22 Tex. Admin. Code § 291.151 - Pharmacies Located in a Freestanding Emergency Medical Care Facility (Class F)
(a) Purpose. The
purpose of this section is to provide standards in the conduct, practice
activities, and operation of a pharmacy located in a freestanding emergency
medical care facility that is licensed by the Texas Department of State Health
Services or in a freestanding emergency medical care facility operated by a
hospital that is exempt from registration as provided by §
254.052,
Health and Safety Code. Class F pharmacies located in a freestanding emergency
medical care facility shall comply with this section.
(b) Definitions. The following words and
terms, when used in this section, shall have the following meanings, unless the
context clearly indicates otherwise.
(1)
Act--The Texas Pharmacy Act, Occupations Code, Subtitle J, as
amended.
(2) Administer--The direct
application of a prescription drug by injection, inhalation, ingestion, or any
other means to the body of a patient by:
(A) a
practitioner, an authorized agent under his supervision, or other person
authorized by law; or
(B) the
patient at the direction of a practitioner.
(3) Automated medication supply system--A
mechanical system that performs operations or activities relative to the
storage and distribution of medications for administration and which collects,
controls, and maintains all transaction information.
(4) Board--The Texas State Board of
Pharmacy.
(5) Consultant
pharmacist--A pharmacist retained by a facility on a routine basis to consult
with the FEMCF in areas that pertain to the practice of pharmacy.
(6) Controlled substance--A drug, immediate
precursor, or other substance listed in Schedules I - V or Penalty Groups 1 - 4
of the Texas Controlled Substances Act, as amended, or a drug immediate
precursor, or other substance included in Schedules I - V of the Federal
Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public
Law 91-513).
(7)
Dispense--Preparing, packaging, compounding, 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.
(8) Distribute--The
delivery of a prescription drug or device other than by administering or
dispensing.
(9) Downtime--Period of
time during which a data processing system is not operable.
(10) Electronic signature--A unique security
code or other identifier which specifically identifies the person entering
information into a data processing system. A facility which utilizes electronic
signatures must:
(A) maintain a permanent list
of the unique security codes assigned to persons authorized to use the data
processing system; and
(B) have an
ongoing security program which is capable of identifying misuse and/or
unauthorized use of electronic signatures.
(11) Floor stock--Prescription drugs or
devices not labeled for a specific patient and maintained at a nursing station
or other FEMCF department (excluding the pharmacy) for the purpose of
administration to a patient of the FEMCF.
(12) Formulary--List of drugs approved for
use in the FEMCF by an appropriate committee of the FEMCF.
(13) Freestanding emergency medical care
facility (FEMCF)--A freestanding facility that is licensed by the Texas
Department of State Health Services pursuant to Chapter 254, Health and Safety
Code, to provide emergency care to patients.
(14) Hard copy--A physical document that is
readable without the use of a special device (i.e., data processing system,
computer, etc.).
(15)
Investigational new drug--New drug intended for investigational use by experts
qualified to evaluate the safety and effectiveness of the drug as authorized by
the federal Food and Drug Administration.
(16) Medication order--An order from a
practitioner or his authorized agent for administration of a drug or
device.
(17)
Pharmacist-in-charge--Pharmacist designated on a pharmacy license as the
pharmacist who has the authority or responsibility for a pharmacy's compliance
with laws and rules pertaining to the practice of pharmacy.
(18) Pharmacy--Area or areas in a facility,
separate from patient care areas, where drugs are stored, bulk compounded,
delivered, compounded, dispensed, and/or distributed to other areas or
departments of the FEMCF, or dispensed to an ultimate user or his or her
agent.
(19) Prescription drug--
(A) A substance for which federal or state
law requires a prescription before it may be legally dispensed to the
public;
(B) A drug or device that
under federal law is required, prior to being dispensed or delivered, to be
labeled with either of the following statements:
(i) Caution: federal law prohibits dispensing
without prescription or "Rx only" or another legend that complies with federal
law; or
(ii) Caution: federal law
restricts this drug to use by or on order of a licensed veterinarian;
or
(C) A drug or device
that is required by any applicable federal or state law or regulation to be
dispensed on prescription only or is restricted to use by a practitioner
only.
(20) Prescription
drug order--
(A) An order from a practitioner
or his authorized agent to a pharmacist for a drug or device to be dispensed;
or
(B) An order pursuant to
Subtitle B, Chapter 157, Occupations Code.
(21) Full-time pharmacist--A pharmacist who
works in a pharmacy from 30 to 40 hours per week or if the pharmacy is open
less than 60 hours per week, one-half of the time the pharmacy is
open.
(22) Part-time pharmacist--A
pharmacist who works less than full-time.
