I, Coby Shorter Ill, Deputy Secretary of State of the State of Texas, DO HEREBY CERTIFY the
`attached are true and correct copies of 22 TAC §§291.20, 291.36, and 291.71 - 291.74
`as in effect on February 10, 2004.
`
`Date Issued: March 5, 2015
`
`Coby Shorter, III,
`Deputy Secretary of State
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`i
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`Texas
`Adm,inlstrative
`·code·
`· Title 22
`Examining Boards
`
`2004.
`[Replaces 2003 Pamphlet]
`
`Amendments effective through
`December 31, 2003
`
`THOMSON
`
`WEST
`
`Yat #40177308
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`ii
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`22 TAC § 291.20
`§ 291.20. Remote Pharmacy Services
`(a) Remote pharmacy 'services using automated
`pharmacy systems. .
`(1) Purpose. The piltpose of this section is to
`provide stanciar"ds fat 'the- provision of pharmacy
`services by a· Class · A or Class C pharmacy in a
`facility that is not at the same location as the Class A
`cir Class C pharmacy through an automated phar(cid:173)
`macy system as outlined in §562.109 of the Texas
`Pharmacy Act ·(Chapters 551~566, Occupations
`Code, as·amended),
`(2) Definitions. The following words and terms,
`when used in this section, shall have the following
`.meanings, unless the context clearly indicates
`otherwise. All other words and terms shall have the
`meanings defined in §291.31 of this title (relating to
`Definitions for Class A (Community) Pharmacies)).
`. (A) Automated pharmacy system-a mechanical
`system that di$p~nses pr~s~ription drugs and main(cid:173)
`~ins relateq tr~:;tctiOn information.
`(B) Dispense'-Preparing, packaging, compound(cid:173)
`ing, or labeling for delivery a prescription drug or
`'device in the course of professional practice to an
`ultimate user or his. agent by or- pursuant to the
`'lawful order of ·a practi~ioner.
`. (C) Remote site-a facility not located at the same
`location as a Class A or Class C pharmacy, at which
`remote. pharmacy services ~e provided using an
`automated pharmacy dispe:p.sing system.
`(D) Prepackaging-the act of repackaging aod
`relabeling quantities of drug products from a manu(cid:173)
`facturer's original'commercial container, or quanti(cid:173)
`ties of Unit. dosed .. drugs, into another cartridge or
`Container for Pisp.ensihg by a phannacist using an
`automated p~acy system.
`(E) Provider phamiacy-the community phar(cid:173)
`macy (Class A) or the .institutional pharmacy (Class
`C) proViding remote'p~arin-acy services.
`(F) Remote pharmacy service-the provision of
`pharmacy services, iD.Cluding the storage and dis(cid:173)
`pensing of prescrj.Ption drugs, in remote sites.
`(G) U~it dose...:.<'ll amount of a drug packaged in
`a dos'age form ready for administration to a particu(cid:173)
`lar patient, by the prescribed route at the prescribed
`time, and properly labeled with name, 'strength, and
`expiration date of the drug.
`(3) General.requirements .
`. (A) A- provider pharmacy may provide remote
`pharmacy services using an automated pharmacy
`system to ajailorprisonoperated by odor the State
`of Texas, a jail or prison .operated by local govern-
`
`TEXAS STATE BOARD OFPHARMAC:Y
`ment or a' healthcare facility regulated under. Chap(cid:173)
`ter 142, 242, 247, or 252, Health aod Safety Code
`provided drugs are administered by a licensed health(cid:173)
`care professional working in ihe jail, prison) .or
`healthcare facility.
`(B) A provider pharmacy may only provide re(cid:173)
`mote pharmacy services uSing an· automated phar(cid:173)
`macy system to inpatients of the remote site.
`(C) A provider pharinacy inay. provide renibie
`pharmacy services at ·more than one remote s;te; · ·
`(D) Before providing remote pharmacy se,.;oces,
`the automated PharmaCy syStem .at· the :reinote _ s_i~e
`must be tested by the provider phillmi.cy and fourtd
`to dispense accurately. The provider pharmacy shall
`make the results .of such testing available to the
`Board upon reqp.est.
