establishing and Maintaining the Veterinarian-Client-Patient Relationship in Bovine Practice,” is available here.

The document also describes AABP-endorsed practices of establishing a veterinarian of record, clarifying relationships among veterinarians and consultants on farms, providing treatment protocols, maintaining treatment records, and prescribing drugs.

The guide is intended to help veterinarians ensure they and their clients communicate and keep records in ways that ensure pharmaceuticals are used in a responsible manner, Dr. Keith Sterner of Ionia, Mich., said in an AABP announcement. Dr. Sterner was chair of the AABP task force that created the guidelines.

The AABP also is developing cattle well-being guidelines, the announcement states.
quoted from here

KUDOS to the State of Washington for including public at large and pharmacy tech on the new pharmacy commission (formerly the board of pharmacy)

Major Changes in State of Washington Regarding Compounding Rules in 2013

The Washington State Legislature has passed a law stating that all compounding done within the state must comply with United States Pharmacopeia (USP) standards for compounding.  The Washington State Pharmacy Quality Assurance Commission (previously known as the Board of Pharmacy), is currently writing rules based on the standards.  Rumor has it state pharmacy inspectors are already beginning to use USP standards in surveying compounding pharmacies.  William E. Fassett, PhD, RPh, FAPha, Professor of Pharmacy Law and Ethics at Washington State University-Spokane has a great summary of some of the changes effecting pharmacies in his Law Matters June 2013 Newsletter found here.  He explains that the Board of Pharmacy is now the Pharmacy Quality Assurance Commission (HB 1609) and that commission typically have a larger number of members and in this case the increase is from 7 to 15 members.  The commission will have 10 pharmacists, 1 pharmacy technician and 4 public members. Dr. Fassett summaries the new law regarding compounding as follows:

Compounding of drugs for office use, incorporation of USP <795> and <797> (HB 1800) – Effective

May 7, 2013
This statute amends the definition of “manufacture” in the Legend Drug Act to include distribution of products compounded by a licensed pharmacy to other state licensed persons for subsequent resale, “unless a specific product item has approval of the board.” However, “manufacture” does not include: (1) compounding by a licensed pharmacy pursuant to an order of a licensed practitioner for use in the practitioner’s practice by
administration to his or her patients; (2) repackaging of a commerciallyavailable medication by a pharmacy in
“small, reasonable quantities” for a practitioner’s office use; (3) distribution of products compounded by a licensed pharmacy to “other appropriately licensed entities under common ownership or control of the facility in which the compounding takes place;” or (4) delivery of finished and appropriately labeled products compounded pursuant to a prescription to “alternate delivery locations, other than the patient’s residence, when requested by the patient, or the prescriber to administer to the patient, or to another licensed pharmacy to dispense to the patient.”

The statute also incorporates USP chapters on compounding into state law, by amending RCW 18.64.270 to read “Any medicinal products that are compounded for patient administration or distribution to a licensed practitioner for patient use or administration shall, at a minimum, meet the standards of the official United States pharmacopeia as it applies to nonsterile products and sterile administered products.”


Contains A Lot of Information: State of Washington June 2013 Minutes from Compounding Stakeholders Meeting

Third Question of the Day December 31, 2013 Why do more state boards of pharmacy not enforce their rules and regulations against non-resident pharmacies?

Second Question of the Day December 31, 2013 Why do more state boards of pharmacy not issue cease and desist orders against compounding pharmacies who have had to recall compounded preparations?

Question of the Day December 31, 2013 With the Texas Board of Pharmacy Adopting New Rules Relating to Compounding Will It finally take enforcement action against some of the compounding pharmacies in its own state?

New Texas Board of Pharmacy Rules Relating to Compounding Effective December 10, 2013 unless noted otherwise


§291.33 Operational Standards, §291.36 Pharmacies Compounding Sterile Preparations (Class A-S)

The amendments to §291.33 clarify that Class A pharmacies will no longer be able to compound sterile preparations after August 31, 2014, unless the pharmacy obtains a Class A-S pharmacy license. New §291.36 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the Texas State Board of Pharmacy appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.


§291.74 Operational Standards, §291.76 Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center, §291.77 Pharmacies Compounding Sterile Preparations (Class C-S)

The amendments to §291.74 and §291.76 clarify that Class C pharmacies will no longer be able to compound sterile preparations after August 1, 2014, unless the pharmacy obtains a Class C-S pharmacy license. New §291.77 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the Texas State Board of Pharmacy appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.


§291.104 Operational Standards, §291.105 Records, §291.106 Pharmacies Compounding Sterile Preparations (Class E-S)

The amendments to §291.104 clarify that Class E pharmacies will no longer be able to compound sterile preparations after August 31, 2014, unless the pharmacy obtains a Class E-S pharmacy license. The amendments to §291.105 add requirements for auto-refill programs. New §291.106 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the TSBP appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.


§291.133 Pharmacies Compounding Sterile Preparations
New §291.133 outlines operating standards for pharmacies that compound sterile preparations, implements the recommendations of the TSBP appointed Task Force on Compounding (Task Force), incorporates provisions included in the United States Pharmacopeia (USP) General Chapter 797, and implements Senate Bill 1100 passed during the 83rd Regular Session of the Texas Legislature regarding pharmacies compounding sterile preparations.

quoted from here

Update on Texas Board of Pharmacy Rules that Became Effective December 10, 2013 and proposed rules being considered for adoption

The Board met on November 4-5, 2013, in Austin, Texas.  To view the meeting agenda and additional materials, click here.   Rules adopted at the November Board meeting were published as adopted in the December 6, 2013, issue of the Texas Register and became effective December 10, 2013.  Rules proposed at the November Board meeting are posted in the December 13, 2013, issues of the Texas Register and are available for public comment until January 24, 2014.  The proposed rules will be considered for adoption at the next TSBP board meeting on February 11, 2014.  You may view a summary of the adopted and proposed rules here.  You may also view the adopted and proposed rule language from the November Board Meeting agenda.  Please note underlined language is new language and language that is being deleted is lined out.  All other language is currently in the rules and is not being changed.

quoted from Texas Board of Pharmacy Newsletter

The Worst Scientific Mistakes, Missteps and Misdeeds Seeded by Colin Klein

Science is not immune to the foibles that plague ordinary, not-parked-at-a-lab-bench citizens. But mistakes made in a lab can be dangerous, and even deadly. Misleading or faulty scientific reports can send other scientists astray, wasting years of time and hard-earned research grants. Badly designed apps and poorly analyzed data can help lose a presidential election.
Every year, a number of scientists are caught in various forms of misbehavior. Now, some scientistseven study  the misdeeds of others. Here are some of the most notable examples of science-related errors, missteps and dishonesty in 2012, ranging from the mildly amusing to the truly deadly.

