Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.

This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge if certain conditions are satisfied, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.

Existing law requires an automated drug delivery system (ADDS) that is installed, leased, owned, or operated in California to be licensed by the board. Existing law exempts an automated unit dose system (AUDS), a type of ADDS, from licensure if the AUDS is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS.

This bill would also exempt from licensure an AUDS that is used to dispense dangerous drugs to emergency room patients in accordance with specified requirements.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.

This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge if certain conditions are satisfied, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.

Existing law requires an automated drug delivery system (ADDS) that is installed, leased, owned, or operated in California to be licensed by the board. Existing law exempts an automated unit dose system (AUDS), a type of ADDS, from licensure if the AUDS is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS.

This bill would also exempt from licensure an AUDS that is used to dispense dangerous drugs to emergency room patients in accordance with specified requirements.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.

This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under certain conditions, if certain conditions are satisfied, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.

Existing law requires an automated drug delivery system (ADDS) that is installed, leased, owned, or operated in California to be licensed by the board. Existing law exempts an automated unit dose system (AUDS), a type of ADDS, from licensure if the AUDS is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS.

This bill would also exempt from licensure an AUDS that is used to provide doses administered dispense dangerous drugs to emergency room patients in accordance with specified requirements.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.

This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under certain conditions, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.

Existing law requires an automated drug delivery system (ADDS) that is installed, leased, owned, or operated in California to be licensed by the board. Existing law exempts an automated unit dose system (AUDS), a type of ADDS, from licensure if the AUDS is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS.

This bill would also exempt from licensure an AUDS that is used to provide doses administered to emergency room patients in accordance with specified requirements.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.

This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under certain conditions, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.

This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under certain conditions, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.

 CONSENT  

Bill No: AB 447

Author: Mark González (D)

Amended: 5/1/25 in Assembly

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 11-0, 6/23/25

AYES: Ashby, Choi, Archuleta, Arreguín, Grayson, Menjivar, Niello, Smallwood-Cuevas, Strickland, Umberg, Weber Pierson

SENATE HEALTH COMMITTEE: 11-0, 7/2/25

AYES: Menjivar, Valladares, Durazo, Gonzalez, Grove, Limón, Padilla, Richardson, Rubio, Weber Pierson, Wiener

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 71-0, 5/23/25 (Consent) - See last page for vote

SUBJECT: Emergency room patient prescriptions

SOURCE: California Chapter of the American College of Emergency Physicians

DIGEST:

This bill authorizes a prescriber to dispense unused medication acquired by a hospital pharmacy to an emergency room patient upon the discharge of that patient if the medication was ordered for and administered to the emergency room patient, according to specified conditions.

ANALYSIS:

Existing law:

1. Regulates pharmaceutical professionals and premises under the Pharmacy Law. (Business and Professions Code (BPC) §§ 4000–4427.8)
2. Establishes the Board of Pharmacy (board) to administer and enforce the Pharmacy Law and delegates to the board the authority to adopt rules and regulations as may be necessary for the protection of the public. (BPC §§ 4001, 4005)
3. Defines “dangerous drug” or “dangerous device” as any drug or device unsafe for self-use in humans or animals and includes any drug or device that by federal or state law can be lawfully dispensed only on prescription. (BPC § 4022)
4. Defines “administer” as the direct application of a drug or device to the body of a patient by injection, inhalation, ingestion, or other means. (BPC § 4016)
5. Defines “dispense,” in relevant part, as the furnishing of drugs or devices directly to a patient by a physician or other healing arts professional acting within their scope of practice. (BPC § 4024(b))
6. Prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice unless all of the following conditions are met:
   1. The dangerous drugs or dangerous devices are dispensed to the prescriber’s own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant. (BPC § 4170(a)(1))
   2. The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient. (BPC § 4170(a)(2))
   3. The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons. (BPC § 4170(a)(3))
   4. The prescriber fulfills all of the labeling requirements imposed upon pharmacists, all of the recordkeeping requirements of the Pharmacy Law, and all of the packaging requirements of good pharmaceutical practice. (BPC § 4170(a)(4))
   5. The prescriber does not use a dispensing device unless the prescriber personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient. (BPC § 4170(a)(5))
   6. The prescriber, before dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy. (BPC § 4170(a)(6))
   7. The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient’s choice. (BPC § 4170(a)(7))
7. Defines “prescriber,” for purposes of prescriber dispensing, as a person who holds a physician’s and surgeon’s certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, a certificate to practice podiatry, a certificate to practice as an independent nurse practitioner, or a certificate to practice as a nurse-midwife, and who is duly registered by the Medical Board of California, the Osteopathic Medical Board of California, the California State Board of Optometry, the California Board of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, the Podiatric Medical Board of California, or the Board of Registered Nursing. (BPC § 4170(d))
8. Authorizes a prescriber to dispense a dangerous drug to an emergency room patient if all of the following apply:
   1. The hospital pharmacy is closed and there is no pharmacist available in the hospital. (BPC § 4068(a)(1))
   2. The dangerous drug is acquired by the hospital pharmacy. (BPC § 4068(a)(2))
   3. The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens. (BPC § 4068(a)(3))
   4. The hospital pharmacy retains the dispensing information and, if the drug is a controlled substance, reports the information to the Department of Justice. (BPC § 4068(a)(4))
   5. The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing. (BPC § 4068(a)(5))
   6. The quantity of drugs dispensed are limited to that amount necessary to maintain uninterrupted therapy while other pharmacies are not readily available or accessible, but shall not exceed a 72-hour supply. (BPC § 4068(a)(6))
   7. The prescriber ensures that the drug label contains all the information required for an ordinary prescription. (BPC § 4068(a)(7))
9. Defines “automated drug delivery system” (ADDS) as a mechanical system that performs operations relative to the storage, dispensing, or distribution of drugs and requires an ADDS to collect and maintain all transaction information to track the movement of drugs in and out of the system. (BPC § 4017.3(a))
10. Defines “automated unit dose system” (AUDS) as a subtype of ADDS used for the storage and retrieval of unit doses of drugs for administration to patients by authorized persons. (BPC § 4017.3(b))
11. Requires that an ADDS be licensed by the board, except as specified. (BPC § 4427.2(a))
12. Exempts an AUDS from licensure if (1) it is operated by a licensed hospital pharmacy, as specified, (2) used solely to provide doses administered to patients while in a licensed general acute care hospital facility, (3) the AUDS complies with all other safety, security, informational, and procedural requirements for an ADDS, and (4) the hospital pharmacy maintains a list of the locations of each AUDS it operates and makes the list available to the board upon request. (BPC § 4427.2(i))

This bill:

1. Authorizes a prescriber to dispense unused medication acquired by a hospital pharmacy to an emergency room patient upon the discharge of that patient if the medication was ordered for and administered to the emergency room patient, if it was administered from single patient use multidose packaging and can be self-administered by the patient, including, but not limited to, an inhaler, eye drop, ear drop, nose drop or spray, topical product, or liquid product, and if dispensing the unused portion of the medication is required to continue the emergency room patient’s treatment.
2. Specifies that the medication dispensed by a prescriber to an emergency room physician cannot be a controlled substance.
3. Requires the prescriber to ensure that the label on the drug contains all of the information Pharmacy Law requires to be on labels.
4. Exempts an AUDS operated by a licensed hospital pharmacy used to provide doses dispensed to an emergency room patient from the requirement to obtain a ADDS license if the hospital pharmacy owns the AUDS and owns the medication and devices in the AUDS.

Background

Dispensing Unused Medications. Ordinarily, hospital emergency room (ER) personnel may not dispense medication to patients for use outside the ER, except under certain circumstances. One such exception authorizes a prescriber (e.g., a physician) to dispense medication to an ER patient when the hospital pharmacy is closed and there is no pharmacist available in the hospital. When dispensing medication pursuant to this authority, the quantity of medication provided may not exceed a 72-hour supply, the prescriber must reasonably believe there is no local pharmacy accessible at the time, and the medication must be labeled with all the information required of a typical pharmacy-issued prescription.

This bill would create an additional authority for prescribers to dispense medication to an ER patient for use outside the hospital. Specifically, it would authorize a prescriber to dispense the unused portion of a medication that was administered to the patient in the ER, provided the medication remains necessary for treatment following discharge.

Because of the existing limitations on prescribers’ authority to dispense medication, any unused portion of a multi-use medication must be disposed of when the patient is discharged, even if the medication is necessary for the patient’s continued treatment. Instead of allowing the ER patient to take home the unused medication, the prescriber who administered the drug will issue a prescription to be filled at an external pharmacy. According to the author and sponsor, this process causes hospitals to unnecessarily waste usable medication and creates additional inconvenience and expense for patients.