`.(E) A provider pharmacy which is licensed as an
`institutional (Class C) pharmacy is required to c~m­
`ply with th,e provisions of §§291.31-'-291.34 of this
`title (relating to Definitions, P~rsonne!, Operational
`Standards, aod· Records for ClassA-(Community)
`Phannaciesr and: this section. ·
`(F) The pharmacist-in'charge of the pr~Vid~r phar(cid:173)
`macy is responsible for· all· plia:i-inacy ···ope·ra:tions
`involving the autOmated pharmacy systeiri located
`at' the ·remote -site inclUding slijJerVis'ioil of the auto(cid:173)
`mated pharmacy system and compliance with· this
`section.
`(G) A pharmacist from the provider pharmacy
`shall be accessible at all times to respond to patient's
`or other health professionals' questions ·and needs
`pertaining to drugs dispensed through .the use of tho
`automated pharmacY sy?tem. Stich access· may be
`through a 24 hour pager service m:- telephone which
`is answered 24 hours a day.
`(4) Operation1<l standards.
`(A) Application for permissi~n to provide phar(cid:173)
`macy services using an automated pharmacy systelll-
`(i) A Class A or Class C Phaimacy shall mah
`application to the board to provide remote phar·
`macy services using an_ automated pharmacy system
`The application shall contain an affidavit with the
`notarized signatures of the pharmacist-in-charge ..
`and the medical_ director or the _person responsible
`for the on-site operation of the facility (e.g., admiD(cid:173)
`istrator, chief operating officer, ·owner, chief execv-(cid:173)
`tive officer), and i'nc!ude the following:
`(I) the name, address, and license number of tht-
`provider pharmacy;
`(II) name and address of the facility where !he
`remote pharmacy services will be provided;
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`PHARMACIES
`(III) a statement indicating that the provider phar(cid:173)
`macy and- ithe facility· have "entered into· a written
`contractor agree;ment which outlines the-services to
`be provided, and- the· responsibilities-.;at.td' account(cid:173)
`abilities of each party in• fulfilling:the;terms· of the
`contract~or agreement.in ·complianCe.--with federal
`and state :laws and regulations;- and·
`.(IV) documentation that the. automated phar(cid:173)
`macy system is located· where medications ate ad(cid:173)
`ministered by license healthcare professionals and
`is:
`(-a-) a facility regulated under Chapter 142, 242,
`247, or 252, Health and Safety Cod~; or
`(-b-) a jail or prison, operated by the State. ,of
`Texas or local government
`.
`. (ii) Such application shall be ~esubmi~d ~very
`two years in conjunction with the a.rpliqtVo;g. for
`renewal of the provider pharmacy's license: 'rhe
`renewal petition shall contairi the d0clurient8.tion
`required in clause (i) of this subparagfaph·except the
`notariZed signature of the medical dire~tor or the
`person responsible for t:l;te _on-~ite opefation .of.. the
`facility (e.g., administrator, chief operating officer,
`owner:. cbief execUtive ciffi.Cei-) is 'not required ..
`(iii) Upon approval of the application, ·the pro·
`vider pharmacy will be sent a certificate which must
`be displayed at .the remote ~ite.
`(B) Notification requirements.
`(i) A provider pharmacy shall notify the board in
`writing within ten days of a change Of location,
`discontinuance of service, or closure of:
`·
`(I)· a remote site ·where an automated pharmacy
`system is operated by thepharinacy; or
`(II) a remote pharmacy service at _a remote site.
`(ii) A provider pharmacy· shall comply with ap·
`propriate federal and state controlled substance
`registrations for each remote site if controlled sub(cid:173)
`stances are maintained within an automated phar(cid:173)
`macy system at the facility.
`(C) Environment/Security.
`(i) A provider pharmacy shall only store·drugs at
`a remote site within an_ automated pharmacy system
`which is "tacked by key or combhiation so as to
`prevent access by unauthorized personnel. .
`(ii) An automated pharmacy system sha,Jl be un·
`der the continuous s-Upervision of a provider phar(cid:173)
`macy pharmacist. To qualify as continuous supervi(cid:173)
`sion, the pharmacist is not required to' be physically
`present at the site of the automated pharmacy sys·
`tern if the·system is supervised ·electronically. by a
`pharmacist;
`
`22 TAG§ 291.20
`(iii} Automated pharmacy systems·. shaH have·ad(cid:173)
`equate. security and· procedures to:
`(I} comply with federal and state laws and regu(cid:173)
`lations;. and .
