Friday, July 13, 2012

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.

Case law in Iowa Regarding Compounding: Houck v. Iowa Board of Pharmacy Examiners


HOUCK v. IOWA BOARD OF PHARMACY EXAMINERS

 
Garvis G. HOUCK, Appellant, v. IOWA BOARD OF PHARMACY EXAMINERS, Appellee.
No. 06-1747.
-- June 27, 2008

Michael M. Sellers of Sellers Law Office, West Des Moines, for appellant.Thomas J. Miller, Attorney General, and Scott M. Galenbeck, Assistant Attorney General, for appellee.
A pharmacist compounded and sold a product to a customer without a prescription.   The customer filed a complaint with the administrative agency that regulates the conduct of pharmacists, and a sanction was imposed against the pharmacist.   In this appeal from the district court's ruling affirming the agency's action, we must decide whether the agency has authority to designate the compounded product as a drug that may be dispensed by a pharmacist only if it has been prescribed by a practitioner.   We conclude the agency acted within its broad authority, and therefore affirm the district court's ruling.
I. Factual and Procedural Background.
Garvis Houck is a licensed Iowa pharmacist and the owner-operator of Houck Drug, a licensed Iowa pharmacy in Clear Lake. In 2002 Shirley Meyer consulted Houck about nasal irritation.   After offering to supply a product to ease Meyer's symptoms, Houck compounded 1 a nasal spray containing a mixture of:  2-deoxy-d-glucose (an antiviral);  dyclonine (an anesthetic);  miconazole (an antifungal);  methylcellulose (a suspending agent);  sodium chloride;  and distilled water.   Each of these substances was, by itself, a nonprescription drug.   Houck sold the compounded product to Meyer in a bottle that was not labeled with a prescription number, a prescriber's name, or a pharmacist's initial on the label.   Meyer used the nose drops once, experienced increased nasal irritation, and filed a complaint with the Iowa Board of Pharmacy Examiners (“board”).
The board assigned an investigator, Jacky Devine, to investigate Meyer's complaint.2  Houck admitted he compounded the nasal spray for Meyer without a prescription based on his experience in compounding some of the same substances for prescribers in the area.   While conducting the investigation of the Meyer complaint, Devine found several violations of pharmacy regulations that had been noted in a prior inspection.   Houck was unable to produce for Devine forms required to record transactions involving narcotics,3 a required log for permanent and nonpermanent pharmacist employees, compounding production records bearing the initials of the compounding pharmacist, and a logbook containing the initials of pharmacists who provided customers certain cough syrups containing codeine.   Houck had been warned about all of these record-keeping deficits in 2000.
The board filed two charges against Houck based on the investigation of the Meyer transaction and the 2002 inspection:  (1) intentional or repeated violation of the board's rules regarding operation of a pharmacy and maintenance of controlled substance records;  and (2) unlawful manufacturing and dispensing of a compounded drug without a prescriber's authorization.   Following a hearing, the board issued a written decision finding Houck committed the alleged violations and placed Houck and Houck Drug on probation for three years with several conditions.   The board specifically ordered Houck to refrain from compounding of any kind without authorization from a prescriber.
Houck sought judicial review in the district court.   He contended the regulations prohibiting pharmacists from compounding, without a prescription, substances separately available without a prescription are unconstitutional.   Houck also asserted the board lacked authority to issue the regulations, and the board's disciplinary action was not supported by substantial evidence.   The district court denied Houck's petition.
II. Scope of Review.
On judicial review of final agency action, we review for errors at law.  Hough v. Iowa Dep't of Pers., 666 N.W.2d 168, 170 (Iowa 2003).   In determining the appropriate scope of review of an agency's interpretation of a statute, the crucial question for the reviewing court is whether the interpretation of the statute has clearly been vested by a provision of law in the agency's discretion. See Iowa Code § 17A.19(10)(c ), (l ).   If the agency has been clearly vested with interpretive authority, we generally defer to the agency's interpretation, and may grant relief only if the agency's interpretation is “irrational, illogical, or wholly unjustifiable.”   Id. § 17A.19(10)(l ).   If the agency has not been clearly vested with discretion to interpret the statute, “we are free to substitute our judgment de novo for the agency's interpretation and determine if the interpretation is erroneous.”  Auen v. Alcoholic Beverages Div., 679 N.W.2d 586, 589-90 (Iowa 2004) (citing Iowa Code § 17A.19(10)(c )).