Pharmaceutical Distributor Contaminates Drug, Causes Outbreak
continue to read here

Monday, December 30, 2013

ihirepharmacy shows number of compounding pharmacy, tech and sales representative jobs available

1099 sales rep opening for compound pain medications

1099 Pharmaceutical Sales Rep or Medical Device

CityWide SolutionsRX - Greater Minneapolis-St. Paul Area

Posted 13 days ago

Job description

We are looking for several Experienced Sales Reps. These positions are best worked in
addition with your current employment (completely confidential). These are 1099
positions and the commissions are lucrative.
If you have Pharmaceutical Sales Experience and if you know doctors in pain
management, or/and in orthopedics, sports medicine, rheumatology, pediatrics,
family practitioners, internists, podiatrists, plastic surgeons, and
vascular/diabetes, we would like to talk to you about selling our compound pain

Disease States covered: anti-inflammatory, neuropathic pain,
combination pain, osteoarthritis, joint or musculoskeletal pain, ect.

You are paid on new AND re-filled scripts giving you monthly
passive income. Re-filled scripts pay out 100% of original commission. The
Average commission Per Script is $200-$450. Commissions are paid out monthly.
quoted from here

Virginia Veterinary Medical Association 2014 Conference


HERE - Virginia Veterinary Medical Association

Dec 6, 2013 - followed by a meeting with the Board of Veterinary Medicine to discuss .... Assistants and the VA Board of Pharmacy, Compounding Issues. Friday .... Leader, Iowa State University College of. Veterinary Medicine. Ames, IA. Christine .... completed International Health Certificates and Certificates of Veterinary Inspection.

Kudos to Leiter's Compounding Pharmacy for publishing its Quality Control Report

Quality Control Report - Leiter's Compounding Pharmacy

Dec 16, 2013 - Cod,Er the fi.rrn nCrnC heirebn ia tipensed sl,,,,lh. ' .... Critical Point: Training for sterile compounding technicians and pharmacists include on-‐line modules as ... Required Reading: Board of Pharmacy Title 16, Section 1751 (State Regulations), ASHP Guideline for Sterile .... Visual inspection of Compounded Sterile.

Prescription Law Changes That Impact Veterinary Practices--Arizona, Florida, New Mexico, and Virginia Clarify in office use rules

A New Jersey bill was introduced to require veterinarians to provide written prescriptions as well as oral and written notification that the prescription item may be obtained from sources other than the veterinarian. The Oregon Veterinary Medical Examining Board is considering regulations to require veterinarians to provide a written prescription to a client upon request. Similar legislation was not introduced in Congress in 2013. The Federal Trade Commission has not yet issued a report or findings after holding a workshop on this topic in the fall of 2012.

The State Agricultural and Rural Leaders, a national group of state legislators, endorsed a resolution supporting The Veterinary Medicine Mobility Act of 2013, currently pending in the U.S. Congress. The legislation aims to change federal law that some DEA offices have interpreted as prohibiting veterinarians from transporting controlled substances to administer and treat patients outside of a registered location. The amendment would clarify that a veterinarian may transport controlled substances outside a registered location (i.e., clinic, hospital, office or clinician's home) to provide comprehensive veterinary care and to protect animal health and welfare.

Arizona, Florida, New Mexico, Texas and Virginia issued rules clarifying in-office use or dispensing of compounded products. The newly-passed federal law, the Drug Quality and Security Act, only regulates compounding pharmacies that produce drugs for human medicine. However, some of the compounding pharmacies that are subject to the law also compound drugs for veterinary medicine and will be impacted.

Concluding a five-year study, a Kansas legislative task force reached the conclusion that veterinarians should not be included in the state's prescription monitoring program. Similarly, Maryland, North Carolina, Tennessee and Wisconsin have decided to exempt licensed veterinarians from the requirements of their state programs, either completely or in certain conditions. Connecticut, Louisiana and Rhode Island made changes or expanded their prescription monitoring programs, which include veterinarians as mandated reporters. The Washington State Department of Health issued rules to implement statutory law that provides alternative, less-burdensome reporting requirements for veterinarians.

quoted from the AVMA

NABP November/December 2013 Newletter contains a lot of compounding information

Iowa and New Jersey Nearing End of Compounding Inpsection Program

Iowa and New Jersey

Inspection Programs

Nearing Completion

The Iowa Board of

Pharmacy partnered with

member boards and NABP

to conduct inspections of

all its nonresident pharmacies

including those

dispensing compounded

drugs to the state following

the 2012 multistate fungal

meningitis outbreak linked

to contaminated injectable

drugs compounded by the

New England Compounding

Center. NABP surveyors

began conducting pharmacy

inspections on behalf of

the Iowa Board of Pharmacy

in December 2012,

and inspections have been

completed at an average rate

of 15 to 20 inspections per

week. To date, more than

500 nonresident pharmacies

that dispense drugs to

patients in Iowa have been

inspected. The program is

projected to be completed

by mid-December 2013.

Similarly, the state

of New Jersey requested

NABP’s assistance in conducting

inspections of pharmacies

engaged in compounding

within the state.

NABP is assisting the New

Jersey Division of Consumer

Affairs (Division) with

planned inspections, under

a contract with the Division

and state’s Attorney General

Jeffrey S. Chiesa. Surveyors

began inspections in July

2013 and are expected to

complete them in the spring

of 2014.

In addition to supporting

these state efforts to expand

inspections, the programs

provided opportunities

for collaboration among

member boards and NABP.

NABP surveyors and board

inspectors developed strong

working relationships that

enabled them to learn from

shared experiences of conducting
quoted from here

USP 797 Standards Powerpoint Lecture


USP <797> Standards – Pharmaceutical Compounding Sterile

19 hours ago - Risk Level Classifications of Compounded Sterile Products ... Manually mixing no more than three products to compound drug admixtures; i.e. Morphine drip, ...

