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.