Untitled Texas Attorney General Opinion

The Attortwy General of Texas
JIM MATTOX tune 19, 1986
Attorney General
Supreme Court Building Ronorable Chet Brooks Opinion No. JM-500
P. 0. Box 12549
Chairman (corrected 7-14-86)
Austin, TX. 79711.2548
512/475.2501 Bealth and Human Resources Re: Proper location of a Class D
Telex 9101974-1357 Committee pharmacy
Telecooier 512/4750256 Texas State Senate
P. 0. Box 12068
714 Jackson, Suite 700
Austin, Texas 78711
Dallas. TX. 75202.4506
2141742-9944 Dear Senator Brooks:
You ask several questions regarding the statutory construction of
4824 Alberta Ave., Suite 180
El Paso, TX. 79905.2793
the Texas Pharmacy Act. In particular, you ask about the BoaEd of
91515353484 Pharmacy's authority to promulgate rules governing Class 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
1001 Texas, Suite 700 provided for four different licensing classifications for pharmacies:
Houston, TX. 77002-3111
713(223-5888
'Class A pharmacy license' or 'conmunity
pharmacy license means a license issued to a
SO6 Broadway, Suite 312 pharmacy dispensing drugs or devices to the
Lubbock, TX. 79401.3479 general ;mblic pursuant to a prescription drug
SC6l747.5239
order.
4309 N. Tenth, Suite S 'Class ‘B pharmacy license' or 'nuclear pharmacy
M~Alkn, TX. 78501~1695 license' means a license issued to a pharmacy
5121882.4547
dispensing or providing radioactive drugs or
devices for administration to an ultimate user.
200 Main Plaza, Suite 400
San Antonio, TX. 78205.2797 'Class C pharmacy license' or 'institutional
512/225-4191 pharmacy license means a license issued to a
pharmacy located in a hospital or other in-patient
An Equal Opportunity/
facility that is licensed under the Texas Hospital
Affirmative Action Employer Licensing 'Law (Article 4437f. Vernon's Texas Civil
Statutes) or Chapter 6, Texas Mental Health Code
(Article :5547-l et seq., Vernon's Texas Civil
Statutes), or to a pharmacy located in a hospital
maintained or operated by the state.
'Clash :D pharmacy license' or 'clinic pharmacy
license' neans a license issued to a pharmacy
p. 2296
Honorable 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 super-
vision 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 super-
vision of a pharmacist. Id. A Class D 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
always be 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 applicant may 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 con-
trolled substances) that are administered or
provided only to patients of the clinic (&, not
to the general pUb:Lic)?
A brief you submitted argues that the Board of Pharmacy must 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 .thanyour brief urges.
If the legislature had :intendedthat any pharmacy that limits its
formulary to "dangerous drugs" must be licensed as a Class D 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.sD pharmacy as one that dispenses "a
limited type of drugs or dev,Lces." Art. 4542a-1, §5(8).
p. 2297
Honorable Chet Brooks - Page 3 (JM-500)
The briefs submitte'i in response to your question show
considerable disagreement shout what the legislature intended a Class
D pharmacy to be. We think that the legislature's obvious intent was
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 clear when all the provisions in the Pharmacy Act that refer
to a Class D pharmacy are read together. First, a Class D 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:onof 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 pharmacy would be somewhere other than a doctor's
office, but nonetheless c:omewhere at which a doctor could leave
standing orders. See art. 4542a-1. $33(a) (allowing a 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 .that the legislature intended a Class D
pharmacy to be located at a clinic that provided medical services so
limited in scope that its ,patients could be adequately served by a
pharmacy that does not requ?-rethe constant presence and expertise of
a licensed pharmacist. The legislature left it to the 'board's
discretion to determine wh::chclinics are in fact so limited in scope
that the needs of their patients can be met by a Class D pharmacy.
In conclusion, it would be consistent with both the statutory
definition of "Class D 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,uld be that it dispensed only "dangerous
drugs."
Your second question 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 a minor emergency
center?
This question seeks answers to factual matters. "Minor emergency
center" has no legal definj.tion. Whether or not the services provided
by such a facility are so limited that a Class D pharmacy could be
located on the premises is a matter within the discretion of the Board
of Pharmacy.
p. 2298
Honorable Chet Brooks - PaHe 4 (JM-500)
SUMMARY
A Class D phalnlacyis one with a formulary that
is limited to ssrving the purposes of a clinic
that provides limited medical services. The Board
of Pharmacy has discretion to determine which
pharmacies can br licensed as Class D pharmacies.
J-I M MATTOX
Attorney General of Texas
JACK HIGHTOWER
First Assistant Attorney General
MARY KELLER
Executive Assistant Attorney General
ROBERT GRAY
Special Assistant Attorney General
RICK GILPIN
Chairman, Opinion Committee
Prepared by Sarah Woelk
Assistant Attorney General
p. 2299