(23) Pharmacy technician--An individual who
is registered with the board as a pharmacy technician and whose responsibility
in a pharmacy is to provide technical services that do not require professional
judgment regarding preparing and distributing drugs and who works under the
direct supervision of and is responsible to a pharmacist.
(24) Pharmacy technician trainee--An
individual who is registered with the board as a pharmacy technician trainee
and is authorized to participate in a pharmacy's technician training
program.
(25) Texas Controlled
Substances Act--The Texas Controlled Substances Act, Health and Safety Code,
Chapter 481, as amended.
(c) Personnel.
(1) Pharmacist-in-charge.
(A) General. Each FEMCF shall have one
pharmacist-in-charge who is employed or under contract, at least on a
consulting or part-time basis, but may be employed on a full-time
basis.
(B) Responsibilities. The
pharmacist-in-charge shall have the responsibility for, at a minimum, the
following:
(i) establishing specifications for
procurement and storage of all materials, including drugs, chemicals, and
biologicals;
(ii) participating in
the development of a formulary for the FEMCF, subject to approval of the
appropriate committee of the FEMCF;
(iii) distributing drugs to be administered
to patients pursuant to the practitioner's medication order;
(iv) filling and labeling all containers from
which drugs are to be distributed or dispensed;
(v) maintaining and making available a
sufficient inventory of antidotes and other emergency drugs, both in the
pharmacy and patient care areas, as well as current antidote information,
telephone numbers of regional poison control center and other emergency
assistance organizations, and such other materials and information as may be
deemed necessary by the appropriate committee of the FEMCF;
(vi) maintaining records of all transactions
of the FEMCF pharmacy as may be required by applicable state and federal law,
and as may be necessary to maintain accurate control over and accountability
for all pharmaceutical materials;
(vii) participating in those aspects of the
FEMCF's patient care evaluation program which relate to pharmaceutical material
utilization and effectiveness;
(viii) participating in teaching and/or
research programs in the FEMCF;
(ix) implementing the policies and decisions
of the appropriate committee(s) relating to pharmaceutical services of the
FEMCF;
(x) providing effective and
efficient messenger and delivery service to connect the FEMCF pharmacy with
appropriate areas of the FEMCF on a regular basis throughout the normal workday
of the FEMCF;
(xi) labeling,
storing, and distributing investigational new drugs, including maintaining
information in the pharmacy and nursing station where such drugs are being
administered, concerning the dosage form, route of administration, strength,
actions, uses, side effects, adverse effects, interactions, and symptoms of
toxicity of investigational new drugs;
(xii) meeting all inspection and other
requirements of the Texas Pharmacy Act and this section; and
(xiii) maintaining records in a data
processing system such that the data processing system is in compliance with
the requirements for an FEMCF; and
(xiv) ensuring that a pharmacist visits the
FEMCF at least once each calendar week that the facility is open.
(2) Consultant
pharmacist.
(A) The consultant pharmacist may
be the pharmacist-in-charge.
(B) A
written contract shall exist between the FEMCF and any consultant pharmacist,
and a copy of the written contract shall be made available to the board upon
request.
(3) Pharmacists.
(A) General.
(i) The pharmacist-in-charge shall be
assisted by a sufficient number of additional licensed pharmacists as may be
required to operate the FEMCF pharmacy competently, safely, and adequately to
meet the needs of the patients of the facility.
(ii) All pharmacists shall assist the
pharmacist-in-charge in meeting the responsibilities as outlined in paragraph
(1)(B) of this subsection and in ordering, administering, and accounting for
pharmaceutical materials.
(iii) All
pharmacists shall be responsible for any delegated act performed by pharmacy
technicians or pharmacy technician trainees under his or her
supervision.
(iv) All pharmacists
while on duty shall be responsible for complying with all state and federal
laws or rules governing the practice of pharmacy.
(B) Duties. Duties of the
pharmacist-in-charge and all other pharmacists shall include, but need not be
limited to, the following:
(i) receiving and
interpreting prescription drug orders and oral medication orders and reducing
these orders to writing either manually or electronically;
(ii) selecting prescription drugs and/or
devices and/or suppliers; and
(iii)
interpreting patient profiles.
(C) Special requirements for compounding
non-sterile preparations. All pharmacists engaged in compounding non-sterile
preparations shall meet the training requirements specified in §
291.131 of this title (relating to
Pharmacies Compounding Non-Sterile Preparations).
(4) Pharmacy technicians and pharmacy
technician trainees.
(A) General. All
pharmacy technicians and pharmacy technician trainees shall meet the training
requirements specified in §
297.6 of this title (relating to
Pharmacy Technician and Pharmacy Technician Trainee Training).
