22 Tex. Admin. Code § 291.74 - Operational Standards
(a) Licensing
requirements.
(1) A Class C 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).
(2)
A Class C 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).
(3) A
Class C pharmacy which changes location and/or name shall notify the board of
the change as specified in §
291.3 of this title.
(4) A Class C 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.
(5) A Class C 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).
(6) A fee as
specified in §
291.6 of this title (relating to
Pharmacy License Fees) will be charged for the issuance and renewal of a
license and the issuance of an amended license.
(7) A separate license is required for each
principal place of business and only one pharmacy license may be issued to a
specific location.
(8) A Class C
pharmacy, licensed under the Act, §560.051(a)(3), which also operates
another type of pharmacy which would otherwise be required to be licensed under
the Act, §560.051(a)(1) (Community Pharmacy (Class A)) or the Act,
§560.051(a)(2) (Nuclear Pharmacy (Class B)), is not required to secure a
license for the such other type of pharmacy; provided, however, such licensee
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 Records), contained in Community Pharmacy (Class A), or
§
291.51 of this title (relating to
Purpose), §
291.52 of this title (relating to
Definitions), §
291.53 of this title (relating to
Personnel), §
291.54 of this title (relating to
Operational Standards), and §
291.55 of this title (relating to
Records), contained in Nuclear Pharmacy (Class B), to the extent such sections
are applicable to the operation of the pharmacy.
(9) A Class C pharmacy engaged in the
compounding of non-sterile preparations shall comply with the provisions of
§
291.131 of this title (relating to
Pharmacies Compounding Non-sterile Preparations).
(10) Class C pharmacy personnel shall not
compound sterile preparations unless the pharmacy has applied for and obtained
a Class C-S pharmacy.
(11) A Class
C pharmacy engaged in the provision of remote pharmacy services, including
storage and dispensing of prescription drugs, shall comply with the provisions
of §
291.121 of this title (relating to
Remote Pharmacy Services).
(12) A
Class C pharmacy engaged in centralized prescription dispensing and/or
prescription drug or medication order processing shall comply with the
provisions of §
291.123 of this title (relating to
Central Prescription Drug or Medication Order Processing) and/or §
291.125 of this title (relating to
Centralized Prescription Dispensing).
(13) A Class C pharmacy with an ongoing
clinical pharmacy program that proposes to allow a pharmacy technician to
verify the accuracy of work performed by another pharmacy technician relating
to the filling of floor stock and unit dose distribution systems for a patient
admitted to the hospital if the patient's orders have previously been reviewed
and approved by a pharmacist shall make application to the board and submit any
information specified on the application.
(14) A rural hospital that wishes to allow a
pharmacy technician to perform the duties specified in §
291.73(e)(2)(D)
of this title (relating to Personnel), shall make application to the board and
submit any information specified on the application.
(A) A rural hospital may not allow a pharmacy
technician to perform the duties specified in §
291.73(e)(2)(D)
of this title until the board has reviewed and approved the application and
issued an amended license to the pharmacy.
(B) Every two years, in conjunction with the
application for renewal of the pharmacy license, the pharmacist-in-charge shall
update the application for pharmacy technicians to perform the duties specified
in §
291.73(e)(2)(D)
of this title and shall attest as required on the application.
(b) Environment.
(1) General requirements.
(A) The institutional pharmacy shall have
adequate space necessary for the storage, compounding, labeling, dispensing,
and sterile preparation of drugs prepared in the pharmacy, and additional
space, depending on the size and scope of pharmaceutical services.
(B) The institutional pharmacy shall be
arranged in an orderly fashion and shall be kept clean. All required equipment
shall be clean and in good operating condition.
(C) A sink with hot and cold running water
exclusive of restroom facilities shall be available to all pharmacy personnel
and shall be maintained in a sanitary condition at all times.
(D) The institutional pharmacy shall be
properly lighted and ventilated.
(E) The temperature of the institutional
pharmacy shall be maintained within a range compatible with the proper storage
of drugs. The temperature of the refrigerator and/or freezer shall be
maintained within a range compatible with the proper storage of
drugs.
(F) If the institutional
pharmacy has flammable materials, the pharmacy shall have a designated area for
the storage of flammable materials. Such area shall meet the requirements set
by local and state fire laws.
(G)
The institutional pharmacy shall store antiseptics, other drugs for external
use, and disinfectants separately from internal and injectable
medications.
(2) Security
requirements.
(A) The institutional pharmacy
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 shall
enter the pharmacy.
