22 Tex. Admin. Code § 291.34 - Records
(a) Maintenance of records.
(1) Every inventory or other record required
to be kept under the provisions of Subchapter B of this chapter (relating to
Community Pharmacy (Class A)) shall be:
(A)
kept by the pharmacy at the pharmacy's licensed location and be available, for
at least two years from the date of such inventory or record, for inspecting
and copying by the board or its representative and to other authorized local,
state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours,
if requested by an authorized agent of the Texas State Board of Pharmacy. If
the pharmacy maintains the records in an electronic format, the requested
records must be provided in a mutually agreeable electronic format if
specifically requested by the board or its representative. Failure to provide
the records set out in this section, either on site or within 72 hours,
constitutes prima facie evidence of failure to keep and maintain records in
violation of the Act.
(2)
Records of controlled substances listed in Schedule II shall be maintained
separately from all other records of the pharmacy.
(3) Records of controlled substances, other
than prescription drug orders, listed in Schedules III-V shall be maintained
separately or readily retrievable from all other records of the pharmacy. For
purposes of this subsection, readily retrievable means that the controlled
substances shall be asterisked, red-lined, or in some other manner readily
identifiable apart from all other items appearing on the record.
(4) Records, except when specifically
required to be maintained in original or hard copy form, may be maintained in
an alternative data retention system, such as a data processing system or
direct imaging system provided:
(A) the
records maintained in the alternative system contain all of the information
required on the manual record; and
(B) the data processing system is capable of
producing a hard copy of the record upon the request of the board, its
representative, or other authorized local, state, or federal law enforcement or
regulatory agencies.
(b) Prescriptions.
(1) Professional responsibility.
(A) Pharmacists shall exercise sound
professional judgment with respect to the accuracy and authenticity of any
prescription drug order they dispense. If the pharmacist questions the accuracy
or authenticity of a prescription drug order, he/she shall verify the order
with the practitioner prior to dispensing.
(B) Prior to dispensing a prescription,
pharmacists shall determine, in the exercise of sound professional judgment,
that the prescription is a valid prescription. A pharmacist may not dispense a
prescription drug unless the pharmacist complies with the requirements of
§562.056 and §562.112 of the Act, and §
291.29 of this title (relating to
Professional Responsibility of Pharmacists).
(C) Subparagraph (B) of this paragraph does
not prohibit a pharmacist from dispensing a prescription when a valid
patient-practitioner relationship is not present in an emergency situation
(e.g., a practitioner taking calls for the patient's regular
practitioner).
(D) The owner of a
Class A pharmacy shall have responsibility for ensuring its agents and
employees engage in appropriate decisions regarding dispensing of valid
prescriptions as set forth in §562.112 of the Act.
(2) Written prescription drug orders.
(A) Practitioner's signature.
(i) Dangerous drug prescription orders.
Written prescription drug orders shall be:
(I)
manually signed by the practitioner; or
(II) electronically signed by the
practitioner using a system that electronically replicates the practitioner's
manual signature on the written prescription, provided:
(-a-) that security features of the system
require the practitioner to authorize each use; and
(-b-) the prescription is printed on paper
that is designed to prevent unauthorized copying of a completed prescription
and to prevent the erasure or modification of information written on the
prescription by the prescribing practitioner. (For example, the paper contains
security provisions against copying that results in some indication on the copy
that it is a copy and therefore render the prescription null and
void.)
(ii)
Controlled substance prescription orders. Prescription drug orders for
Schedules II, III, IV, or V controlled substances shall be manually signed by
the practitioner. Prescription drug orders for Schedule II controlled
substances shall be issued on an official prescription form as required by the
Texas Controlled Substances Act, §481.075.
(iii) Other provisions for a practitioner's
signature.
(I) A practitioner may sign a
prescription drug order in the same manner as he would sign a check or legal
document, e.g., J.H. Smith or John H. Smith.
(II) Rubber stamped signatures may not be
used.
(III) The prescription drug
order may not be signed by a practitioner's agent but may be prepared by an
agent for the signature of a practitioner. However, the prescribing
practitioner is responsible in case the prescription drug order does not
conform in all essential respects to the law and regulations.
(B) Prescription drug
orders written by practitioners in another state.
(i) Dangerous drug prescription orders. A
pharmacist may dispense prescription drug orders for dangerous drugs issued by
practitioners in a state other than Texas in the same manner as prescription
drug orders for dangerous drugs issued by practitioners in Texas are
dispensed.
(ii) Controlled
substance prescription drug orders.
(I) A
pharmacist may dispense prescription drug orders for Schedule II controlled
substances issued by a practitioner in another state provided:
(-a-) the prescription is dispensed as
specified in §
315.9 of this title (relating to
Pharmacy Responsibility - Out-of-State Practitioner - Effective September 1,
2016);
(-b-) the prescription drug
order is an original written prescription issued by a person practicing in
another state and licensed by another state as a physician, dentist,
veterinarian, or podiatrist, who has a current federal Drug Enforcement
Administration (DEA) registration number, and who may legally prescribe
Schedule II controlled substances in such other state; and
(-c-) the prescription drug order is not
dispensed after the end of the thirtieth day after the date on which the
prescription is issued.
(II) A pharmacist may dispense prescription
drug orders for controlled substances in Schedules III, IV, or V issued by a
physician, dentist, veterinarian, or podiatrist in another state provided:
(-a-) the prescription drug order is issued
by a person practicing in another state and licensed by another state as a
physician, dentist, veterinarian, or podiatrist, who has a current federal DEA
registration number, and who may legally prescribe Schedules III, IV, or V
controlled substances in such other state;
(-b-) the prescription drug order is not
dispensed or refilled more than six months from the initial date of issuance
and may not be refilled more than five times; and
(-c-) if there are no refill instructions on
the original prescription drug order (which shall be interpreted as no refills
authorized) or if all refills authorized on the original prescription drug
order have been dispensed, a new prescription drug order is obtained from the
prescribing practitioner prior to dispensing any additional quantities of
controlled substances.
