Wednesday, July 18, 2012

Compounded Drugs Barred From AAEP Convention

By Jsseica Tremayne
Veterinary pharmaceutical compounding companies will not be permitted to display or discuss compounded products at the American Assn. of Equine Practitioners’ annual convention in December in San Diego. It is the first time compounding products will be excluded from a veterinary conference.
AAEP’s board of directors in cooperation with the association’s Drug Compounding task force made the decision, citing their non-regulatory status as a blockade in enforcing lawful product sales. Association representatives say the ban is the only way to ensure AAEP isn’t an instrument in the sale of illegal and potentially harmful drugs.
“We support legal compounding methods,” says Sally Baker, AAEP’s director of public relations.
“In the past, we asked compounding pharmacies to sign an agreement stating they would not sell or exhibit products not in compliance with Food and Drug Administration rules, but we found that companies were not abiding by the agreement and this action is a direct effect of some compounders’ non-compliance.”
The International Academy of Compounding Pharmacists (IACP), which represents compounding pharmacists, responded to AAEP’s decision with a letter, followed by numerous unreturned phone calls, according to L.D. King, the group’s executive director.
“The IACP wants to work with AAEP to conceive a plan that doesn’t essentially exclude compounders from their convention,” King says. “I acknowledge that some compounding companies engage in poor practices, but eliminating all compounders is an injustice to the profession and the companies.”
An ongoing point of concern with IACP and compounding pharmacies is that FDA regulations are “impossible to be in 100 percent compliance with,” King says.
“AAEP adopted FDA’s policy, which rules out the use of pure (bulk) ingredients to be used in compounding,” King says. “This is an impossible request to make and there’s no patient safety reason for it.”
AAEP says compounded drugs were displayed at its 2007 convention were available through FDA-approved venues, and that was against the signed policy and the driving force behind its current decision.
“I agree that FDA compliance is difficult to adhere to 100 percent in regard to practice reality,” says Charlotte Lacroix, DVM, JD, of Veterinary Business Advisors Inc., Whitehouse Station, N.J. “However, the profession’s concern is stopping the pirating of brand-name drugs that could cause an adverse reaction to the pet.”
While no agency has denied the benefits legitimate compounding pharmacies bring to the industry, IACP is taking AAEP’s decision personally, making accusations that big pharmaceutical companies have bought the association’s decision.
“We’d like AAEP to disclose its financial ties to drug makers,” King says. “It’s not a coincidence that AAEP’s corporate partners are largely composed of drug companies, which account for the majority of the complaints against compounding pharmacies.”
Because AAEP is a non-profit organization, some authorities in the industry find IACP’s comments to be off focus and counterproductive.
“Compounders need to stop their whining accusations against AAEP and look to their own profession to find a way to eliminate the problems,” Lacroix says. “More stringent monitoring is necessary to give compounding pharmacies more legitimacy.”
Lacroix cautions veterinarians and organizations hosting conventions to be wary of putting faith in compounding companies without investigating their practices.
“It would be difficult to pin AAEP or another association as liable for a mishap when a compounded drug sold at a convention harms an animal,” Lacroix says.
“However, there is a false sense of legitimacy to companies introduced in convention exhibit halls. AAEP is very brave for taking the first step in an attempt to eliminate rogue practices. If anything, they are losing money with this decision by making the purchase of booth space less attractive to compounding pharmacies.”
Lacroix says AAEP’s stance isn’t an overreaction, noting that the backlash against a harmful compounded drug is directed at the prescribing veterinarian.
“Practitioners are the first in line to be sued if an animal they’ve treated is harmed by a compounded drug,” Lacroix says. “Veterinarians can be sure the compounding company they’ve purchased from will not be ready to indemnify the veterinarian if they lose their license over prescribing a compounded drug having an adverse affect.”
Due to AAEP’s decision, last year’s tally of 17 compounding pharmacies has fallen to single digits for 2008.
Meds for Vets in Sandy, Utah, is among the compounding companies that will not be attending the conference.
“AAEP is one of many shows we exhibit at,” says Jan Erickson, president, Meds for Vets.
“Conventions are an effective and efficient way to communicate with the consumer. We have been attending the AAEP convention for eight years. We’ll lose out on sales at the conference and the contacts we’d make that spur year-round business.”
Erickson says the AAEP decision was unexpected.
“We fill a gap within the industry that is needed,” Erickson says. “I feel like AAEP has turned its back on the compounding industry. I don’t feel like there is a purpose for us to attend the conference. We’ll advertise elsewhere.”
Cornerstone Pharmacy and Compounding in Versailles, Ky., plans to attend the AAEP convention, but is uncertain about long-term financial implications that its inability to discuss compounded drugs there will have.
“Last year AAEP representatives examined our literature and pharmaceuticals like police,” says Robin Reed, owner of Cornerstone Pharmacy and Compounding. “We are unhappy that we can’t display our new products. AAEP is an important show for us. I’m hopeful the decision will be reversed next year.”
Pharmacy Resources Inc. in Denver, Colo., says 80 percent of its business is equine related and common ground must be found with AAEP.
“I’ll be going to the conference primarily to touch base with my existing clients,” says Gregg Pederson, owner of Pharmacy Resources. “AAEP has historically been the only convention I attend, but if I’m not permitted to discuss my business next year, I’ll have to go elsewhere.”
Despite not being allowed to exhibit compounded drugs at this year’s convention, not all compounding companies share heightened concern regarding AAEP’s decision.
“We will still have a booth at this year’s AAEP conference,” says Andy Clark, DVM, chief executive officer of Hagyard Equine Medical Institute/Hagyard Pharmacy in Lexington, Ky.
“I don’t agree with IACP’s conclusions about AAEP. I think AAEP made the decision to eliminate compounding pharmacy displays for educational purposes. They want to make a stance against copy-cat drug makers. They have the right to control their trade show as they deem necessary.”
AAEP says it will reconsider allowing companies to exhibit compounded drugs for future conventions, but says there will be no change in the current year’s decision.
“I hope other organizations consider following suit,” Lacroix says. “AAEP will be the test case.”
The American Animal Hospital Assn. and the American Veterinary Medical Assn. representatives said their associations currently do not plan to similarly restrict compounding pharmacies.