The legislature has delegated broad authority to the Board of Pharmacy Examiners for the regulation of the practice of pharmacy in Iowa. Iowa Code section 147.76 (2007) 4 confers upon the board the authority to “adopt all necessary and proper rules to implement and interpret [chapter 155A].” See also Iowa Code § 155A.3(3) (stating the term “board” in chapter 155A refers to the board of pharmacy examiners).   We have previously held similar language in other statutes constituted a clear vesting in the agency of the authority to interpret a statute.  Thoms v. Iowa Pub. Employees' Ret. Sys., 715 N.W.2d 7, 11 (Iowa 2006) (finding a clear vesting of interpretive authority where a statute directed the agency to “adopt ․ rules ․ and take other action it deems necessary for the administration of the retirement system”);  Auen, 679 N.W.2d at 590 (holding grant of authority to an agency to adopt rules “necessary to carry out this chapter” clearly vested in the agency authority to interpret a statute);  City of Marion v. Iowa Dep't of Revenue & Fin., 643 N.W.2d 205, 207 (Iowa 2002) (holding statute providing “[t]he director shall have the power and authority to prescribe all rules not inconsistent with the provisions of this chapter, necessary and advisable for its detailed administration and to effectuate its purposes,” vested authority in the department of revenue and finance to interpret section 422.45(20)).  Section 147.76 clearly vests the board of pharmacy examiners with authority to interpret chapter 155A. We will therefore overturn the board's interpretation of that chapter only if it is “irrational, illogical, or wholly unjustifiable.”  Iowa Code § 17A.19(10)(l ).
We review an agency's factual findings for substantial evidence based on the record viewed as a whole.  Id. § 17A.19 (10)(f).   Substantial evidence is
the quantity and quality of evidence that would be deemed sufficient by a neutral, detached, and reasonable person, to establish the fact at issue when the consequences resulting from the establishment of that fact are understood to be serious and of great importance.
Id. § 17A.19(10)(f)(1).
We review constitutional claims de novo.  Wright v. Iowa Dep't of Corr., 747 N.W.2d 213, 216 (Iowa 2008).
III. Discussion.
A. Board's Authority to Regulate Compounding of Nonprescription Drugs.
1. Board's authority to define “prescription drugs.”   The primary controversy in this case centers on the board's interpretation of Iowa Code section 155A.3(35).   This statute defines a “prescription drug” as any of the following:
a.  A substance for which federal or state law requires a prescription before it may be legally dispensed to the public.
b. A drug or device that under federal law is required, prior to being dispensed or delivered, to be labeled with one of the following statements:
(1) Caution:  Federal law prohibits dispensing without a prescription.
(2) Caution:  Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Caution:  Federal law restricts this device to sale by, or on the order of, a physician.
(4) Rx only.
c. A drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only, or is restricted to use by a practitioner only.
Iowa Code § 155A.3(35) (emphasis added).   The board has interpreted subsection (c ) as a positive grant of authority by the legislature to the board to enact regulations requiring that certain drugs be dispensed on prescription only.   Relying on such authority, the board enacted rule 20.2, a rule which, in relevant part, prohibits a pharmacist from dispensing compounds consisting of exclusively nonprescription components without a prescription from a practitioner.5  Iowa Admin.   Code r. 657-20.2. Rule 20.2 thus brings a compound made from exclusively nonprescription components within the definition of a “prescription drug” in section 155A.3(35)(c ).   Houck contends section 155A.3(35)(c ) does not vest the board with the authority to designate as a “prescription drug” a compounded substance consisting of a combination of nonprescription substances.