(C) Prescription drug orders written by
practitioners in the United Mexican States or the Dominion of Canada.
(i) Controlled substance prescription drug
orders. A pharmacist may not dispense a prescription drug order for a Schedule
II, III, IV, or V controlled substance issued by a practitioner in the Dominion
of Canada or the United Mexican States.
(ii) Dangerous drug prescription drug orders.
A pharmacist may dispense a dangerous drug prescription issued by a person
licensed in the Dominion of Canada or the United Mexican States as a physician,
dentist, veterinarian, or podiatrist provided:
(I) the prescription drug order is an
original written prescription; and
(II) if there are no refill instructions on
the original written prescription drug order (which shall be interpreted as no
refills authorized) or if all refills authorized on the original written
prescription drug order have been dispensed, a new written prescription drug
order shall be obtained from the prescribing practitioner prior to dispensing
any additional quantities of dangerous drugs.
(D) Prescription drug orders issued by an
advanced practice registered nurse, physician assistant, or pharmacist.
(i) A pharmacist may dispense a prescription
drug order that is:
(I) issued by an advanced
practice registered nurse or physician assistant provided the advanced practice
registered nurse or physician assistant is practicing in accordance with
Subtitle B, Chapter 157, Occupations Code; and
(II) for a dangerous drug and signed by a
pharmacist under delegated authority of a physician as specified in Subtitle B,
Chapter 157, Occupations Code.
(ii) Each practitioner shall designate in
writing the name of each advanced practice registered nurse or physician
assistant authorized to issue a prescription drug order pursuant to Subtitle B,
Chapter 157, Occupations Code. A list of the advanced practice registered
nurses or physician assistants designated by the practitioner must be
maintained in the practitioner's usual place of business. On request by a
pharmacist, a practitioner shall furnish the pharmacist with a copy of the
written authorization for a specific advanced practice registered nurse or
physician assistant.
(E)
Prescription drug orders for Schedule II controlled substances. No Schedule II
controlled substance may be dispensed without a written prescription drug order
of a practitioner on an official prescription form as required by the Texas
Controlled Substances Act, §481.075.
(3) Oral prescription drug orders.
(A) An oral prescription drug order for a
controlled substance from a practitioner or a practitioner's designated agent
may only be received by a pharmacist or a pharmacist-intern under the direct
supervision of a pharmacist.
(B) A
practitioner shall designate in writing the name of each agent authorized by
the practitioner to communicate prescriptions orally for the practitioner. The
practitioner shall maintain at the practitioner's usual place of business a
list of the designated agents. The practitioner shall provide a pharmacist with
a copy of the practitioner's written authorization for a specific agent on the
pharmacist's request.
(C) A
pharmacist may not dispense an oral prescription drug order for a dangerous
drug or a controlled substance issued by a practitioner licensed in the
Dominion of Canada or the United Mexican States unless the practitioner is also
licensed in Texas.
(4)
Electronic prescription drug orders.
(A)
Dangerous drug prescription orders.
(i) An
electronic prescription drug order for a dangerous drug may be transmitted by a
practitioner or a practitioner's designated agent:
(I) directly to a pharmacy; or
(II) through the use of a data communication
device provided:
(-a-) the confidential
prescription information is not altered during transmission; and
(-b-) confidential patient information is not
accessed or maintained by the operator of the data communication device other
than for legal purposes under federal and state law.
(ii) A practitioner shall
designate in writing the name of each agent authorized by the practitioner to
electronically transmit prescriptions for the practitioner. The practitioner
shall maintain at the practitioner's usual place of business a list of the
designated agents. The practitioner shall provide a pharmacist with a copy of
the practitioner's written authorization for a specific agent on the
pharmacist's request.
(B)
Controlled substance prescription orders. A pharmacist may only dispense an
electronic prescription drug order for a Schedule II, III, IV, or V controlled
substance in compliance with federal and state laws and the rules of the Drug
Enforcement Administration outlined in Part 1300 of the Code of Federal
Regulations.
(C) Prescriptions
issued by a practitioner licensed in the Dominion of Canada or the United
Mexican States. A pharmacist may not dispense an electronic prescription drug
order for a dangerous drug or controlled substance issued by a practitioner
licensed in the Dominion of Canada or the United Mexican States unless the
practitioner is also licensed in Texas.
(5) Facsimile (faxed) prescription drug
orders.
(A) A pharmacist may dispense a
prescription drug order for a dangerous drug transmitted to the pharmacy by
facsimile.
(B) A pharmacist may
dispense a prescription drug order for a Schedule III-V controlled substance
transmitted to the pharmacy by facsimile provided the prescription is manually
signed by the practitioner and not electronically signed using a system that
electronically replicates the practitioner's manual signature on the
prescription drug order.
(C) A
pharmacist may not dispense a facsimile prescription drug order for a dangerous
drug or controlled substance issued by a practitioner licensed in the Dominion
of Canada or the United Mexican States unless the practitioner is also licensed
in Texas.
(6) Original
prescription drug order records.
(A) Original
prescriptions may be dispensed only in accordance with the prescriber's
authorization as indicated on the original prescription drug order, including
clarifications to the order given by the practitioner or the practitioner's
agent and recorded on the prescription.
(B) Notwithstanding subparagraph (A) of this
paragraph, a pharmacist may dispense a quantity less than indicated on the
original prescription drug order at the request of the patient or patient's
agent.
(C) Original prescriptions
shall be maintained by the pharmacy in numerical order and remain legible for a
period of two years from the date of filling or the date of the last refill
dispensed.
(D) If an original
prescription drug order is changed, such prescription order shall be invalid
and of no further force and effect; if additional drugs are to be dispensed, a
new prescription drug order with a new and separate number is required.