(B) Each
pharmacist on duty shall be responsible for the security of the institutional
pharmacy, including provisions for adequate safeguards against theft or
diversion of dangerous drugs, controlled substances, and records for such
drugs.
(C) The institutional
pharmacy shall have locked storage for Schedule II controlled substances and
other drugs requiring additional security.
(c) Equipment and supplies. Institutional
pharmacies distributing medication orders shall have the following equipment:
(1) data processing system including a
printer or comparable equipment; and
(2) refrigerator and/or freezer and a system
or device (e.g., thermometer) to monitor the temperature to ensure that proper
storage requirements are met.
(d) 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:
(1) current copies of the following:
(A) Texas Pharmacy Act and rules;
(B) Texas Dangerous Drug Act and
rules;
(C) Texas Controlled
Substances Act and regulations; and
(D) Federal Controlled Substances Act and
regulations (or official publication describing the requirements of the Federal
Controlled Substances Act and regulations);
(2) at least one current or updated reference
from each of the following categories:
(A)
drug interactions. A reference text on drug interactions, such as Drug
Interaction Facts. A separate reference is not required if other references
maintained by the pharmacy contain drug interaction information including
information needed to determine severity or significance of the interaction and
appropriate recommendations or actions to be taken;
(B) a general information reference
text;
(3) a current or
updated reference on injectable drug products;
(4) basic antidote information and the
telephone number of the nearest regional poison control center;
(5) metric-apothecary weight and measure
conversion charts.
(e)
Absence of a pharmacist.
(1) Medication
orders.
(A) In facilities 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 may be removed
from the institutional 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 patient;
(II) name of
device or drug, strength, and dosage form;
(III) dose prescribed;
(IV) quantity taken;
(V) time and date; and
(VI) signature (first initial and last name
or full signature) or electronic signature of person making
withdrawal;
(iv) The
original or direct copy of the medication order may substitute for such record,
providing the medication order meets all the requirements of clause (iii) of
this subparagraph; and
(v) The
pharmacist shall verify the withdrawal of drugs from the pharmacy and perform a
drug regimen review as specified in subsection (g)(1)(B) of this section as
soon as practical, but in no event more than 72 hours from the time of such
withdrawal.
(B) In
facilities with a part-time or consultant pharmacist, if a practitioner orders
a drug for administration to a bona fide patient of the facility 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 institutional 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 meet the same requirements as specified in
subparagraph (A)(iii) and (iv) of this paragraph;
(iv) The pharmacist shall verify the
withdrawal of drugs from the pharmacy after a reasonable interval, but in no
event may such interval exceed seven days; and
(v) The pharmacist shall perform a drug
regimen review as specified in subsection (g)(1)(B) of this section as follows:
(I) If the facility has an average daily
inpatient census of ten or less, the pharmacist shall perform the drug review
after a reasonable interval, but in no event may such interval exceed seven (7)
days; or
(II) If the facility has
an average inpatient daily census above ten, the pharmacist shall perform the
drug review after a reasonable interval, but in no event may such interval
exceed 96 hours.
(vi) The
average daily inpatient census shall be calculated by hospitals annually
immediately following the submission of the hospital's Medicare Cost Report and
the number used for purposes of subparagraph (B)(v)(I) and (II) of this
paragraph shall be the average of the inpatient daily census in the report and
the previous two reports for a three year period.
(2) Floor stock. In facilities
using a floor stock method of drug distribution, the following is applicable:
(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;
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 (first initial
and last name or full signature) or electronic signature of person making the
withdrawal.
(D) The
pharmacist shall verify the withdrawal of drugs from the pharmacy after a
reasonable interval, but in no event may such interval exceed seven
days.
(3) Rural
hospitals. In rural hospitals when a pharmacy technician performs the duties
listed in §
291.73(e)(2)(D)
of this title, the following is applicable:
(A) the pharmacy technician shall make a
record of all drugs distributed from the pharmacy. The record shall be
maintained in the pharmacy for two years and contain the following information:
(i) name of patient or location where floor
stock is distributed;
(ii) name of
device or drug, strength, and dosage form;
(iii) dose prescribed or ordered;
(iv) quantity distributed;
(v) time and date of the distribution;
and
(vi) signature (first initial
and last name or full signature) or electronic signature of nurse or
practitioner that verified the actions of the pharmacy technician.
(B) The original or direct copy of
the medication order may substitute for the record specified in subparagraph
(A) of this paragraph, provided the medication order meets all the requirements
of subparagraph (A) of this paragraph.