`(II) maintain patient confidentiality.
`(iv) Access to the· automated pharmacy system
`shall be liinited to pharmacists or personnel who:
`(!) are designated in writing by the pharmacist(cid:173)
`in-charge; and
`(II) have completed documented training concern(cid:173)
`ing their duties associated with the automated ·phar(cid:173)
`macy system.
`(v) Drugs shaH be stored. in compliance with the
`provisions of §291.33(1) of this title inclucling the
`requirements for temp'era:ture, proper stOrage con(cid:173)
`·
`tainers, and handling of outdated drugs.
`(D) Prescription dispensing and delivery.
`(i) Drugs shall only be dispens,ed ·at a remote site
`through an automated pharmaCy' SyStem after re(cid:173)
`ceipt of an original prescription drug order by a
`pharmacist at the provider Phimn:aey·fu a riianner
`authorized by §291.34(b) ofthis'title.'·
`(ii) A pharmacist at the provider pharmacy shall
`control all operations of the autoffiated phanna~y
`system and approve the release of the initial dose of
`a prescription drug order. Subsequent doses-from_an
`approved prescription drug order may be removed
`from the automated medication syStem after this
`initial approval. Any change made in the prescrip(cid:173)
`tion drug order shall require a new approval by a
`pharmacist to release the drug.
`(iii) A pharmacist at the provider pharmacy shall
`conduct a drug regimen review as specified in §291.
`33(c) of this title prior to releasing a prescription
`drug order to the automated pharmacy system.
`(iv) Drugs dispensed by the provider pharmacy
`through an automated pharmacy system shall com(cid:173)
`ply With the labeling or labeling alternatives sped- -
`lied in §291.33(c) of this title.
`(v) An automated pharmacy system used to meet
`the emergency medication needs for residentS of a
`remote site must comply with the requirements for
`emergency medication kits in subsection (b) of this
`section
`(E) ·Drugs.
`(i) Drugs for use in an automated pharmacy sys(cid:173)
`tem shaH be packaged in the original manufactur·
`er's ·container or be prepackaged in the provider
`pharmacy and labeled in compliance with the board's
`prepackaging requirements for the class of pharmacy.
`(ii) Drugs dispensed from the automated phar(cid:173)
`macy system may be returned to the pharmacy for
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`'22 TAC §C:l9l:20
`reuse .provided-- the: drugs are in,. sealed, tamper
`evident packaging which has not been opened.
`· .(F) .Stocking·.an aut.omated pharmacy system.
`(i) Stocking of drugs in an automated pharmacy
`system shall be completed by. a pharmacist or a
`certified phariD~cy tec;1;mician .under the direct su(cid:173)
`pervision of a:· Ph~m~cist, .except as provided in
`clause (ii) of thi~ .subparagraph.
`(ii) If the automated pharmacy system uses· re(cid:173)
`movable cartridges or: containers to hold drugs, the
`prepackaging of tlui cartridges or containers shall
`oc;:_cur at the p_r!JVider pharmacy unless provided by
`an fDA. approved repackager. The prepackaged car(cid:173)
`. tridge:5 or containers may be sent to the remote site
`io be ioaded into the machine by personnel desig(cid:173)
`. nate'd'by the pharmacist-in-charge provided:
`(I) a pharmacist verifies the cartridge or con-
`tainer has been properly filled and labeled;
`(II) the individual cartridges or containers are
`_transported to .the ;remote site in a secure, tamper(cid:173)
`eVi.deiit container;' and.
`..
`(m) the a~tpmai~d ph~rmacy system uses bar(cid:173)
`. co_ding,_ micx:<;>~l:riP •. ·9r· t:)ther technologies to ensure
`'that th~ ··contafne:fS ·_·are. accurately loaded in the
`·_·_a~torn:at~d:J,h~acy Sys-tem.
`. . -·
`. ··· . . ·;
`._.' . .
`(iii)" ;J~l! drugs to b~ ·stocked in the automated
`pharmacy syst<im. shall be delivered to the remote
`site by. the pro~ider Pharmacy.