The authority created by this bill is designed specifically for medications contained in multi-use packaging that are difficult or impossible to separate into discrete doses. For example, an inhaler may come in an aerosol container with 30 doses, but an ER patient may only require 3 doses during their ER stay. However, unlike with pills or capsules, there is no way for the hospital pharmacy to separate out 3 aerosol doses to administer to one ER patient and save the remaining 27 doses for other patients. Nor can a prescriber measure out a 72-hour supply of aerosol doses and dispense it to the patient upon discharge under the existing prescriber authority. This bill, therefore, creates a pathway for prescribers and hospital pharmacies to dispense portions of necessary medication that would otherwise be disposed of.

Expansion of AUDS Licensure Exemption. To help streamline the processing and distribution of drugs throughout the facility, hospital pharmacies often maintain an automated drug delivery system, or ADDS. An ADDS is an automated cabinet that securely stores medications for ready access by authorized employees. Hospitals may also use a subtype of ADDS known as an automated unit dose system, or AUDS, which specifically dispenses individually-packaged doses for hospital personnel to administer to patients. By packaging and dispensing drugs in single doses, the use of an AUDS can help reduce human error and expedite delivery of medications.

All operators of an ADDS must obtain a license for the system from the Board. However, if an ADDS is an AUDS operated by a licensed hospital pharmacy and is used solely to administer doses to patients in an acute care hospital, the ADDS is exempt from the licensure requirement. This licensure exemption does not exempt the hospital pharmacy from following all other safety, recordkeeping, reporting, and inspection requirements under the Pharmacy Law—it merely exempts the hospital pharmacy from obtaining a separate license and paying the licensing fee. This bill would expand the licensure exemption to expressly exempt AUDSs used to provide medication to ER patients under existing prescriber dispensing authority or under the proposed authority in this bill.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

SUPPORT: (Verified 8/19/25)

California Chapter of the American College of Emergency Physicians (source)
California Emergency Nurses Association
California Hospital Association
California Medical Association
California Pharmacists Association

California Society of Health-system Pharmacists
California State Association of Psychiatrists

Climate Health Now Action Fund
Physician Assistant Board

OPPOSITION: (Verified 8/18/25)

None received

ARGUMENTS IN SUPPORT: Supporters note that this bill will promote efficient use of health care resources, reduce costs, and improve environmental sustainability — all while upholding the highest standards of patient care. Supporters also write that the bill improve health care efficiency, support vulnerable populations, and reduce financial burdens on patients and our health care delivery system.

The bill’s sponsor, the California Chapter of the American College of Emergency Medicine adds that “Current California law results in redundant prescriptions, increased cost to the health system, and increased medical waste. AB 447 would allow providers to dispense remaining doses of non-narcotic prescriptions to emergency room patients. Allowing patients to take home the remaining doses of their multiuse medication will reduce unnecessary spending, medical waste, and guarantee timely access to necessary prescriptions.”

ASSEMBLY FLOOR: 71-0, 5/23/25

AYES: Addis, Aguiar-Curry, Ahrens, Alanis, Alvarez, Arambula, Ávila Farías, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Calderon, Caloza, Carrillo, Castillo, Connolly, Davies, DeMaio, Dixon, Elhawary, Flora, Fong, Gabriel, Gallagher, Garcia, Gipson, Jeff Gonzalez, Mark González, Hadwick, Haney, Harabedian, Hart, Hoover, Irwin, Jackson, Kalra, Krell, Lackey, Lee, Lowenthal, Macedo, McKinnor, Muratsuchi, Ortega, Pacheco, Papan, Patel, Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Ransom, Celeste Rodriguez, Michelle Rodriguez, Rogers, Blanca Rubio, Schiavo, Solache, Soria, Stefani, Ta, Tangipa, Valencia, Wallis, Ward, Wilson, Zbur, Rivas

NO VOTE RECORDED: Bryan, Chen, Ellis, Nguyen, Sanchez, Schultz, Sharp-Collins, Wicks

Prepared by: Sarah Mason / B., P. & E.D. /

8/21/25 16:45:23

**** END ****

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Angelique Ashby, Chair

2025 - 2026 Regular

Bill No: AB 447 Hearing Date: June 23, 2025

Subject: Emergency room patient prescriptions

SUMMARY:

Authorizes a prescriber to dispense unused medication acquired by a hospital pharmacy to an emergency room patient upon the discharge of that patient if the medication was ordered for and administered to the emergency room patient, according to specified conditions.

NOTE: This measure is double-referred to the Senate Committee on Health, second.