However, an original prescription drug order for a dangerous drug may be
changed in accordance with paragraph (10) of this subsection relating to
accelerated refills.
(E) Original
prescriptions shall be maintained in three separate files as follows:
(i) prescriptions for controlled substances
listed in Schedule II;
(ii)
prescriptions for controlled substances listed in Schedules III-V;
and
(iii) prescriptions for
dangerous drugs and nonprescription drugs.
(F) Original prescription records other than
prescriptions for Schedule II controlled substances may be stored in a system
that is capable of producing a direct image of the original prescription
record, e.g., a digitalized imaging system. If original prescription records
are stored in a direct imaging system, the following is applicable:
(i) the record of refills recorded on the
original prescription must also be stored in this system;
(ii) the original prescription records must
be maintained in numerical order and separated in three files as specified in
subparagraph (D) of this paragraph; and
(iii) the pharmacy must provide immediate
access to equipment necessary to render the records easily readable.
(7) Prescription drug
order information.
(A) All original
prescriptions shall bear:
(i) the name of the
patient, or if such drug is for an animal, the species of such animal and the
name of the owner;
(ii) the address
of the patient; provided, however, that a prescription for a dangerous drug is
not required to bear the address of the patient if such address is readily
retrievable on another appropriate, uniformly maintained pharmacy record, such
as medication records;
(iii) the
name, address and telephone number of the practitioner at the practitioner's
usual place of business, legibly printed or stamped, and if for a controlled
substance, the DEA registration number of the practitioner;
(iv) the name and strength of the drug
prescribed;
(v) the quantity
prescribed numerically, and if for a controlled substance:
(I) numerically, followed by the number
written as a word, if the prescription is written;
(II) numerically, if the prescription is
electronic; or
(III) if the
prescription is communicated orally or telephonically, as transcribed by the
receiving pharmacist;
(vi) directions for use;
(vii) the intended use for the drug unless
the practitioner determines the furnishing of this information is not in the
best interest of the patient;
(viii) the date of issuance;
(ix) if a faxed prescription:
(I) a statement that indicates that the
prescription has been faxed (e.g., Faxed to); and
(II) if transmitted by a designated agent,
the name of the designated agent;
(x) if electronically transmitted:
(I) the date the prescription drug order was
electronically transmitted to the pharmacy, if different from the date of
issuance of the prescription; and
(II) if transmitted by a designated agent,
the name of the designated agent; and
(xi) if issued by an advanced practice nurse
or physician assistant in accordance with Subtitle B, Chapter 157, Occupations
Code:
(I) the name, address, telephone number,
and if the prescription is for a controlled substance, the DEA number of the
supervising practitioner; and
(II)
the address and telephone number of the clinic where the prescription drug
order was carried out or signed; and
(xii) if communicated orally or
telephonically:
(I) the initials or
identification code of the transcribing pharmacist; and
(II) the name of the prescriber or
prescriber's agent communicating the prescription information.
(B) At the time of
dispensing, a pharmacist is responsible for documenting the following
information on either the original hardcopy prescription or in the pharmacy's
data processing system:
(i) the unique
identification number of the prescription drug order;
(ii) the initials or identification code of
the dispensing pharmacist;
(iii)
the initials or identification code of the pharmacy technician or pharmacy
technician trainee performing data entry of the prescription, if
applicable;
(iv) the quantity
dispensed, if different from the quantity prescribed;
(v) the date of dispensing, if different from
the date of issuance; and
(vi) the
brand name or manufacturer of the drug or biological product actually
dispensed, if the drug was prescribed by generic name or interchangeable
biological name or if a drug or interchangeable biological product other than
the one prescribed was dispensed pursuant to the provisions of the Act,
Chapters 562 and 563.
(C)
Prescription drug orders may be utilized as authorized in Title 26, Part 1,
Chapter 554 of the Texas Administrative Code.
(i) A prescription drug order is not required
to bear the information specified in subparagraph (A) of this paragraph if the
drug is prescribed for administration to an ultimate user who is
institutionalized in a licensed health care institution (e.g., nursing home,
hospice, hospital). Such prescription drug orders must contain the following
information:
(I) the full name of the
patient;
(II) the date of
issuance;
(III) the name, strength,
and dosage form of the drug prescribed;
(IV) directions for use; and
(V) the signature(s) required by 26 TAC
§
554.1506(relating to Drug
Orders).
(ii)
Prescription drug orders for dangerous drugs shall not be dispensed following
one year after the date of issuance unless the authorized prescriber renews the
prescription drug order.
(iii)
Controlled substances shall not be dispensed pursuant to a prescription drug
order under this subparagraph.
(8) Refills.
(A) General information.
(i) Refills may be dispensed only in
accordance with the prescriber's authorization as indicated on the original
prescription drug order except as authorized in paragraph (10) of this
subsection relating to accelerated refills.
(ii) If there are no refill instructions on
the original prescription drug order (which shall be interpreted as no refills
authorized) or if all refills authorized on the original prescription drug
order have been dispensed, authorization from the prescribing practitioner
shall be obtained prior to dispensing any refills and documented as specified
in subsection (l) of this section.
(B) Refills of prescription drug orders for
dangerous drugs or nonprescription drugs.
(i)
Prescription drug orders for dangerous drugs or nonprescription drugs may not
be refilled after one year from the date of issuance of the original
prescription drug order.
(ii) If
one year has expired from the date of issuance of an original prescription drug
order for a dangerous drug or nonprescription drug, authorization shall be
obtained from the prescribing practitioner prior to dispensing any additional
quantities of the drug.
(C) Refills of prescription drug orders for
Schedules III-V controlled substances.
(i)
Prescription drug orders for Schedules III-V controlled substances may not be
refilled more than five times or after six months from the date of issuance of
the original prescription drug order, whichever occurs first.