`, ((}) Quality ~~s\lrante program. A pharmacy that
`provides,pharq1acY _services through an automated
`pharmacy system _a_t a remote site shall operate
`. ,accordi:n,g to a, written p;rogram ·for quality assur(cid:173)
`ance ef..-the'. autoni;;tted ph~acy system which:
`(i) requi~es -~ontig~pus' .-~upervision of the auto(cid:173)
`mated phar;ma.cy system; and
`(ii) ,- est_ablish.es · mechc~mism~ and procedures to
`routine~y ~es_t .tlie ac::ct:J.r~cy_ of th_e automated phar(cid:173)
`. macy system- at a mini~um __ of every six months and
`whenever any upgrade or .change is made to the
`system and documen!$.each-such.act;ivity.
`(H) Policies and procedures of operation.
`(i) A ·pharmacy that provides pharmacy services
`through an automated .pharmacy system at a remote
`site shall operate. according to written.policies and
`procedures. The policy and procedure manual shall
`include, but not be limited.to, the following:
`(I) a; current!ist· of the name and· address of the
`pharmacist-in,charge, and personnel designated by
`the pharmacist-in-charge to-have access to the drugs
`stored in the automated pharmacy. system;
`(II) duties which may. only be -performed by a
`pharmacist;
`
`~b.·
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`TEXAS STATE BOARD OF PHARMACY
`(III) a copy of the portion ofthe written' contract
`or agreement between the pharmacy and the facility
`which outlines. the services .to. be .p1"9vided· and the
`responsibilities and; accountabilities .. of _each. p~rty
`relating to the op,ration of the automated pharmacy
`system in fulfilling the terms of the contract.' in
`compliance with federaland·state laws.and.regtjla-
`tions;
`.--·~
`(IV) date of1ast review/revision of the policy. and
`procedure m~q.al;_ and
`(V) policies and procedures for: . ·
`(-a-) security;.·
`(-b-) operation oftlie aiitcimated pharmacy·sys(cid:173)
`tem;
`C-c-) preventative maintenance· Of the--automated
`pharmacy system;
`(-d-) sanitation;
`(-e-i .s(ora~e ofdrugs;
`(-f-) dispensing;
`(-g-) supervision;.
`(-h-) driig procurement;
`(-i-) receiving ofdrugs;
`(-j-) delivery of drugs; and
`(-k-) recordkeeping.
`(ii) A pharmacy that provides pharmacy services
`through an automated ph-armacy system a~ _a rez:note
`site shall, at least annually, review its written. poli(cid:173)
`cies and procedur'es, 'revise them if D.eCesSarY, and
`docUment the rev.iew.
`·
`.
`(iii) A pharma~y providing remote pharm~cys~~­
`vices using aii aUtomated· Pharniacy ~ySteffi · SP,~ll
`maintain a written plan fOr recovefy from an eVent
`which interrupts the ability of the automated phar(cid:173)
`macy system to dispense prescription drugs.· The
`written plan for recovery shall include:
`(I) planning and preparation for maintaining phar(cid:173)
`macy services when an automated pharmacy system
`is experiencing downtime;·
`(II) procedures for response when an automated
`pharmacy system is experiencing downtime; and
`(III)· procedures for the maintenance' and testing
`of the written plan for recovery.
`(5) Records.
`(A) Maintenance ofrecords.
`(i) Every record required under this section must
`be maintained by the provider pharmacy for: two
`years.
`(ii) The provider pharmacy shall maintain origi(cid:173)
`nal prescription drug orders fol"' drugs dispensed
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`PHARMACIES
`from an automated· pharmacy system in·compliance
`with §29(34(b) of this title:
`(iii). if'prescript~on drug records are maintained
`in a data proce·ss"ing system, the Systefn shall h8.ve a
`workablet(electronic) data retention systeni which
`can produce a separat~ audit trail of drug usage by
`the pro.Vider pharmacy and each remote site for the
`preceding' tWo years·as specified in §291.34(e).ofthis
`title.
`(B) Prescriptions. Prescription drug orders .shall
`meet the requirements· of §291.34(b) of this:title.
`(C) Records of dispensing. Dispensing records for
`a prescription drug order shall be maintained by the
`provider pharmacy in the manner required by §291.