Article found in Veterniary Phamacy News here.

Education About Compounding is Essential


This article from the Veterinary Practice News makes excellent points about why educating veterinarians is so important and must be done.

Education is Key

By Marissa Heflin


The American Assn. of Equine Practitioners has set its own Equine Veterinary Compounding Guidelines. The organization wants to educate veterinarians on compounded drugs so they can make the best choice for patients, says Eleanor Green, DVM, Dipl. ACVIM, Dipl. ABVP.
“Veterinarians need to be aware that compounded products are not FDA-approved products and that they have not gone through the rigorous testing nor have they gone through the rigorous quality assurance process that FDA-approved drugs do,” she said.
“They also need to educate their clients when they are faced with picking a drug for their patient to weigh the benefits versus the risks.
And it is a risk because there is a larger percentage (of compounded products) that do not contain what the label says, so it can either be insufficient treatment or it can be toxic.”
Prescribing veterinarians should understand that their professional liability policy may not respond to allegations of negligence arising from the use of compounded drugs, according to the AAEP’s guidelines. The organization encourages veterinarians insured with the AVMA-Professional Liability Insurance Trust to review comments at AVMAplit.com.
In addition, veterinarians need to be aware that compounding, including formulation in a novel drug-delivery system such as transdermals may affect the absorption and depletion of a drug, according to the AVMA’s policy on compounding. This may result in drug concentrations above or below the therapeutic range and lead to an adverse drug event, including therapeutic failure.

Article found here

Tuesday, July 17, 2012

48 Charged in Massive Medicaid Fraud Case

A nationwide prescription drug ring bought mountains of HIV medications and other drugs from down-and-out Medicaid recipients in New York City, then marketed the pills to pharmacies that dispensed them to unsuspecting consumers, authorities said Tuesday. To read rest of article, click here.

Monday, July 16, 2012

Kansas: Pharmacy Law Update at Kansas Pharmacy Association Conference in September

At the Kansas Pharmacy Association conference on September 30, 2012, at 10:15am - noon Debra Billingsley, Executive Director, Kansas State Board of Pharmacy, will present a CE entitled Pharmacy Law Update.  To view entire schedule, click here.

$10,000 fine Imposed Against Intrathecal Compounding Specialists

The Louisana Board of Pharmacy assessed a fine of  $10,000 plus cost against Intrathecal Compounding Specialists.  The fine was for six counts, including accountability for the diversion of 220 pints of promethazine with codeine syrup and over 16,000 tablets of hydrocodone/acetaminophen 10/500 over a six-month period of time. 


Source found here .

Saturday, July 14, 2012

Brilliant Blue G Complaint Filed by Josephine Bienick Against Franck's

Here is the complaint filed for personal injury product liability  filed by Josephine Bienick against Franck's Lab.  The case was originally filed in state court but because of the diversity of the parties (located in different states) the case has been removed to federal district court in the Northern District of Indiana.  For complete docket click here. To view the complaint click here.

Additional Deadlines in K-V Litigation


07/10/2012    MINUTE ORDER denying 5 Motion for Order Requiring Defendants to File Administrative Record by July 20, 2012. Upon consideration of plaintiffs' motion and the matters discussed at the conference call on this date, it is ORDERED that defendants file the Administrative Record in this action on or before August 10, 2012. Signed by Judge Amy Berman Jackson on 7/10/12. (lcabj1) Modified on 7/10/2012 to reflect that this is a Minute Order (jth). (Entered: 07/10/2012)
07/10/2012    Minute Entry for proceedings held before Judge Amy Berman Jackson: Telephone Conference held in Chambers on 7/10/2012. (NO REPORTER PRESENT) (jth) (Entered: 07/10/2012)
07/10/2012    Set/Reset Deadlines: Defendants to file the Administrative Record by 8/10/2012. (jth) (Entered: 07/10/2012)

To see first post with deadlines, click here

Docket Enter for State Court Case filed Against Franck's and Removed To Federal Court


Here is the docket for a personal injury product liability case filed by Josephine Bienick against Franck's Lab.  The case was originally filed in state court but because of the diversity of the parties (located in different states) the case has been removed to federal district court in the Northern District of Indiana.  A copy of the complaint will be available in a subsequent post.


U.S. District Court Northern District of Indiana [LIVE]
USDC Northern Indiana (Fort Wayne)
CIVIL DOCKET FOR CASE #: 1:12-cv-00197-TLS-RBC


Bienick v. Franck's Lab Inc
Assigned to: Judge Theresa L Springmann
Referred to: Magistrate Judge Roger B Cosbey
Case in other court:  Allen Superior Court, 02D01-1204-CT-210
Cause: 28:1332 Diversity-Petition for Removal

Date Filed: 06/19/2012
Jury Demand: None
Nature of Suit: 365 Personal Inj. Prod. Liability
Jurisdiction: Diversity
Plaintiff
Josephine Bienick represented by David L Farnbauch
Sweeney Law Firm - FW/IN
8109-B Lima Road
Fort Wayne, IN 46818
260-420-3137
Fax: 260-969-0321
Email: dlf@sweeneylawfirm.com
ATTORNEY TO BE NOTICED

V.
Defendant
Franck's Lab Inc
doing business as
Franck's Compounding Lab
represented by David I Rubin
Harrison & Moberly LLP - Ind/IN
10 West Market St Suite 700
Indianapolis, IN 46204
317-639-4511
Fax: 317-639-9565
Email: drubin@harrisonmoberly.com
ATTORNEY TO BE NOTICED

Stephen J Peters
Harrison & Moberly LLP - Ind/IN
10 West Market St Suite 700
Indianapolis, IN 46204
317-639-4511
Fax: 317-639-9565
Email: speters@harrisonmoberly.com
ATTORNEY TO BE NOTICED