(ii) If a prescription drug order for a
Schedule III, IV, or V controlled substance has been refilled a total of five
times or if six months have expired from the date of issuance of the original
prescription drug order, whichever occurs first, a new and separate
prescription drug order shall be obtained from the prescribing practitioner
prior to dispensing any additional quantities of controlled
substances.
(D)
Pharmacist unable to contact prescribing practitioner. If a pharmacist is
unable to contact the prescribing practitioner after a reasonable effort, a
pharmacist may exercise his or her professional judgment in refilling a
prescription drug order for a drug, other than a Schedule II controlled
substance, without the authorization of the prescribing practitioner, provided:
(i) failure to refill the prescription might
result in an interruption of a therapeutic regimen or create patient
suffering;
(ii) the quantity of
prescription drug dispensed does not exceed a 72-hour supply;
(iii) the pharmacist informs the patient or
the patient's agent at the time of dispensing that the refill is being provided
without such authorization and that authorization of the practitioner is
required for future refills;
(iv)
the pharmacist informs the practitioner of the emergency refill at the earliest
reasonable time;
(v) the pharmacist
maintains a record of the emergency refill containing the information required
to be maintained on a prescription as specified in this subsection;
(vi) the pharmacist affixes a label to the
dispensing container as specified in §
291.33(c)(7) of
this title (relating to Operational Standards); and
(vii) if the prescription was initially
filled at another pharmacy, the pharmacist may exercise his or her professional
judgment in refilling the prescription provided:
(I) the patient has the prescription
container, label, receipt or other documentation from the other pharmacy that
contains the essential information;
(II) after a reasonable effort, the
pharmacist is unable to contact the other pharmacy to transfer the remaining
prescription refills or there are no refills remaining on the
prescription;
(III) the pharmacist,
in his or her professional judgment, determines that such a request for an
emergency refill is appropriate and meets the requirements of clause (i) of
this subparagraph; and
(IV) the
pharmacist complies with the requirements of clauses (ii) - (vi) of this
subparagraph.
(E) Natural or man-made disasters. If a
natural or man-made disaster has occurred that prohibits the pharmacist from
being able to contact the practitioner, a pharmacist may exercise his or her
professional judgment in refilling a prescription drug order for a drug, other
than a Schedule II controlled substance, without the authorization of the
prescribing practitioner, provided:
(i)
failure to refill the prescription might result in an interruption of a
therapeutic regimen or create patient suffering;
(ii) the quantity of prescription drug
dispensed does not exceed a 30-day supply;
(iii) the governor of Texas has declared a
state of disaster;
(iv) the board,
through the executive director, has notified pharmacies that pharmacists may
dispense up to a 30-day supply of prescription drugs;
(v) the pharmacist informs the patient or the
patient's agent at the time of dispensing that the refill is being provided
without such authorization and that authorization of the practitioner is
required for future refills;
(vi)
the pharmacist informs the practitioner of the emergency refill at the earliest
reasonable time;
(vii) the
pharmacist maintains a record of the emergency refill containing the
information required to be maintained on a prescription as specified in this
subsection;
(viii) the pharmacist
affixes a label to the dispensing container as specified in §
291.33(c)(7) of
this title; and
(ix) if the
prescription was initially filled at another pharmacy, the pharmacist may
exercise his or her professional judgment in refilling the prescription
provided:
(I) the patient has the prescription
container, label, receipt or other documentation from the other pharmacy that
contains the essential information;
(II) after a reasonable effort, the
pharmacist is unable to contact the other pharmacy to transfer the remaining
prescription refills or there are no refills remaining on the
prescription;
(III) the pharmacist,
in his or her professional judgment, determines that such a request for an
emergency refill is appropriate and meets the requirements of clause (i) of
this subparagraph; and
(IV) the
pharmacist complies with the requirements of clauses (ii) - (viii) of this
subparagraph.
(F) Emergency Refills of Insulin and
Insulin-Related Equipment or Supplies.
(i) A
pharmacist may exercise the pharmacist's professional judgment in refilling a
prescription for insulin or insulin-related equipment or supplies without the
authorization of the prescribing practitioner if the pharmacist:
(I) is unable to contact the practitioner
after reasonable effort;
(II) is
provided with documentation showing that the patient was previously prescribed
insulin or insulin-related equipment or supplies by a practitioner;
(III) assesses the patient to determine
whether the emergency refill is appropriate;
(IV) creates a record that documents the
patient's visit that includes a notation describing the documentation provided
under subclause (II) of this clause; and
(V) makes a reasonable attempt to inform the
practitioner of the emergency refill at the earliest reasonable time.
(ii) The quantity of an emergency
refill of insulin may not exceed a 30-day supply. The quantity of an emergency
refill of insulin-related equipment or supplies may not exceed the lesser of a
30-day supply or the smallest available package.
(G) Auto-Refill Programs. A pharmacy may use
a program that automatically refills prescriptions that have existing refills
available in order to improve patient compliance with and adherence to
prescribed medication therapy. The following is applicable in order to enroll
patients into an auto-refill program:
(i)
Notice of the availability of an auto-refill program shall be given to the
patient or patient's agent, and the patient or patient's agent must
affirmatively indicate that they wish to enroll in such a program and the
pharmacy shall document such indication.
(ii) The patient or patient's agent shall
have the option to withdraw from such a program at any time.
(iii) Auto-refill programs may be used for
refills of dangerous drugs, and Schedules IV and V controlled substances.
Schedules II and III controlled substances may not be dispensed by an
auto-refill program.
(iv) As is
required for all prescriptions, a drug regimen review shall be completed on all
prescriptions filled as a result of the auto-refill program. Special attention
shall be noted for drug regimen review warnings of duplication of therapy and
all such conflicts shall be resolved with the prescribing practitioner prior to
refilling the prescription.
(9) Records Relating to Dispensing Errors. If
a dispensing error occurs, the following is applicable.