`34(d) or (e) of this title.
`(D) Transaction information.
`(i) The automated pharmacy system shall elec(cid:173)
`tronically record all transactions involving dx:ugs
`stored in, removed, or dispensed 'from ·the system.
`(ii) Records of dispensing from an automated
`pharmacy system for a patient shall be maintained
`by the providing pharmacy and include tlie:
`'(I) 'identity of the system accessed;
`(II) identification of the individual accessing the
`system;
`(III) date of transaction;
`· (IV).· name, strength, dosage form, and quantity of
`drug accessed; and
`(V) name of the patient for whom the drug was
`accessed.
`(iii) Records of stocking or removal from an au(cid:173)
`tomated pharmacy system shall be maintained by
`·
`the pharmacy and include the:
`(I) dat.e;
`(II) name, strength, dosage form, and quantity·of
`drug stocked or removed;
`(III) name, initials, or identification code of the
`person stocking or removing d:r;ugs from .the system;
`(IV) name, initials, or identification code of the
`pharmacist who checks and verifies that the system
`!Jas b,een accurate! y filled;
`(E) Patient medication records. Patient medica(cid:173)
`tion records sh;;;lll.be c.reated and ID!!int"!-ined by the
`provider pharmacy in the manner required by §291.
`34(c) of this title.
`(F), lnvelftory. ,
`(i) A provider pharmacy shall:
`(I) keep a record of all drugs sent to and returned
`from ·a:remote site separate from the records of the
`811
`
`22 TAC § 291.20
`provider pharmacy and from any other remote site's
`records; and
`(II) keep a perpetual inventory of controlled sub(cid:173)
`stances received and dispensed or distributed from
`each reffiote site.
`(ii) As specified in §291.17 of this title (relating to
`Inventory Requirements for All Classes of Pharma(cid:173)
`cies), a provider pharmacy shall conduct an inven(cid:173)
`tory at each remote site: The following is applicable
`to this inventory.
`(I) The inventory of each remote site and the
`provider pharmacy shall. be. taken on the same day.
`(II) The inventory of each remote site shall be
`included with, but listed separately from, the drugs
`of other remote sites and Separately ·from the drugs
`of the provider pharmacy.
`(b) Remote pharmacy services using emergency
`medication kits.
`(1) Purpose. The purpose of this section is . to
`provide standards for the provision of pharmacy
`services by a Class A or Class C pharmacy in a
`facility that is not at the same· location as the Class A
`or Class C pharmacy through. an emergency medi(cid:173)
`cation kit as outlined in §562.108 of the Texas
`Pharmacy Act (Chapters 551-566, Occupations
`·
`Code, as amended).
`(2) Definitions. The following words and terms,
`when used in this section, shall have the. fOllowing
`meanings, unless the context clearly indicates
`otherwise. All other words and terms shall have the
`meanings defined in §291.31 of this title.
`(A) Automated pharmacy system-a mechanical
`s)rstem that dispenses pre.SCription drugs and main(cid:173)
`tains related transaction information.
`(B) Dispense-Preparing, packaging, compound(cid:173)
`ing, or labeling for delivery a prescription drug or
`device in· the cOurse of professional practice to an
`ultimate user or his agent by or pursuant to the
`lawful order of a practitioner.
`(C) Emergency medication kits----;:;oiltrolled sub(cid:173)
`stances and dangerous drugs maintai'neP b.Y a com(cid:173)
`munity. pharmacy (Class A) or an institUtional phar(cid:173)
`macy (Class C) at an institution licensed under
`Chapter 242 or 252, Health and Safety Code; to meet
`the emergency medicatiop. needs·of a·resident at that
`iristitution.
`·(D) Remote site-a facility not located at the same
`location as a Class A or Class C pharmacy. at which
`remote pharmacy services are provided using an .
`emergency medication kit.
`(E). Prepackaging-the act of repackaging and
`relabeling quantities of_drug products from a manu-
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`TEXAS STATE BOARD OF PJIA.RMACY
`accountabilities of each party in ful:fiUing_the ~e_nns
`of the contract or agreement in- compliance with
`federal and state laws and regulations; and
`. (IV) documentation that the ·emei:gencY..rtledica(cid:173)
`tion kit is located in a. facility ,regulated under
`Chapter 242, or 252, Health and Safety Code.