Existing law:

1. Regulates pharmaceutical professionals and premises under the Pharmacy Law. (Business and Professions Code (BPC) §§ 4000–4427.8)
2. Establishes the Board of Pharmacy (board) to administer and enforce the Pharmacy Law and delegates to the board the authority to adopt rules and regulations as may be necessary for the protection of the public. (BPC §§ 4001, 4005)
3. Defines “dangerous drug” or “dangerous device” as any drug or device unsafe for self-use in humans or animals and includes any drug or device that by federal or state law can be lawfully dispensed only on prescription. (BPC § 4022)
4. Defines “administer” as the direct application of a drug or device to the body of a patient by injection, inhalation, ingestion, or other means. (BPC § 4016)
5. Defines “dispense,” in relevant part, as the furnishing of drugs or devices directly to a patient by a physician or other healing arts professional acting within their scope of practice. (BPC § 4024(b))
6. Prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice unless all of the following conditions are met:
   1. The dangerous drugs or dangerous devices are dispensed to the prescriber’s own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant. (BPC § 4170(a)(1))
   2. The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient. (BPC § 4170(a)(2))
   3. The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons. (BPC § 4170(a)(3))
   4. The prescriber fulfills all of the labeling requirements imposed upon pharmacists, all of the recordkeeping requirements of the Pharmacy Law, and all of the packaging requirements of good pharmaceutical practice. (BPC § 4170(a)(4))
   5. The prescriber does not use a dispensing device unless the prescriber personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient. (BPC § 4170(a)(5))
   6. The prescriber, before dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy. (BPC § 4170(a)(6))
   7. The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient’s choice. (BPC § 4170(a)(7))
7. Defines “prescriber,” for purposes of prescriber dispensing, as a person who holds a physician’s and surgeon’s certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, a certificate to practice podiatry, a certificate to practice as an independent nurse practitioner, or a certificate to practice as a nurse-midwife, and who is duly registered by the Medical Board of California, the Osteopathic Medical Board of California, the California State Board of Optometry, the California Board of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, the Podiatric Medical Board of California, or the Board of Registered Nursing. (BPC § 4170(d))
8. Authorizes a prescriber to dispense a dangerous drug to an emergency room patient if all of the following apply:
   1. The hospital pharmacy is closed and there is no pharmacist available in the hospital. (BPC § 4068(a)(1))
   2. The dangerous drug is acquired by the hospital pharmacy. (BPC § 4068(a)(2))
   3. The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens. (BPC § 4068(a)(3))
   4. The hospital pharmacy retains the dispensing information and, if the drug is a controlled substance, reports the information to the Department of Justice. (BPC § 4068(a)(4))
   5. The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing. (BPC § 4068(a)(5))
   6. The quantity of drugs dispensed are limited to that amount necessary to maintain uninterrupted therapy while other pharmacies are not readily available or accessible, but shall not exceed a 72-hour supply. (BPC § 4068(a)(6))
   7. The prescriber ensures that the drug label contains all the information required for an ordinary prescription. (BPC § 4068(a)(7))
9. Defines “automated drug delivery system” (ADDS) as a mechanical system that performs operations relative to the storage, dispensing, or distribution of drugs and requires an ADDS to collect and maintain all transaction information to track the movement of drugs in and out of the system. (BPC § 4017.3(a))
10. Defines “automated unit dose system” (AUDS) as a subtype of ADDS used for the storage and retrieval of unit doses of drugs for administration to patients by authorized persons. (BPC § 4017.3(b))
11. Requires that an ADDS be licensed by the board, except as specified. (BPC § 4427.2(a))
12. Exempts an AUDS from licensure if (1) it is operated by a licensed hospital pharmacy, as specified, (2) used solely to provide doses administered to patients while in a licensed general acute care hospital facility, (3) the AUDS complies with all other safety, security, informational, and procedural requirements for an ADDS, and (4) the hospital pharmacy maintains a list of the locations of each AUDS it operates and makes the list available to the board upon request. (BPC § 4427.2(i))

This bill:

1. Authorizes a prescriber to dispense unused medication acquired by a hospital pharmacy to an emergency room patient upon the discharge of that patient if the medication was ordered for and administered to the emergency room patient, if it was administered from single patient use multidose packaging and can be self-administered by the patient, including, but not limited to, an inhaler, eye drop, ear drop, nose drop or spray, topical product, or liquid product, and if dispensing the unused portion of the medication is required to continue the emergency room patient’s treatment.
2. Specifies that the medication dispensed by a prescriber to an emergency room physician cannot be a controlled substance.
3. Requires the prescriber to ensure that the label on the drug contains all of the information Pharmacy Law requires to be on labels.
4. Exempts an AUDS operated by a licensed hospital pharmacy used to provide doses dispensed to an emergency room patient from the requirement to obtain a ADDS license if the hospital pharmacy owns the AUDS and owns the medication and devices in the AUDS.