(C) The pharmacist shall:
(i) verify and document the verification of
all distributions made from the pharmacy in the absence of a pharmacist as soon
as practical, but in no event more than seven (7) days from the time of such
distribution;
(ii) perform a drug
regimen review for all medication orders as specified in subsection (g)(1)(B)
of this section and document such verification including any discrepancies
noted by the pharmacist as follows:
(I) If the
facility has an average daily inpatient census of ten or less, the pharmacist
shall perform the drug review as soon as practical, but in no event more than
seven (7) days from the time of such distribution; or
(II) If the facility has an average daily
inpatient census above ten, the pharmacist shall perform the drug review after
a reasonable interval, but in no event may such interval exceed 96
hours;
(iii) review any
discrepancy noted by the pharmacist with the pharmacy technician(s) and make
any change in procedures or processes necessary to prevent future problems;
and
(iv) report any adverse events
that have a potential for harm to a patient to the appropriate committee of the
hospital that reviews adverse events.
(D) The average daily inpatient census shall
be calculated by hospitals annually immediately following the submission of the
hospital's Medicare Cost Report and the number used for purposes of
subparagraph (C)(ii)(I) and (II) of this paragraph shall be the average of the
inpatient daily census in the report and the previous two reports for a three
year period.
(f) Drugs.
(1) Procurement, preparation and storage.
(A) 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.
(B) The
pharmacist-in-charge shall have the responsibility for determining
specifications of all drugs procured by the facility.
(C) Institutional 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).
(D) 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).
(E) Any drug
bearing an expiration date may not be distributed beyond the expiration date of
the drug.
(F) Outdated and other
unusable drugs shall be removed from stock and shall be quarantined together
until such drugs are disposed of properly.
(2) Formulary.
(A) A formulary shall be developed by the
facility committee performing the pharmacy and therapeutics function for the
facility. For the purpose of this section, a formulary is a compilation of
pharmaceuticals that reflects the current clinical judgment of a facility's
medical staff.
(B) The
pharmacist-in-charge or pharmacist designated by the pharmacist-in-charge shall
be a full voting member of the committee performing the pharmacy and
therapeutics function for the facility, when such committee is performing the
pharmacy and therapeutics function.
(C) A practitioner may grant approval for
pharmacists at the facility to interchange, in accordance with the facility's
formulary, for the prescribed drugs on the practitioner's medication orders
provided:
(i) the pharmacy and therapeutics
committee has developed a formulary;
(ii) the formulary has been approved by the
medical staff committee of the facility;
(iii) there is a reasonable method for the
practitioner to override any interchange; and
(iv) the practitioner authorizes pharmacists
in the facility 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.
(3) Prepackaging of drugs.
(A) Distribution within a facility.
(i) Drugs may be prepackaged in quantities
suitable for internal distribution 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:
(I) brand
name and strength of the drug; or if no brand name, then the generic name,
strength, and name of the manufacturer or distributor;
(II) facility's unique lot number;
(III) expiration date based on currently
available literature; and
(IV)
quantity of the drug, if the quantity is greater than one.
(iii) Records of prepackaging shall be
maintained to show:
(I) name of the drug,
strength, and dosage form;
(II)
facility's unique lot number;
(III)
manufacturer or distributor;
(IV)
manufacturer's lot number;
(V)
expiration date;
(VI) quantity per
prepackaged unit;
(VII) number of
prepackaged units;
(VIII) date
packaged;
(IX) name, initials, or
electronic signature of the prepacker; and
(X) name, initials, or electronic signature
of the responsible pharmacist.
(iv) Stock packages, prepackaged units, and
control records shall be quarantined together until checked/released by the
pharmacist.
(B)
Distribution to other Class C (Institutional) pharmacies under common
ownership.
(i) Drugs may be prepackaged in
quantities suitable for distribution to other Class C (Institutional)
pharmacies under common ownership 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:
(I) brand
name and strength of the drug; or if no brand name, then the generic name,
strength, and name of the manufacturer or distributor;
(II) facility's unique lot number;
(III) expiration date based on currently
available literature;
(IV) quantity
of the drug, if the quantity is greater than one; and
(V) name of the facility responsible for
prepackaging the drug.