(A) Original prescription drug orders:
(i) shall not be destroyed and must be
maintained in accordance with subsection (a) of this section; and
(ii) shall not be altered. Altering includes
placing a label or any other item over any of the information on the
prescription drug order (e.g., a dispensing tag or label that is affixed to
back of a prescription drug order must not be affixed on top of another
dispensing tag or label in such a manner as to obliterate the information
relating to the error).
(B) Prescription drug order records
maintained in a data processing system:
(i)
shall not be deleted and must be maintained in accordance with subsection (a)
of this section;
(ii) may be
changed only in compliance with subsection (e)(2)(B) of this section;
and
(iii) if the error involved
incorrect data entry into the pharmacy's data processing system, this record
must be either voided or cancelled in the data processing system, so that the
incorrectly entered prescription drug order may not be dispensed, or the data
processing system must be capable of maintaining an audit trail showing any
changes made to the data in the system.
(10) Accelerated refills. In accordance with
§562.0545 of the Act, a pharmacist may dispense up to a 90-day supply of a
dangerous drug pursuant to a valid prescription that specifies the dispensing
of a lesser amount followed by periodic refills of that amount if:
(A) the total quantity of dosage units
dispensed does not exceed the total quantity of dosage units authorized by the
prescriber on the original prescription, including refills;
(B) the patient consents to the dispensing of
up to a 90-day supply and the physician has been notified electronically or by
telephone;
(C) the physician has
not specified on the prescription that dispensing the prescription in an
initial amount followed by periodic refills is medically necessary;
(D) the dangerous drug is not a psychotropic
drug used to treat mental or psychiatric conditions; and
(E) the patient is at least 18 years of
age.
(c)
Patient medication records.
(1) A patient
medication record system shall be maintained by the pharmacy for patients to
whom prescription drug orders are dispensed.
(2) The patient medication record system
shall provide for the immediate retrieval of information for the previous 12
months that is necessary for the dispensing pharmacist to conduct a prospective
drug regimen review at the time a prescription drug order is presented for
dispensing.
(3) The
pharmacist-in-charge shall assure that a reasonable effort is made to obtain
and record in the patient medication record at least the following information:
(A) full name of the patient for whom the
drug is prescribed;
(B) address and
telephone number of the patient;
(C) patient's age or date of birth;
(D) patient's gender;
(E) any known allergies, drug reactions,
idiosyncrasies, and chronic conditions or disease states of the patient and the
identity of any other drugs currently being used by the patient which may
relate to prospective drug regimen review;
(F) pharmacist's comments relevant to the
individual's drug therapy, including any other information unique to the
specific patient or drug; and
(G) a
list of all prescription drug orders dispensed (new and refill) to the patient
by the pharmacy during the last two years. Such lists shall contain the
following information:
(i) date
dispensed;
(ii) name, strength, and
quantity of the drug dispensed;
(iii) prescribing practitioner's
name;
(iv) unique identification
number of the prescription; and
(v)
name or initials of the dispensing pharmacists.
(4) A patient medication record shall be
maintained in the pharmacy for two years. If patient medication records are
maintained in a data processing system, all of the information specified in
this subsection shall be maintained in a retrievable form for two years and
information for the previous 12 months shall be maintained online. A patient
medication record must contain documentation of any modification, change, or
manipulation to a patient profile.
(5) Nothing in this subsection shall be
construed as requiring a pharmacist to obtain, record, and maintain patient
information other than prescription drug order information when a patient or
patient's agent refuses to provide the necessary information for such patient
medication records.
(d)
Prescription drug order records maintained in a manual system.
(1) Original prescriptions shall be
maintained in three files as specified in subsection (b)(6)(D) of this
section.
(2) Refills.
(A) Each time a prescription drug order is
refilled, a record of such refill shall be made:
(i) on the back of the prescription by
recording the date of dispensing, the written initials or identification code
of the dispensing pharmacist, the initials or identification code of the
pharmacy technician or pharmacy technician trainee preparing the prescription
label, if applicable, and the amount dispensed. (If the pharmacist merely
initials and dates the back of the prescription drug order, he or she shall be
deemed to have dispensed a refill for the full face amount of the prescription
drug order); or
(ii) on another
appropriate, uniformly maintained, readily retrievable record, such as
medication records, that indicates by patient name the following information:
(I) unique identification number of the
prescription;
(II) name and
strength of the drug dispensed;
(III) date of each dispensing;
(IV) quantity dispensed at each
dispensing;
(V) initials or
identification code of the dispensing pharmacist;
(VI) initials or identification code of the
pharmacy technician or pharmacy technician trainee preparing the prescription
label, if applicable; and
(VII)
total number of refills for the prescription.
(B) If refill records are maintained in
accordance with subparagraph (A)(ii) of this paragraph, refill records for
controlled substances in Schedules III-V shall be maintained separately from
refill records of dangerous drugs and nonprescription drugs.
(3) Authorization of refills.
Practitioner authorization for additional refills of a prescription drug order
shall be noted on the original prescription, in addition to the documentation
of dispensing the refill as specified in subsection (l) of this
section.
(4) Each time a
modification, change, or manipulation is made to a record of dispensing,
documentation of such change shall be recorded on the back of the prescription
or on another appropriate, uniformly maintained, readily retrievable record,
such as medication records. The documentation of any modification, change, or
manipulation to a record of dispensing shall include the identification of the
individual responsible for the alteration.
(e) Prescription drug order records
maintained in a data processing system.
(1)
General requirements for records maintained in a data processing system.
(A) Compliance with data processing system
requirements. If a Class A pharmacy's data processing system is not in
compliance with this subsection, the pharmacy must maintain a manual record
keeping system as specified in subsection (d) of this section.
(B) Original prescriptions. Original
prescriptions shall be maintained in three files as specified in subsection
(b)(6)(D) of this section.
