Section 1753 - Furnishing to Home Health Agencies and Licensed HospicesSubject to the following conditions, a licensed pharmacy may furnish to a home health agency licensed under provisions of Chapter 8 (commencing with section 1725 of Division 2 of the Health and Safety Code) or to a hospice licensed under provisions of Chapter 8.5 (commencing with section 1745 of Division 2 of the Health and Safety Code) dangerous drugs for parenteral therapy other than controlled substances, in a portable container for furnishing to patients at home for emergency treatment or adjustment of parenteral drug therapy by the home health agency or licensed hospice.
(a) The pharmacy, having ownership and responsibility for the portable containers, shall ensure that each portable container is: (1) furnished by a registered pharmacist;(2) sealed in such a manner that a tamper-proof seal must be broken to gain access to the drugs;(3) under the effective control of a registered nurse, pharmacist or delivery person at all times when not in the pharmacy;(4) labeled on the outside of the container with a list of the contents;(5) maintained at an appropriate temperature according to United States Pharmacopeia Standards (1995, 23rd Revision), and protected at all times from extreme temperatures that could damage the contents.(b) The portable container may contain up to:(1) 1000mL of 0.9% sodium chloride intravenous infusion in containers of a size determined by the pharmacy;(2) 1000mL of 5% dextrose in water injection in containers of a size determined by the pharmacy;(3) two vials of urokinase 5000 units;(4) Each of the following items shall be in sealed, unused containers; the furnishing pharmacy may select any or all of these dangerous drugs in up to five dosage units for inclusion in the sealed, portable container: (A) heparin sodium lock flush 100 units/mL;(B) heparin sodium lock flush 10 units/mL;(C) epinephrine HCl solution 1:1,000;(D) epinephrine HCl solution 1:10,000;(E) diphenhydramine HCl 50mg/mL;(F) methylprednisolone 125mg/2mL;(G) normal saline, preserved, up to 30 mL vials;(H) naloxone 1mg/mL 2 mL;(J) prochlorperazine 10mg/2mL;(K) promethazine 25mg/mL;(N) insulin (human) 100 units/mL;(O) bumetamide 0.5mg/2mL;(Q) EMLA Cream 5 gm tube;(R) Lidocaine 1 percent 30mL vials.(5) The pharmacy shall ensure that the specific dangerous drugs and quantities to be included in the portable container are listed in the home health agency's or licensed hospice's policies and procedures.(c) The pharmacy shall not supply a portable container to a home health agency or licensed hospice which does not: (1) implement and maintain policies and procedures for:(A) the storage, temperature stability and transportation of the portable container;(B) the furnishing of dangerous drugs from the portable container upon the written or oral authorization of a prescriber; and(C) a specific treatment protocol for the administration of each medication contained in the portable container.(2) have the policies, procedures and protocols reviewed and revised (as needed) annually by a group of professional personnel including a physician and surgeon, a pharmacist and a registered nurse.(d) A copy of these policies, procedures and protocols shall be maintained by the furnishing pharmacy from each home health agency or licensed hospice for which the pharmacy furnishes portable containers.(e) In cases where a drug has been administered to a patient pursuant to the oral order of a licensed prescriber, the pharmacy shall ensure that the oral order is immediately written down by the registered nurse or pharmacist and communicated by copy or fax within 24 hours to the furnishing pharmacy, with a copy of the prescriber-signed document forwarded to the dispensing pharmacy within 20 days.(f) The pharmacy shall ensure that within seven days (168 hours) after the seal has been broken on the portable container, the home health agency's director of nursing service or a registered nurse employed by the home health agency or licensed hospice returns the container to the furnishing pharmacy. The furnishing pharmacy shall then perform an inventory of the drugs used from the container, and if the container will be reused, must restock and reseal the container before it is again furnished to the home health agency or licensed hospice.(g) The furnishing pharmacy shall have written policies and procedures for the contents, packaging, inventory monitoring, labeling and storage instructions of the portable container.(h) The furnishing pharmacy shall ensure that the home health agency or licensed hospice returns the portable containers to the furnishing pharmacy at least every 60 days for verification of product quality, quantity, integrity and expiration dates, or within seven days (168 hours) after the seal has been broken.(i) The furnishing pharmacy shall maintain a current inventory and record of all items placed into and furnished from the portable container.Cal. Code Regs. Tit. 16, § 1753
1. Renumbering of former section 1751.11 to new section 1753, including amendment of subsection (b)(5), filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38). Note: Authority cited: Sections 4005 and 4057, Business and Professions Code. Reference: Sections 4040, 4057, 4081 and 4332, Business and Professions Code.
1. Renumbering of former section 1751.11 to new section 1753, including amendment of subsection (b)(5), filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).