Extra Steps Urged for Regulating Compounding Pharmacies - Medical News - Pri-Med Online

Extra Steps Urged for Regulating Compounding Pharmacies - Medical News - Pri-Med Online

Fourth Question of the Day December 30, 2013 When a compounding pharmacy advertises that compounded hormones are "better" for women does this violate state or federal law? Should it be a violation?

Third Question of the Day December 30, 2013 When a pharmacy advertises testing for hormone levels, then suggest the formula for the hormone replacements and then tells patients to either take the information to their doctor or refers patients to a doctor, what at the civil and criminal legal issues with this fact pattern? So fact pattern but it involves pain management?

Second Question of the Day December 30, 2013 How many compounding pharmacies and pharmacists are falsely advertising their compounded preparations? How many are breaking the law in the manner they advertise? Should they be prosecuted by the state or federal government?

Question of the Day December 30, 2013 Is it enough that NECC (and the insurance co.) have reached a civil settlement or should the company and its owners also be held criminally responsible?

For those who miss the 4 part series done by Fred Hiers here are links to all the aticles he did on compounding recently

New pharmacy safeguards: Real change or window dressing?

Published December 23, 2013
The Florida Board of Pharmacy wants the public's trust.
  • State inspections found lacking for pharmacies

    State inspections found lacking for pharmacies

    Published December 22, 2013
    After the NECC debacle, some states, including Florida, began taking a look at what their drug-making pharmacies were doing.
  • Changing times don't bring changing rules for compounders

    Changing times don't bring changing rules for compounders

    Published December 22, 2013
    Corner drugstores or drug manufacturers? That is the central question driving the debate over pharmaceutical compounders.
  • For nation's drug supply, a mixture of regulations

    For nation's drug supply, a mixture of regulations

    Published December 21, 2013
    The Marion Pain Management Center in Ocala had been running a few minutes behind when Roseann Fusco walked in, but that was little concern.
  • New England Compounding Center owners reach settlement | Drug Store News

    New England Compounding Center owners reach settlement | Drug Store News

    FDA Moves Quickly to Implement Compounding Provisions of DQSA

    FDA is moving quickly to give regulatory flesh to the compounding provisions of the new Drug Quality and Security Act of 2013 (DQSA), signed into law by President Obama on November 27.
    On December 4, a week after the signing, FDA issued three draft guidances and three companion Federal Register (FR) notices related to the implementation of the compounding provisions of the act.
    The three draft guidances cover: ● overarching rules for what constitutes pharmacy compounding and how enforcement for violations may be applied ● a definition of a new category of compounder created by the DQSA – “an outsourcing facility” – and the registration requirements, and ● interim requirements for ongoing reporting of information to FDA by the outsourced facilities on their products and services.
    The FR notices explain that FDA will be producing listings of bulk drug substances used in pharmacy compounding and products made from those substances as well as a list of “difficult-to-compound” products.  The agency is requesting that industry nominate candidates for the lists.  Included in the FR notices are the information required for nominations to be considered as well as a template for the submission of candidates for the difficult to compound list.
    The 60-day comment period on the three guidances extends until February 3. Comments on the FR notices are due by March 4.
    The speed at which the agency is moving in the act’s implementation reflects the central place that compounding operations have occupied on FDA’s inspection and health protection radar screen since the fall 2012 meningitis outbreak caused by fungal-contaminated sterile methylpredisone produced by NECC (IPQ Special Report November, 2012).
    Pharmaceutical manufacturers are impacted by what is happening in the compounding arena and should be paying close attention to how the new act is being implemented.
    A longstanding issue is the line between compounding and unapproved drugs, which may compete with products that have to meet stringent approval and inspection demands. The drug shortage issue is also at play in that pharmacy compounders step in to fill perceived market gaps – again, often with unclear authority to do so.
    The association of pharma products with the quality and public health problems created by compounding pharmacies and other handlers of their products downstream in the distribution chain is also of very real concern to the industry – both in terms of brand-name tarnishing, but also in their potential involvement in recalls and other follow up legal and enforcement actions.
    [The story continues for subscribers beginning on page 2.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes (rhodes@IPQpubs.com).  For subscription/license information, click here.]

    Texas Board of Pharmacy officer PIC training

    Pharmacist-in-Charge Training

    Powered by GoToTraining®
    Are you a new pharmacist-in-charge (PIC) or just need a refresher on the requirements and responsibilities as PIC? The Texas State Board of Pharmacy (TSBP) is hosting a free one-hour webinar on Thursday, January 16, 2014, at 10:00 a.m. This program is intended for individuals interested in learning about the responsibilities of the PIC, primarily in community (Class A) pharmacy settings. This program will also be held on the following dates: April 9, 2014 at 10:00 a.m. https://student.gototraining.com/r/6856480098723933952 July 15, 2014, at 10:00 a.m. https://student.gototraining.com/r/4500919372725489664 October 9, 2014 at 10:00 a.m. https://student.gototraining.com/r/7461886594140228608 Each webinar will cover the same information; please only register for one program.

    Texas Board of Pharmacy is hosting free one-hour webcase on rule changes and most common deficiencies during inspection

    Texas Pharmacy Laws and Rules Update

    The Texas State Board of Pharmacy (TSBP) is hosting a free one-hour webcast on Thursday, February 27, 2014, at 2:00 p.m. The program will review recent changes to pharmacy rules; and review the most common deficiencies found during inspections of pharmacies. One hour of continuing education (CE) credit approved by TSBP is available for attendees of the program.