(C)
Requirements for backup systems.
(i) The
pharmacy shall maintain a backup copy of information stored in the data
processing system using disk, tape, or other electronic backup system and
update this backup copy on a regular basis, at least monthly, to assure that
data is not lost due to system failure.
(ii) Data processing systems shall have a
workable (electronic) data retention system that can produce an audit trail of
drug usage for the preceding two years as specified in paragraph (2)(H) of this
subsection.
(D) Change or
discontinuance of a data processing system.
(i) Records of dispensing. A pharmacy that
changes or discontinues use of a data processing system must:
(I) transfer the records of dispensing to the
new data processing system; or
(II)
purge the records of dispensing to a printout that contains the same
information required on the daily printout as specified in paragraph (2)(C) of
this subsection. The information on this hard copy printout shall be sorted and
printed by prescription number and list each dispensing for this prescription
chronologically.
(ii)
Other records. A pharmacy that changes or discontinues use of a data processing
system must:
(I) transfer the records to the
new data processing system; or
(II)
purge the records to a printout that contains all of the information required
on the original document.
(iii) Maintenance of purged records.
Information purged from a data processing system must be maintained by the
pharmacy for two years from the date of initial entry into the data processing
system.
(E) Loss of data.
The pharmacist-in-charge shall report to the board in writing any significant
loss of information from the data processing system within 10 days of discovery
of the loss.
(2) Records
of dispensing.
(A) Each time a prescription
drug order is filled or refilled, a record of such dispensing shall be entered
into the data processing system.
(B) Each time a modification, change or
manipulation is made to a record of dispensing, documentation of such change
shall be recorded in the data processing system. The documentation of any
modification, change, or manipulation to a record of dispensing shall include
the identification of the individual responsible for the alteration. Should the
data processing system not be able to record a modification, change, or
manipulation to a record of dispensing, the information should be clearly
documented on the hard copy prescription.
(C) The data processing system shall have the
capacity to produce a daily hard copy printout of all original prescriptions
dispensed and refilled. This hard copy printout shall contain the following
information:
(i) unique identification number
of the prescription;
(ii) date of
dispensing;
(iii) patient
name;
(iv) prescribing
practitioner's name and the supervising physician's name if the prescription
was issued by an advanced practice registered nurse, physician assistant or
pharmacist;
(v) name and strength
of the drug product actually dispensed; if generic name, the brand name or
manufacturer of drug dispensed;
(vi) quantity dispensed;
(vii) initials or an identification code of
the dispensing pharmacist;
(viii)
initials or an identification code of the pharmacy technician or pharmacy
technician trainee performing data entry of the prescription, if
applicable;
(ix) if not immediately
retrievable via computer display, the following shall also be included on the
hard copy printout:
(I) patient's
address;
(II) prescribing
practitioner's address;
(III)
practitioner's DEA registration number, if the prescription drug order is for a
controlled substance;
(IV) quantity
prescribed, if different from the quantity dispensed;
(V) date of issuance of the prescription drug
order, if different from the date of dispensing; and
(VI) total number of refills dispensed to
date for that prescription drug order; and
(x) any changes made to a record of
dispensing.
(D) The daily
hard copy printout shall be produced within 72 hours of the date on which the
prescription drug orders were dispensed and shall be maintained in a separate
file at the pharmacy. Records of controlled substances shall be readily
retrievable from records of non-controlled substances.
(E) Each individual pharmacist who dispenses
or refills a prescription drug order shall verify that the data indicated on
the daily hard copy printout is correct, by dating and signing such document in
the same manner as signing a check or legal document (e.g., J.H. Smith, or John
H. Smith) within seven days from the date of dispensing.
(F) In lieu of the printout described in
subparagraph (C) of this paragraph, the pharmacy shall maintain a log book in
which each individual pharmacist using the data processing system shall sign or
electronically sign a statement each day, attesting to the fact that the
information entered into the data processing system that day has been reviewed
by him or her and is correct as entered. Such log book shall be maintained at
the pharmacy employing such a system for a period of two years after the date
of dispensing; provided, however, that the data processing system can produce
the hard copy printout on demand by an authorized agent of the Texas State
Board of Pharmacy. If no printer is available on site, the hard copy printout
shall be available within 72 hours with a certification by the individual
providing the printout, stating that the printout is true and correct as of the
date of entry and such information has not been altered, amended, or
modified.
(G) The
pharmacist-in-charge is responsible for the proper maintenance of such records,
for ensuring that such data processing system can produce the records outlined
in this section, and that such system is in compliance with this
subsection.
(H) The data processing
system shall be capable of producing a hard copy printout of an audit trail for
all dispensing (original and refill) of any specified strength and dosage form
of a drug (by either brand or generic name or both) during a specified time
period.
(i) Such audit trail shall contain all
of the information required on the daily printout as set out in subparagraph
(C) of this paragraph.
(ii) The
audit trail required in this subparagraph shall be supplied by the pharmacy
within 72 hours, if requested by an authorized agent of the Texas State Board
of Pharmacy.
(I) Failure
to provide the records set out in this subsection, either on site or within 72
hours, constitutes prima facie evidence of failure to keep and maintain records
in violation of the Act.
(J) The
data processing system shall provide online retrieval (via computer display or
hard copy printout) of the information set out in subparagraph (C) of this
paragraph of:
(i) the original controlled
substance prescription drug orders currently authorized for refilling;
and
(ii) the current refill history
for Schedules III, IV, and V controlled substances for the immediately
preceding six-month period.
(K) In the event that a pharmacy using a data
processing system experiences system downtime, the following is applicable:
(i) an auxiliary procedure shall ensure that
refills are authorized by the original prescription drug order and that the
maximum number of refills has not been exceeded, or authorization from the
prescribing practitioner shall be obtained prior to dispensing a refill;
and
(ii) all of the appropriate
data shall be retained for online data entry as soon as the system is available
for use again.