`(ii) Such application shall be resubmitted every
`two years in conjunction with the applicatiOn- for
`renewal of the provider phannacy's licenSe. ·The
`renewal petition shall contain. ,the documentation
`required in clause (i) of this subparagraph except the
`notarized signature Of the medical director or: the
`person responsible fo;r the on-site operation of the
`facility (e.g., ad.ininistrator:. ~wner, chief executive
`officer, chief operating offiCer) is not reqqired.
`(iii) Upon approval of the application, the pro(cid:173)
`vider pharmacy will be sent- a certificate which must
`be displayed at the remote site.
`(B) Notification requirements.
`(i) A provider pharmacy shall notify the board in
`writing within ten days of a change of location,
`discontinuance of servi~e. Or closure of:
`·
`(I) a remote site where an emergency medication
`kit is operated by the pharmacy; or
`_ (II) a remote pharmacy service at a remote site.
`(ii) A provider pharmacy shall comply with ap(cid:173)
`propriate federal and state controlled subst~ni::e
`registratibhs for each remote site if cozltrolled s"ub(cid:173)
`stances are maintained within an emergency medi(cid:173)
`cation kit at the facility.
`(C) Environment/Security.
`(i) Emergency medication kits shall liave ad-
`equate seCurity and procedures to:
`(I) prevent unauthorized access;
`
`22 TAC § 291.20
`facturer's originatco~ercial container. or quanti(cid:173)
`ties of unit dosed drugs, into another cartridge or
`container for dispensing by a pharmacist using an
`emergency ~edicat~o~_.kit.
`(F) Provider pharmacy-the community phar(cid:173)
`macy (Class A) or the institutional pharmacy (Class
`C) providing r~_~ot~_ph~acy services.
`(G) Remote pharmacy service-the provision of
`pharmacy service;s, including the storage and. dis(cid:173)
`pensing of prescripti_on drugs, i~ remOte sites.
`(3) General requirements.
`(A) A provider pharmacy may provide remote
`phann-acy services using- an emergency medication
`kit to an institution regwated under Chapter 242, or
`252·, Bealth and Safety Code.
`(B) A provider pharmacy may provide. remote
`pharmacy ~ervices at m'ore than one remote site.
`(C) A provider pharmacy shall not place an emer(cid:173)
`gency medication kit in a remote- site which already
`has a kit from another provider pharmacy.
`(D) A provider phairnacy which is licensed as an
`institUtional (Class C) pharmacy is required to com(cid:173)
`ply with the provisions of §§291.31-291.34 of this
`title and this section.
`(E) The phaimacist-in-charge of the provider phar(cid:173)
`macy is responsible for all pharmacy operations
`involving the emergency medication kit located at
`the remote· site· including supervision of the emer(cid:173)
`gency medication kit and compliance with this
`section.
`(4) Operational standards.
`(A) Application for permission to provide phar-
`macy services usipg aD. emergencY medication kit.
`(i) A Class A or Class C Pharmacy shall make
`application to tile. boarcl to provide remote phar-
`(II) comply with federal and state laws and regu-
`macy services using an emergency medication kit.
`lations; and
`The application shall contain an affidavit with the
`(III) maintain patient confidentiality.
`notarized siguatures of the pharmacist-in-charge,
`(ii) Access to the emergency medication kit shall
`and the med!cal direc~or or the person responsible
`be limited to· pharmacists and licensed healthcare
`for the on-site operation of the facility (e.g., admin-
`personnel employed by the facility.
`iSt.rator, owner, chief exer;Utive officer; chief operat-
`(iii) Drugs shall be stored in compliance with the
`ing officer), and irldudeihe following:
`(I) the nartle, addres~, and license number of the
`provisions of §291.33(£) of this title including· the
`requirements for temperature, proper storage Con-
`provider phannacyi
`tainers, and handling of outdated drugs.
`(II) name and address of the healthcare facility
`(D) Prescription dispensing and delivery.