(B) Duties. Pharmacy technicians and pharmacy
technician trainees may not perform any of the duties listed in paragraph
(3)(B) of this subsection. Duties may include, but need not be limited to, the
following functions, under the direct supervision of a pharmacist:
(i) prepacking and labeling unit and multiple
dose packages, provided a pharmacist supervises and conducts a final check and
affixes his or her name, initials, or electronic signature to the appropriate
quality control records prior to distribution;
(ii) preparing, packaging, compounding, or
labeling prescription drugs pursuant to medication orders, provided a
pharmacist supervises and checks the preparation;
(iii) compounding non-sterile preparations
pursuant to medication orders provided the pharmacy technicians or pharmacy
technician trainees have completed the training specified in §
291.131 of this title;
(iv) bulk compounding, provided a pharmacist
supervises and conducts in-process and final checks and affixes his or her
name, initials, or electronic signature to the appropriate quality control
records prior to distribution;
(v)
distributing routine orders for stock supplies to patient care areas;
(vi) entering medication order and drug
distribution information into a data processing system, provided judgmental
decisions are not required and a pharmacist checks the accuracy of the
information entered into the system prior to releasing the order or in
compliance with the absence of pharmacist requirements contained in subsection
(d)(6)(D) and (E) of this section;
(vii) maintaining inventories of drug
supplies;
(viii) maintaining
pharmacy records; and
(ix) loading
drugs into an automated medication supply system. For the purpose of this
clause, direct supervision may be accomplished by physically present
supervision or electronic monitoring by a pharmacist.
(C) Procedures.
(i) Pharmacy technicians and pharmacy
technician trainees shall handle medication orders in accordance with standard
written procedures and guidelines.
(ii) Pharmacy technicians and pharmacy
technician trainees shall handle prescription drug orders in the same manner as
pharmacy technicians or pharmacy technician trainees working in a Class A
pharmacy.
(D) Special
requirements for compounding non-sterile preparations. All pharmacy technicians
and pharmacy technician trainees engaged in compounding non-sterile
preparations shall meet the training requirements specified in §
291.131 of this title.
(5) Owner. The owner of an FEMCF
pharmacy shall have responsibility for all administrative and operational
functions of the pharmacy. The pharmacist-in-charge may advise the owner on
administrative and operational concerns. The owner shall have responsibility
for, at a minimum, the following, and if the owner is not a Texas licensed
pharmacist, the owner shall consult with the pharmacist-in-charge or another
Texas licensed pharmacist:
(A) establishing
policies for procurement of prescription drugs and devices and other products
dispensed from the FEMCF pharmacy;
(B) establishing and maintaining effective
controls against the theft or diversion of prescription drugs;
(C) if the pharmacy uses an automated
medication supply system, reviewing and approving all policies and procedures
for system operation, safety, security, accuracy and access, patient
confidentiality, prevention of unauthorized access, and malfunction;
(D) providing the pharmacy with the necessary
equipment and resources commensurate with its level and type of practice;
and
(E) establishing policies and
procedures regarding maintenance, storage, and retrieval of records in a data
processing system such that the system is in compliance with state and federal
requirements.
(6)
Identification of pharmacy personnel. All pharmacy personnel shall be
identified as follows:
(A) Pharmacy
technicians. All pharmacy technicians shall wear an identification tag or badge
that bears the person's name and identifies him or her as a pharmacy
technician.
(B) Pharmacy technician
trainees. All pharmacy technician trainees shall wear an identification tag or
badge that bears the person's name and identifies him or her as a pharmacy
technician trainee.
(C) Pharmacist
interns. All pharmacist interns shall wear an identification tag or badge that
bears the person's name and identifies him or her as a pharmacist
intern.
(D) Pharmacists. All
pharmacists shall wear an identification tag or badge that bears the person's
name and identifies him or her as a pharmacist.
(d) Operational standards.
(1) Licensing requirements.
(A) An FEMCF pharmacy shall register annually
or biennially with the board on a pharmacy license application provided by the
board, following the procedures specified in §
291.1 of this title (relating to
Pharmacy License Application).
(B)
An FEMCF pharmacy which changes ownership shall notify the board within 10 days
of the change of ownership and apply for a new and separate license as
specified in §
291.3 of this title (relating to
Required Notifications).
(C) An
FEMCF pharmacy which changes location and/or name shall notify the board of the
change within 10 days and file for an amended license as specified in §
291.3 of this title.
(D) A pharmacy owned by a partnership or
corporation which changes managing officers shall notify the board in writing
of the names of the new managing officers within 10 days of the change,
following the procedures in §
291.3 of this title.