(3) Authorization of refills. Practitioner
authorization for additional refills of a prescription drug order shall be
noted as follows:
(A) on the hard copy
prescription drug order;
(B) on the
daily hard copy printout; or
(C)
via the computer display.
(f) Limitation to one type of recordkeeping
system. When filing prescription drug order information a pharmacy may use only
one of the two systems described in subsection (d) or (e) of this
section.
(g) Transfer of
prescription drug order information. For the purpose of initial or refill
dispensing, the transfer of original prescription drug order information is
permissible between pharmacies, subject to the following requirements:
(1) The transfer of original prescription
drug order information for controlled substances listed in Schedules III, IV,
or V for the purpose of refill dispensing is permissible between pharmacies on
a one-time basis only. However, pharmacies electronically sharing a real-time,
online database may transfer up to the maximum refills permitted by law and the
prescriber's authorization.
(2) The
transfer of original prescription drug order information for dangerous drugs is
permissible between pharmacies without limitation up to the number of
originally authorized refills.
(3)
The transfer is communicated orally by telephone or via facsimile:
(A) directly by a pharmacist or
pharmacist-intern to another pharmacist or pharmacist-intern for prescription
drug order information for controlled substances; or
(B) directly by a pharmacist,
pharmacist-intern, or pharmacy technician to another pharmacist,
pharmacist-intern, or pharmacy technician for prescription drug order
information for dangerous drugs.
(4) Both the original and the transferred
prescription drug orders are maintained for a period of two years from the date
of last refill.
(5) The individual
transferring the prescription drug order information shall:
(A) write the word "void" on the face of the
invalidated prescription or the prescription is voided in the data processing
system;
(B) record the name,
address, and if for a controlled substance, the DEA registration number of the
pharmacy to which it was transferred, and the name of the receiving individual
on the reverse of the invalidated prescription or stored with the invalidated
prescription drug order in the data processing system;
(C) record the date of the transfer and the
name of the individual transferring the information; and
(D) if the prescription is transferred
electronically, provide the following information:
(i) date of original dispensing and
prescription number;
(ii) number of
refills remaining and if a controlled substance, the date(s) and location(s) of
previous refills;
(iii) name,
address, and if a controlled substance, the DEA registration number of the
transferring pharmacy;
(iv) name of
the individual transferring the prescription; and
(v) if a controlled substance, the name,
address, DEA registration number, and prescription number from the pharmacy
that originally dispensed the prescription, if different.
(6) The individual receiving the
transferred prescription drug order information shall:
(A) write the word "transfer" on the face of
the prescription or indicate in the prescription record that the prescription
was a transfer; and
(B) reduce to
writing all of the information required to be on a prescription as specified in
subsection (b)(7) of this section, and the following:
(i) date of issuance and prescription
number;
(ii) original number of
refills authorized on the original prescription drug order;
(iii) date of original dispensing;
(iv) number of valid refills remaining, and
if a controlled substance, the date(s) and location(s) of previous
refills;
(v) name, address, and if
for a controlled substance, the DEA registration number of the transferring
pharmacy;
(vi) name of the
individual transferring the prescription; and
(vii) name, address, and if for a controlled
substance, the DEA registration number, of the pharmacy that originally
dispensed the prescription, if different; or
(C) if the prescription is transferred
electronically, create an electronic record for the prescription that includes
the receiving pharmacist's name and all of the information transferred with the
prescription including all of the information required to be on a prescription
as specified in subsection (b)(7) of this section, and the following:
(i) date of original dispensing;
(ii) number of refills remaining and if a
controlled substance, the prescription number(s), date(s) and location(s) of
previous refills;
(iii) name,
address, and if for a controlled substance, the DEA registration
number;
(iv) name of the individual
transferring the prescription; and
(v) name, address, and if for a controlled
substance, the DEA registration number, of the pharmacy that originally filled
the prescription.
(7) Both the individual transferring the
prescription and the individual receiving the prescription must engage in
confirmation of the prescription information by such means as:
(A) the transferring individual faxes the
hard copy prescription to the receiving individual; or
(B) the receiving individual repeats the
verbal information from the transferring individual and the transferring
individual verbally confirms that the repeated information is
correct.
(8) Pharmacies
transferring prescriptions electronically shall comply with the following:
(A) Prescription drug orders may not be
transferred by non-electronic means during periods of downtime except on
consultation with and authorization by a prescribing practitioner; provided,
however, that during downtime, a hard copy of a prescription drug order may be
made available for informational purposes only, to the patient or a pharmacist,
and the prescription may be read to a pharmacist by telephone;
(B) The original prescription drug order
shall be invalidated in the data processing system for purposes of filling or
refilling, but shall be maintained in the data processing system for refill
history purposes;
(C) If the data
processing system does not have the capacity to store all the information as
specified in paragraphs (5) and (6) of this subsection, the pharmacist is
required to record this information on the original or transferred prescription
drug order;
(D) The data processing
system shall have a mechanism to prohibit the transfer or refilling of
controlled substance prescription drug orders that have been previously
transferred; and
(E) Pharmacies
electronically accessing the same prescription drug order records may
electronically transfer prescription information if the following requirements
are met:
(i) The original prescription is
voided and the pharmacies' data processing systems store all the information as
specified in paragraphs (5) and (6) of this subsection;
(ii) Pharmacies not owned by the same entity
may electronically access the same prescription drug order records, provided
the owner, chief executive officer, or designee of each pharmacy signs an
agreement allowing access to such prescription drug order records;
and
(iii) An electronic transfer
between pharmacies may be initiated by a pharmacist intern, pharmacy
technician, or pharmacy technician trainee acting under the direct supervision
of a pharmacist.
(9) An individual may not refuse to transfer
original prescription information to another individual who is acting on behalf
of a patient and who is making a request for this information as specified in
this subsection. The transfer of original prescription information must be
completed within four business hours of the request.