After carefully reviewing chapter 155A in light of the board's authority to implement and interpret that chapter, we cannot say the board's interpretation of section 155A.3(35)(c ) as a positive grant of authority to the board to designate all compounded substances as “prescription drugs” is irrational, illogical, or wholly unjustifiable.   The plain language of section 155A.3(35)(c ) clearly evidences legislative intent to identify, at least in part through state administrative rule, those substances which may be dispensed by pharmacists only if prescribed by a practitioner.   As we have already noted, the board has been vested with broad authority to adopt rules to “implement and interpret” chapter 155A. Iowa Code § 147.76. The board is the agency charged with administering Iowa Code chapter 124 (“Controlled Substances”) and Iowa Code chapter 126 (“Iowa Drug, Device, and Cosmetic Act”).   Id. §§ 124.101(3), .201, .301;  126.2(3), .17.   The board asserts, and Houck does not dispute, that no other state administrative agency is assigned regulatory power over controlled substances or prescription drugs.   We conclude the board's interpretation of section 155A.3(35)(c ) as a statutory authorization to identify prescription drugs by administrative rule is not irrational, illogical, or wholly unjustifiable.   It is an interpretation that gives reasonable and logical meaning to the words “or regulation” in the statute.   See T & K Roofing Co. v. Iowa Dep't of Educ., 593 N.W.2d 159, 162 (Iowa 1999) (noting interpretations that render a portion of a statute redundant or irrelevant should be avoided).
Houck contends the general assembly enumerated in chapter 124 the list of drugs which may be regulated as “prescription drugs” under chapter 155A. According to Houck, the board's only authority to influence what is a “prescription drug” is its role in recommending to the general assembly the appropriate classification for controlled substances in chapter 124.   Iowa Code § 124.201. Chapters 124 and 155A, however, do not narrowly limit the board's authority to regulate prescription drugs in the manner suggested by Houck.
As averred by Houck, chapter 124 lists five categories, or schedules, of “controlled substances.”   See generally id. §§ 124.203-.212. As the term is used in chapter 124, a “controlled substance” is “a drug, substance, or immediate precursor in schedules I through V of division II of this chapter.”   Id. § 124.101(5).   The schedules categorize various substances according to their relative potential for abuse, the degree to which the substance has an accepted medical use, and likelihood that abuse of the substance would lead to psychic or physical dependence.  Id. § 124.201. Contrary to Houck's assertion, however, chapter 124 does not define “prescription drug”;  nor does it purport to present an exhaustive list of substances which may be only dispensed by a pharmacist pursuant to a practitioner's prescription.   We find no limitation in chapter 124 on the board's authority to define “prescription drugs.”
Our rejection of Houck's contention that chapter 124 limits the board's authority to define “prescription drugs” is strengthened by the careful distinctions drawn by the general assembly in chapter 155A between “controlled substances” and “prescription drugs.”   A “prescription drug” may be either a “drug” or “device.” 6  Id. § 155A.3(35)(c ).   A “drug” is any of the following:
a. A substance recognized as a drug in the current official United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia, or other drug compendium or any supplement to any of them.
b. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.
c. A substance, other than food, intended to affect the structure or any function of the body of humans or other animals.
d. A substance intended for use as a component of any substance specified in paragraph “a ”, “b ”, or “c ”.
e. A controlled substance.
Id. § 155A.3(13) (emphasis added).   As in chapter 124, the term “controlled substance” in chapter 155A refers to the substances or precursors to the substances listed in the chapter 124 schedules.  Id. § 155A.3(6).   Thus, in chapter 155A the terms “drug” and “prescription drug” are not limited to the substances in the controlled substance schedules.   Although the legislature has granted the board only the limited authority to recommend to the general assembly substances to be designated as “controlled substances,” id. § 124.201, no such limitation appears in section 155A.3(35)(c) in connection with the board's authority to define “prescription drugs.”