Date Filed # Docket Text
04/27/2012 1   STATE COURT COMPLAINT against Franck's Lab Inc filed by Josephine Bienick filed in Allen Superior Court Case No. 02D01-1204-CT-00210.(jcp) (Entered: 06/20/2012)
06/19/2012 2   NOTICE OF REMOVAL by Franck's Lab Inc from Allen Superior Court, case number 02D01-1204-CT-00210. ( Filing fee $ 350, receipt INN1002227) filed by Franck's Lab Inc. (Attachments: # 1 Civil Cover Sheet)(jcp) (Entered: 06/20/2012)
06/19/2012 3   NOTICE of Appearance by David I Rubin on behalf of Franck's Lab Inc (jcp) (Entered: 06/20/2012)
06/19/2012 4   NOTICE of Appearance by Stephen J Peters on behalf of Franck's Lab Inc (jcp) (Entered: 06/20/2012)
06/19/2012 5   Corporate Disclosure Statement by Franck's Lab Inc. (jcp) (Entered: 06/20/2012)
06/21/2012 6   AGREED NOTICE to extend time to file answer filed by Franck's Lab Inc ; answer due by July 24, 2012. (Peters, Stephen) (Entered: 06/21/2012)
06/21/2012 7   CERTIFICATE OF SERVICE by Franck's Lab Inc Proof of Service Upon Attorney of Record and Proof of Filing of Notice in State Court (Peters, Stephen) (Entered: 06/21/2012)
06/22/2012 8   NOTICE of Hearing: Telephonic Rule 16 Preliminary Pretrial Conference set for 8/6/2012 11:00 AM in US District Court - Fort Wayne before Magistrate Judge Roger B Cosbey. Court to initiate call. (mr) (Entered: 06/22/2012)
06/22/2012 9   MAGISTRATE JUDGE CONSENT FORMS sent to all parties (Standard Track). (mr) (Entered: 06/22/2012)

Friday, July 13, 2012

Part of Franck's network sold

http://www.ocala.com/article/20120712/ARTICLES/120719895/1005/sports01?p=2&tc=pg

Pennsylannia Proposal Regarding Compounding Practices

State Board of Pharmacy -Compounding Practices-
49 Pa. Code
Chapter 27
(16A-5419)



This proposal can be found here.
Fall 2012, as ProposedThis proposed rulemaking would establish standards for the compounding of drugs by pharmacists. Statutory Authority: Section 6(k)(9) of the Pharmacy Act, 63 P. S. § 390-6(k)(9) grants the authority to promulgate rules and regulations to effectuate the purposes of the act. Section 2 of the Pharmacy Act, 63 P. S. § 390-2(11) defines the practice of pharmacy to include the compounding of drugs.

Melanie Zimmerman
(717) 783-7156

Virginia Passes Bill to Expand Pharmacist's Compounding Authority: HB 733

Virginia laws now grant pharmacists additional authority to compound.  The article below explains the new law and can be found here

Pharmacists; compounding authority. (HB733)

Introduced By

Progress

Introduced
Passed Committee
Passed House
Passed Senate
Signed by Governor
Became Law

Description

Pharmacists; compounding authority.  Increases pharmacists' authority to compound to allow the compounding of (i) a commercially manufactured drug whose manufacturer has notified the FDA that the drug is unavailable due to a current drug shortage, or (ii) a commercially manufactured drug when the prescriber has indicated in the prescription for an individual patient that there is an emergent need for a drug that is not readily available. Amends § 54.1-3410.2 (“Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements.”), of the Code of Virginia.

Outcome

Bill Has Passed
View Bill's History

Easier Access to Veterinarian Disciplinary Records Needed

In line with the recent post found here about Pharmacy Boards making their disciplinary records more transparent, state veterinary boards also need to make their disciplinary records more transparent.  This article found here sums up the problem:

I have more complaints filed against me than a used-car lot not that you ll ever know about it.
When she picked up her kitten, Pumpkin, from the veterinarian after a routine spaying, Mount Pleasant, S.C., resident Marcia Rosenberg was stunned to find the cat nearly comatose. Soon Pumpkin s body was wracked with seizures, and her stomach swelled. Rosenberg rushed Pumpkin to another vet, who saved the cat, but the distraught owner called her state s veterinary board to complain. Told that the board had no procedure for alerting consumers about disciplinary actions taken against incompetent vets, Rosenberg mounted a successful campaign to have such actions posted on the South Carolina veterinary board s website.
Tracking complaints against vets often requires a bit of detective work. Some state veterinary boards list disciplinary actions against vets, while others do not. And complaints typically aren' t disclosed until a board investigation and judicial ruling have determined a case of wrongdoing. On her own, Rosenberg says she was able to find that the veterinarian had previously had his license suspended in Ohio and since then had more than a dozen complaints against him in South Carolina.

Inspection Report for Veterinary Practices in Virginia

In May 2012, Virginia revised its inspection report for Veterinary Practices operating in its state.  That report can be found here.  The report contains the following section:

Bulk Reconstitution of Injectable, Bulk Compounding or Prepackaging
 17  Major 18VAC150-20-190(J) Veterinary establishments in which bulk reconstitution of injectable, bulk compounding or the prepackaging of drugs is
performed shall maintain adequate control records for a period of one year or until the expiration whichever is greater.
 18 Major 18VAC150-20-190(J) Reconstitution, compounding and prepackaging records shall show the following:
1. Name of the drug(s) used;
2. Strength, if any;
3. Date repackaged;
4. Quantity prepared;
5. Initials of the veterinarian verifying the process;
6. Assigned lot or control number;
7. Manufacturer’s or distributor’s name and lot or control number; and
8. Expiration date.
Guidance: When drugs are taken from a stock bottle and put into another container prior to prescribing in anticipation of future dispensing, the drugs are considered to be prepackaged. Dispensing, labeling and recordkeeping requirements must be followed when prepackaging drugs. 
Transferring drugs to another container can affect the stability of the product. Expiration dates play an important role in maintaining the stability of a drug. The expiration date for a drug prepackaged is the same as the original stock bottle or is one year from the date of transfer whichever is less. Drugs should be stored under conditions which meet the United States Pharmacopeia and the National Formulary (USP-NF) specifications or manufacturers’ suggested storage for each drug.