    Georgia Board of Pharmacy December 2013 Public Board Actions List

    December 2013 Public Board Actions List

    Georgia Board of Pharmacy

    2 Peachtree Street

    36th Floor

    Atlanta, GA 30303

    PH: (404) 651-8000

    FX: (678) 717-6694

    Licensee’s Name: Number: Profession: Type of Action Taken:

    Alley, Lynda RPH012282 Pharmacist Approve public consent order

    Champine, Jeffrey RPH025342 Pharmacist Approve order for reinstatement

    Duluth Rexall Pharmacy Inc. PHRE002924 Retail Pharmacy Approve public consent order
    quoted from here

    South Dakota Board of Pharmacy Minutes from December 6, 2013 Meeting

    Friday, December 6, 2013, 9:00 A.M.
    Avera Prairie Center Building - Presentation Room; 1000 E. 23rd St., Sioux Falls, SD 
    Members Present: Lisa Rave, Jeff Nielsen, Diane Dady, and Lenny Petrik
    Staff Present: Executive Director Randy Jones; PDMP Director Kari Shanard-Koenders; Inspectors Gary Karel; and Senior Secretary Rita Schulz
    Others Present: Andrea Darr, Avera ePharmacy; Sue Schaefer, SD Pharmacist’s Association; Dennis Hedge, SDSU College of Pharmacy; Lora VanDyke, Pharmacy Specialties, Inc.; Scott Setzepfandt, Genentech; Bill Ladwig, Lewis Drug; and Tom Johnson, Avera McKennan Pharmacy
    Present by Phone: Arlene Ham-Burr (Board Member) and Paula Stotz (Staff Member)
    The meeting was called to order by Lisa Rave at 9:00 a.m. with introductions of Board members, staff, and others in attendance.
    A. Minutes 
    Jeff Nielsen moved for approval of the September 12th, 2013 meeting minutes.  Seconded by Diane Dady.  Motion carried. 
    B. Financial Report 
    The Board Financial Report was reviewed and approved.  Executive Director Randy Jones provided an overview and highlighted remaining balance.  
    The status of salaries in the PDMP program due to the government shut-down was discussed along with additional information needed to acquire grant funds awarded.  
    C. Staff Reports
    Employee Update:
    Director Jones requested the minutes reflect the passing of inspector Ron Johnson on October 25th.   A brief conversation was held in regards to the open position which will be discussed at a future Board meeting.  
    Inspector Reports
    Inspector:  Gary Karel
    Education to PICs on the following:
    • HIPAA – New Guidelines
    • Electronic Retention of Health Records
    • Sterile Compounding – working with the various facilities to remodel pharmacies to conduct compounding for hazardous drugs (chemo) and nonhazardous drugs. 
    • New pharmacies at Avera Sacred Heart and SDHSC in Yankton.
    • Reinforce CS record keeping.  Encourage annual audits.  Lewis is conducting six-month audits.
    • AMDD – working with PIC to have on file Board of Pharmacy approval letter.
    Discussion introduced by Bill Ladwig was held on spot inventory checks, cameras, and other security precautions in pharmacies.  Also discussed was Medicaid D and prescription storage.

     Inspector:  Paula Stotz
    • Encouraged audits be completed more often and noted her inspections reflected items noted in Gary’s report.
     PDMP Report:  Kari Shanard– Koenders-PDMP Director
    • Education letters were mailed out.  An education letter is a letter sent to prescribers and dispensers who met criteria of a patient being prescribed or dispensed to over a course of 90 days.  Letters will go out in January, April, July, and October. 
    • Discussion was held on method of payments.  Also, discussion was held on DCI contacts for pharmacies and this information will be made available.
    Statistical Reports
     Licensing activities were reviewed and discussion followed.
    D. Approvals – 60% now have automation and this number will increase.  Kessler’s Pharmacy and Medicine Shoppe Advanced Care now have letter reflecting approvals but approvals had been in place for some time.
    Regional Health; AMDD Revised
    Kessler’s Pharmacy; Aberdeen – AMDD*
    Regional Outpatient Pharmacy; Rapid City – AMDD Revised        
    Medicine Shoppe Advanced Care; Rapid City – AMDD*
    Randall Pharmacy; Redfield – Credit Return of Unit Dose
    E. Variances – 3:1 ratio variances are increasing.  Discussion was held on this ratio and further discussion will be put on Board’s future agenda.
    Wal-Mart; Brookings  - 3:1 Technician Ratio
    Hy-Vee (S. Minn); Sioux Falls – 3:1 Technician Ratio
    Omnicare; Sioux Falls – 3:1 Technician Ratio
    Wal-Mart; Spearfish – 3:1 Technician Ration (renewal)
    F. Complaints, Investigations, Disciplinary Actions, Loss / Theft Reports – Explanation of Complaint was provided and followed by discussion.
    Medicap Pharmacy; Rapid City – Complaint
    Wal-Mart Pharmacy; Rapid City – Compliant         
    Haisch Pharmacy; Canton – Complaint
    Family Pharmacy (Clinic); Mobridge – Loss / Theft
    Family Pharmacy (Downtown); Mobridge – Loss / Theft
    Hy-Vee Pharmacy; Watertown – Loss / Theft
    Murdy Pharmacy; Aberdeen – Loss / Theft
    Omnicare; Loss/Theft

    Iowa Board of Pharmacy has formed a Pharmacy Compounding Task Force

    Pharmacy Compounding Task Force
    The Iowa Board of Pharmacy and the Iowa Pharmacy Association

    have established a new task force to review Iowa laws

    and rules pertaining to pharmacy compounding, the licensing

    and regulation of nonresident pharmacies, and drug wholesalers.

    The following individuals have agreed to participate: DeeAnn

    Wedemeyer-Oleson, Lucinda Harms, Gayle Mayer, Alisha

    Eggers, Jack Kampf, Jim Ponto, Ron Hartman, Nic Mastascusa,

    Cindy Marek, Sue Hoffman, Tammy Sharp-Becker, Karmen

    Jorgenson, Manda Johnson, James Van Winkle, Karen Merrill,

    Ken Saunders, Ed Maier, and Sharon Meyer. The task force held
    its first meeting on November 12, 2013. It will make recommendations

    to the Board sometime during the first half of 2014.

    How many compounding pharmacies or pharmacists follow this Iowa rule regarding Advertising Compounding Services?

    Iowa Board of Pharmacy Rule 20.3(4)(c). Advertising compounding services. A compounding pharmacy or pharmacist may advertise or otherwise promote the fact that the pharmacy or pharmacist provides prescription drug compounding services. A compounding pharmacy or pharmacist shall not make a claim, assertion, or inference of professional superiority in the compounding of drug products that cannot be substantiated. All advertisements shall meet the requirements contained in rule 657—8.12(126,147).