2. Validity of the board's compounding rule.   Having found the board could rationally conclude it had the authority to require a drug to be dispensed by prescription only, we must determine whether the board's compounding rule is irrational, illogical, or wholly unjustifiable.   Houck contends the relevant portion of the rule is irrational because it forbids pharmacists, who have special training regarding interactions between drugs, from combining and distributing compounds consisting exclusively of substances available without a prescription while allowing nonpharmacists to do so.   We disagree.   The board's inclusion of all compounded substances within the definition of “prescription drug” is sufficiently related to the goals of chapter 155A to survive our scrutiny under the applicable deferential standard of judicial review.
Rule 20.2 is properly within the bounds of the board's authority under section 155A.3(35).   As noted above, that statute requires a “prescription drug” be a “drug or device.”  Id. § 155A.3(35)(c ).   A “drug” includes “[a] substance, other than food, intended to affect the structure or any function of the body of humans.”  Id. § 155A.3(13)(c ).   The product compounded by Houck for Meyer easily fits within this definition of “drug.”   Rule 20.2 promulgated by the board expressly confines the definition of compounding to “preparing, mixing, assembling, packaging, and labeling a drug or device for an identified individual patient․” Iowa Admin.   Code r. 657-20.2 (emphasis added).   Because the rule applies only to compounded “drugs” and “devices,” it is firmly within the board's authority to require that drugs or devices be dispensed on prescription only.
A rational and logical connection exists between the rule and the board's duties under chapter 155A. The purpose of chapter 155A is “to promote, preserve, and protect the public health, safety, and welfare through the effective regulation of the practice of pharmacy․” Iowa Code § 155A.2. The board asserts it enacted rule 20.2 in order to draw a bright line between the practice of medicine and the practice of pharmacy.   Generally speaking, the practice of medicine involves the intake of patients, diagnosis of illnesses, and prescription of treatment, while the practice of pharmacy primarily consists of preparing and dispensing medications.   By requiring the “prescriber/patient/pharmacist” relationship as a prerequisite to the dispensing of compounded drugs by pharmacists, the board has exercised administrative discretion to prohibit pharmacists from diagnosing illnesses and prescribing treatment for their customers-functions traditionally undertaken by doctors.   The board could rationally and logically have concluded this exercise of discretion clearly separating the pharmacist function from that of the prescriber advances the health, safety, and welfare of pharmacists' customers.
Our confidence in the conclusion the board's rule is neither illogical nor unreasonable is not diminished by the fact that it does not preclude nonpharmacists from compounding nonprescription substances.   Nonpharmacists are not licensed to dispense drugs, and do not hold themselves out as experts in compounding substances sold to treat health problems suffered by human beings.   As a consequence, there is no significant market for the compounding services of nonpharmacists.   Pharmacists, on the other hand, are licensed and widely regarded by their customers as experts who reliably dispense drugs manufactured by others or compounded by them.   The board could logically and rationally conclude the substantial market for the compounding services of pharmacists justifies regulation, and the nonexistent demand for compounding services by nonpharmacists does not.   Furthermore, chapter 155A grants the board no authority to regulate the activities of nonpharmacists.
Houck correctly posits that pharmacists are not prohibited by statute or agency rule from recommending nonprescription medications to customers who describe their symptoms and seek advice.   He relies on this fact to support his contention that the board does not truly draw the line between pharmacy and medicine at “diagnosing” and “prescribing.”   Even if we acknowledge the apparent plausibility of Houck's contention, however, we conclude it does not undermine the board's authority to prohibit compounding of drugs without a prescription or render rule 20.2 irrational.   The board could rationally conclude, as it did, that compounding of substances-including “drugs” not enumerated as controlled substances under chapter 124 and consisting entirely of “over-the-counter” components-by pharmacists without a prescription for the treatment of maladies or symptoms presented by customers poses risks to the public health, safety, and welfare.   Accordingly, rule 20.2 is not rendered invalid as a consequence of the board's failure to require a prescription for the dispensing by pharmacists of “over-the-counter” drugs manufactured by others.