(E) An FEMCF pharmacy shall notify the board
in writing within 10 days of closing, following the procedures in §
291.5 of this title (relating to
Closing a Pharmacy).
(F) A fee as
specified in §
291.6 of this title (relating to
Pharmacy License Fees) will be charged for issuance and renewal of a license
and the issuance of an amended license.
(G) A separate license is required for each
principal place of business and only one pharmacy license may be issued to a
specific location.
(H) An FEMCF
pharmacy, which also operates another type of pharmacy which would otherwise be
required to be licensed under the Act, §560.051(a)(1), concerning
community pharmacy (Class A), is not required to secure a license for the other
type of pharmacy; provided, however, such license is required to comply with
the provisions of §
291.31 of this title (relating to
Definitions), §
291.32 of this title (relating to
Personnel), §
291.33 of this title (relating to
Operational Standards), §
291.34 of this title (relating to
Records), and §
291.35 of this title (relating to
Official Prescription Requirements), to the extent such sections are applicable
to the operation of the pharmacy.
(I) An FEMCF pharmacy engaged in the
compounding of non-sterile preparations shall comply with the provisions of
§
291.131 of this title.
(2) Environment.
(A) General requirements.
(i) Each FEMCF shall have a designated work
area separate from patient areas, and which shall have space adequate for the
size and scope of pharmaceutical services and shall have adequate space and
security for the storage of drugs.
(ii) The FEMCF pharmacy shall be arranged in
an orderly fashion and shall be kept clean. All required equipment shall be
clean and in good operating condition.
(B) Special requirements.
(i) The FEMCF pharmacy shall have locked
storage for Schedule II controlled substances and other controlled drugs
requiring additional security.
(ii)
The FEMCF pharmacy shall have a designated area for the storage of poisons and
externals separate from drug storage areas.
(C) Security.
(i) The pharmacy and storage areas for
prescription drugs and/or devices shall be enclosed and capable of being locked
by key, combination, or other mechanical or electronic means, so as to prohibit
access by unauthorized individuals. Only individuals authorized by the
pharmacist-in-charge may enter the pharmacy or have access to storage areas for
prescription drugs and/or devices.
(ii) The pharmacist-in-charge shall consult
with FEMCF personnel with respect to security of the drug storage areas,
including provisions for adequate safeguards against theft or diversion of
dangerous drugs, controlled substances, and records for such drugs.
(iii) The pharmacy shall have locked storage
for Schedule II controlled substances and other drugs requiring additional
security.
(3)
Equipment and supplies. FEMCFs supplying drugs for outpatient use shall have
the following equipment and supplies:
(A) data
processing system including a printer or comparable equipment;
(B) adequate supply of child-resistant,
moisture-proof, and light-proof containers; and
(C) adequate supply of prescription labels
and other applicable identification labels.
(4) Library. A reference library shall be
maintained that includes the following in hard copy or electronic format and
that pharmacy personnel shall be capable of accessing at all times:
(A) current copies of the following:
(i) Texas Pharmacy Act and rules;
(ii) Texas Dangerous Drug Act and
rules;
(iii) Texas Controlled
Substances Act and rules; and
(iv)
Federal Controlled Substances Act and rules or official publication describing
the requirements of the Federal Controlled Substances Act and rules;
(B) at least one current or
updated general drug information reference which is required to contain drug
interaction information including information needed to determine severity or
significance of the interaction and appropriate recommendations or actions to
be taken; and
(C) basic antidote
information and the telephone number of the nearest regional poison control
center.
(5) Drugs.
(A) Procurement, preparation, and storage.
(i) The pharmacist-in-charge shall have the
responsibility for the procurement and storage of drugs, but may receive input
from other appropriate staff of the facility, relative to such
responsibility.
(ii) The
pharmacist-in-charge shall have the responsibility for determining
specifications of all drugs procured by the facility.
(iii) FEMCF pharmacies may not sell,
purchase, trade, or possess prescription drug samples, unless the pharmacy
meets the requirements as specified in §
291.16 of this title (relating to
Samples).
(iv) All drugs shall be
stored at the proper temperatures, as defined in the USP/NF and in §
291.15 of this title (relating to
Storage of Drugs).
(v) Any drug
bearing an expiration date may not be dispensed or distributed beyond the
expiration date of the drug.
(vi)
Outdated drugs shall be removed from dispensing stock and shall be quarantined
together until such drugs are disposed of.
(B) Formulary.
(i) A formulary may be developed by an
appropriate committee of the FEMCF.
(ii) The pharmacist-in-charge, consultant
pharmacist, or designee shall be a full voting member of any committee which
involves pharmaceutical services.