Virginia Board of Pharmacy Revisions to Compliance Requirements of 797

In June 12, 2012, th e Virginia Board of Pharmacy revised its police on compliance requirements of USP Chapter 797 for facilities engaged in sterile compounding.  Those revisions can be found here and state as follows:

Guidance Document: 110-36  Revised:  June 12, 2012
June 8, 2004
Revised: June 7, 2005, June 5, 2006, June 4, 2008, June 12 2012
Virginia Board of Pharmacy
COMPLIANCE WITH USP STANDARDS FOR COMPOUNDING
§54.1-3410.2 requires pharmacies performing sterile or non-sterile compounding to comply with USP
Standards.  USP standards for sterile and non-sterile compounding may be found in the current editions
of the USP-NF.  In accordance with 18VAC110-20-170, the Board requires a pharmacy to maintain
references consistent with the pharmacy’s scope of practice and with public safety.  
USP Chapter 795 lists the requirements for non-sterile compounding including information about the
compounding environment, equipment, stability criteria and beyond-use dating and records. USP
Chapter 797 lists requirements for policies and procedures, training and evaluation of personnel
performing sterile compounding, determining risk levels and the physical standards for the sterile
compounding area. The Board expects that the requirements of Chapters 795 and 797 will be found in
compliance at time of inspection.
The terms “annually” and “semiannually” as used in USP Chapters 795 and 797 are defined to mean
every 12 months and every 6 months, respectively.  Records associated with annual and semiannual
requirements shall be maintained for 2 years from the date performed.  Such records may be
maintained in offsite storage or as an electronic image that provides an exact image of the document
that is clearly legible provided such offsite or electronic storage is retrievable and made available for
inspection or audit within 48 hours of a request by the Board or an authorized agent.





Flordia Board of Pharmacy's April 2012 Settlement With Paul Franck and Franck's Lab

The April 11, 2012 meeting of the Florida Department of Health Board of Pharmacy contains a discussion of the settlement agreement made with Paul Franck and Francks Lab.  It can be found here and states as follows:


Wednesday, April 11, 2012 – 8:00 a.m.
8:00 a.m. Call To Order by Cynthia Griffin, PharmD, Chair
The meeting was called to order by the Chair, Dr. Griffin. All Board members were present.
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. Page 8 of 19
(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.

Flordia Department of Health Board of Pharmacy Discussing Compounding Done at Hospitals

The approved meeting minutes from the Florida Department of Health Board of Pharmacy for February 7-8, 2012, found here contain a discussion regarding compounding done by hospitals.  The matter was referred to the board's attorney to determine whether the practice was legal under Florida laws.  The minutes provide:

C.   Executive Director’s Report – Mark Whitten
1. Board Correspondence
a. Hospital Pharmacy Compounding Practices - Marty Dix
Dr. Charzetta James was present and sworn in by the court reporter. Dr. James was represented by Marty Dix. 
Marty Dix discussed with the Board a specific practice of prescription filling for hospitals: Marty Dix
relayed a practice where a pharmacy fills prescriptions for a hospital such as in powder form that the
hospital would hold. Then upon an order from a physician the material is used for patients and for
example compounded to a particular strength per the physicians order. The purpose of the discussion was to determine if this practice was permissible. Marty Dix and Mike McQuone, from the Florida Society of Health-System Pharmacists, expressed that based on discussions with pharmacies this model was exactly what multiple entities currently practice.
After discussion by the Board, issues were raised that included the following:
-An expectation was expressed that when medicine is received it is received in its final form and
manipulation is not allowed; There was concern that there may not be regulation that allows the
hospital to further manipulate it
- Questions regarding where data verification exists in the process were raised
- Issues with writing prescriptions for drugs to be received by an entity such as a hospital instead of
an individual
- Who is responsible for the final patient product 
Based on the Board discussion, Dr. Griffin suggested the issue be referred to the Board attorney for
review and further discussion regarding the statutes and rules around this practice scenario. After review and discussion by the Board attorney, Board office, and inquiring parties, the determination will be brought back before the Board. 

During the April 10-11th meeting the board's attorney stated she felt this practice was acceptable.  Those board minutes are found here and state:

3. Hospital Pharmacy Compounding Practices – Marty Dix – Addendum
Mrs. Dudley re-introduced the correspondence received from Marty Dix regarding hospital compounding that was on the agenda of the last Board meeting. Mrs. Dudley relayed that she did not see anything that prevents the practice outline in the letter but felt they need a community pharmacy permit. Marty Dix responded that they do have a community pharmacy permit. After some discussion, Mrs. Dudley stated that as the Board attorney she felt this was an acceptable practice.

Thursday, July 12, 2012

Idaho State Board of Pharmacy Presentation on Idaho Pharmacy Law

In the Spring of 2012, the Idaho State Board of Pharmacy presented on the jurisprudence of Idaho pharmacy law.  The slides used during the presentation can be found here.