3. Constitutional challenge.   Houck also contends the board's regulation violates the equal protection clauses of the federal and Iowa Constitutions because it unfairly discriminates against pharmacists with respect to compounding of nonprescription substances.   See U.S. Const. amend.   XIV;  Iowa Const. art. I, § 6. Houck is a licensed pharmacist, and is therefore not similarly situated to a non-pharmacist.   The legislature may therefore treat him differently than a non-pharmacist.   See In re Det. of Hennings, 744 N.W.2d 333, 339 (Iowa 2008) (noting dissimilar treatment of persons not similarly situated does not offend equal protection).   Because he has failed to demonstrate dissimilar treatment of similarly situated individuals, Houck's equal protection challenge to the board's rule is without merit.
B. Noncompounding Violations.   Houck also broadly asserts the factual findings underlying the board's decision to sanction him for the other, noncompounding violations were not supported by substantial evidence.   While asserting the board made its findings of fact “based solely on its compliance officer's report regarding arguable and meaningless minor violations” of administrative rules, and that the violations were the result of a “hyper-technical application” of administrative rules, Houck does not actually assail the substantiality of the evidence supporting the facts found by the board.   Upon a careful review of the record, we find ample support for the board's finding that Houck engaged in a “pattern of choosing which rules to follow and which rules to ignore.”   The board's findings are supported by substantial evidence.
C. Sanction. We have previously noted the limited scope of judicial review of sanctions imposed by administrative agencies.   When a “licensing board is made up of members of the profession they are licensing, the court should not second guess the board's decision” as to the appropriate sanction.  Burns v. Bd. of Nursing of Iowa, 528 N.W.2d 602, 605 (Iowa 1995).   The pharmacy board is primarily constituted of pharmacists, see Iowa Code § 174.14(5), and we see no basis in the record to depart from this sound rule.   We accordingly uphold the board's findings that Houck's serial violations of administrative rules warranted the imposition of a three-year probation.
IV. Conclusion.
We find the board could have rationally concluded the general assembly delegated to it the authority to designate drugs compounded by pharmacists as “prescription drugs” to be dispensed only if prescribed by a practitioner.   The rule adopted by the board consistent with that authority is not irrational, illogical, or wholly unjustifiable.   The board's adoption of that rule and enforcement of it against Houck did not deprive him of equal protection of the law.   The board's factual findings are supported by substantial evidence in the record.
AFFIRMED.
FOOTNOTES
1.   The Iowa Administrative Code defines “compounding” as “preparing, mixing, assembling, packaging, and labeling a drug or device for an identified patient․” Iowa Admin.   Code r. 657-20.2.
2.   Devine had investigated for the board a similar complaint against Houck in October of 2000.   That complaint also arose as a consequence of Houck's compounding of “over-the-counter” substances without a prescription.   Devine found Houck's records to be out of compliance in several particulars with the board's regulations at that time, and warned Houck against compounding and selling substances without a prescription.
3.   Houck later provided Devine with most, but not all, of the missing forms.
4.   The events giving rise to this case occurred in 2002.   Accordingly, the statutes controlling our disposition were codified in the 2001 Iowa Code. Those statutes were renumbered and relocated in the code without substantive change after 2001.   The parties have uniformly cited those statutes as they appear in the 2007 Code, and we will do so as well.
5.   The Iowa Code defines a “practitioner” asa physician, dentist, podiatric physician, veterinarian, or other person licensed or registered to distribute or dispense a prescription drug or device in the course of professional practice in this state or a person licensed by another state in a health field in which, under Iowa law, licensees in this state may legally prescribe drugs.Iowa Code § 155A.3(33).
6.   A “device” is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a practitioner.”   Iowa Code § 155A.3(10).   This case does not involve a “device,” and we therefore consider only the portion of the statute pertaining to “drugs.”
HECHT, Justice.
All justices concur except BAKER, J., who takes no part.