(iii) Records of prepackaging shall be
maintained to show:
(I) name of the drug,
strength, and dosage form;
(II)
facility's unique lot number;
(III)
manufacturer or distributor;
(IV)
manufacturer's lot number;
(V)
expiration date;
(VI) quantity per
prepackaged unit;
(VII) number of
prepackaged units;
(VIII) date
packaged;
(IX) name, initials, or
electronic signature of the prepacker;
(X) name, initials, or electronic signature
of the responsible pharmacist; and
(XI) name of the facility receiving the
prepackaged drug.
(iv)
Stock packages, prepackaged units, and control records shall be quarantined
together until checked/released by the pharmacist.
(v) The pharmacy shall have written procedure
for the recall of any drug prepackaged for another Class C pharmacy under
common ownership. The recall procedures shall require:
(I) notification to the pharmacy to which the
prepackaged drug was distributed;
(II) quarantine of the product if there is a
suspicion of harm to a patient;
(III) a mandatory recall if there is
confirmed or probable harm to a patient; and
(IV) notification to the board if a mandatory
recall is instituted.
(4) Sterile preparations prepared in a
location other than the pharmacy. A distinctive supplementary label shall be
affixed to the container of any admixture. The label shall bear at a minimum:
(A) patient's name and location, if not
immediately administered;
(B) name
and amount of drug(s) added;
(C)
name of the basic solution;
(D)
name or identifying code of person who prepared admixture; and
(E) expiration date of solution.
(5) Distribution.
(A) Medication orders.
(i) Drugs may be given to patients in
facilities 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 (2)(C) of this
subsection.
(ii) Drugs may be
distributed only from the original or a direct copy of the practitioner's
medication order.
(iii) Pharmacy
technicians and pharmacy technician trainees may not receive oral medication
orders.
(iv) Institutional
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.
(B) Procedures.
(i) Written policies and procedures for a
drug distribution system (best suited for the particular institutional
pharmacy) shall be developed and implemented by the pharmacist-in-charge, with
the advice of the committee performing the pharmacy and therapeutics function
for the facility.
(ii) The written
policies and procedures for the drug distribution system shall include, but not
be limited to, procedures regarding the following:
(I) pharmaceutical care services;
(II) handling, storage and disposal of
cytotoxic drugs and waste;
(III)
disposal of unusable drugs and supplies;
(IV) security;
(V) equipment;
(VI) sanitation;
(VII) reference materials;
(VIII) drug selection and
procurement;
(IX) drug
storage;
(X) controlled
substances;
(XI) investigational
drugs, including the obtaining of protocols from the principal
investigator;
(XII) prepackaging
and manufacturing;
(XIII) stop
orders;
(XIV) reporting of
medication errors, adverse drug reactions/events, and drug product
defects;
(XV) physician
orders;
(XVI) floor
stocks;
(XVII) drugs brought into
the facility;
(XVIII) furlough
medications;
(XIX)
self-administration;
(XX) emergency
drug supply;
(XXI)
formulary;
(XXII) monthly
inspections of nursing stations and other areas where drugs are stored,
distributed, administered or dispensed;
(XXIII) control of drug samples;
(XXIV) outdated and other unusable
drugs;
(XXV) routine distribution
of patient medication;
(XXVI)
preparation and distribution of sterile preparations;
(XXVII) handling of medication orders when a
pharmacist is not on duty;
(XXVIII)
use of automated compounding or counting devices;
(XXIX) use of data processing and direct
imaging systems;
(XXX) drug
administration to include infusion devices and drug delivery systems;
(XXXI) drug labeling;
(XXXII) recordkeeping;
(XXXIII) quality assurance/quality
control;
(XXXIV) duties and
education and training of professional and nonprofessional staff;
(XXXV) procedures for a pharmacy technician
to verify the accuracy of work performed by another pharmacy technician, if
applicable;
(XXXVI) operation of
the pharmacy when a pharmacist in not on-site; and
(XXXVII) emergency preparedness plan, to
include continuity of patient therapy and public safety.
(6) Discharge
Prescriptions. Discharge prescriptions must be dispensed and labeled in
accordance with §
291.33 of this title (relating to
Operational Standards) except that certain medications packaged in unit-of-use
containers, such as metered-dose inhalers, insulin pens, topical creams or
ointments, or ophthalmic or otic preparation that are administered to the
patient during the time the patient was a patient in the hospital, may be
provided to the patient upon discharge provided the pharmacy receives a
discharge order and the product bears a label containing the following
information:
(A) name of the
patient;
(B) name and strength of
the medication;
(C) name of the
prescribing or attending practitioner;
(D) directions for use;
(E) duration of therapy (if applicable);
and
(F) name and telephone number
of the pharmacy.
