                                                     February 24,200O



Ms. Gay Dodson, R.Ph.                                        Opinion No. JC-0186
Executive Director/Secretary
Texas State Board of Pharmacy                                Re:      Whether state law permits the use of an
William P. Hobby Building, Suite 3-600                       automated     dispensing     machine to dispense
333 Guadalupe Street, Box 21                                 prescription drugs at anursing home (RQ-0121.JC)
Austin. Texas 78701-3942

Dear Ms. Dodson:

         On behalf of the Texas State Board of Pharmacy (the “Board”), you ask whether state law
permits the use of an automated dispensing machine to dispense prescription drugs at a nursing
home. We conclude that because the machine you describe dispenses prescription drugs, a function
that state law generally reserves to licensed pharmacies, the facility where it is located must be
licensed as a pharmacy and must be under a pharmacist’s continuous onsite supervision as required
by the Texas Pharmacy Act, TEX. Oct. CODEANN., tit. 3, subtit. .I, chs. 55 l-566 (Vernon 2000) (the
“Act”).’ The automated dispensing machine you describe would not be under a pharmacist’s
continuous onsite supervision and is therefore not permitted under the Act.

          You provide the following description of the type of automated dispensing machine at issue:

                               The automated dispensing system is a machine, which is
                     designed to mechanically sort and then individually label and package
                     oral medications for administration to patients in long-term care
                     facilities (i.e., nursing homes). A licensed pharmacist would load the
                     machine with bulk medications.       A nurse at a nursing home would
                     input a prescription order into an on-site computer.          Then a
                     pharmacist at an off-site pharmacy would review the prescription
                     order with the patient’s medication record. When the review is
                     complete, the pharmacist would send the order to the automated
                     dispensing system at the nursing home and instruct the machine to
                     prepare and dispense the prescription for the patient. Access to the
                     bulk medications contained in the automated dispensing system other
                     than those dispensed would be limited to a licensed pharmacist.



           ‘In the last legislative   session, the Seventy-sixth Legislature codified the Act, former article 4542%1, in title
3, subtitle J of the Occupations       Code. We refer to the Act as codified unless otherwise noted.
Ms. Gay Dodson, R.Ph. - Page 2                  (X-0186)




Letter from Gay Dodson, R.Ph., to Elizabeth Robinson, Chair, Opinion Committee, Office of the
Attorney General, at 1 (Oct. 4, 1999) (on file with Opinion Committee) [hereinafter “Request
Letter”].

         The Board seeks our opinion “regarding the use of an automated dispensing system at a
facility which does not have a valid pharmacy license, such as a nursing home, and the dispensing
of controlled substances and/or dangerous drugs through the use of such a system by a pharmacist
not physically located at the facility.” Id. In order to resolve this issue, you pose two questions:

                        1. Under the provisions of the Texas Dangerous Drug Act,
               Chapter 483, Health and Safety Code, and the Texas Controlled
               Substances Act, Chapter 481, Health and Safety Code, may a
               pharmacy store bulk unlabeled dangerous drugs and/or controlled
               substances in an automated dispensing system at a facility, such as a
               nursing home, if this facility is not licensed as a pharmacy and is at
               a location other than the licensed pharmacy?

                       2. If bulk unlabeled dangerous drugs and/or controlled
               substances may be stored in such a system, does a pharmacist have to
               be physically present at the facility where the automated dispensing
               system is located when a prescription is dispensed using the system?

Id. at l-2. Because we conclude that the automated dispensing machine you describe is not
permitted under the Texas Pharmacy Act, we do not reach your question about the Dangerous Drug
Act and Controlled Substances Act and storage of drugs at a nursing home in an automatic
dispensing machine.

        We answer your query based on the licensing requirements ofthe Act andthe Act’s extensive
and detailed definitions of technical terms, which the Code Construction Act mandates that we
apply. See TEX. GOV’T CODEANN. 4 3 11 .Ol I@) (Vernon 1998) (“Words and phrases that have
acquired a technical or particular meaning, whether by legislative definition or otherwise, shall be
construed accordingly.“); see also TEX. OCC.CODEANN. 5 1.002 (Vernon 2000) (Code Construction
Act “applies to the construction of each provision in this code except as otherwise expressly
provided by this code”).