`where the remote pharmacy services will be pro-
`(i) Drugs in the emergency medication kit shall be
`vided;
`(III) a statement indicating that the provider phar-
`accessed for administration to meet the emergency
`medication needs of a resident of the remote site
`macy and the healthcare facility have entered into a
`written contract or agreement which outlines the
`pursuant to an order from a practitioner. The-pre-
`scription drug order for the drugs used from the
`services to be provided and the responsibilities and
`812
`
`812
`
`

`
`PHARMACIES
`emergency medication kit shall be forwardedJo the
`provider pharmacy in a.manner authorized by §291.
`34(b) of this title.
`(ii) The remote site shall notify the provider phar(cid:173)
`macy of each entry into an emergency. medication
`kit. Such notification shall meet the requirements of
`paragraph (S)(D)(ii) of this subsection.
`·
`(E) Drugs.
`(i) The contentS of an emergency medication kit:
`(I) may consist of dangerous drugs and ~ontrolled
`substances; and
`(II) shall be determined by the consultant phar-·
`macist, pharmacist-in-charge of the provider phar(cid:173)
`macy, medical director, and the director 'of nurses
`~nd limited to those drugs necessary to meet the
`resident's emergency medication needs. For the
`PlJ!POSe of this S~:J:bsection, this shall mean a situa(cid:173)
`tion in which a drug cannot be supplied by a
`pharmacy within a reasonable time period.
`(ii). When deciding on the drugs to be placed in
`the emergency medication kit, the consultant phar(cid:173)
`macist, pharmaCist-in-charge of the provider phar(cid:173)
`macy, me4ical director, and the director 6f nurses
`must determine, s'elect, and record a prudent num(cid:173)
`ber of drugs for potential emergency incidents based
`on:
`(I) clinical criteria applicable to each facility's
`demographics;
`(II) the facility's census; and
`(III) the facility's healthcare environment.
`(iii) A current list of the drugs stored in· each
`remote site's emergency medication kit shall be
`maintained by the provider· pharmacy and a copy
`kept with the emergency medication kit.
`(iv) An automated pharmacy system may be used
`as an emergency medication kit provide·d. the system
`limits emergency access to only those· drugs ap(cid:173)
`proved for the emergency medication kit.
`(v) Drugs for use in an emergency medication kit
`shall be packaged in the original manufacturer's
`container or prepackaged in the provider pharmacy
`andlabeled in compliance with the board's prepack(cid:173)
`aging requirements for the class of pharmacy.
`(F) Stocking emergency medication kits.
`(i) Stocking of drugs in an emergency medication
`kit shall be completed at the provider pharmacy or
`remote site by a pharmacist or certified pharmacy
`technician under the direct supervision of a phar(cid:173)
`macist, except as provided in clause (ii) of this
`subparagraph.
`(ii) If the emergency medicatipn .kit is an auto(cid:173)
`mated pharmacy system which uses removable car~
`813
`
`22 TAC § 291.20
`~dges or containers to hold drugs, the prepackag(cid:173)
`ing of the cartridges or containers shall occur at the
`provider pharmacy unless provided by and FDA
`approved· repackager. The prepackaged cartridges
`or containers may be sent to the remote site to be
`loaded into the machine by personnel designated by
`the pharmacist-in-charge provided:
`(I). a. pharmacist verifies the cartridge or con(cid:173)
`tainer has been properly filled and labeled;
`(II) the individual cartridges or containers are
`transported to the remote Site in a secure, tamper(cid:173)
`evident cOntainer; and
`(III) the automated pharmacy system uses bar(cid:173)
`coding, microchip, or other tec:hnolbgies to ensure
`that the containers are accurately loaded in the
`automated "ph~acy system.
`(iii) All drugs to be stocked in the emergency
`medication kit shall be delivered to the remote site
`by the provider pharmacy.
`(G) Policies and procedures of operation.
`(i) A provider pharmacy that provides pharmacy
`services through an emergency medication kit at a
`remote site shall operate according to written poli(cid:173)
`cies and procedures. The policy and procedure
`manual shall include, but not be limited to, the
`following:
`(I) duties which may ouly be performed by a
`pharmacist;
`·
`(II) a copy of the written. contract or agreement
`between the pharmacy and the facility which out(cid:173)
`lines the services to be provided and the responsi(cid:173)
`bilities and accountabilities of each party in fulfilling
`the t~rms of the contract in complial).ce with federal
`and state laws and regulations;
`(III) date of last review/revision of the policy and
`procedure manual; and
`·
`(IV) policies and procedures for:
`(-a-) security;
`(-b-) operation of the emergency medication kit;
`(-c-) pr~ventative maintenance of the automated
`pharmacy system· if the emergency medication kit is
`an automated pharmacy system;
`(-d-) sanitation;
`· (-e-) storage of drugs;
`(-f-) dispensing;
`(-g-) supervision;
`(-h-) drug procurement;
`(-i-) receiving of drugs;
`(-j-) delivery of drugs; and
`(-k-) recordkeeping.