(10) When transferring a compounded
prescription, a pharmacy is required to provide all of the information
regarding the compounded preparation, including the formula, unless the formula
is patented or otherwise protected, in which case, the transferring pharmacy
shall, at a minimum, provide the quantity or strength of all of the active
ingredients of the compounded preparation.
(11) The electronic transfer of multiple or
bulk prescription records between two pharmacies is permitted provided:
(A) a record of the transfer as specified in
paragraph (5) of this subsection is maintained by the transferring
pharmacy;
(B) the information
specified in paragraph (6) of this subsection is maintained by the receiving
pharmacy; and
(C) in the event that
the patient or patient's agent is unaware of the transfer of the prescription
drug order record, the transferring pharmacy must notify the patient or
patient's agent of the transfer and must provide the patient or patient's agent
with the telephone number of the pharmacy receiving the multiple or bulk
prescription drug order records.
(h) Distribution of controlled substances to
another registrant. A pharmacy may distribute controlled substances to a
practitioner, another pharmacy, or other registrant, without being registered
to distribute, under the following conditions.
(1) The registrant to whom the controlled
substance is to be distributed is registered under the Controlled Substances
Act to dispense that controlled substance.
(2) The total number of dosage units of
controlled substances distributed by a pharmacy may not exceed 5.0% of all
controlled substances dispensed and distributed by the pharmacy during the
12-month period in which the pharmacy is registered; if at any time it does
exceed 5.0%, the pharmacy is required to obtain an additional registration to
distribute controlled substances.
(3) If the distribution is for a Schedule
III, IV, or V controlled substance, a record shall be maintained that
indicates:
(A) the actual date of
distribution;
(B) the name,
strength, and quantity of controlled substances distributed;
(C) the name, address, and DEA registration
number of the distributing pharmacy; and
(D) the name, address, and DEA registration
number of the pharmacy, practitioner, or other registrant to whom the
controlled substances are distributed.
(4) A pharmacy shall comply with 21 CFR 1305
regarding the DEA order form (DEA 222) requirements when distributing a
Schedule II controlled substance.
(i) Other records. Other records to be
maintained by a pharmacy:
(1) a log of the
initials or identification codes that will identify each pharmacist, pharmacy
technician, and pharmacy technician trainee who is involved in the dispensing
process, in the pharmacy's data processing system (the initials or
identification code shall be unique to ensure that each individual can be
identified, i.e., identical initials or identification codes shall not be
used). Such log shall be maintained at the pharmacy for at least seven years
from the date of the transaction;
(2) suppliers' invoices of dangerous drugs
and controlled substances; a pharmacist shall verify that the controlled
substances listed on the invoices were actually received by clearly recording
his/her initials and the actual date of receipt of the controlled
substances;
(3) suppliers' credit
memos for controlled substances and dangerous drugs;
(4) a copy of inventories required by §
291.17 of this title (relating to
Inventory Requirements);
(5)
reports of surrender or destruction of controlled substances and/or dangerous
drugs to an appropriate state or federal agency;
(6) records of distribution of controlled
substances and/or dangerous drugs to other pharmacies, practitioners, or
registrants; and
(7) a copy of any
notification required by the Texas Pharmacy Act or the sections in this
chapter, including, but not limited to, the following:
(A) reports of theft or significant loss of
controlled substances to the DEA and the board;
(B) notifications of a change in
pharmacist-in-charge of a pharmacy; and
(C) reports of a fire or other disaster that
may affect the strength, purity, or labeling of drugs, medications, devices, or
other materials used in the diagnosis or treatment of injury, illness, and
disease.
(j)
Permission to maintain central records. Any pharmacy that uses a centralized
recordkeeping system for invoices and financial data shall comply with the
following procedures.
(1) Controlled substance
records. Invoices and financial data for controlled substances may be
maintained at a central location provided the following conditions are met:
(A) Prior to the initiation of central
recordkeeping, the pharmacy submits written notification by registered or
certified mail to the divisional director of the Drug Enforcement
Administration as required by
Title 21, Code of Federal
Regulations, §
1304.04(a), and submits a
copy of this written notification to the board. Unless the registrant is
informed by the divisional director of the Drug Enforcement Administration that
permission to keep central records is denied, the pharmacy may maintain central
records commencing 14 days after receipt of notification by the divisional
director;
(B) The pharmacy
maintains a copy of the notification required in subparagraph (A) of this
paragraph; and
(C) The records to
be maintained at the central record location shall not include executed DEA
order forms, prescription drug orders, or controlled substance inventories that
shall be maintained at the pharmacy;
(2) Dangerous drug records. Invoices and
financial data for dangerous drugs may be maintained at a central
location;
(3) Access to records. If
the records are kept on microfilm, computer media, or in any form requiring
special equipment to render the records easily readable, the pharmacy shall
provide access to such equipment with the records; and
(4) Delivery of records. The pharmacy agrees
to deliver all or any part of such records to the pharmacy location within two
business days of written request of a board agent or any other authorized
official.
(k) Ownership
of pharmacy records. For the purposes of these sections, a pharmacy licensed
under the Act is the only entity that may legally own and maintain prescription
drug records.
(l) Documentation of
consultation. When a pharmacist, pharmacist-intern, or pharmacy technician
consults a prescriber as described in this section, the individual shall
document such occurrences on the hard copy or in the pharmacy's data processing
system associated with the prescription and shall include the following
information:
(1) date the prescriber was
consulted;
(2) name of the person
communicating the prescriber's instructions;
(3) any applicable information pertaining to
the consultation; and
(4) initials
or identification code of the pharmacist, pharmacist-intern, or pharmacy
technician performing the consultation clearly recorded for the purpose of
identifying the individual who performed the consultation if the information is
recorded on the hard copy prescription.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.