(7)
Redistribution of Donated Prepackaged Prescription Drugs.
(A) A participating provider may dispense to
a recipient donated prescription drugs that are prepackaged and labeled in
accordance with §
442.0515,
Health and Safety Code, and this paragraph.
(B) Drugs may be prepackaged in quantities
suitable for distribution to a recipient only by a pharmacist or by pharmacy
technicians or pharmacy technician trainees under the direction and direct
supervision of a pharmacist.
(C)
The label of a prepackaged prescription drug a participating provider dispenses
to a recipient shall indicate:
(i) brand name
and strength of the drug; or if no brand name, then the generic name, strength,
and name of the manufacturer or distributor;
(ii) participating provider's lot
number;
(iii) participating
provider's beyond use date; and
(iv) quantity of the drug, if the quantity is
greater than one.
(D)
Records of prepackaged prescription drugs dispensed to a recipient shall be
maintained to show:
(i) name of the drug,
strength, and dosage form;
(ii)
participating provider's lot number;
(iii) manufacturer or distributor;
(iv) manufacturer's lot number;
(v) manufacturer's expiration date;
(vi) quantity per prepackaged unit;
(vii) number of prepackaged units;
(viii) date packaged;
(ix) name, initials, or written or electronic
signature of the prepacker; and
(x)
written or electronic signature of the responsible pharmacist.
(E) Stock packages, repackaged
units, and control records shall be quarantined together until checked/released
by the pharmacist.
(g) Pharmaceutical care services.
(1) The pharmacist-in-charge shall assure
that at least the following pharmaceutical care services are provided to
patients of the facility:
(A) Drug utilization
review. A systematic ongoing process of drug utilization review shall be
developed in conjunction with the medical staff to increase the probability of
desired patient outcomes and decrease the probability of undesired outcomes
from drug therapy.
(B) Drug regimen
review.
(i) For the purpose of promoting
therapeutic appropriateness, 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.
(ii) The drug regimen review shall be
conducted on a prospective basis when a pharmacist is on duty, except for an
emergency order, and on a retrospective basis as specified in subsection (e)(1)
or (e)(3) of this section when a pharmacist is not on duty.
(iii) Any questions regarding the order must
be resolved with the prescriber and a written notation of these discussions
made and maintained.
(iv) The drug
regimen review may be conducted by remotely accessing the pharmacy's electronic
data base from outside the pharmacy by an individual Texas licensed pharmacist
employee of the pharmacy, provided the pharmacy establishes controls to protect
the privacy of the patient and the security of confidential records.
(C) Education. The
pharmacist-in-charge in cooperation with appropriate multi-disciplinary staff
of the facility shall develop policies that assure that:
(i) the patient and/or patient's caregiver
receives information regarding drugs and their safe and appropriate use;
and
(ii) health care providers are
provided with patient specific drug information.
(D) Patient monitoring. The
pharmacist-in-charge in cooperation with appropriate multi-disciplinary staff
of the facility shall develop policies to ensure that the patient's response to
drug therapy is monitored and conveyed to the appropriate health care
provider.
(2) Other
pharmaceutical care services which may be provided by pharmacists in the
facility include, but are not limited to, the following:
(A) managing drug therapy as delegated by a
practitioner as allowed under the provisions of the Medical Practice
Act;
(B) administering
immunizations and vaccinations under written protocol of a physician;
(C) managing patient compliance
programs;
(D) providing
preventative health care services; and
(E) providing case management of patients who
are being treated with high-risk or high-cost drugs, or who are considered
"high risk" due to their age, medical condition, family history, or related
concern.
(h)
Emergency rooms.
(1) During the times a
pharmacist is on duty in the facility any prescription drugs supplied to an
outpatient, including emergency department patients, may only be dispensed by a
pharmacist.
(2) When a pharmacist
is not on duty in the facility, the following is applicable for supplying
prescription drugs to be taken home by the patient for self-administration from
the emergency room. If the patient has been admitted to the emergency room and
assessed by a practitioner at the hospital, the following procedures shall be
observed in supplying prescription drugs from the emergency room.
(A) Dangerous drugs and/or controlled
substances may only be supplied in accordance with the system of control and
accountability for dangerous drugs and/or controlled substances administered or
supplied from the emergency room; such system shall be developed and supervised
by the pharmacist-in-charge or staff pharmacist designated by the
pharmacist-in-charge.