`
`813
`
`

`
`. I
`
`22 T.ltC § 291.20
`(Ul A pharmacy that provides pharmacy services
`through an emergency medication kit at~ a;--remote
`site shall, at least annually, review its written poli(cid:173)
`des and procedures, revise them if necessary, -and
`document the review.
`(iii) A pharmacy providing remote pharmacy ser(cid:173)
`\ices using an emergency iriedication kit which is _an
`automated phannacy sy_stem,.shall maintafu, a.· writ(cid:173)
`ten plan for recovery ftoni.an-event which-interrupts
`the ability of the automated. pharmacy system to
`provide emergency."mf:dications. The _written plan
`for recovery shall include:
`(I) planning and preparati,on for maintaining phar(cid:173)
`macy services v.r~en an automated pharmacy system
`is experiencing downtirn_e;
`(I!) procedures for response when an automated
`pharm~cy system is experiencing downtirile;-_ and
`(Ill) procedures for the· maintenance and testing·
`of the written plan for recovery.
`(5) Records.
`(A) . Maintenance ,of records.
`(i) Every ·record '~equired u·nder this sectiori muSt
`be' maintained by the provider pharmacy for two
`years.
`(ii) The providet pharmacy shall maintain origi:·.
`nal prescription drug orders for drugs dispen~ed'
`from an eriiergeD.CY' medication kit in conipliartce
`with §291.34(b) of this title.
`(B)' Prescriptions'. Prescription drug orders shall
`meet the requirements of §291.34(b) of this title.
`(C) Records of dispensillg. Dispensing records for
`a prescription drug order shall be maintain~d by the
`provider pharmacy in the manner required by §291.
`34(d) or (e) of this title.
`(D) Transaction information.
`(i) A prescription drug order shall be maintained
`by the provider pharmacy as the record of removal
`of a drug from an emergency medication kit for
`administration- to a patient."
`(ii) The remote site shall notify the provider phar(cid:173)
`macy electronically or in writing of each entry into
`an emergency medication kit.· Such notification may
`be included on the prescription drug order or a
`separate document and shall include the name,
`strength, and quantity of the drug removed, the time
`of removal, and the name of the person removing
`the drug.
`(iii) A separate record of siocking, removal, or
`dispensing for administration from an emergency
`medication kit shall be maintained by the pharmacy
`and include the:
`
`TEXAS STATE BOARD OF:PHARMACY
`(I) date;
`(II) name, 'strength, dosagdorm,' and.quantity of
`drug stocked, rerooved, or dispensed 'for administra(cid:173)
`tion;
`, (III)'i:!ame, initials;· or ideiitification''code of the
`pe·rsbn stocking,: removilig, ·of dispe_ilSiTig fOr admhJ.~:­
`istration, drugS from- th~ sy.Steni;
`(IV) name, initials, or identification code of the
`pharmacist who checks and verifies that the system
`has' ·been .accurately' filled; and
`(V) unique prescription number assigned to the
`prescription drug order when the::drug is adminis-
`tered to the patient.
`·
`(E) Inventory.
`(i) A ptot'idei pharmacy shall:
`(I) k'.'ep .arecord 6rall drugs sentt~ and returned
`from a reni6te site sepal-ate from the records of the
`provider pharmacy and from any a the~ remote site's
`records; and
`(II) ·l<:.eep a perpetual inventory, of controlled sub(cid:173)
`stanCes, i:eceiyed and dispensed or, .distributed from
`~!ilch rem9t~ site.
`. . · '
`.
`·
`(ii) As specified.in §291.17 of this title, ·a provider
`pharmacy shall cop.duct an inventory at. each r~mote
`site. The following is applicable to this inv