HB 446 — An Act amending the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act, in licensing of health care facilities, providing for medication offered to patient.

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20212439 THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL Session of No.

446 2025 INTRODUCED BY SANCHEZ, KHAN, GUENST, GIRAL, PIELLI, HOWARD, DONAHUE, HADDOCK, HILL-EVANS, FREEMAN, FLEMING, CIRESI, CERRATO, GREEN, VENKATVENKAT, FRANKEL, BURGOS AND FRANKEL,SHAFFER,SI, FEBRUARY 3, 2025 AS REPORTEDOCTOBER FROM8, COMMITTEE2025ND ONCONSIDERATION, HEALTH, HOUSE OF REPRESENTATIVES, AS AMENDED, JUNE 25, 2025 AN ACT Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An act relating to health care;

prescribing the powers and providing the powers and duties of the State Healthd Coordinating Council, health systems agencies and Health Care Policy Board in the Department of Health,Health; and State Health Facility Hearing Board in the Department of Justice;

establishing and providing the powers and duties of the State Health Coordinating Council, health systems agencies and Health Care Policy Board in the Department of Health, and State Health providing for certification of need of health care providers and prescribing penalties," in licensing of health care facilities, providing for medication offered to patient.

(a) General rule.--For a facility-provided medication administered to a patient during an episode of care in a healthhospital <--or careambulatory HOSPITALsurgical OR AMBULATORY SURGICAL facility, any UNUSEDunused <-- portion of the medication billed to the patient or that iswould unusedotherwise <--be discarded after partial use during the episode of care shall be offered to the patient at no additional charge upon discharge whenif: the medication may be required for continuing treatment.

(b)(1) Facilityoffering option.--For a facility-provided medication administered to a patient during an episode of care in a health care facility, any portion of the medication that is unused that would otherwise be wasted shall be offered to the patient atmeets no additional charge upon discharge when the medicationprescriber's isstandard requiredof forcare; continuing treatment.

(c)and Labeling.--A(2) facility-provided medication shall be labeled consistent with labeling requirements under the actprescriber ofdetermines Septemberthat 27, 1961 (P.L.1700, No.699), known as the "Pharmacy Act." (d) Counseling waived.--If a facility-provided medication is usedrequired infor ancontinuing operatingtreatment. room or emergency department setting, the prescriber shall counsel the patient on the medication's proper use and administration and the requirements of pharmacist counseling shall be waived.

OR(b) THATDuties WOULDwhen OTHERWISEdispensing BEmedication.--Notwithstanding DISCARDEDany <--other AFTERprovision PARTIALof USElaw, DURINGwhen THEa EPISODEfacility-provided OFmedication CAREis SHALLdispensed BEin OFFEREDaccordance TOwith THEsubsection PATIENT(a), ATthe NOfollowing ADDITIONALapply: CHARGE UPON DISCHARGE IF:

(1) OFFERINGA THEfacility-provided MEDICATIONmedication TOthat THEcontains PATIENTa MEETSlabel THEwith PRESCRIBER'Sthe STANDARDsame OFinformation CARE;used during institutional administration as required under 49 Pa.

ANDCode (2)§ THE27.18(v) PRESCRIBER(relating DETERMINESto THATstandards THEof FACILITY-PROVIDEDpractice) MEDICATIONshall ISfulfill REQUIREDthe FORlabeling CONTINUINGrequirements TREATMENT.under the act of September 27, 1961 (P.L.1700, No.699), known as the "Pharmacy Act," the act of April 14, 1972 (P.L.233, No.64), known as "The Controlled Substance, Drug, Device and Cosmetic Act," or regulations promulgated by the State Board of Pharmacy.

(B)(2) DUTIES WHEN DISPENSING MEDICATION.--NOTWITHSTANDING ANY OTHER PROVISION OF LAW, WHEN A FACILITY-PROVIDEDprescriber MEDICATIONmay ISfulfill DISPENSEDthe INpharmacist ACCORDANCEcounseling WITHrequirements SUBSECTIONunder (A),49 THEPa. FOLLOWING APPLY:

(1)Code A§ FACILITY-PROVIDED27.19(d) MEDICATIONor THAT(e) CONTAINS(relating Ato LABELprospective WITHdrug THEreview SAMEand INFORMATIONpatient USEDcounseling) DURINGby INSTITUTIONALoffering ADMINISTRATIONto AScounsel REQUIREDor UNDERby 49counseling PA.a patient or caregiver in accordance with the regulation.

CODE(3) §A 27.18(V)hospital 20250HB0446PN2021or -ambulatory 2surgical -facility (RELATINGshall TOinclude, STANDARDSin OFany PRACTICE)discharge SHALLinstructions, FULFILLthe THEfollowing: LABELING REQUIREMENTS UNDER THE ACT OF SEPTEMBER 27, 1961 (P.L.1700, NO.699), KNOWN AS THE "PHARMACY ACT," THE ACT OF APRIL 14, 1972 (P.L.233, NO.64), KNOWN AS "THE CONTROLLED SUBSTANCE, DRUG, DEVICE AND COSMETIC ACT," OR REGULATIONS PROMULGATED BY THE STATE BOARD OF PHARMACY.