More Transparency in and Easier Access of Discipline Records Needed: Tennessee Case Fails to Name Pharmacy and Pharmacists

More transparency of disciplinary records is needed regarding violations of compounding rules and regulations.  Right now one must go to each individual state board of pharmacy to determine if a pharmacy or pharmacist that compounds drugs has been disciplined.  In same states, the records are not available online.  In other states, one maybe able to see that a pharmacist or pharmacy has been disciplined but it cannot be seen what the discipline was for.  In most states, you can obtain the information by writing the state board.  Some states require the requestor of the information to pay to have the information copied.  In other states, you can see that a compounding pharmacy or pharmacist was disciplined but you cannot determine the name of either.  An example of this is found in the board minutes of the Tennessee Department of Health Board of Pharmacy for Jan. 2012.  The minutes contain the following enter: 
Jan. 2012--Tennessee
5. Case No.: L11-PHR-RBS-20100093
Complaint generated from period inspection of Respondent’s compounding pharmacy. Periodic inspection found 20 partially filled compounding drugs which had expiration dates going back to 2009 and a hood which had not been recertified since 2007. At time of initial inspection Respondent stated that routine checks are conducted relating to expiration dates, however the shelf where the expired medication were found was inadvertently missed. A subsequent inspection was conducted which found that all expired drugs had been removed and that the non sterile hood had been recertified.
Prior discipline: none
Recommendation: Letter of Warning
Dr. Stephens made the motion to issue a Letter of Instruction to the pharmacy for the expired drugs. Dr. Smothers seconded the motion. The motion carried.
While this entry lets the public know that Tennessee is taking disciplinary action against pharmacies and pharmacists who break the compounding regulations and rules, it is not helpful  to consumers who want  to make informed decisions about which  pharmacies and pharmacists to use.  Easier access to disciplinary actions is greatly needed in the compounding world.  Such public access could encourage more compliance with the rules and regulations.

Missouri case Law Regarding Retail Sale of Veterinary Drugs: United Pharmacal Company of Missouri Inc. v. Missouri Board of Pharmacy


UNITED PHARMACAL COMPANY OF MISSOURI INC v. MISSOURI BOARD OF PHARMACY

UNITED PHARMACAL COMPANY OF MISSOURI, INC., Appellant, v. MISSOURI BOARD OF PHARMACY, Respondent.
No. SC 87316.
-- December 19, 2006