(B) Only
dangerous drugs and/or controlled substances listed on the emergency room drug
list may be supplied; such list shall be developed by the pharmacist-in-charge
and the facility's emergency department committee (or like group or person
responsible for policy in that department) and shall consist of dangerous drugs
and/or controlled substances of the nature and type to meet the immediate needs
of emergency room patients.
(C)
Dangerous drugs and/or controlled substances may only be supplied in
prepackaged quantities not to exceed a 72-hour supply in suitable containers
and appropriately prelabeled (including necessary auxiliary labels) by the
institutional pharmacy.
(D) At the
time of delivery of the dangerous drugs and/or controlled substances, the
practitioner or licensed nurse under the supervision of a practitioner shall
appropriately complete the label with at least the following information:
(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 dangerous drug or controlled substance; or if no brand name, then the
generic name, strength, and the name of the manufacturer or distributor of the
dangerous drug or controlled substance;
(vii) quantity supplied; and
(viii) unique identification
number.
(E) The
practitioner, or a licensed nurse under the supervision of the practitioner,
shall give the appropriately labeled, prepackaged drug to the patient and
explain the correct use of the drug.
(F) A perpetual record of dangerous drugs
and/or controlled substances supplied from the emergency room shall be
maintained in the emergency room. Such record shall include the following:
(i) date supplied;
(ii) practitioner's name;
(iii) patient's name;
(iv) brand name and strength of the dangerous
drug or controlled substance; or if no brand name, then the generic name,
strength, and the name of the manufacturer or distributor of the dangerous drug
or controlled substance;
(v)
quantity supplied; and
(vi) unique
identification number.
(G) The pharmacist-in-charge, or staff
pharmacist designated by the pharmacist-in-charge, shall verify the correctness
of this record at least once every seven days.
(i) Radiology departments.
(1) During the times a pharmacist is on duty,
any prescription drugs dispensed to an outpatient, including radiology
department patients, may only be dispensed by a pharmacist.
(2) When a pharmacist is not on duty, the
following procedures shall be observed in supplying prescription drugs from the
radiology department.
(A) Prescription drugs
may only be supplied to patients who have been scheduled for an x-ray
examination at the facility.
(B)
Prescription drugs may only be supplied in accordance with the system of
control and accountability for prescription drugs administered or supplied from
the radiology department and supervised by the pharmacist-in-charge or staff
pharmacist designated by the pharmacist-in-charge.
(C) Only prescription drugs listed on the
radiology drug list may be supplied; such list shall be developed by the
pharmacist-in-charge and the facility's radiology committee (or like group or
persons responsible for policy in that department) and shall consist of drugs
for the preparation of a patient for a radiological procedure.
(D) Prescription drugs may only be supplied
in prepackaged quantities in suitable containers and prelabeled by the
institutional pharmacy with the following information:
(i) name and address of the
facility;
(ii) directions for
use;
(iii) name and strength of the
prescription drug--if generic name, the name of the manufacturer or distributor
of the prescription drug;
(iv)
quantity;
(v) facility's lot number
and expiration date; and
(vi)
appropriate ancillary label(s).
(E) At the time of delivery of the
prescription drug, the practitioner or practitioner's agent shall complete the
label with the following information:
(i)
date supplied;
(ii) name of
physician;
(iii) name of patient;
and
(iv) unique identification
number.
(F) The
practitioner or practitioner's agent shall give the appropriately labeled,
prepackaged prescription drug to the patient.
(G) A perpetual record of prescription drugs
supplied from the radiology department shall be maintained in the radiology
department. Such records shall include the following:
(i) date supplied;
(ii) practitioner's name;
(iii) patient's name;
(iv) brand name and strength of the
prescription drug; or if no brand name, then the generic name, strength, dosage
form, and the name of the manufacturer or distributor of the prescription
drug;
(v) quantity supplied;
and
(vi) unique identification
number.
(H) The
pharmacist-in-charge, or a pharmacist designated by the pharmacist-in-charge,
shall verify the correctness of this record at least once every seven
days.
(j)
Automated devices and systems.
