| (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;
(iii) the drug is not in the possession of the ultimate
user prior to administration;
(iv) the pharmacist-in-charge has determined that the
institution:
(I) maintains medication administration records which
include adequate directions for use for the drug(s) prescribed;
(II) maintains records of ordering, receipt, and administration
of the drug(s); and
(III) provides for appropriate safeguards for the control
and storage of the drug(s); and
(v) the dispensing container bears a label that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) name and strength of each drug product dispensed;
(-c-) name of the patient; and
(-d-) name of the prescribing practitioner of each
drug product, or the pharmacist who signed the prescription drug order;
(II) 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; and
(III) for each drug product sets forth the directions
for use and cautionary statements, if any, contained on the prescription
drug order or required by law.
(3) Labeling. The patient med-pak shall be accompanied
by a patient package insert, in the event that any drug contained
therein is required to be dispensed with such insert as accompanying
labeling. Alternatively, such required information may be incorporated
into a single, overall educational insert provided by the pharmacist
for the total patient med-pak.
(4) Packaging. In the absence of more stringent packaging
requirements for any of the drug products contained therein, each
container of the patient med-pak shall comply with official packaging
standards. Each container shall be either not reclosable or so designed
as to show evidence of having been opened.
Cont'd... |
