An agency that possesses sterile water or saline, certain vaccines
or tuberculin, or certain dangerous drugs, as specified by this section,
must comply with the provisions of this section.
(1) Possession of sterile water or saline. An agency
or its employees, who are RNs or LVNs, may purchase, store, or transport
for the purpose of administering to their home health or hospice clients
under physician's orders:
(A) sterile water for injection and irrigation; and
(B) sterile saline for injection and irrigation.
(2) Possession of certain vaccines or tuberculin.
(A) An agency or its employees, who are RNs or LVNs,
may purchase, store, or transport for administering to the agency's
employees, home health or hospice clients, or client family and household
members under physician's standing orders the following dangerous
drugs:
(i) hepatitis B vaccine;
(ii) influenza vaccine;
(iii) tuberculin purified protein derivative for tuberculosis
testing;
(iv) pneumococcal polysaccharide vaccine; and
(v) any other vaccine approved, authorized for emergency
use, or otherwise permitted for use by the United States Food and
Drug Administration to treat or mitigate the spread of a communicable
disease, as defined by Texas Health and Safety Code §81.003.
(B) An agency that purchases, stores, or transports
a vaccine or tuberculin under this section must ensure that any standing
order for the vaccine or tuberculin:
(i) is signed and dated by the physician;
(ii) identifies the vaccine or tuberculin covered by
the order;
(iii) indicates that the recipient of the vaccine or
tuberculin has been assessed as an appropriate candidate to receive
the vaccine or tuberculin and has been assessed for the absence of
any contraindication;
(iv) indicates that appropriate procedures are established
for responding to any negative reaction to the vaccine or tuberculin;
and
(v) orders that a specific medication or category of
medication be administered if the recipient has a negative reaction
to the vaccine or tuberculin.
(C) An agency or the agency's authorized employees
may purchase, store, or transport vaccines or tuberculin in a sealed
portable container only if the agency has established policies and
procedures to ensure that:
(i) the container is handled properly with respect
to storage, transportation, and temperature stability according to
manufacturer's instructions; and
(ii) the agency adheres to guidance from the Centers
for Disease Control and Prevention and the Texas Health and Human
Services Commission.
(3) Possession of certain dangerous drugs.
(A) In compliance with Texas Health and Safety Code §142.0063,
an agency or its employees, who are RNs or LVNs, may purchase, store,
or transport for the purpose of administering to their home health
or hospice patients, in accordance with subparagraph (C) of this paragraph,
the following dangerous drugs:
(i) any of the following items in a sealed portable
container of a size determined by the dispensing pharmacist:
(I) 1,000 milliliters of 0.9 percent sodium chloride
intravenous infusion;
(II) 1,000 milliliters of 5.0 percent dextrose in water
injection; or
(III) sterile saline; or
(ii) not more than five dosage units of any of the
following items in an individually sealed, unused portable container:
(I) heparin sodium lock flush in a concentration of
10 units per milliliter or 100 units per milliliter;
(II) epinephrine HCI solution in a concentration of
one to 1,000;
(III) diphenhydramine HCI solution in a concentration
of 50 milligrams per milliliter;
(IV) methylprednisolone in a concentration of 125 milligrams
per two milliliters;
(V) naloxone in a concentration of one milligram per
milliliter in a two-milliliter vial;
(VI) promethazine in a concentration of 25 milligrams
per milliliter;
(VII) glucagon in a concentration of one milligram
per milliliter;
(VIII) furosemide in a concentration of 10 milligrams
per milliliter;
(IX) lidocaine 2.5 percent and prilocaine 2.5 percent
cream in a five-gram tube; or
(X) lidocaine HCL solution in a concentration of 1
percent in a two-milliliter vial.
(B) An agency or the agency's authorized employees
may purchase, store, or transport dangerous drugs in a sealed portable
container only if the agency has established policies and procedures
to ensure that:
(i) the container is handled properly with respect
to storage, transportation, and temperature stability;
(ii) a drug is removed from the container only on a
physician's written or oral order;
(iii) the administration of any drug in the container
is performed in accordance with a specific treatment protocol; and
(iv) the agency maintains a written record of the dates
and times the container is in the possession of an RN or LVN.
(C) An agency or the agency's authorized employee who
administers a drug listed in subparagraph (A) of this paragraph may
administer the drug only in the client's residence, under physician's
orders, in connection with the provision of emergency treatment or
the adjustment of:
(i) parenteral drug therapy; or
(ii) vaccine or tuberculin administration.
(D) If an agency or the agency's authorized employee
administers a drug listed in subparagraph (A) of this paragraph, pursuant
to a physician's oral order, the agency must receive a signed copy
of the order:
(i) not later than 24 hours after receipt of the order,
reduce the order to written form and send a copy of the form to the
dispensing pharmacy by mail or fax transmission; and
(ii) not later than 20 days after receipt of the order,
send a copy of the order, as signed by and received from the physician,
to the dispensing pharmacy.
(E) A pharmacist that dispenses a sealed portable container
under this subsection will ensure that the container:
(i) is designed to allow access to the contents of
the container only if a tamper-proof seal is broken;
(ii) bears a label that lists the drugs in the container
and provides notice of the container's expiration date, which is the
earlier of:
(I) the date that is six months after the date on which
the container is dispensed; or
(II) the earliest expiration date of any drug in the
container; and
(iii) remains in the pharmacy or under the control
of a pharmacist, RN, or LVN.
(F) If an agency or the agency's authorized employee
purchases, stores, or transports a sealed portable container under
this subsection, the agency must deliver the container to the dispensing
pharmacy for verification of drug quality, quantity, integrity, and
expiration dates not later than the earlier of:
(i) the seventh day after the date on which the seal
on the container is broken; or
(ii) the date for which notice is provided on the container
label.
(G) A pharmacy that dispenses a sealed portable container
under this section is required to take reasonable precautionary measures
to ensure that the agency receiving the container complies with subparagraph
(F) of this paragraph. On receipt of a container under subparagraph
(F) of this paragraph, the pharmacy will perform an inventory of the
drugs used from the container and will restock and reseal the container
before delivering the container to the agency for reuse.
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| Source Note: The provisions of this §558.303 adopted to be effective February 1, 2002, 26 TexReg 9159; amended to be effective October 15, 2003, 28 TexReg 8955; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427; amended to be effective June 1, 2022, 47 TexReg 3143 |