(iii) A practitioner may grant approval for
pharmacists at the FEMCF to interchange, in accordance with the facility's
formulary, for the drugs on the practitioner's medication orders provided:
(I) a formulary has been developed;
(II) the formulary has been approved by the
medical staff of the FEMCF;
(III)
there is a reasonable method for the practitioner to override any interchange;
and
(IV) the practitioner
authorizes a pharmacist in the FEMCF to interchange on his/her medication
orders in accordance with the facility's formulary through his/her written
agreement to abide by the policies and procedures of the medical staff and
facility.
(C)
Prepackaging and loading drugs into automated medication supply system.
(i) Prepackaging of drugs.
(I) Drugs may be prepackaged in quantities
suitable for internal distribution only by a pharmacist or by pharmacy
technicians or pharmacy technician trainees under the direction and direct
supervision of a pharmacist.
(II)
The label of a prepackaged unit shall indicate:
(-a-) brand name and strength of the drug; or
if no brand name, then the generic name, strength, and name of the manufacturer
or distributor;
(-b-) facility's lot
number;
(-c-) expiration date;
and
(-d-) quantity of the drug, if
quantity is greater than one.
(III) Records of prepackaging shall be
maintained to show:
(-a-) the name of the
drug, strength, and dosage form;
(-b-) facility's lot number;
(-c-) manufacturer or distributor;
(-d-) manufacturer's lot number;
(-e-) expiration date;
(-f-) quantity per prepackaged
unit;
(-g-) number of prepackaged
units;
(-h-) date
packaged;
(-i-) name, initials, or
electronic signature of the prepacker; and
(-j-) signature or electronic signature of
the responsible pharmacist.
(IV) Stock packages, repackaged units, and
control records shall be quarantined together until checked/released by the
pharmacist.
(ii) Loading
bulk unit of use drugs into automated medication supply systems. Automated
medication supply systems may be loaded with bulk unit of use drugs only by a
pharmacist, by pharmacy technicians or pharmacy technician trainees under the
direction and direct supervision of a pharmacist, or by a licensed nurse who is
authorized by the pharmacist to perform the loading of the automated medication
supply system. For the purpose of this clause, direct supervision may be
accomplished by physically present supervision or electronic monitoring by a
pharmacist. In order for the pharmacist to electronically monitor, the
medication supply system must allow for bar code scanning to verify the loading
of drugs, and a record of the loading must be maintained by the system and
accessible for electronic review by the pharmacist.
(6) Medication orders.
(A) Drugs may be administered to patients in
FEMCFs only on the order of a practitioner. No change in the order for drugs
may be made without the approval of a practitioner except as authorized by the
practitioner in compliance with paragraph (5)(B) of this subsection.
(B) Drugs may be distributed only pursuant to
the copy of the practitioner's medication order.
(C) FEMCF pharmacies shall be exempt from the
labeling provisions and patient notification requirements of §562.006 and
§562.009 of the Act, as respects drugs distributed pursuant to medication
orders.
(D) In FEMCFs with a
full-time pharmacist, if a practitioner orders a drug for administration to a
bona fide patient of the facility when the pharmacy is closed, the following is
applicable:
(i) prescription drugs and devices
only in sufficient quantities for immediate therapeutic needs of a patient may
be removed from the FEMCF pharmacy;
(ii) only a designated licensed nurse or
practitioner may remove such drugs and devices;
(iii) a record shall be made at the time of
withdrawal by the authorized person removing the drugs and devices. The record
shall contain the following information:
(I)
name of the patient;
(II) name of
device or drug, strength, and dosage form;
(III) dose prescribed;
(IV) quantity withdrawn;
(V) time and date; and
(VI) signature or electronic signature of the
person making the withdrawal;
(iv) the medication order in the patient's
chart may substitute for such record, provided the medication order meets all
the requirements of clause (iii) of this subparagraph;
(v) the pharmacist shall verify the
withdrawal of a controlled substance as soon as practical, but in no event more
than 72 hours from the time of such withdrawal; and
(vi) the pharmacist shall verify the
withdrawal of a dangerous drug at a reasonable interval, but such verification
must occur at least once in every calendar week.
(E) In FEMCFs with a part-time or consultant
pharmacist, if a practitioner orders a drug for administration to a bona fide
patient of the FEMCF when the pharmacist is not on duty, or when the pharmacy
is closed, the following is applicable:
(i)
prescription drugs and devices only in sufficient quantities for therapeutic
needs may be removed from the FEMCF pharmacy;
(ii) only a designated licensed nurse or
practitioner may remove such drugs and devices;
(iii) a record shall be made at the time of
withdrawal by the authorized person removing the drug or device as described in
clauses (6)(D)(iii) and (iv) of this subsection; and
(iv) the pharmacist shall verify withdrawals
at a reasonable interval, but such verification must occur at least once in
every calendar week that the pharmacy is open.