FISCAL EFFECT:

This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations, the Board estimates a revenue loss of $20,000 from the loss of annual renewal fees for AUDSs and the Department of Consumer Affairs Office of Information Services states new enforcement codes will be required in its electronic licensing and enforcement system, at a cost of $1,000, which is absorbable within maintenance resources.

COMMENTS:

1. Purpose. The California Chapter of the American College of Emergency Physicians is the Sponsor of this bill. According to the Author, “Access to healthcare remains a significant challenge for communities across California. Whether due to financial barriers, difficulties reaching medical facilities, or limited time off work, many Californians struggle to obtain the care they need. AB 447 seeks to ease this burden by allowing emergency room patients to take home the remaining doses of non-narcotic medications they started during treatment. Under this bill, patients will no longer be forced to make an additional trip to a pharmacy to continue essential treatment—reducing both unnecessary expenses and delays in care. This policy will not only save patients time and money but also help combat excessive medical waste in our healthcare system.

The Author states that “Patients frequently visit emergency departments (EDs) with conditions requiring prescription medications. These medications are often dispensed in multi-dose packaging from the hospital pharmacy, resulting in leftover doses once treatment in the ED concludes. Common examples include eye drops, inhalers, and liquid antibiotics. Under existing law, the remaining doses cannot be sent home with the patient or used for other patients, leading to unnecessary medical waste. Patients discharged from the ED with a prescription for the same medication must then visit an outpatient pharmacy to obtain it. In areas without 24-hour pharmacies, this can result in treatment delays. Even where pharmacies are readily available, this practice creates an unnecessary and duplicate expense. Current California law results in redundant prescriptions, increased healthcare costs, and excessive medical waste. AB 447 would allowing patients to take home the remaining doses of their prescribed multi-use medications --- in turn, this would reduce unnecessary spending, decrease medical waste, and ensure timely access to necessary treatments.”

1. Background.

Dispensing Unused Medications. Ordinarily, hospital emergency room (ER) personnel may not dispense medication to patients for use outside the ER, except under certain circumstances. One such exception authorizes a prescriber (e.g., a physician) to dispense medication to an ER patient when the hospital pharmacy is closed and there is no pharmacist available in the hospital. When dispensing medication pursuant to this authority, the quantity of medication provided may not exceed a 72-hour supply, the prescriber must reasonably believe there is no local pharmacy accessible at the time, and the medication must be labeled with all the information required of a typical pharmacy-issued prescription.

This bill would create an additional authority for prescribers to dispense medication to an ER patient for use outside the hospital. Specifically, it would authorize a prescriber to dispense the unused portion of a medication that was administered to the patient in the ER, provided the medication remains necessary for treatment following discharge.

Because of the existing limitations on prescribers’ authority to dispense medication, any unused portion of a multi-use medication must be disposed of when the patient is discharged, even if the medication is necessary for the patient’s continued treatment. Instead of allowing the ER patient to take home the unused medication, the prescriber who administered the drug will issue a prescription to be filled at an external pharmacy. According to the author and sponsor, this process causes hospitals to unnecessarily waste usable medication and creates additional inconvenience and expense for patients.

The authority created by this bill is designed specifically for medications contained in multi-use packaging that are difficult or impossible to separate into discrete doses. For example, an inhaler may come in an aerosol container with 30 doses, but an ER patient may only require 3 doses during their ER stay. However, unlike with pills or capsules, there is no way for the hospital pharmacy to separate out 3 aerosol doses to administer to one ER patient and save the remaining 27 doses for other patients. Nor can a prescriber measure out a 72-hour supply of aerosol doses and dispense it to the patient upon discharge under the existing prescriber authority. This bill, therefore, creates a pathway for prescribers and hospital pharmacies to dispense portions of necessary medication that would otherwise be disposed of.

Expansion of AUDS Licensure Exemption. To help streamline the processing and distribution of drugs throughout the facility, hospital pharmacies often maintain an automated drug delivery system, or ADDS. An ADDS is an automated cabinet that securely stores medications for ready access by authorized employees. Hospitals may also use a subtype of ADDS known as an automated unit dose system, or AUDS, which specifically dispenses individually-packaged doses for hospital personnel to administer to patients. By packaging and dispensing drugs in single doses, the use of an AUDS can help reduce human error and expedite delivery of medications.