R. Dan Boulware, R. Todd Ehlert, Sharon Kennedy, St. Joseph, for Appellant.Jeremiah W. (Jay) Nixon, Atty. Gen., Sharon K. Euler, Asst. Atty. Gen., Kansas City, for Respondent.
Is the retail sale of veterinary drugs the “practice of pharmacy” regulated by the state board of pharmacy?
The state board of pharmacy administers and enforces the statutes and regulations relating to licensing and regulation of pharmacists and pharmacies.   Sections 338.110 and 338.140.1  United Pharmacal Company of Missouri is a retail store that sells animal feeds and products.
For about 20 years, United Pharmacal has also sold federal legend drugs-i.e., prescription drugs-to consumers who have prescriptions from veterinarians for treatment of their animals.   United Pharmacal does not sell or dispense drugs for human use.   The company has engaged in this practice without a license from the pharmacy board and does not employ a licensed pharmacist.
In 1994 and 1997, the pharmacy board investigated United Pharmacal for selling animal legend drugs without a pharmacy license, each time taking no action.   In 2000, however, a board staff member undertook a third investigation of United Pharmacal.   The staff member concluded that this conduct is the practice of pharmacy, in violation of the Missouri Pharmacy Practices Act, chapter 338.
Based on this investigation, the pharmacy board issued a “Cease and Desist Warning” letter to United Pharmacal, declaring that the company's practices constituted the “practice of pharmacy” without a license in violation of sections 338.010.1 and 338.220.   The letter ordered United Pharmacal to stop selling animal legend drugs to consumers without a pharmacy license and informed the company that violating the Act also constituted a crime.
In response, United Pharmacal filed a declaratory judgment action in the circuit court of Buchanan County seeking a declaration that the pharmacy board engaged in improper rulemaking and that the pharmacy board did not have authority to regulate United Pharmacal's activity.   This Court held that venue was improper in Buchanan County, vacated the trial court's judgment, and remanded the case for transfer to the Cole County Circuit Court.  United Pharmacal Company of Missouri, Inc. v. Missouri Board of Pharmacy, 159 S.W.3d 361, 363 (Mo. banc 2005).
On remand, United Pharmacal amended its petition requesting a declaration that the Act does not grant the pharmacy board the authority to regulate the retail sale of veterinary prescription drugs.   United Pharmacal also argued that, if the circuit court determined the act regulated this activity, it would be unconstitutionally vague.   United Pharmacal moved for summary judgment.   The circuit court denied the motion and entered judgment, holding that the sale of veterinary legend drugs is within the pharmacy board's regulatory powers because it is “the practice of pharmacy.”   United Pharmacal appeals.
Because this action involves the validity of a statute, this Court has exclusive appellate jurisdiction.   Mo. Const. art.   V, section 3.
Does the Pharmacy Act Cover Veterinary Drugs?
United Pharmacal presents two arguments on appeal:  first, that the circuit court erred in holding that the retail sale of veterinary prescription drugs used for treating animals constitutes “the practice of pharmacy” under the Act;  and, second, that the Act, as construed by the circuit court, violates due process because it is unconstitutionally vague and it fails to inform persons of ordinary intelligence that the retail sale of veterinary prescriptions drugs to consumers for use in animals is the “practice of pharmacy.”   This Court reviews this question of law de novo.  Smith v. Shaw, 159 S.W.3d 830, 832 (Mo. banc 2005).
This controversy can be resolved by reading the statute.   It is unnecessary to reach United Pharmacal's constitutional challenge.
The statutory language guides this Court's analysis.   The goal of statutory analysis is to ascertain the intent of the legislature, as expressed in the words of the statute.  American Healthcare Management, Inc. v. Director of Revenue, 984 S.W.2d 496, 498 (Mo. banc 1999) (citing Hyde Park Housing Partnership v. Director of Revenue, 850 S.W.2d 82, 84 (Mo. banc 1993)).   This goal is achieved by giving the language used its plain and ordinary meaning.  Id. When the legislative intent cannot be determined from the plain meaning of the statutory language, rules of statutory construction may be applied to resolve any ambiguity.  Bosworth v. Sewell, 918 S.W.2d 773, 777 (Mo. banc 1996).
The Statutes
Section 338.010, defining the “practice of pharmacy,” provides in relevant part:
1.  The “practice of pharmacy” shall mean the interpretation and evaluation of prescription orders;  the compounding, dispensing and labeling of drugs and devices pursuant to prescription orders;  the participation in drug selection according to state law and participation in drug utilization reviews;  the proper and safe storage of drugs and devices and the maintenance of proper records thereof;  consultation with patients and other health care practitioners about the safe and effective use of drugs and devices;  and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management and control of a pharmacy.   No person shall engage in the practice of pharmacy unless he is licensed under the provisions of this chapter․ This chapter shall also not be construed to prohibit or interfere with any legally registered practitioner of medicine, dentistry, podiatry, or veterinary medicine, or the practice of optometry in accordance with and as provided in sections 195.070 and 336.220, RSMo, in the compounding or dispensing of his own prescriptions.  (Emphasis added).
Section 338.210, defining “pharmacy,” is also relevant to this Court's analysis.   It provides in part:
1.  Pharmacy refers to any location where the practice of pharmacy occurs or such activities are offered or provided by a pharmacist or another acting under the supervision and authority of a pharmacist, including every premises or other place:
(1) Where the practice of pharmacy is offered or conducted;
(2) Where drugs, chemicals, medicines, prescriptions, or poisons are compounded, prepared, dispensed or sold or offered for sale at retail;
(3) Where the words “pharmacist”, “apothecary”, “drugstore”, “drugs”, and any other symbols, words or phrases of similar meaning or understanding are used in any form to advertise retail products or services;
(4) Where patient records or other information is maintained for the purpose of engaging or offering to engage in the practice of pharmacy or to comply with any relevant laws regulating the acquisition, possession, handling, transfer, sale or destruction of drugs, chemicals, medicines, prescriptions or poisons.
.    .    .    .    .
The pharmacy board asserts that United Pharmacal's sale of veterinary legend drugs constitutes “the dispensing” of drugs that require a prescription and, therefore, is the “practice of pharmacy” under section 338.010.   Under the board's analysis, United Pharmacal would also qualify as a pharmacy under section 338.210.   The board argues that section 338.010 applies to any entity that dispenses prescription drugs, and since the statute does not specifically exempt the sale of veterinary drugs, United Pharmacal's activity is regulated under the Act.
United Pharmacal maintains that its activity is not regulated because the Act does not expressly empower the pharmacy board to regulate the sale of drugs for animal use pursuant to veterinary prescriptions.   United Pharmacal relies on section 338.010's inclusion of “consultation with patients and other health care practitioners” as the practice of pharmacy, arguing that this demonstrates a legislative intent to limit the Act's scope to drugs dispensed for human use.   United Pharmacal bolsters its argument by pointing to other portions of the Act, specifically to section 338.220, which contains a list of eleven classifications for pharmacy licenses, none of which applies to persons or businesses engaged in the retail sale of veterinary drugs.2
These arguments highlight the statute's ambiguity.   Both parties' arguments are supported by parts of section 338.010.   For example, section 338.010 can be construed broadly, as the pharmacy board suggests, to encompass the sale of all prescription drugs because it does not exempt veterinary drugs.   Because “drug” is not defined in the statute, its meaning is ascertained from the dictionary definition.   One definition of “drug” is “a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal.”   WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY (1993).   This definition supports the board's contention that veterinary drugs are within the Act.