(7) Floor stock. In facilities using a floor
stock method of drug distribution, the pharmacy shall establish designated
floor stock areas outside of the central pharmacy where drugs may be stored, in
accordance with the pharmacy's policies and procedures. The following is
applicable for removing drugs or devices in the absence of a pharmacist:
(A) prescription drugs and devices may be
removed from the pharmacy only in the original manufacturer's container or
prepackaged container;
(B) only a
designated licensed nurse or practitioner may remove such drugs and
devices;
(C) a record shall be made
at the time of withdrawal by the authorized person removing the drug or device
and the record shall contain the following information:
(i) name of the drug, strength, and dosage
form;
(ii) quantity
removed;
(iii) location of floor
stock;
(iv) date and time;
and
(v) signature or electronic
signature of person making the withdrawal;
(D) the medication order in the patient's
chart may substitute for the record required in subparagraph (C) of this
paragraph, provided the medication order meets all the requirements of
subparagraph (C) of this paragraph; and
(E) if a stored drug or device is returned to
the pharmacy from floor stock areas, a record shall be made by the authorized
person returning the drug or device. The record shall contain the following
information:
(i) drug name, strength, and
dosage form, or device name;
(ii)
quantity returned;
(iii) previous
floor stock location for the drug or device;
(iv) date and time; and
(v) signature or electronic signature of
person returning the drug or device.
(8) Policies and procedures. Written policies
and procedures for a drug distribution system, appropriate for the freestanding
emergency medical facility, shall be developed and implemented by the
pharmacist-in-charge with the advice of the appropriate committee. The written
policies and procedures for the drug distribution system shall include, but not
be limited to, procedures regarding the following:
(A) controlled substances;
(B) investigational drugs;
(C) prepackaging and manufacturing;
(D) medication errors;
(E) orders of physician or other
practitioner;
(F) floor
stocks;
(G) adverse drug
reactions;
(H) drugs brought into
the facility by the patient;
(I)
self-administration;
(J) emergency
drug tray;
(K) formulary, if
applicable;
(L) drug storage
areas;
(M) drug samples;
(N) drug product defect reports;
(O) drug recalls;
(P) outdated drugs;
(Q) preparation and distribution of IV
admixtures;
(R) procedures for
supplying drugs for postoperative use, if applicable;
(S) use of automated medication supply
systems;
(T) use of data processing
systems; and
(U) drug regimen
review.
(9) Drugs
supplied for outpatient use. Drugs provided to patients for take home use shall
be supplied according to the following procedures.
(A) Drugs may only be supplied to patients
who have been admitted to the FEMCF.
(B) Drugs may only be supplied in accordance
with the system of control and accountability established for drugs supplied
from the FEMCF; such system shall be developed and supervised by the
pharmacist-in-charge or staff pharmacist designated by the
pharmacist-in-charge.
(C) Only
drugs listed on the approved outpatient drug list may be supplied; such list
shall be developed by the pharmacist-in-charge and the medical staff and shall
consist of drugs of the nature and type to meet the immediate postoperative
needs of the FEMCF patient.
(D)
Drugs may only be supplied in prepackaged quantities not to exceed a 72-hour
supply in suitable containers and appropriately prelabeled (including name,
address, and phone number of the facility and necessary auxiliary labels) by
the pharmacy, provided, however that topicals and ophthalmics in original
manufacturer's containers may be supplied in a quantity exceeding a 72-hour
supply.
(E) At the time of delivery
of the drug, the practitioner shall complete the label, such that the
prescription container bears a label with at least the following information:
(i) date supplied;
(ii) name of practitioner;
(iii) name of patient;
(iv) directions for use;
(v) brand name and strength of the drug; or
if no brand name, then the generic name of the drug dispensed, strength, and
the name of the manufacturer or distributor of the drug; and
(vi) unique identification number.
(F) After the drug has been
labeled, the practitioner or a licensed nurse under the supervision of the
practitioner shall give the appropriately labeled, prepackaged medication to
the patient.
(G) A perpetual record
of drugs which are supplied from the FEMCF shall be maintained which includes:
(i) name, address, and phone number of the
facility;
(ii) date
supplied;
(iii) name of
practitioner;
(iv) name of
patient;
(v) directions for
use;
(vi) brand name and strength
of the drug; or if no brand name, then the generic name of the drug dispensed,
strength, and the name of the manufacturer or distributor of the drug;
and
(vii) unique identification
number.