All operators of an ADDS must obtain a license for the system from the Board. However, if an ADDS is an AUDS operated by a licensed hospital pharmacy and is used solely to administer doses to patients in an acute care hospital, the ADDS is exempt from the licensure requirement. This licensure exemption does not exempt the hospital pharmacy from following all other safety, recordkeeping, reporting, and inspection requirements under the Pharmacy Law—it merely exempts the hospital pharmacy from obtaining a separate license and paying the licensing fee. This bill would expand the licensure exemption to expressly exempt AUDSs used to provide medication to ER patients under existing prescriber dispensing authority or under the proposed authority in this bill.

1. Arguments in Support. Supporters note that this bill will promote efficient use of health care resources, reduce costs, and improve environmental sustainability — all while upholding the highest standards of patient care. Supporters also write that the bill improve health care efficiency, support vulnerable populations, and reduce financial burdens on patients and our health care delivery system.

The bill’s sponsor, the California Chapter of the American College of Emergency Medicine adds that “Current California law results in redundant prescriptions, increased cost to the health system, and increased medical waste. AB 447 would allow providers to dispense remaining doses of non-narcotic prescriptions to emergency room patients. Allowing patients to take home the remaining doses of their multiuse medication will reduce unnecessary spending, medical waste, and guarantee timely access to necessary prescriptions.”

SUPPORT AND OPPOSITION:

Support:

California Chapter of the American College of Emergency Physicians
California Emergency Nurses Association
California Hospital Association
California Medical Association
California Pharmacists Association
California State Association of Psychiatrists

Climate Health Now Action Fund
Physician Assistant Board

Opposition:

None received

-- END --

Date of Hearing: May 14, 2025

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Buffy Wicks, Chair

ABPCA Bill Id:AB 447

Author:(Mark González) – As Amended Ver:May 1, 2025

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill allows a prescriber to dispense an unused portion of a dangerous drug (prescription drug) that is acquired by the hospital pharmacy to an emergency room (ER) patient upon discharge, under specified conditions.

Specifically, this bill:

1. Authorizes a prescriber, notwithstanding any other provision of the Pharmacy Law, to dispense an unused portion of a prescription drug acquired by the hospital pharmacy to an ER patient upon discharge under all of the following conditions:
   1. The prescription drug is not a controlled substance.
   2. The prescription drug has been ordered and administered to the ER patient.
   3. The prescription drug was administered from single patient multiuse packaging and can be self-administered by the patient, including, but not limited to, an inhaler, eye drop, ear drop, nose drop or spray, topical product, or liquid product.
   4. Dispensing the unused portion of the prescription drug is required to continue treatment of the ER patient.
   5. The prescriber ensures that the label on the drug contains all of the information required by existing drug labeling requirements.
2. Expands existing licensure exemptions for AUDSs to also apply when the hospital pharmacy is closed, as specified, and under the authority authorized by this bill.

FISCAL EFFECT:

The California State Board of Pharmacy estimates a revenue loss of $20,000 from the loss of annual renewal fees for AUDSs (Pharmacy Board Contingent Fund).

The Department of Consumer Affairs Office of Information Services states new enforcement codes will be required in its electronic licensing and enforcement system, at a cost of $1,000, which is absorbable within maintenance resources.

COMMENTS:

1. Purpose. This bill is sponsored by the California Chapter of the American College of Emergency Physicians (California ACEP). According to the author:

[C]urrent regulations contribute to unnecessary medical waste and increased healthcare costs by preventing patients from taking home remaining doses of their prescribed multi-use medications. [This bill] provides a straightforward yet crucial solution to reduce redundant prescriptions, lower healthcare expenses, and minimize medical waste. By allowing patients to take home the remaining doses of their prescribed non-narcotic multi-use medications—such as eye drops, inhalers, and liquid antibiotics—this bill will ensure timely access to necessary treatments, reduce waste, and help patients continue their recovery without unnecessary delays.

1. Dispensing Drugs to ER Patients. Under existing law, a prescriber may dispense a prescription drug (including a controlled substance) to an ER patient if certain requirements are met, including that the hospital pharmacy is closed, there is no pharmacist available in the hospital, and the quantity of drugs is limited to a 72-hour supply. This bill applies in a broader situation (it is not conditioned on a hospital pharmacy being closed), but to a narrower class of drugs. Specifically, this bill allows a prescriber to dispense an unused portion of a prescription drug package that can be self-administered by the patient, if the drug was in a multiuse package and the unused portion is required to continue treatment of the ER patient. This bill applies to an inhaler, eye drop, ear drop, nose drop, spray topical product, or liquid product. The bill does not apply to controlled substances.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: April 29, 2025

ASSEMBLY COMMITTEE ON HEALTH

Mia Bonta, Chair

ABPCA Bill Id:AB 447

Author:(Mark González) – As Amended Ver:April 9, 2025

SUBJECT: Emergency room patient prescriptions.