         The Act defines a “pharmacy” as “a facility at which a prescription drug or medication order
is received, processed, or dispensed under this subtitle, Chapter48 1 or 483, Health and Safety Code,
or the [federal] Comprehensive Drug Abuse Prevention and Control Act of 1970.” TEX. OCC. CODE
ANN. § 551.003(31) (Vernon 2000) (emphasis added). “Dispense” means “to prepare, package,
compound, or label, in the course of professional practice, a prescription drug or device for delivery
to an ultimate user or the user’s agent under a practitioner’s lawful order.” Id. $ 551.003(16); see
also id. 5 551.003(13)     (“Deliver” or “delivery” means “the actual, constructive, or attempted
Ms. Gay Dodson, R.Ph. - Page 3                    (K-0186)




transfer of a prescription drug or device or controlled substance from one person to another, with or
without consideration.“),    (22) (“Labeling” means the process of affixing a label      to a drug or
device container . .“). Under the Act, a “pharmacist” is a person licensed by the Board to practice
pharmacy. See id. § 55 1.003(28). The “practice ofpharmacy” includes, among other things, “being
responsible for: (i) dispensing a prescription drug order or distributing amedication order; [and] (ii)
compounding or labeling a drug or device.” Id. § 55 1.003(33)(E).

         The dispensing of prescription drugs is an essential function of both a pharmacy and a
pharmacist, which the Act is intended to govern. Only certain persons-namely           health care
professionals, college ofphatmacy professors, drug researchers-and    home and community support
services agencies are permitted to dispense drugs outside the Act’s scope. See id. $ 551.004.

         As you have described the automatic dispensing machine, an offsite “pharmacist would send
[an] order to the automated dispensing system at the nursing home and instruct the machine to
prepare and dispense the prescription for the patient.” Request Letter at 1. The machine would
“individually label and package oral medications for administration to patients” from the bulk
medications stored in the machine. See id. Based on this description, it appears that the machine
would “package        or label, in the course of professional practice, a prescription drug or device for
delivery to an ultimate user or the user’s agent under a practitioner’s lawful order,” TEX. OCC. CODE
ANN. 5 551.003(16) (Vernon 2000), and would thus “dispense” prescription drugs within the
meaning of the Act, see id. For this reason, we conclude that a nursing home where such a machine
is located would be “a facility at which a prescription drug or medication order is . dispensed” and
therefore would be a “pharmacy” within the meaning of the Act. See id. 5 551.003(31).

       Under the Act, a pharmacy must be licensed by the Board. See id. 5 560.001(a) (“A person
may not operate a pharmacy in this state unless the pharmacy is licensed by the board.“). A separate
pharmacy license is required for each principal place of business of a pharmacy and only one
pharmacy license may be issued for each specific location. See id. 5 560.102.

        The Act provides for five pharmacy classifications.        A Class A pharmacy license or
community pharmacy license authorizes a pharmacy to dispense a drug or device to the public. See
id. 5 560.05 l(b). A Class B pharmacy license authorizes a pharmacy to dispense a radioactive drug
or device to the public. See id. 5 560.051(c). A Class C institutional pharmacy license may be
issued to a pharmacy located in: a hospital or other inpatient facility licensed under chapter 241 or
577 of the Health and Safety Code; a hospice inpatient facility licensed under chapter 142 of the
Health and Safety Code; an ambulatory surgical center licensed under chapter 243 of the Health
and Safety Code; or a state hospital. See id. 5 560.051(d), as untended by Act of May 27, 1999,
76th Leg., R.S., ch. 1518, 4 1, 1999 Tex. Gen. Laws 5241. A Class D clinic pharmacy license
authorizes a pharmacy to dispense a limited type of drug or device. See TEX. Oct. CODE ANN.
5 560.05 1(e) (Vernon 2000). Finally, a Class E nonresident pharmacy license pertains to a pharmacy
located in another state. See id. § 560.051(f). The board may determine the classification under
which a pharmacy may be licensed. See id. 5 560.05 l(g). Given these classifications, it appears that
the location of an automated drug dispensing machine would generally require a Class A pharmacy
Ms. Gay Dodson, R.Ph. - Page 4                    (JC-0186)




license although a Class C license might be available with regard to a machine located at a nursing
home with licensed hospital facilities.