(H) The
pharmacist-in-charge, or a pharmacist designated by the pharmacist-in-charge,
shall review the records at least once in every calendar week that the pharmacy
is open.
(10) Drug
regimen review.
(A) A pharmacist shall
evaluate medication orders and patient medication records for:
(i) known allergies;
(ii) rational
therapy--contraindications;
(iii)
reasonable dose and route of administration;
(iv) reasonable directions for use;
(v) duplication of therapy;
(vi) drug-drug interactions;
(vii) drug-food interactions;
(viii) drug-disease interactions;
(ix) adverse drug reactions;
(x) proper utilization, including
overutilization or underutilization; and
(xi) clinical laboratory or clinical
monitoring methods to monitor and evaluate drug effectiveness, side effects,
toxicity, or adverse effects, and appropriateness to continued use of the drug
in its current regimen.
(B) A retrospective, random drug regimen
review as specified in the pharmacy's policies and procedures shall be
conducted on a periodic basis to verify proper usage of drugs not to exceed 31
days between such reviews.
(C) Any
questions regarding the order must be resolved with the prescriber and a
written notation of these discussions made and maintained.
(e) Records.
(1) Maintenance of records.
(A) Every inventory or other record required
to be kept under the provisions of this section (relating to Pharmacies Located
in a Freestanding Emergency Medical Care Facility (Class F) shall be:
(i) kept by the pharmacy 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 other authorized
local, state, or federal law enforcement agencies; and
(ii) supplied by the pharmacy within 72
hours, if requested by an authorized agent of the board. 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
subsection, either on site or within 72 hours, constitutes prima facie evidence
of failure to keep and maintain records in violation of the Act.
(B) Records of controlled
substances listed in Schedule II shall be maintained separately and readily
retrievable from all other records of the pharmacy.
(C) Records of controlled substances listed
in Schedules III - V shall be maintained separately or readily retrievable from
all other records of the pharmacy. For purposes of this subparagraph, "readily
retrievable" means that the controlled substances shall be asterisked,
redlined, or in some other manner readily identifiable apart from all other
items appearing on the record.
(D)
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 or direct imaging system, provided:
(i) the records in the alternative data
retention system contain all of the information required on the manual record;
and
(ii) the alternative data
retention 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.
(E) Controlled substance records shall be
maintained in a manner to establish receipt and distribution of all controlled
substances.
(F) An FEMCF pharmacy
shall maintain a perpetual inventory of controlled substances listed in
Schedules II - V which shall be verified by a pharmacist for completeness and
reconciled at least once in every calendar week that the pharmacy is
open.
(G) Distribution records for
controlled substances, listed in Schedules II - V, shall include the following
information:
(i) patient's name;
(ii) practitioner's name who ordered the
drug;
(iii) name of drug, dosage
form, and strength;
(iv) time and
date of administration to patient and quantity administered;
(v) signature or electronic signature of
individual administering the controlled substance;
(vi) returns to the pharmacy; and
(vii) waste (waste is required to be
witnessed and cosigned, manually or electronically, by another
individual).
(H) The
record required by subparagraph (G) of this paragraph shall be maintained
separately from patient records.
(I) A pharmacist shall conduct an audit by
randomly comparing the distribution records required by subparagraph (G) of
this paragraph with the medication orders in the patient record on a periodic
basis to verify proper administration of drugs not to exceed 30 days between
such reviews.
(2) Patient
records.
(A) Each medication order or set of
orders issued together shall bear the following information:
(i) patient name;
(ii) drug name, strength, and dosage
form;
(iii) directions for
use;
(iv) date; and
(v) signature or electronic signature of the
practitioner or that of his or her authorized agent, defined as a licensed
nurse employee or consultant/full or part-time pharmacist of the
FEMCF.
(B) Medication
orders shall be maintained with the medication administration record in the
medical records of the patient.
(3) General requirements for records
maintained in a data processing system.
(A) If
an FEMCF pharmacy's data processing system is not in compliance with the
board's requirements, the pharmacy must maintain a manual recordkeeping
system.
(B) The facility 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 to assure that data is not lost due to system
failure.
(C) 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 which contains:
(I)
all of the information required on the original document; or
(II) for records of distribution and return
for all controlled substances, the same information as required on the audit
trail printout as specified in subparagraph (F) of this paragraph. The
information on the printout shall be sorted and printed by drug name and list
all distributions and returns chronologically.
(D) 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) 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.