SUMMARY: Permits a prescriber to dispense an unused portion of a dangerous drug (a prescription drug) that is acquired by the hospital pharmacy to an emergency room (ER) patient upon discharge, subject to specified conditions. Expands the existing licensure exemption for an automated unit dose system (AUDS) that is used by a prescriber in a hospital or a psychiatric health facility to dispense dangerous drugs to ER patients under this bill and existing law. Specifically, this bill:

1. Permits a prescriber, notwithstanding any other provision of the Pharmacy Law, to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an ER patient upon discharge under the following conditions:
   1. The dangerous drug is not a controlled substance;
   2. The dangerous drug has been ordered and administered to the ER patient;
   3. The dangerous drug was administered from multiuse packaging and can be self-administered by the patient, including, but not limited to, an inhaler, eye drop, ear drop, nose drop or spray, topical product, or liquid product;
   4. Dispensing the unused portion of the dangerous drug is required to continue treatment of the ER patient; and,
   5. The prescriber ensures that the label on the drug contains all of the information required by existing law drug labeling requirements.
2. Expands the existing licensure exemption for an AUDS that exempts AUDSs used by prescribers to provide doses to ER patients under the existing law authority to do so when the hospital pharmacy is closed, as specified, and under the authority authorized by this bill.

EXISTING LAW:

1. Establishes the California State Board of Pharmacy (BoP), and requires the licensure and regulation of pharmacists and pharmacies. [Business and Professions Code (BPC) § 4000 et seq.]
2. Permits a prescriber to dispense a dangerous drug, including a controlled substance, to an ER patient if all of the following apply:
   1. The hospital pharmacy is closed and there is no pharmacist available in the hospital;
   2. The dangerous drug is acquired by the hospital pharmacy;
   3. The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens;
   4. The hospital pharmacy retains the dispensing information and, if the drug is a Schedule II, Schedule III, or Schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to the Controlled Substance Utilization Review and Evaluation System (CURES);
   5. The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient; and,
   6. The quantity of drugs dispensed to any patient under these provisions is limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but not to exceed a 72-hour supply. [BPC § 4068]
3. Requires the prescriber, in when dispensing a danger drug pursuant to 2) above, to ensure that the label on the drug contains all the information required by Section 4076. [BPC § 4068]
4. Prohibits a pharmacist from dispensing a prescription except in a container that meets the requirements of state and federal law and is correctly labeled, which includes the manufacturer’s trade name or the commonly used name or the principal active ingredients of the drug, the directions for use of the drug, the name/names of the patient, the name of the prescriber, the date of issue and the condition or purpose for which the drug was prescribed. [BPC § 4076]
5. Requires an automated drug delivery system installed, leased, owned, or operated in California to be licensed by the BoP. [BPC § 4427.2]
6. Defines an “automated drug delivery system” (ADDS) to means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. Requires an ADDS to collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. [BPC § 4017.3]
7. Defines an “AUDS” as an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. [Ibid.]
8. Exempts a AUDS operated by a licensed hospital pharmacy that is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility from the requirement to obtain an ADDS license, if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS. [BPC § 4427.2]

FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, access to health care remains a significant challenge for communities across California. Whether due to financial barriers, difficulties reaching medical facilities, or limited time off work, many Californians struggle to obtain the care they need. This bill seeks to ease this burden by allowing ER patients to take home the remaining doses of non-narcotic medications they started during treatment. Under this bill, patients will no longer be forced to make an additional trip to a pharmacy to continue essential treatment—reducing both unnecessary expenses and delays in care. This policy will not only save patients time and money but also help combat excessive medical waste in our health care system.
2. BACKGROUND ON DISPENSING TO ER PATIENTS. Existing law permits a prescriber to dispense a dangerous drug (including a controlled substance) to an ER patient if certain requirements are met, including that the hospital pharmacy is closed, there is no pharmacist available in the hospital, and the quantity of drugs is limited to a 72-hour supply. This bill applies in a broader situation (current law applies when a hospital pharmacy is closed) but to a narrower class of drugs. Specifically, this bill permits a prescriber to dispense an unused portion of a dangerous drug from a multiuse package that can be self-administered by the patient, when the unused portion is required to continue treatment of the ER patient. Specific example this bill would apply to include are an inhaler, eye drop, ear drop, nose drop or spray topical product, or liquid product. The authority to dispense an unused portion of a drug authorized under this bill does not apply to controlled substances.
3. BACKGROUND ON AUDS. Hospital pharmacies often use an automated drug delivery system, or ADDS to streamline the processing and distribution of drugs. An ADDS is an automated cabinet that securely stores medications for ready access by authorized employees. Hospitals may also use a subtype of ADDS known as an automated unit dose system, or AUDS, which specifically dispenses individually-packaged doses for hospital personnel to administer to patients. The use of an AUDS can help reduce human error and expedite delivery of medications. Operators of an ADDS must obtain a license from the BoP (the original licensure application fee is $525 and the renewal fee is $453), and prior to the issuance of the license, the BoP is required to conduct a pre-licensure inspection within 30 days of a completed application for an ADDS license.