(2)(i) AWritten PRESCRIBERinstructions MAYfor FULFILLthe THEfacility-provided PHARMACISTmedication's COUNSELINGproper REQUIREMENTSuse UNDERand 49administration, PA.including the remaining number of doses to the extent quantifiable or 20250HB0446PN2439 - 2 - calculable.

CODE(ii) §A 27.19(D)phone ORnumber (E)to (RELATINGcontact TOCONTACT PROSPECTIVEINFORMATION DRUG<-- REVIEWFOR ANDthe PATIENTprescriber COUNSELING)or BYpharmacist. OFFERING TO COUNSEL OR BY COUNSELING A PATIENT OR CAREGIVER IN ACCORDANCE WITH THE REGULATION.

(3)(c) AExemption HOSPITALfrom ORoutpatient AMBULATORYdispensing SURGICALrequirements.--A FACILITYfacility-provided SHALLmedication INCLUDE,that INis ANYoffered DISCHARGEor INSTRUCTIONS,dispensed THEin FOLLOWING:accordance with this section shall not be considered outpatient dispensing under the "Pharmacy Act," "The Controlled Substance, Drug, Device and Cosmetic Act" or regulations promulgated by the State Board of Pharmacy.

(I)(d) WRITTENLiability INSTRUCTIONSprotection.--A FORprescriber, THEpharmacist, FACILITY-PROVIDEDhospital MEDICATION'Sor PROPERambulatory USEsurgical ANDfacility ADMINISTRATION,acting INCLUDINGin THEgood REMAININGfaith NUMBERand OFin DOSESaccordance TOwith THEthis EXTENTsection QUANTIFIABLEshall ORnot CALCULABLE.be held civilly or administratively liable for any injury or harm resulting from a patient's misuse, nonadherence or failure to follow discharge instructions related to a facility-provided medication, unless the injury or harm results from gross negligence or willful misconduct.

(II) A PHONE NUMBER TO CONTACT THE PRESCRIBER OR PHARMACIST.

(C) EXEMPTION FROM OUTPATIENT DISPENSING REQUIREMENTS.--A FACILITY-PROVIDED MEDICATION THAT IS OFFERED OR DISPENSED IN ACCORDANCE WITH THIS SECTION SHALL NOT BE CONSIDERED OUTPATIENT DISPENSING UNDER THE "PHARMACY ACT," "THE CONTROLLED SUBSTANCE, DRUG, DEVICE AND COSMETIC ACT" OR REGULATIONS PROMULGATED BY THE STATE BOARD OF PHARMACY.

(D) LIABILITY PROTECTION.--A PRESCRIBER, PHARMACIST, HOSPITAL OR AMBULATORY SURGICAL FACILITY ACTING IN GOOD FAITH AND IN ACCORDANCE WITH THIS SECTION SHALL NOT BE HELD CIVILLY OR ADMINISTRATIVELY LIABLE FOR ANY INJURY OR HARM RESULTING FROM A PATIENT'S MISUSE, NONADHERENCE OR FAILURE TO FOLLOW DISCHARGE 20250HB0446PN2021 - 3 - INSTRUCTIONS RELATED TO A FACILITY-PROVIDED MEDICATION, UNLESS THE INJURY OR HARM RESULTS FROM GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

"Facility-provided medication." A topicalmulti-use antibiotic,MULTI-DOSE anti-drug <-- inflammatory,product dilationintended orfor glaucomaa dropsingle orpatient ointmentthat oris nasalclinically sprayappropriate thatfor athe healthacute careA facilityCLINICAL employeecondition hascausing onREQUIRING standby<-- orTREATMENT thatDURING isthe retrievedhospital fromor aambulatory dispensingsurgical systemfacility forepisode aof specifiedcare patientand APPROPRIATE for continued use duringpost- <-- discharge, such as eye drops, ear drops, a proceduretopical cream or visit.an emergency inhaler.

AThe MULTI-USEterm DRUGdoes <--not PRODUCTinclude INTENDEDa FORproduct Athat SINGLEis PATIENTused THATintravenously ISor CLINICALLYis APPROPRIATEa FORDRUG THECLASSIFIED ACUTEAS CONDITIONA CAUSINGcontrolled THE<-- HOSPITALsubstance ORUNDER AMBULATORYTHE SURGICALCONTROLLED FACILITYSUBSTANCE, EPISODEDRUG, OFDEVICE CARE AND FOR<-- CONTINUEDCOSMETIC USEACT. POST-DISCHARGE, SUCH AS EYE DROPS, EAR DROPS, A TOPICAL CREAM OR AN EMERGENCY INHALER.

THE20250HB0446PN2439 TERM- DOES3 NOT- INCLUDE"Prescriber." A PRODUCTperson THATthat ISis USEDlicensed, INTRAVENOUSLYregistered ORor ISotherwise Aauthorized CONTROLLEDto SUBSTANCE.distribute, dispense and administer a controlled substance, other drug or device in the course of professional practice or research in this Commonwealth.

"Prescriber." A person that is licensed, registered or otherwise authorized to distribute, dispense or AND administer a <-- controlled substance, other drug or device in the course of professional practice or research in this Commonwealth.

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