    Iowa Board of Pharmacy Minutes from last January 2013 show compounding rule changes: Chapter 13, "Sterile Compound Practices," and Chapter 20, Pharmacy Compounding: How Many Are following these Rules?

    Monday, December 30, 2013 Drug Shortage Report blog: Bennett Burr Power Grab--the transfer of authority from states to the federal government

    When politicians start talking about “bi-partisan cooperation,” smart citizens get nervous. It usually means another transfer of freedom and taxes to the federal government at the expense of individuals, families, localities, and states.

    Case in point: 
    Denver Post op-ed by two U.S. Senators (or their staffs) on their latest “bipartisan” deal. The Senators are Michael Bennett (D.-Colo.) and Richard Burr (R.-N.C.). The op-ed is pure political blather, a haze of almost incomprehensible feel-good rhetoric. But the upshot is this: The two distinguished solons are very proud of themselves for managing yet another transfer of authority from the states to the federal government.

    continue to read here

    Antibiotic Use in Animals Under Fire--Every day, Americans use some 51 tons of antibotics


    by Michael Smith, North American Correspondent, MedPage Today
    Every day, Americans use some 51 tons of antibiotics.
    But only about a fifth of that is to treat human illness. Most of the rest is given to livestock -- and not because the animals are sick. Instead -- despite increasing antibiotic resistance among pathogens -- the drugs are used for what the FDA calls "production purposes": to help animals gain weight more rapidly or to improve feed efficiency.
    Those uses, the agency said in a guidance issued in December, are no longer "judicious" and should be stopped.
    Last year, the FDA asked farmers voluntarily to agree only to use antibiotics to promote animal health and only then if the use is approved by a veterinarian.
    In the December guidance, the agency asked drug-makers to take production uses off antibiotic labels within 3 years
    continue to read here

    Food Safety Modernization Act and Animal Feed - Transcript of the December 6 Meeting on the Proposed Rule on Preventative Controls for Animal Food available

    Sunday, December 29, 2013

    Question of Day December 29, 2013 When will the FDA publish the 483 issued to Diamondback Drugs issued on May 17, 2013?

    Diamondback Drugs of Delaware, LLC

    May 17, 2013
    483 issued

    California Board of Pharmacy Disciplinary Action--Kudos for already issued cease and desist against Abrams Royal Pharmacy--also action against several others including Westside Pharmacy

    Abrams Royal Pharmacy, NSC 99466
    Dallas, TX
    Cease and desist immediately from compounding sterile injectable drug products.
    Decision effective 12/23/2013.
    View the Decision
    De Soto Pharmacy, PHY 32271, Administrative Case AC 3662
    Canoga Park, CA
    Through a disciplinary action of the board, the license is voluntarily surrendered.
    Decision effective 11/27/2013.
    View the Decision
    De Soto Pharmacy, PHY 50809, Statement of Issues Case SI 4311
    Canoga Park, CA
    Through a disciplinary action of the board the license is issued, and the license is subject to a Letter of Public Reprimand.
    Decision effective 11/27/2013.
    View the Decision
    Fountain Valley Cancer Center Pharmacy, PHY 43274, LSC 99020, Administrative Case AC 4551
    Fountain Valley, CA
    Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three months or by January 1, 2014, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
    Decision effective 11/27/2013.
    View the Decision
    Half Moon Bay Pharmacy, PHY 44400, Administrative Case AC 4349
    Half Moon Bay, CA
    Through a disciplinary action of the board, the license is subject to a letter of public reprimand.
    Decision effective 10/9/2013.
    View the Decision
    RX Care Pharmacy, PHY 46138, Administrative Case AC 3254
    Torrance, CA
    Through a disciplinary action of the board, the license is revoked and canceled and the right to practice or operate has ended. President Michael Voldman is prohibited from owning any board licensed entity.
    Decision effective 11/27/2013.
    View the Decision
    UPAS Pharmacy, PHY 36112, Administrative Case AC 4190
    San Diego, CA
    Through a disciplinary action of the board, the license is revoked, the revocation is stayed, and the license shall continue on probation for an additional four years. The terms and conditions of probation include posting a notice of probation.
    Decision effective 10/7/2013.
    View the Decision
    Walgreens No 06683, PHY 46263, Administrative Case AC 3695
    Visalia, CA
    Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three years. The terms and conditions of probation include posting a notice of probation.
    Decision effective 11/12/2013.
    View the Decision
    Westlake Care Pharmacy, PHY 49290, Administrative Case AC 4231
    Westlake Village, CA
    Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for sixty days or by December 1, 2013, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
    Decision effective 11/27/2013.
    View the Decision
    Westside Pharmacy, PHY 15178, Administrative Case AC 4385
    Fresno, CA
    Through a disciplinary action of the board, the license is voluntarily surrendered.
    Decision effective 12/17/2013.
    View the Decision

    Industry Uncertain What Effect New Law Will Have


    Published: Sunday, December 29, 2013 at 10:47 p.m.
    Last Modified: Sunday, December 29, 2013 at 10:47 p.m.
    It was too much for federal regulators to ignore and the public to tolerate: 64 people dead after a Massachusetts pharmacy shipped contaminated drugs to 23 states.

    The New England Compounding Center in Massachusetts had already been in hot water with both federal and state regulators for a decade leading up to the debacle. The Massachusetts violations had left many angry national lawmakers asking why federal regulators had not closed the business down, much less allowed it to pump thousands of doses of fungal-contaminated drugs into the patient stream.
    continue to read here

    Unknown Risks of Pharmacy-Compounded Drugs

    Larry D. Sasich, PharmD, MPH, Chair;                      

