| (6) metric-apothecary weight and measure conversion
charts.
(e) Library. A reference library shall be maintained
which includes the following in hard-copy or electronic format:
(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 rules; and
(D) Federal Controlled Substances Act and rules (or
official publication describing the requirements of the Federal Controlled
Substances Act and rules);
(2) at least one current or updated reference from
each of the following categories:
(A) a patient prescription drug information reference
text or leaflets which are designed for the patient and must be available
to the patient;
(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) if the pharmacy dispenses veterinary prescriptions,
a general reference text on veterinary drugs; and
(3) basic antidote information and the telephone number
of the nearest Regional Poison Control Center.
(f) Drugs.
(1) Procurement 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 relative to such responsibility.
(B) Prescription drugs and devices and nonprescription
Schedule V controlled substances shall be stored within the prescription
department or a locked storage area.
(C) All drugs shall be stored at the proper temperature,
as defined in the USP/NF and §291.15 of this title (relating
to Storage of Drugs).
(2) Out-of-date drugs or devices.
(A) Any drug or device bearing an expiration date shall
not be dispensed beyond the expiration date of the drug or device.
(B) Outdated drugs or devices shall be removed from
dispensing stock and shall be quarantined together until such drugs
or devices are disposed of properly.
(3) Nonprescription Schedule V controlled substances.
(A) Schedule V controlled substances containing codeine,
dihydrocodeine, or any of the salts of codeine or dihydrocodeine may
not be distributed without a prescription drug order from a practitioner.
(B) A pharmacist may distribute nonprescription Schedule
V controlled substances which contain no more than 15 milligrams of
opium per 29.5729 ml or per 28.35 Gm provided:
(i) such distribution is made only by a pharmacist;
a nonpharmacist employee may not distribute a nonprescription Schedule
V controlled substance even if under the supervision of a pharmacist;
however, after the pharmacist has fulfilled professional and legal
responsibilities, the actual cash, credit transaction, or delivery
may be completed by a nonpharmacist:
(ii) not more than 240 ml (eight fluid ounces), or
not more than 48 solid dosage units of any substance containing opium,
may be distributed to the same purchaser in any given 48-hour period
without a prescription drug order;
(iii) the purchaser is at least 18 years of age; and
(iv) the pharmacist requires every purchaser not known
to the pharmacist to furnish suitable identification (including proof
of age where appropriate).
(C) A record of such distribution shall be maintained
by the pharmacy in a bound record book. The record shall contain the
following information:
(i) true name of the purchaser;
(ii) current address of the purchaser;
(iii) name and quantity of controlled substance purchased;
(iv) date of each purchase; and
(v) signature or written initials of the distributing
pharmacist.
(4) Class A 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).
(g) Prepackaging of drugs.
(1) 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.
(2) 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) facility's beyond use date; and
(D) quantity of the drug, if the quantity is greater
than one.
(3) Records of prepackaging shall be maintained to
show:
(A) name of the drug, strength, and dosage form;
(B) facility's lot number;
(C) manufacturer or distributor;
(D) manufacturer's lot number;
(E) manufacturer's 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.
(4) Stock packages, repackaged units, and control records
shall be quarantined together until checked/released by the pharmacist.
(h) Customized patient medication packages.
(1) Purpose. In lieu of dispensing two or more prescribed
drug products in separate containers, a pharmacist may, with the consent
of the patient, the patient's caregiver, or the prescriber, provide
a customized patient medication package (patient med-pak).
(2) Label.
(A) The patient med-pak shall bear a label stating:
(i) the name of the patient;
(ii) the unique identification number for the patient
med-pak itself and a separate unique identification number for each
of the prescription drug orders for each of the drug products contained
therein;
(iii) the name, strength, physical description or identification,
and total quantity of each drug product contained therein;
(iv) the directions for use and cautionary statements,
if any, contained in the prescription drug order for each drug product
contained therein;
(v) if applicable, a warning of the potential harmful
effect of combining any form of alcoholic beverage with any drug product
contained therein;
(vi) any storage instructions or cautionary statements
required by the official compendia;
(vii) the name of the prescriber of each drug product;
(viii) the name, address, and telephone number of the
pharmacy;
(ix) the initials or an identification code of the
dispensing pharmacist;
(x) the date after which the prescription should not
be used or beyond-use-date. Unless otherwise specified by the manufacturer,
the beyond-use-date shall be one year from the date the med-pak is
dispensed or the earliest manufacturer's expiration date for a product
contained in the med-pak if it is less than one-year from the date
dispensed. The beyond-use-date may be placed on the prescription label
or on a flag label attached to the bottle. A beyond-use-date is not
required on the label of a prescription dispensed to a person at the
time of release from prison or jail if the prescription is for not
more than a 10-day supply of medication;
(xi) either on the prescription label or the written
information accompanying the prescription, the statement "Do not flush
unused medications or pour down a sink or drain." A drug product on
a list developed by the Federal Food and Drug Administration of medicines
recommended for disposal by flushing is not required to bear this
statement; and
(xii) any other information, statements, or warnings
required for any of the drug products contained therein.
(B) If the patient med-pak allows for the removal or
separation of the intact containers therefrom, each individual container
shall bear a label identifying each of the drug product contained
therein.
(C) The dispensing container is not required to bear
the label as specified in subparagraph (A) of this paragraph if:
(i) the drug is prescribed for administration to an
ultimate user who is institutionalized in a licensed health care institution
(e.g., nursing home, hospice, hospital);
(ii) no more than a 90-day supply is dispensed at one
time;
Cont'd... |