(1) Automated
compounding or counting devices. If a pharmacy uses automated compounding or
counting devices:
(A) the pharmacy shall have
a method to calibrate and verify the accuracy of the automated compounding or
counting device and document the calibration and verification on a routine
basis;
(B) the devices may be
loaded with unlabeled drugs only by a pharmacist or by pharmacy technicians or
pharmacy technician trainees under the direction and direct supervision of a
pharmacist;
(C) the label of an
automated compounding or counting device container shall indicate the brand
name and strength of the drug; or if no brand name, then the generic name,
strength, and name of the manufacturer or distributor;
(D) records of loading unlabeled drugs into
an automated compounding or counting device shall be maintained to show:
(i) name of the drug, strength, and dosage
form;
(ii) manufacturer or
distributor;
(iii) manufacturer's
lot number;
(iv) expiration
date;
(v) date of
loading;
(vi) name, initials, or
electronic signature of the person loading the automated compounding or
counting device; and
(vii)
signature or electronic signature of the responsible pharmacist; and
(E) the automated compounding or
counting device shall not be used until a pharmacist verifies that the system
is properly loaded and affixes his or her signature to the record specified in
subparagraph (D) of this paragraph.
(2) Automated medication supply systems.
(A) Authority to use automated medication
supply systems. A pharmacy may use an automated medication supply system to
fill medication orders provided that:
(i) the
pharmacist-in-charge is responsible for the supervision of the operation of the
system;
(ii) the automated
medication supply system has been tested by the pharmacy and found to dispense
accurately. The pharmacy shall make the results of such testing available to
the Board upon request; and
(iii)
the pharmacy will make the automated medication supply system available for
inspection by the board for the purpose of validating the accuracy of the
system.
(B) Quality
assurance program. A pharmacy which uses an automated medication supply system
to fill medication orders shall operate according to a written program for
quality assurance of the automated medication supply system which:
(i) requires continuous monitoring of the
automated medication supply system; and
(ii) establishes mechanisms and procedures to
test the accuracy of the automated medication supply system at least every six
months and whenever any upgrade or change is made to the system and documents
each such activity.
(C)
Policies and procedures of operation.
(i)
When an automated medication supply system is used to store or distribute
medications for administration pursuant to medication orders, it shall be
operated according to written policies and procedures of operation. The
policies and procedures of operation shall establish requirements for operation
of the automated medication supply system and shall describe policies and
procedures that:
(I) include a description of
the policies and procedures of operation;
(II) provide for a pharmacist's review and
approval of each original or new medication order prior to withdrawal from the
automated medication supply system:
(-a-)
before the order is filled when a pharmacist is on duty except for an emergency
order;
(-b-) retrospectively within
72 hours in a facility with a full-time pharmacist when a pharmacist is not on
duty at the time the order is made; or
(-c-) retrospectively within 7 days in a
facility with a part-time or consultant pharmacist when a pharmacist is not on
duty at the time the order is made;
(III) provide for access to the automated
medication supply system for stocking and retrieval of medications which is
limited to licensed healthcare professionals, pharmacy technicians, or pharmacy
technician trainees acting under the supervision of a pharmacist;
(IV) provide that a pharmacist is responsible
for the accuracy of the restocking of the system. The actual restocking may be
performed by a pharmacy technician or pharmacy technician trainee;
(V) provide for an accountability record to
be maintained which documents all transactions relative to stocking and
removing medications from the automated medication supply system;
(VI) require a prospective or retrospective
drug regimen review is conducted as specified in subsection (g) of this
section; and
(VII) establish and
make provisions for documentation of a preventative maintenance program for the
automated medication supply system.
(ii) A pharmacy which uses an automated
medication supply system to fill medication orders shall, at least annually,
review its written policies and procedures, revise them if necessary, and
document the review.
(D)
Automated medication supply systems used for storage and recordkeeping of
medications located outside of the pharmacy department (e.g., Pyxis). A
pharmacy technician or pharmacy technician trainee may restock an automated
medication supply system located outside of the pharmacy department with
prescription drugs provided:
(i) prior to
distribution of the prescription drugs a pharmacist verifies that the
prescription drugs pulled to stock the automated supply system match the list
of prescription drugs generated by the automated medication supply system
except as specified in §
291.73(e)(2)(C)(ii)
of this title; or
(ii) all of the following occur:
(I) the prescription drugs to restock the
system are labeled and verified with a machine readable product identifier,
such as a barcode;
(II) either:
(-a-) the drugs are in tamper evident product
packaging, packaged by an FDA registered repackager or manufacturer, that is
shipped to the pharmacy; or
(-b-)
if any manipulation of the product occurs in the pharmacy prior to restocking,
such as repackaging or extemporaneous compounding, the product must be checked
by a pharmacist; and
(III) quality assurance audits are conducted
according to established policies and procedures to ensure accuracy of the
process.