    1. Sana R. Sukkari, BScPharm, MPhil, Assistant Professor
    + Author Affiliations
    1. Department of Pharmacy Practice
    2. Department of Pharmacy Practice, School of Pharmacy, Lake Erie College of Osteopathic Medicine, Erie, Pa
    To the Editor: In August 2006, the United States Food and Drug Administration (FDA) announced that warning letters had been issued to three pharmacies that were producing and distributing thousands of doses of compounded inhalation medications not approved by the FDA.1 These inhalation medications were used to treat patients with such respiratory diseases as asthma, bronchitis, cystic fibrosis, and emphysema.1
    Pharmacy compounding traditionally involves such practices as manipulating an FDA-approved dosage form, such as a tablet or capsule, to prepare a solution or suspension for individual patients who have difficulties in swallowing.2 Traditional pharmacy compounding may also involve preparing an FDA-approved medication excluding a specific ingredient to which an individual patient may have a hypersensitivity.2 The FDA permits such traditional practices by pharmacies.
    By contrast, nontraditional practices of pharmacy compounding—such as those that prompted the FDA warnings—include the mass production of drug combinations from bulk substances that are sometimes of unknown origin.1 These drug combinations may be exact copies or slightly modified versions of FDA-approved pharmaceutical products.2 The FDA has expressed concern that such nontraditional practices of pharmacy compounding may expose patients to unnecessary health risks.1,2
    The true extent of nontraditional pharmacy compounding in the United States is unknown. However, the FDA and many state public health authorities have expressed serious concerns about quality and safety issues regarding compounded inhalation drugs.2,3 For example, minutes from the May 2007 meeting of the Ohio State Board of Pharmacy reveal disciplinary action against one pharmacy-compounding facility.3 According to our calculations based on numbers provided in these minutes, between July 2005 and November 2005, the pharmacy in question compounded and dispensed 119 prescriptions for an estimated 7530 doses of inhalation medications, including five different drug-combination products.3 Two of the five compounded products were identical to FDA-approved medications, while three were unapproved combinations.3 Of the seven drug substances that were used to produce the combinations, five were available as FDA-approved inhalation medications, while two (betamethasone and dexamethasone) were not.3 
    continue to read here


    Justice Department Recovers $3.8 Billion from False Claims Act Cases in Fiscal Year 2013

    Justice Department Recovers $3.8 Billion from False Claims Act Cases in Fiscal Year 2013
    Second Largest Annual Recovery in History Whistleblower Lawsuits Soar to 752
    The Justice Department secured $3. 8 billion in settlements and judgments from civil cases involving fraud against the government in the fiscal year ending Sept. 30, 2013, Assistant Attorney General for the Civil Division Stuart F. Delery announced today.   This dollar amount, which is the second largest annual recovery of its type in history, brings total recoveries under the False Claims Act since January 2009 to $ 17 billion – nearly half the total recoveries since the Act was amended 27 years ago in 1986.
    The Justice Department’s fiscal year 2013 efforts recovered more than $3 billion for the fourth year in a row and are surpassed only by last year’s nearly $5 billion in recoveries.   As in previous years, the largest recoveries related to health care fraud, which reached $2. 6  billion.   Procurement fraud (related primarily to defense contracts) accounted for another $ 890  million – a record in that area.
    “It has been another banner year for civil fraud recoveries, but more importantly, it has been a great year for the taxpayer and for the millions of Americans, state agencies and organizations that benefit from government programs and contracts,” said Assistant Attorney General Delery.   “The $3. 8 billion in federal False Claims Act recoveries in fiscal year 2013, plus another $443 million in recoveries for state Medicaid programs, restores scarce taxpayer dollars to federal and state governments.   The government’s success in these cases is also a strong deterrent to others who would misuse public funds, which means government programs designed to keep us safer, healthier and economically more prosperous can do so without the corrosive effects of fraud and false claims.”

    Southern District of Texas Prosecutes Doctor for introducing misbranded drugs

    LAREDO, Texas – Eduardo Miranda M.D., 55, of Laredo, has pleaded guilty to one count of introducing misbranded drugs into the country, announced United States Attorney Kenneth Magidson.

    From October 2007 through January 2009, Miranda, a doctor who specializes in treating patients with cancer, ordered cancer drugs from a pharmacy called QSP, based in Canada. These drugs were not approved for distribution or use in the U.S. and did not bear adequate labeling for use. Some of the drugs had instructions and labeling in other languages. QSP was also not an authorized distributor or a retailer of these drugs in Canada. 

    Miranda then used these drugs interchangeably with Food and Drug Administration (FDA) - approved versions on his patients and filed insurance claims with Medicaid, Medicare and Blue Cross/Blue Shield of Texas as if he were using lawfully-approved versions.
    As part of the plea agreement, Miranda has agreed to pay back the reimbursement he had received while using non-approved versions - more than $1 million.
    He was permitted to remain on bond pending his sentencing, which will be set at a later date. At that time, he will face up to a year in federal prison and/or a possible $100,000 fine.

    The case was investigated by the FDA and Texas Attorney General’s Office-Medicaid Fraud Control Unit and prosecuted by Assistant United States Attorneys (AUSA) Raul Guerra and Sonah Lee and former AUSAs Sam Louis, Diana Song and D.J. Young.

    You will Want to Read the Discussion the Alabama Board of Pharmacy Had About the DQSA (sorry about format but it was in transcript form and difficult to reformat)

    MS. ALVERSON: All right. As was
    mentioned, the Senate passed the compounding bill this week on Monday. Donnie mentioned it
    and once that gets implemented, and of course
    when things get implemented, what you expect is going to happen doesn't always happen and the agency that writes it comes up with different
    quirks in there but I think it's -- this bill is going to put us in a more difficult position in that the bill allows manufacturers -- what we all know to be manufacturers -- to make a choice: Do you want to put yourself under FDA compliance or don't you?

    And you might think that most people would say, well, why would I want to be inspected by the FDA but some businesses to be
    able to sell what they're manufacturing are
    going to need that FDA certification because
    their customers are going to demand it but there will be others that don't and so for our office, it's going to mean much more in-depth inspections going through a lot more paperwork,looking at shipping records, looking at compounding records, all of which we most certainly intend to do but it is going -- it's going to be balancing whether the FDA picks up certain components or if -- or if we pick up those components for manufacturers in the State
    and I guess we won't know until we actually see
    how that law is implemented.

    Important Fact:

    In March 2013, eight states (New York, Pennsylvania, Maryland, New Jersey,

    Delaware, Virginia, West Virginia, and Massachusetts) agreed to operate all of their racetracks

    under strict new rules that will limit the number of approved medications for racehorses to 24

    and will require the drugs to be accredited under standards set forth by the Racing Medication
    and Testing Consortium. The agreement is set to take effect on January 1, 2014.

    Memorandum from Ranking Member Henry A. Waxman, “H.R. 2012 doping at horse racing


    Memorandum from Ranking Member Henry A. Waxman, “H.R. 2012 ...