         All pharmacies must be supervised by a pharmacist. See id. 8 562.101(a). The degree of
supervision required depends upon the type ofpharmacy. Under section 562.101 ofthe Act, aClass
A pharmacy “is required to be under the continuous on-site supervision of a pharmacist during the
time the pharmacy is open for pharmacy services.” Id. 5 562.101(b). Similarly, a Class C pharmacy
in an institution with more than 100 beds “is required to be under the continuous on-site supervision
of a pharmacist during the time the pharmacy is open for pharmacy services.” Id. $562.101(c). A
smaller institution “is required to have the services of a pharmacist on a part-time or consulting basis
according to the needs of the institution.” Id. 6 562.101 (d). We assume that most nursing homes
associated with licensed hospitals are associated with hospitals with more than 100 beds.

         Section 562.101 generally requires that a pharmacist be physically present at a Class A or
larger-institution Class C pharmacy when it is open for “pharmacy services.” This supervision
requirement clearly contemplates a traditional retail establishment that is open for business during
certain hours of the day. However, we cannot conclude that this requirement is inapplicable to a
pharmacy operating by way ofthe type of automated dispensing machine you describe, which would
dispense drugs at intermittent times at the instruction of a pharmacist located off-site. The Act
makes no exception to the continuous on-site supervision requirement for Class A pharmacies or the
Class C pharmacies to which it applies. Nor does the Act authorize the Board to make exceptions
to the requirement by rule.

        In sum, the Act includes in the definition of“pharmacy” facilities at which prescription drugs
are dispensed and generally requires the licensing of all such facilities. The Act also generally
requires licensed pharmacies to operate under the continuous onsite supervision of a pharmacist and
does not provide an exception for the type ofautomated dispensing machine described in your query.
Thus, the automated dispensing machine you describe, which by definition would dispense drugs
without the onsite supervision of a pharmacist, is not permitted under the Act.

         Finally, we are aware that one point of automated drug dispensing machines is to eliminate
the expense of such onsite supervision and to reduce the cost of providing prescription drugs to
nursing home patients. While the Act may not take into account the advanced technology you
describe, which appears to allow a pharmacist to closely supervise via computer the dispensing of
prescription drugs by a machine at an off-site location, it is clear in prohibiting the off-site
supervision you describe. We are not at liberty to depart from the Act’s terms. Although it may be
the case that the Act should be amended to specifically address, and perhaps embrace, such
technological advances, that is a policy choice that must be made by the legislature rather than this
office.
Ms. Gay Dodson, R.Ph. - Page 5                  (JC-0186)




                                     SUMMARY


                      The Texas Pharmacy Act, TEX. Oct. CODEANN., tit. 3, subtit.
              J, chs. 551-566 (Vernon 2000), includes in the definition of
              “pharmacy” all facilities at which prescription drugs are dispensed
              and generally requires the licensing of all such facilities. The Act
              also generally requires licensed pharmacies to operate under the
              continuous onsite supervision of a pharmacist and does not provide
              an exception for the type of automated dispensing machine described
              in your query. Thus, an automated prescription drug dispensing
              machine, which would dispense prescription drugs without the onsite
              supervision of a pharmacist, is not permitted under the Act.

                                            Y     sve       truly



                                          4&&T
                                            JOkN     CORNYN
                                            Attorney General of Texas



ANDY TAYLOR
First Assistant Attorney General

CLARK RENT ERVIN
Deputy Attorney General - General Counsel

ELIZABETH ROBINSON
Chair, Opinion Committee

Mary R. Crouter
Assistant Attorney General - Opinion Committee