(E)
Recovery Plan. A pharmacy which uses an automated medication supply system to
store or distribute medications for administration pursuant to medication
orders shall maintain a written plan for recovery from a disaster or any other
situation which interrupts the ability of the automated medication supply
system to provide services necessary for the operation of the pharmacy. The
written plan for recovery shall include:
(i)
planning and preparation for maintaining pharmacy services when an automated
medication supply system is experiencing downtime;
(ii) procedures for response when an
automated medication supply system is experiencing downtime;
(iii) procedures for the maintenance and
testing of the written plan for recovery; and
(iv) procedures for notification of the Board
and other appropriate agencies whenever an automated medication supply system
experiences downtime for more than two days of operation or a period of time
which significantly limits the pharmacy's ability to provide pharmacy
services.
(3)
Verification of medication orders prepared by the pharmacy department through
the use of an automated medication supply system. A pharmacist must check drugs
prepared pursuant to medication orders to ensure that the drug is prepared for
distribution accurately as prescribed. This paragraph does not apply to
automated medication supply systems used for storage and recordkeeping of
medications located outside of the pharmacy department.
(A) This check shall be considered
accomplished if:
(i) a check of the final
product is conducted by a pharmacist after the automated system has completed
preparation of the medication order and prior to delivery to the patient;
or
(ii) the following checks are
conducted by a pharmacist:
(I) if the
automated medication supply system contains unlabeled stock drugs, a pharmacist
verifies that those drugs have been accurately stocked; and
(II) a pharmacist checks the accuracy of the
data entry of each original or new medication order entered into the automated
medication supply system before the order is filled.
(B) If the final check is
accomplished as specified in subparagraph (A)(ii) of this paragraph, the
following additional requirements must be met.
(i) The medication order preparation process
must be fully automated from the time the pharmacist releases the medication
order to the automated system until a completed medication order, ready for
delivery to the patient, is produced.
(ii) The pharmacy has conducted initial
testing and has a continuous quality assurance program which documents that the
automated medication supply system dispenses accurately as specified in
paragraph (2)(A) and (B) of this subsection.
(iii) The automated medication supply system
documents and maintains:
(I) the name(s),
initials, or identification code(s) of each pharmacist responsible for the
checks outlined in subparagraph (A)(ii) of this paragraph; and
(II) the name(s), initials, or identification
code(s) and specific activity(ies) of each pharmacist or pharmacy technician or
pharmacy technician trainee who performs any other portion of the medication
order preparation process.
(iv) The pharmacy establishes mechanisms and
procedures to test the accuracy of the automated medication supply system at
least every month rather than every six months as specified in paragraph (2)(B)
of this subsection.
(4) Automated checking device.
(A) For the purpose of this subsection, an
automated checking device is a fully automated device which confirms, after a
drug is prepared for distribution but prior to delivery to the patient, that
the correct drug and strength has been labeled with the correct label for the
correct patient.
(B) The final
check of a drug prepared pursuant to a medication order shall be considered
accomplished using an automated checking device provided:
(i) a check of the final product is conducted
by a pharmacist prior to delivery to the patient or the following checks are
performed by a pharmacist:
(I) the prepackaged
drug used to fill the order is checked by a pharmacist who verifies that the
drug is labeled and packaged accurately; and
(II) a pharmacist checks the accuracy of each
original or new medication order.
(ii) the medication order is prepared,
labeled, and made ready for delivery to the patient in compliance with Class C
(Institutional) pharmacy rules; and
(iii) prior to delivery to the patient:
(I) the automated checking device confirms
that the correct drug and strength has been labeled with the correct label for
the correct patient; and
(II) a
pharmacist performs all other duties required to ensure that the medication
order has been prepared safely and accurately as prescribed.
(C) If the final check
is accomplished as specified in subparagraph (B) of this paragraph, the
following additional requirements must be met.
(i) The pharmacy has conducted initial
testing of the automated checking device and has a continuous quality assurance
program which documents that the automated checking device accurately confirms
that the correct drug and strength has been labeled with the correct label for
the correct patient.
(ii) The
pharmacy documents and maintains:
(I) the
name(s), initials, or identification code(s) of each pharmacist responsible for
the checks outlined in subparagraph (B)(i) of this paragraph; and
(II) the name(s), initials, or identification
code(s) and specific activity(ies) of each pharmacist, pharmacy technician, or
pharmacy technician trainee who performs any other portion of the medication
order preparation process.
(iii) The pharmacy establishes mechanisms and
procedures to test the accuracy of the automated checking device at least
monthly.
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.