Despite this definition, the statute does not expressly state that veterinary drugs are covered under the statute.   There is no express language giving the pharmacy board authority to regulate United Pharmacal's activity.   Internal ambiguity also results from section 338.010's reference to “consultation with patients” as the “practice of pharmacy.”   This language appears to limit the scope of the statute to human patients, notably because of the “consultation” language and based on the dictionary definition of “patient”-“a sick individual esp. when awaiting or under the care and treatment of a physician or surgeon,” or “a client for medical service (as of a physician or dentist).”   WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY (1993).   This definition of “patient” suggests that the statute is limited to drugs dispensed for human use.
Section 338.010 creates further ambiguity by providing an exception from regulation under chapter 338 for veterinarians dispensing their own medications.   This provision is unnecessary if the statute does not cover veterinary drugs.   In summary, section 338.010's ambiguity is evident-the definition of “drugs” supports the board's position but the definition of “patient” supports United Pharmacal's position.   Legislative intent on this issue cannot be discerned from section 338.010's plain language.
Because the plain language does not answer this question, this Court must turn to recognized principles of statutory construction.   To discern legislative intent, “the Court may review the earlier versions of the law, or examine the whole act to discern its evident purpose, or consider the problem that the statute was enacted to remedy.”  In re M.D.R., 124 S.W.3d 469, 472 (Mo. banc 2004);  See also State ex rel. Nixon v. QuikTrip Corp., 133 S.W.3d 33, 37 (Mo. banc 2004).  “Statutory construction should not be hyper technical but instead should be reasonable, logical, and should give meaning to the statutes.”  In re Boland, 155 S.W.3d 65, 67 (Mo. banc 2005).
A review of the Act provides little clarity.   Nowhere does chapter 388 discuss the retail sale of veterinary prescription drugs.   The Act does not define “drugs” or “patients.”   Nor does it indicate whether the act applies to prescriptions written for all drugs, or just those prescription drugs intended for use in humans.   Neither does section 330.210, defining “pharmacy,” provide any clear intent that the sale of veterinary legend drugs is governed by the Act. The section listing classifications for pharmacy licenses does not include a license for the dispensing of veterinary drugs.   The pharmacy board's authority to regulate United Pharmacal can be inferred from some of the Act's language, but it is not explicit.
This Court declines to infer, or read into the statute, a legislative intent to regulate veterinary prescriptions, when it is not clear from the act.
The cases suggest it may be helpful to look to the agency's interpretation of the statute it enforces.   See, e.g., Morton v. Missouri Air Conservation Com'n, 944 S.W.2d 231, 236-237 (Mo.App.1997).   But to what interpretation should this Court defer?   The board apparently concluded, after two previous investigations, that United Pharmacal was not engaged in the practice of pharmacy.   The board was aware of United Pharmacal's practice for nearly ten years, yet took no action to regulate this practice.   At the time the board sent its “Cease and Desist” letter, there had been no intervening statutory change altering the board's scope of authority.   The board has not articulated why it has changed its statutory interpretation.
The board does not have the power to broaden the scope of its statutory authority.  Soars v. Soars-Lovelace, Inc., 346 Mo. 710, 142 S.W.2d 866, 871 (1940).   As a regulatory body, the board regularly deals with the general assembly.   For many years, the board left the regulation of veterinary pharmacies out of the board's duties, and there was no legislative response.   There is no reason for this Court to defer to the board's recent change in statutory interpretation.
The board also argues that this Court should look to chapters 196 and 195 for guidance.   Chapter 196, the Food, Drug and Cosmetic Act, contains provisions to protect the public by ensuring that drugs are accurately labeled and pure.   Chapter 195, the Comprehensive Drug Control Act of 1989, regulates dispensing certain controlled substances.   Both of these chapters define “drug” as including substances or articles used by both humans and animals.   Sections 196.010(5) and 195.010(14).   The board argues that these statutes should be read in pari material with chapter 338 so as to include within its scope those drugs sold for animal use.   This argument is unpersuasive largely because both chapters 196 and 195 expressly encompass drugs for animal use.   Their intent to regulate drugs for animal use is clear.   The Missouri Pharmacy Practices Act does not expressly regulate veterinary drugs.   Had the general assembly intended to grant the pharmacy board the authority to regulate the dispensing of animal drugs, it could have done so expressly, just as it did in chapters 195 and 196.
The decision not to include the sale of veterinary drugs as the practice of pharmacy is a policy decision for the general assembly.   “[A]dministrative agencies-legislative creations-possess only those powers expressly conferred or necessarily implied by statute.”  Bodenhausen v. Missouri Bd. of Registration for Healing Arts, 900 S.W.2d 621, 622 (Mo. banc 1995).   Because it is uncertain that United Pharmacal's activity is regulated under chapter 338, it is equally uncertain that the pharmacy board could legally issue United Pharmacal a license and regulate that license.3
Because there is a possibility that United Pharmacal could face a criminal penalty, this Court will apply the rule of lenity.   The rule of lenity dictates that ambiguity in a criminal statute must be resolved against the government.  Goings v. Missouri Department of Corrections, 6 S.W.3d 906, 908 (Mo. banc 1999);  State v. Harper, 855 S.W.2d 474, 479 (Mo.App.1993);  Fainter v. State, 174 S.W.3d 718, 721 (Mo.App.2005).   Traditionally, this rule applies to statutes defining criminal behavior and providing for sentencing.  State v. Jones, 899 S.W.2d 126, 127 (Mo.App.1995);  State v. Rowe, 63 S.W.3d 647, 650 (Mo. banc 2002);  Woods v. State, 176 S.W.3d 711, 712-713 (Mo. banc.2005).   The rule, however, is applicable where violation of a civil statute has penal consequences.  J.S. v. Beaird, 28 S.W.3d 875, 877 (Mo. banc 2000);  See also, City of Kansas City v. Tyson, 169 S.W.3d 927 (Mo.App.2005).   Section 338.195 provides that failing to comply with chapter 338 is a class C felony.   Under the rule of lenity, the statute should be construed so that the sale of veterinary drugs is not considered the “practice of pharmacy” and subject to the criminal sanctions of section 338.195.
Conclusion
The “practice of pharmacy” statute cannot be read to cover the retail sale of veterinary prescription drugs used for treating animals.   Because this issue is dispositive, the Court does not reach United Pharmacal's contention that the provisions of the pharmacy practices act are unconstitutional.   The judgment of the circuit court is reversed.
I concur in the principal opinion's determination that those engaged in the retail sale of veterinary drugs are not subject to regulation by the board of pharmacy under chapter 338, RSMo 2000.   I write separately to disagree with the principal opinion's determination that it should reach this result in part by application of the “rule of lenity.”   While the principal opinion is correct that the rule of lenity is applied in interpreting ambiguous criminal statutes, here we are asked in a declaratory judgment action to determine generally whether an administrative agency has authority to regulate the dispensing of veterinary drugs at retail, not specifically whether someone can be held to account under a criminal or penal statute.   In this circumstance, the analysis of whether the pharmacy act applies to a particular party should be determined by application of the rules of construction normally applied to statutes that contain both remedial and penal provisions.   The analysis in this case need not be complicated by applying a rule of construction intended for criminal cases to this declaratory judgment context.
