JIM MATTOX Attorney General

Supreme Court Building P.0. Box 12549 Austin, TX. 79711.2548 512/475.2501 Telex 9101974-1357 Telecooier 512/4750256

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An EqualOpportunity/ Affirmative Action Employer 

# The Attortwy General of Texas

tune 19, 1986

Ronorable Chet Brooks Chairman Bealth andHuman Resources Committee Texas State Senate P. 0. Box 12068 Austin, Texas 78711

Dear SenatorBrooks: OpinionNo. JM-500 (corrected7-14-86) Re: Proper location of a Class D pharmacy

You ask severalquestionsregarding the statutoryconstructionof the Texas Pharmacy Act. In particular, you ask about the BoaEd of Pharmacy'sauthority to promulgaterules governingClass D pharmacies. To put your questim in context, we will first set out the statutes governing Class D !?bamacies. Since 1981 the Texas Pharmacy Act has provided for four different licensingclassificationsfor pharmacies:

'Class A pharmacy license' or 'conmunity pharmacy license means a license issued to a pharmacy dispensing drugs or devices to the general ;mblic pursuant to a prescription drug order.

'Class‘Bpharmacy license'or 'nuclearpharmacy license' means a license issued to a pharmacy dispensing or providing radioactive drugs or devices for administrationto an ultimateuser.
'Class C pharmacy license' or 'institutional pharmacy license means a license issued to a pharmacy located in a hospital or other in-patient facility that is licensedunder the Texas Hospital Licensing 'Law(Article4437f.Vernon's Texas Civil Statutes) or Chapter 6, Texas Mental Health Code (Article :5547-let seq., Vernon's Texas Civil Statutes), or to a pharmacy located in a hospital maintained or operatedby the state.
'Clash:Dpharmacy license' or 'clinicpharmacy license' neans a license issued to a pharmacy

p. 2296Honorable Chet Brooks - Pagmz2 (JM-500)

dispensing a lisited type of drugs or devices pursuant to a prexription drug order.

V.T.C.S. art. 4542a-1, §5(5)-(8).

The Pharmacy Act requires all pharmacies to be under the supervision of a pharmacist. V.T.C.S. art. 4542a-1, 929(c). Class A pharmacies,Class B pharmacLes,and Class C pharmacies in institutions with more than 100 beds must be under the continuous on-site supervision of a pharmacist. Id. A ClassD pharmacy, in contrast,must be under the continuous supe=ision of a pharmacist "whose services shall be required according to the needs of the pharmacy." Id. In other words, the supervising pharmacist of a Class D phacy need not alwaysbe on-site.

The State Board of Pharmacy has authority to adopt rules for the proper administration and enforcement of the Pharmacy Act. Art. 4542a-1, 916(a). Also, the act specifically provides that the board shall have "discretion to determine under which classifications a pharmacy applicantmay be 1Lcensed.u Art. 4542a-1, $29(e). :

Your first question about the regulation of Class D pharmacies is:

1. Does the Texas Board of Pharmacy have the

authority to change the definition of 'limited type of drug' in a manner which would preclude an outpatient clinic from being eligible for a Class D permit if that clinic limits the drugs it dispenses to only'dangerous drugs (&, no controlled substances) that are administered or provided only to patientsof the clinic (&, not to the generalpUb:Lic)?

A brief you submitted argues that the Board of Pharmacymust grant a Class D license to a pharmacy seeking such a license as long as that pharmacy limits its formulary to dangerous drugs. We think that the legislature intended a Class! D pharmacy to be more restricted in the range of drugs it dispenses .than your briefurges.
If the legislaturehad :intended that any pharmacy that limits its formulary to "dangerousdrugs"must be licensedas a ClassD pharmacy, it could have easily done :so. The Pharmacy Act defines "dangerous drug." V.T.C.S. art. 4542;~1, V.T.C.S. 55(12). Therefore, it would have been a simple matter for the legislature to define a Class D pharmacy as one that dispenses only "dangerous drugs." Instead, the legislature described a C3.as.s D pharmacy as one that dispenses "a limited type of drugs or dev,Lces."Art. 4542a-1, §5(8).

p. 2297Honorable Chet Brooks - Page 3 (JM-500)

The briefs submitte'i in response to your question show considerabledisagreement shout what the legislature intended a Class D pharmacy to be. We think that the legislature'sobvious intentwas to allow clinics that provide a limited range of medical services to maintain a pharmacy wit11 a formulary that meets the limited pharmaceutical needs of the clinic's patients. We think that this intent is clearwhen all theprovisions in the PharmacyAct that refer to a ClassD pharmacy are read together. First, a ClassD pharmacy is
a "clinic" pharmacy that (.ispensesa "limited type of drugs." Art. 4542a-1, 55(s). Second, a clinic pharmacy need not be under the continuous on-site supervi!ri:on of a pharmacist. Third, the Pharmacy Act indicates that a clinic pharmacy does not serve the general public. See Art. 4542a-1, 530(h). Finally, the legislature made clear that~clinic pharmacywould be somewhereother than a doctor's office, but nonetheless c:omewhereat which a doctor could leave standing orders. See art. 4542a-1. $33(a) (allowinga physician to delegate the administering;or provision of dangerous drugs in the physician's office); art. 4542a-1, 533(b) (allowing a physician to delegate the administering or provision of dangerous drugs if such provision is provided thrcugh a Class D pharmacy). Taken together, these provisions indicate .thatthe legislature intended a Class D pharmacy to be located at a clinic that providedmedical services so limited in scope that its ,patientscould be adequately served by a pharmacy that does not requ?-rethe constantpresence and expertise of
a licensed pharmacist. The legislature left it to the 'board's discretion to determinewh::chclinics are in fact so limited in scope that theneeds of theirpatients canbe met by a ClassD pharmacy.

In conclusion, it would be consistent with both the statutory definitionof "ClassD pharmacy" and also with the purpose of a Class D pharmacy to define "limited type of drugs" in a way that would preclude an applicant from obtaining a Class D license if the only limit on its formulary wc,uldbe that it dispensed only "dangerous drugs."

Your secondquestion J.6:

2. May a Class D pharmacy be located on the premises of a physician's practice located in a facility commonl~~ referred to as aminor emergency center?
This question seeks answers to factualmatters. "Minor emergency center"has no legaldefinj.tion.Whether or not the servicesprovided by such a facility are so limited that a Class D pharmacy could be locatedon thepremises is amatterwithin the discretionof the Board of Pharmacy.

p. 2298Honorable Chet Brooks - PaHe 4 (JM-500)

SUMMARY

A ClassD phalnlacyis onewith a formulary that is limited to ssrving the purposes of a clinic that provides limitedmedical services. The Board of Pharmacy has discretion to determine which pharmacies canbr licensedas ClassD pharmacies.

J-I M MATTOX Attorney General of Texas

JACK HIGHTOWER FirstAssistantAttorney General

MARY KELLER ExecutiveAssistantAttorney General

ROBERT GRAY SpecialAssistantAttorney General

RICK GILPIN Chairman,Opinion Committee
Preparedby SarahWoelk AssistantAttorney General

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