    Some Aspects of Doping and Medication Control in Equine Sports


    Purchase on Springer.com

    $29.95 / €24.95 / £19.95*
    * Final gross prices may vary according to local VAT.
    Get Access


    This chapter reviews drug and medication control in equestrian sports and addresses the rules of racing, the technological advances that have been made in drug detection and the importance of metabolism studies in the development of effective drug surveillance programmes. Typical approaches to screening and confirmatory analysis are discussed, as are the quality processes that underpin these procedures. The chapter also addresses four specific topics relevant to equestrian sports: substances controlled by threshold values, the approach adopted recently by European racing authorities to control some therapeutic substances, anabolic steroids in the horse and LC–MS analysis in drug testing in animal sports and metabolism studies. The purpose of discussing these specific topics is to emphasise the importance of research and development and collaboration to further global harmonisation and the development and support of international rules.

    NSW Supreme Court Grants Injunction to Racing Veterinarians


    December 27, 2013
    The vets sought a delay in the start of a plan to license veterinarians treating racehorses in training. ... Read More

    MUST READ! Trainer on a mission to rid his sport of doping

    Trainer on a mission to rid his sport of doping

    The Toadstool Millionaires: A Social History of Patent Medicines and the Federal Authority to Regulate the Compounding of Human Drugs by James Harvey Young

    The Toadstool Millionaires: A Social History of Patent ...The Toadstool Millionaires: A Social History of Patent Medicines in America before Federal Regulation. ... A Social History of Patent Medicines in America before Federal Regulation by James Harvey Young
    Federal Authority to Regulate the Compounding of Human Drugs
    Federal Authority to Regulate the Compounding of Human DrugsFederal Regulation of Compounded Drugs ... 12 See James Harvey Young, The Toadstool Millionaires: A Social History of Patent Medicines in America Before ... testified before a Senate subcommittee in 1938 in support of the legislation that while the

    American Bar Association Health Law Section 15th Annual Conference on Emerging Issues in Healthcare Law Feb. 26th-March 1, 2014 in Litchfield Park, AZ


    now available - American Bar Association


    Best, worst racing stories of 2013-drugs remain a problems in the Sport of Kings

    Ritvo and Lukas inspired, but drugs remain a problem in the Sport of Kings

    Updated: December 29, 2013, 10:52 AM ET
    By Bill Finley | Special to ESPN.com
    watch video and read here

    Rider warned, horse owner banned in doping case

    Rider warned, horse owner banned in doping case

    Must Read: Experts: Florida Regulators Still Not Doing Enough by Fred Hiers


    Published: Saturday, December 28, 2013 at 11:19 p.m.
    Last Modified: Saturday, December 28, 2013 at 11:19 p.m.
    The Florida Board of Pharmacy wants the public's trust.

    continue to read here

    Essential read! Editorial: Compound problems

    Published: Sunday, December 29, 2013 at 6:01 a.m.

    Last Modified: Thursday, December 26, 2013 at 10:41 p.m.
    If chemical weapons killed 64 people on U.S. soil, the nation would be in a frenzy trying to determine what measures could be taken to prevent it from happening again.
    Yet Americans largely reacted with a shrug when 64 people died, including four in Ocala, and thousands more were sickened last year due to tainted steroid injections.
    Sure, the incident led to national media coverage of problems at the Massachusetts compounding pharmacy where the steroid was produced and others like it. But the state and federal response has been mostly voluntary regulations that inspire little confidence that compounding pharmacies are receiving adequate oversight.
    For the past nine months, Star-Banner staff writer Fred Hiers has investigated the thousands of compounding pharmacies in Florida and beyond that are becoming significant players in the nation's drug market. His eye-opening series recently published in The Sun, “Compound Fractures,” shows that the public remains at risk from unsafe drugs made at those pharmacies.
    Last year's 64 deaths made for the most deadly compounding calamity in U.S. history. But they weren't the first deaths connected to compounding pharmacies. Drugs made in compounding pharmacies in Alabama, Maryland, South Carolina and Texas were previously linked to deaths due to problems such as drug contamination, improper sterilization practices and potency levels far higher than drug labels indicated.
    continue to read here

    Saturday, December 28, 2013

    FDA issues notice of recall of compounded drugs

    Must Read: FDA Warning Letter that Lead to a Civil Complaint Being Filed-compounding pharmacy did not have patient-specific prescriptions; unapproved new drugs; misbranded drugs and adulteration charges: Will we be seeing more and more of these types of warning letters in the future for those who fail to comply with the DQSA?





    August 30, 2013


    Scot M. Silber


    FVS Holdings, Inc. dba. Green Valley Drugs

    1850 Whitney Mesa Dr

    Suite 180

    Henderson, NV 89014-2091


    Dear Mr. Silber:


    Between March 11, 2013, and March 15, 2013, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Green Valley Drugs, located at 1850 Whitney Mesa Drive in Henderson, Nevada 89014. During the inspection, the investigators noted that you were not receiving valid prescriptions for individually-identified patients for a significant number of drug products you were producing. In addition, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, we observed technicians touching the open neck of sterile vials and the bottom of sterile stoppers with non-sterile gloves and performing hand-stoppering during aseptic filling operations. In addition, staff was observed reaching over uncapped vials containing sterile drug products during filling operations, thus disrupting the unidirectional air protecting the vials and allowing for potential contact of the vial top surfaces with non-sterile gown sleeves. Furthermore, FDA investigators noted that sterilized vials are stored uncovered and unprotected from microbial contamination on a shelf in the cleanroom. These practices place your firm’s aseptically-produced injectable products at considerable risk of microbial contamination. These observations and others were noted on an FDA Form 483 issued on March 15, 2013. 


    During teleconferences with your firm on April 5 and April 8, 2013, we expressed our concerns about your firm’s poor personnel aseptic practices.


    During our April 9, 2013 teleconference, you stated that you would cease sterile drug production and make corrections based on the findings identified in the FDA Form 483 issued on March 15, 2013. You also indicated that you would request an FDA re-inspection after the corrections have been made. We expect that you will notify this office before resuming production of sterile drug products. We have not received a written response to the Form 483 issued March 15, 2013.


    We acknowledge the April 11. 2013 voluntary recall of all sterile products compounded, repackaged, and distributed by Green Valley Drugs.


