| (H) An FEMCF pharmacy, which also operates another
type of pharmacy which would otherwise be required to be licensed
under the Act, §560.051(a)(1), concerning community pharmacy
(Class A), is not required to secure a license for the other type
of pharmacy; provided, however, such license is required to comply
with the provisions of §291.31 of this title (relating to Definitions), §291.32
of this title (relating to Personnel), §291.33 of this title
(relating to Operational Standards), §291.34 of this title (relating
to Records), and §291.35 of this title (relating to Official
Prescription Requirements), to the extent such sections are applicable
to the operation of the pharmacy.
(I) An FEMCF pharmacy engaged in the compounding of
non-sterile preparations shall comply with the provisions of §291.131
of this title.
(2) Environment.
(A) General requirements.
(i) Each FEMCF shall have a designated work area separate
from patient areas, and which shall have space adequate for the size
and scope of pharmaceutical services and shall have adequate space
and security for the storage of drugs.
(ii) The FEMCF pharmacy shall be arranged in an orderly
fashion and shall be kept clean. All required equipment shall be clean
and in good operating condition.
(B) Special requirements.
(i) The FEMCF pharmacy shall have locked storage for
Schedule II controlled substances and other controlled drugs requiring
additional security.
(ii) The FEMCF pharmacy shall have a designated area
for the storage of poisons and externals separate from drug storage
areas.
(C) Security.
(i) The pharmacy and storage areas for prescription
drugs and/or devices shall be enclosed and capable of being locked
by key, combination, or other mechanical or electronic means, so as
to prohibit access by unauthorized individuals. Only individuals authorized
by the pharmacist-in-charge may enter the pharmacy or have access
to storage areas for prescription drugs and/or devices.
(ii) The pharmacist-in-charge shall consult with FEMCF
personnel with respect to security of the drug storage areas, including
provisions for adequate safeguards against theft or diversion of dangerous
drugs, controlled substances, and records for such drugs.
(iii) The pharmacy shall have locked storage for Schedule
II controlled substances and other drugs requiring additional security.
(3) Equipment and supplies. FEMCFs supplying drugs
for outpatient use shall have the following equipment and supplies:
(A) data processing system including a printer or comparable
equipment;
(B) adequate supply of child-resistant, moisture-proof,
and light-proof containers; and
(C) adequate supply of prescription labels and other
applicable identification labels.
(4) Library. A reference library shall be maintained
that includes the following in hard copy or electronic format and
that pharmacy personnel shall be capable of accessing at all times:
(A) current copies of the following:
(i) Texas Pharmacy Act and rules;
(ii) Texas Dangerous Drug Act and rules;
(iii) Texas Controlled Substances Act and rules; and
(iv) Federal Controlled Substances Act and rules or
official publication describing the requirements of the Federal Controlled
Substances Act and rules;
(B) at least one current or updated general drug information
reference which is required to contain drug interaction information
including information needed to determine severity or significance
of the interaction and appropriate recommendations or actions to be
taken; and
(C) basic antidote information and the telephone number
of the nearest regional poison control center.
(5) Drugs.
(A) Procurement, preparation, and storage.
(i) The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from
other appropriate staff of the facility, relative to such responsibility.
(ii) The pharmacist-in-charge shall have the responsibility
for determining specifications of all drugs procured by the facility.
(iii) FEMCF pharmacies may not sell, purchase, trade,
or possess prescription drug samples, unless the pharmacy meets the
requirements as specified in §291.16 of this title (relating
to Samples).
(iv) All drugs shall be stored at the proper temperatures,
as defined in the USP/NF and in §291.15 of this title (relating
to Storage of Drugs).
(v) Any drug bearing an expiration date may not be
dispensed or distributed beyond the expiration date of the drug.
(vi) Outdated drugs shall be removed from dispensing
stock and shall be quarantined together until such drugs are disposed
of.
(B) Formulary.
(i) A formulary may be developed by an appropriate
committee of the FEMCF.
(ii) The pharmacist-in-charge, consultant pharmacist,
or designee shall be a full voting member of any committee which involves
pharmaceutical services.
(iii) A practitioner may grant approval for pharmacists
at the FEMCF to interchange, in accordance with the facility's formulary,
for the drugs on the practitioner's medication orders provided:
(I) a formulary has been developed;
(II) the formulary has been approved by the medical
staff of the FEMCF;
(III) there is a reasonable method for the practitioner
to override any interchange; and
(IV) the practitioner authorizes a pharmacist in the
FEMCF to interchange on his/her medication orders in accordance with
the facility's formulary through his/her written agreement to abide
by the policies and procedures of the medical staff and facility.
(C) Prepackaging and loading drugs into automated medication
supply system.
(i) Prepackaging of drugs.
(I) Drugs may be prepackaged in quantities suitable
for internal distribution only by a pharmacist or by pharmacy technicians
or pharmacy technician trainees under the direction and direct supervision
of a pharmacist.
(II) The label of a prepackaged unit shall indicate:
(-a-) brand name and strength of the drug; or if no
brand name, then the generic name, strength, and name of the manufacturer
or distributor;
(-b-) facility's lot number;
(-c-) expiration date; and
(-d-) quantity of the drug, if quantity is greater
than one.
(III) Records of prepackaging shall be maintained to
show:
(-a-) the name of the drug, strength, and dosage form;
(-b-) facility's lot number;
(-c-) manufacturer or distributor;
(-d-) manufacturer's lot number;
(-e-) expiration date;
(-f-) quantity per prepackaged unit;
(-g-) number of prepackaged units;
(-h-) date packaged;
(-i-) name, initials, or electronic signature of the
prepacker; and
(-j-) signature or electronic signature of the responsible
pharmacist.
(IV) Stock packages, repackaged units, and control
records shall be quarantined together until checked/released by the
pharmacist.
(ii) Loading bulk unit of use drugs into automated
medication supply systems. Automated medication supply systems may
be loaded with bulk unit of use drugs only by a pharmacist, by pharmacy
technicians or pharmacy technician trainees under the direction and
direct supervision of a pharmacist, or by a licensed nurse who is
authorized by the pharmacist to perform the loading of the automated
medication supply system. For the purpose of this clause, direct supervision
may be accomplished by physically present supervision or electronic
monitoring by a pharmacist. In order for the pharmacist to electronically
monitor, the medication supply system must allow for bar code scanning
to verify the loading of drugs, and a record of the loading must be
maintained by the system and accessible for electronic review by the
pharmacist.
(6) Medication orders.
(A) Drugs may be administered to patients in FEMCFs
only on the order of a practitioner. No change in the order for drugs
may be made without the approval of a practitioner except as authorized
by the practitioner in compliance with paragraph (5)(B) of this subsection.
(B) Drugs may be distributed only pursuant to the copy
of the practitioner's medication order.
Cont'd... |