DISCUSSION:
The rule of lenity “gives a criminal defendant the benefit of a lesser penalty where there is an ambiguity in the statute allowing for more than one interpretation.”  Woods v. State, 176 S.W.3d 711, 712 (Mo. banc 2005).   It is a rule of mercy that, until recently, had been applied exclusively in criminal cases.   A search in the Missouri cases database on Westlaw for the term “lenity” reveals thirty-two cases invoking the rule of lenity.1  All but two of these cases involve criminal defendants urging that a criminal statute is ambiguous and the defendant therefore is entitled to the more lenient interpretation.   The two exceptions are J.S. v. Beaird, 28 S.W.3d 875 (Mo. banc 2000), and City of Kansas City v. Tyson, 169 S.W.3d 927, 929 (Mo.App. W.D.2005), which expressly followed J.S. v. Beaird.
In all other civil cases involving statutes containing both remedial and penal provisions, this Court has applied the rule of construction that, “[w]here a statute is both remedial and penal, remedial in one part while penal in another, it should be considered a remedial statute when enforcement of the remedy is sought and penal when enforcement of the penalty is sought.”  City of St. Louis v. Carpenter, 341 S.W.2d 786, 788 (Mo.1961) (construing civil statute broadly where only remedial provisions were implicated).   Remedial statutes are interpreted liberally to give broad meaning to their remedial purpose.   See Abrams v. Ohio Pacific Express, 819 S.W.2d 338, 341 (Mo. banc 1991).   Statutes of a penal nature, on the other hand, “are always strictly construed, and can be given no broader application than is warranted by [their] plain and unambiguous terms.”  City of Charleston ex rel. Brady v. McCutcheon, 360 Mo. 157, 227 S.W.2d 736, 738 (banc 1950).
The court of appeals has followed this rule of statutory interpretation fairly closely.   See Kansas City Star Co. v. Shields, 771 S.W.2d 101, 104 (Mo.App. W.D.1989) (holding that one sub-section of a statute is penal because it imposes a fine, but “the other portions of the statute ․ are to be liberally construed”);  Structo Corp. v. Leverage Inv. Enterprises, Ltd., 613 S.W.2d 197, 202 n. 2 (Mo.App. W.D.1981) (“When the remedial part of a statute, also penal in other aspects, is the subject of enforcement, it is considered remedial for the purposes of decision”);  State ex rel. Ashcroft v. Wahl, 600 S.W.2d 175, 180 (Mo.App. W.D.1980) (refusing to construe a civil statute that contained penalty provisions strictly against the state because “any possibility of a criminal charge ha[d] been abandoned by the state” and therefore the “penal attributes of [the statute] are ․ not in this case”).
While the practical effect of strict construction of a penal statute normally would be the same as would application of the rule of lenity, Missouri courts interpreting remedial statutes never utilized the rule of lenity in a case involving a statute that contained both civil remedial and penal provisions until J.S. v. Beaird, 28 S.W.3d 875 (Mo. banc 2000).   In that case, a citizen convicted of a sex offense sought injunctive and declaratory relief from the sexually violent predator statute's registration requirement.   This Court employed a contextual reading of the statute to conclude that its requirement of registration upon “coming into any county” did not apply to individuals whose county of residence did not change.  Id. at 876-77.   The Court also noted that the rule of lenity “reinforced” its “contextual reading” because, although “the requirement of registration is not necessarily punitive, sections 589.400 to 589.425 penalize a failure to register as a class A misdemeanor and subsequent offenses as a class D felony.” Id. at 877.
The Court in J.S. acknowledged (at least implicitly) that the statute had both remedial and penal provisions, but it neither expressly relied on those distinctions to reach its conclusion, nor mention the fact that it was the first to use the rule of lenity to interpret a civil statute in a declaratory judgment action.   Similarly here, the principal opinion does not acknowledge the distinctions between the remedial and penal provisions of the pharmacy statute, employing instead the rule of lenity.
J.S. is also unusual in that it is apparently only the third of this Court's cases to seek a declaratory judgment regarding the scope and application of a civil regulatory act that contains both remedial and penal provisions.   The two prior cases to do so are City of St. Louis v. Carpenter, 341 S.W.2d 786, 788 (Mo.1961), and Borden Co. v. Thomason, 353 S.W.2d 735, 753 (Mo. banc 1962).   According to Carpenter, the statute before it was remedial in effect;  thus, it was construed liberally.  341 S.W.2d at 788 (“coverage of the law ․ is remedial and should be liberally construed”).   By contrast, in Borden, despite the presence of penalty provisions that included treble damages, this Court broadly construed the statute because it “contains no criminal penalties and is not a criminal statute, and is not required to be strictly construed against the State.”  Borden, 353 S.W.2d at 755.   Although J.S. did not expressly overrule Borden's or Carpenter's use of a broad construction in a declaratory judgment action, by borrowing the rule of lenity from the criminal context to interpret a statute with both remedial and penal provisions, it implicitly rejected the conclusion in those cases that statutes with both penal and remedial provisions should be broadly or liberally construed.
This Court in both J.S. and this case could have reached the same result in reliance on the traditional method of analyzing a civil statute, set out above, without borrowing the rule of lenity from the criminal law.   Where, as here, the Court interprets the reach of a civil statute that provides penal sanctions for noncompliance, it is appropriate to employ strict construction to limit its scope to only those persons or entities that are clearly regulated by the statute's literal meaning.   If the scope of such statutes were given a broad construction, then a class of persons who reasonably believed that they were not required to comply with the statute could unexpectedly be at risk of punitive sanctions for noncompliance,2 which would be inconsistent with prior Missouri cases construing penal statutes strictly according to their terms.
In sum, as this case does not involve an immediate threat of criminal sanctions, but merely seeks a declaration whether a particular class of person or entity is subject to regulation under the pharmacy act, reliance on the rule of lenity is misplaced.   It would be more appropriate to hold that, in a context such as this, the statute will be given a narrow construction.
For these reasons, I concur in the result.
FOOTNOTES
1.   Unless otherwise noted, all references are to RSMo 2000.
2.   1․ The following classes of pharmacy permits or licenses are hereby established:(1) Class A:  Community/ambulatory;(2) Class B:  Hospital outpatient pharmacy;(3) Class C:  Long-term care;(4) Class D:  Nonsterile compounding;(5) Class E:  Radio pharmaceutical;(6) Class F:  Renal dialysis;(7) Class G:  Medical gas;(8) Class H:  Sterile product compounding;(9) Class I:  Consultant services;(10) Class J:  Shared service;(11) Class K:  Internet.
3.   See section 338.050, a license applicant must qualify under sections 338.010 and 338.020 in order for the board to issue a license.
1.   A search in the Missouri cases database on Westlaw for the term “lenity” yields 38 results.   The oldest six of those cases (three of which are from the 19th century) use the term “lenity” in the opinion, but not as a term of art in reference to the rule of lenity.
2.   As a criminal violation would require proof of a knowing violation, and as it would be difficult to prove knowing violation of a statute never before held to apply to a particular class of persons, the likelihood of imposition of criminal sanctions is small, but nonetheless would be an additional potential risk of a broad interpretation.
MICHAEL A. WOLFF, Chief Justice.
PRICE, TEITELMAN, LIMBAUGH, RUSSELL and WHITE, JJ., concur.LAURA DENVIR STITH, J., concurs in result in separate opinion filed.