(F) The data processing system shall have the
capacity to produce a hard copy printout of an audit trail of drug distribution
and return for any strength and dosage form of a drug (by either brand or
generic name or both) during a specified time period. This printout shall
contain the following information:
(i)
patient's name or patient's facility identification number;
(ii) prescribing or attending practitioner's
name;
(iii) name, strength, and
dosage form of the drug product actually distributed;
(iv) total quantity distributed from and
returned to the pharmacy;
(v) if
not immediately retrievable via electronic image, the following shall also be
included on the printout:
(I) prescribing or
attending practitioner's address; and
(II) practitioner's DEA registration number,
if the medication order is for a controlled substance.
(G) An audit trail printout for
each strength and dosage form of the drugs distributed during the preceding
month shall be produced at least monthly and shall be maintained in a separate
file at the facility. The information on this printout shall be sorted by drug
name and list all distributions/returns for that drug
chronologically.
(H) The pharmacy
may elect not to produce the monthly audit trail printout if the data
processing system has a workable (electronic) data retention system which can
produce an audit trail of drug distribution and returns for the preceding two
years. The audit trail required in this clause shall be supplied by the
pharmacy within 72 hours, if requested by an authorized agent of the board, or
other authorized local, state, or federal law enforcement or regulatory
agencies.
(I) In the event that an
FEMCF pharmacy which uses a data processing system experiences system downtime,
the pharmacy must have an auxiliary procedure which will ensure that all data
is retained for online data entry as soon as the system is available for use
again.
(4) 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.
(A) The registrant to whom the controlled
substance is to be distributed is registered under the Controlled Substances
Act to possess that controlled substance.
(B) The total number of dosage units of
controlled substances distributed by a pharmacy may not exceed 5.0% of all
controlled substances dispensed 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.
(C) If the
distribution is for a Schedule III, IV, or V controlled substance, a record
shall be maintained which indicates:
(i) the
actual date of distribution;
(ii)
the name, strength, and quantity of controlled substances
distributed;
(iii) the name,
address, and DEA registration number of the distributing pharmacy;
and
(iv) the name, address, and DEA
registration number of the pharmacy, practitioner, or other registrant to whom
the controlled substances are distributed.
(D) A pharmacy shall comply with 21 CFR 1305
regarding the DEA order form (DEA 222) requirements when distributing a
Schedule II controlled substance.
(5) Other records. Other records to be
maintained by the pharmacy include:
(A) a
permanent log of the initials or identification codes which identifies each
pharmacist by name. The initials or identification code shall be unique to
ensure that each pharmacist can be identified, i.e., identical initials or
identification codes cannot be used;
(B) suppliers' invoices of dangerous drugs
and controlled substances dated and initialed or signed by the person receiving
the drugs;
(i) a pharmacist shall verify that
the controlled substances listed on the invoices were added to the pharmacy's
perpetual inventory by clearly recording his/her initials and the date of
review of the perpetual inventory; and
(ii) for controlled substances, the documents
retained must contain the name, strength and quantity of controlled substances
distributed, and the name, address and DEA number of both registrants; the
supplier and the receiving pharmacy;
(C) supplier's credit memos for controlled
substances and dangerous drugs;
(D)
a copy of inventories required by §
291.17 of this title (relating to
Inventory Requirements) except that a perpetual inventory of controlled
substances listed in Schedule II may be kept in a data processing system if the
data processing system is capable of producing a hard copy of the perpetual
inventory on site;
(E) reports of
surrender or destruction of controlled substances and/or dangerous drugs to an
appropriate state or federal agency or reverse distributor;
(F) records of distribution of controlled
substances and/or dangerous drugs to other pharmacies, practitioners, or
registrants; and
(G) a copy of any
notification required by the Texas Pharmacy Act or these rules, including, but
not limited to, the following:
(i) reports of
theft or significant loss of controlled substances to DEA and the
board;
(ii) notification of a
change in pharmacist-in-charge of a pharmacy; and
(iii) reports of a fire or other disaster
which 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.
(6) Permission to maintain central records.
Any pharmacy that uses a centralized recordkeeping system for invoices and
financial data shall comply with the following procedures.
(A) Controlled substance records. Invoices
and financial data for controlled substances may be maintained at a central
location provided the following conditions are met:
(i) Prior to the initiation of central
recordkeeping, the pharmacy submits written notification by registered or
certified mail to the divisional director of DEA as required by the Code of
Federal Regulations, Title 21, §1304(a), and submits a copy of this
written notification to the board. Unless the registrant is informed by the
divisional director of DEA 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;
(ii) The pharmacy maintains a copy of the
notification required in this subparagraph; and
(iii) The records to be maintained at the
central record location shall not include executed DEA order forms,
prescription drug orders, or controlled substance inventories, which shall be
maintained at the pharmacy.
(B) Dangerous drug records. Invoices and
financial data for dangerous drugs may be maintained at a central
location.
(C) 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.
(D) 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.
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.