    Based on FDA’s March 11-March 15, 2013 inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).


    A. Compounded Drugs Under the FDCA


    The FDCA establishes agency jurisdiction over “new drugs,” including compounded drugs.  See Medical Ctr. Pharm. v. Mukasey, 536 F.3d 383, 393-94 (5th Cir. 2008) (“compounded drugs are not exempt from the FDCA's ‘new drug’ definition, § 321(p)”).  The drugs that pharmacists compound are not FDA-approved and lack an FDA finding of safety and efficacy. Because compounded drugs are “new drugs” under the FDCA that are unapproved, the statute generally prohibits their introduction into interstate commerce.


    However, FDA has long recognized the important public health function served by traditional pharmacy compounding. FDA regards traditional compounding as the extemporaneous combining, mixing, or altering of ingredients by a pharmacist in response to a physician’s prescription to create a medication tailored to the specialized needs of an individual patient. See Thompson v. Western States Medical Center, 535 U.S. 357, 360-61 (2002). Traditional compounding typically is used to prepare medications that are not available commercially, such as a drug for a patient who is allergic to an ingredient in a mass-produced drug, or diluted dosages for children.  As a matter of agency discretion, FDA has historically not taken enforcement action against traditional compounding in recognition of the benefit that it affords patients when FDA‑approved, commercially available drugs are inadequate or unavailable.


    In 1997, Congress enacted, as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA), a provision that related to pharmacy compounding, codified in section 503A of the FDCA (21 U.S.C. § 353a). In 2001, the Ninth Circuit Court of Appeals declared this section invalid because it included unconstitutional restrictions on commercial speech and those restrictions could not be severed from the rest of section 503A. Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001). The Supreme Court affirmed the Ninth Circuit ruling that the advertising restrictions violated the First Amendment, but it did not consider whether these restrictions could be severed from the rest of section 503A. Thompson v. Western States Medical Center, 535 U.S. 357 (2002). In 2008, the Fifth Circuit Court of Appeals held that the restrictions on commercial speech could be severed from the rest of 503A and that the remainder of 503A is valid and in force. Medical Ctr., 536 F.3d at 404. Thus, the decisions of the Fifth and Ninth Circuits directly conflict on whether the non-advertising provisions of section 503A are valid and in effect.


    Your facility is located within the Ninth Circuit where section 503A is invalid, and where FDA continues to apply the enforcement policy articulated in Compliance Policy Guide section 460.200 [“Pharmacy Compounding”], issued by FDA on May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39, 409 (June 7, 2002)) (the “CPG”). The CPG identifies a non-exhaustive list of factors that the Agency considers in deciding whether to initiate an enforcement action with respect to compounding. 


    The CPG recognizes that traditional pharmacy compounding practice involves receipt of valid prescriptions for individually identified patients prior to distribution of a drug.[1] During the FDA inspection, investigators observed that your firm does not receive valid prescriptions for individually-identified patients for a significant number of drug products you produce. Based on this factor alone, your conduct does not qualify for the agency’s exercise of enforcement discretion set forth in the CPG and remains subject to all of the FDCA’s requirements.[2] In addition, we remind you that there are other factors that FDA considers in determining whether to exercise enforcement discretion under the CPG.   


    B. Violations of the FDCA


    The drug products that you manufacture and distribute are unapproved new drugs and misbranded drugs in violation of sections 505(a) and 502(f)(1) [21 U.S.C. §§ 355(a) and 352(f)(1)] of the FDCA, respectively. In addition, your sterile drug products are prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. As such, all sterile products you manufacture are adulterated within the meaning of section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)] of the FDCA. Furthermore, the manufacture of those drugs is subject to FDA’s Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210 and 211. FDA investigators observed significant CGMP violations at your facility, causing such drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)].


    Unapproved New Drug Products


    You do not have any FDA-approved applications on file for the drug products you manufacture and distribute, including Methylprednisolone Acetate 40mg/mL and 80mg/mL.[3]  Under sections 301(d) and 505(a) of the FDCA [21 U.S.C. §§ 331(d) and 355(a)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA [21 U.S.C. § 355] is in effect for the drug.  Your marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.


    Misbranded Drug Products


    Additionally, because the drug products you manufacture and distribute are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses.  Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] and they are not exempt from the requirements of section 502(f)(1) of the FDCA (see, e.g., 21 C.F.R. §201.115). The introduction or delivery for introduction into interstate commerce of these products therefore violates sections 301(a) of the FDCA [21 U.S.C. § 331(a)].  


    Adulteration Charges


    Additionally, FDA investigators noted that your sterile drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA [21 U.S.C. § 351(a)(2)(A)]. These conditions include technicians touching the open neck of sterile vials and the bottom of sterile stoppers with non-sterile gloves and performing hand-stoppering during aseptic filling operations. In addition, staff was observed reaching over uncapped vials containing sterile drug products during filling operations, thus disrupting the unidirectional air protecting the vials and allowing for potential contact of the vial top surfaces with non-sterile gown sleeves.


    FDA investigators also noted CGMP violations at your facility, causing the drugs  you manufacture to be adulterated under section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)]. The violations include, for example:


    1.    Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).


    2.    Your firm failed to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(b)).


    3.    Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).


    4.    Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to product aseptic conditions (21 CFR 211.42(c)(10)(v)).


    5.    Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a))


    6.    Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).


    7.    Your firm does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product (21 CFR 211.167(a)).


    C. Conclusion


    The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.


    You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.  Other federal agencies may take this Warning Letter into account when considering the award of contracts.


    FDA strongly recommends that your management immediately undertake a comprehensive assessment of your manufacturing operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess the acceptability of your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation. 


    Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Your written reply should be addressed to:


    Lawton W. Lum, Director of Compliance

    FDA San Francisco District Office

    U.S. Food and Drug Administration

    1431 Harbor Bay Parkway

    Alameda, CA 94502-7070


    If you have questions regarding any issues in this letter, please contact Russell A. Campbell, Compliance Officer at 510-337- 6861.




    Kathleen M. Lewis, J.D.

    District Director




    Larry L. Pinson, Executive Secretary

    Nevada Board of Pharmacy
    431 W. Plumb Ln.
    Reno, NV 89509