However, if an ADDS is an AUDS operated by a licensed hospital pharmacy and is used solely to administer doses to patients in an acute care hospital, the ADDS is exempt from the licensure requirement. When an ADDS that is used by a prescriber to dispense medication to an ER patient under the existing prescriber dispensing authority (for example, up to a 72-hour supply when the pharmacy is closed). This bill would expand the licensure exemption to expressly exempt AUDSs used to provide medication to ER patients under existing prescriber dispensing authority, and under the additional authority to dispense drugs from multiuse packaging that can be administered by the patient in this bill. The author indicates the purpose of this change is that without the exemption, many hospitals may choose not to dispense medications, and it will only result in a minimal loss of revenue to the BoP.

1. SUPPORT. This bill is sponsored by the California Chapter of the American College of Emergency Physicians (Cal-ACEP), which writes that patients often present to the ER with conditions that require prescription treatments. These treatments are dispensed from the hospital pharmacy containing more doses than will be used in the duration of the emergency department (ED) visit. Frequently, one dose of a multi-use medication, including eye drops, inhalers and liquid antibiotics are administered and then the remainder must be disposed of. Cal-ACEP states that, under existing law, the remaining doses cannot be sent home with the patient they were prescribed for, and they cannot be used for other patients. Patients who receive these types of treatments leave the ED with a prescription for the same medication that they must pick up at an outpatient pharmacy to continue treating their condition. In areas where there are no 24-hour pharmacies, this can mean waiting until business hours start and potentially missing treatment doses. Even when readily available, it is an unnecessary, duplicate expense. Cal-ACEP states that, while ER-specific data is not currently available, studies of other care settings have found that as much as 50% of prepared multiuse drugs, including eye drops and inhalers, are discarded instead of being used again or dispersed to the patient. Current California law results in redundant prescriptions, increased cost to the health system, and increased medical waste. Allowing patients to take home the remaining doses of their multiuse medication will reduce unnecessary spending, medical waste, and guarantee timely access to necessary prescriptions.
2. PREVIOUS LEGISLATION. SB 1913 (Committee on Business and Professions) Chapter, 695, Statutes of 2004, among other provisions, authorizes the dispensing of prescription drugs to an ER patient under the above described circumstances.
3. DOUBLE REFERRAL. This bill is double referred, and it passed the Assembly Committee on Business and Professions Committee with a 15-0 vote on April 8, 2025.
4. CLARIFYING AMENDMENTS. Following discussions, the author has agreed to amend this bill to clarify the authority to dispense an unused portion applies when “all” of the circumstances in this bill are met, to clarify drugs administered under this bill are from single “patient use multi-dose packaging,” and to clarify that the exemption from licensure for an AUDS operated by a licensed hospital pharmacy applies to drugs “dispensed” under the existing law authority and as expanded by this bill.

REGISTERED SUPPORT / OPPOSITION:

Support

California Chapter of the American College of Emergency Physicians (sponsor)
California Emergency Nurses Association
California Hospital Association
California Medical Association
California State Association of Psychiatrists

Opposition

None on file

Analysis Prepared by: Scott Bain / HEALTH / (916) 319-2097

Date of Hearing: April 8, 2025

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Marc Berman, Chair

ABPCA Bill Id:AB 447 (

Author:Mark González) – As Amended Ver:March 28, 2025

NOTE: This bill is double referred and if passed by this Committee will be re-referred to the Assembly Health Committee.

SUBJECT: Healing arts: pharmacy: emergency room patient prescriptions

SUMMARY: Authorizes a prescriber to dispense the unused portion of a dangerous drug to an emergency room patient upon discharge from the hospital under specified conditions; expands the existing licensure exemption for an automated unit dose system (AUDS) to exempt AUDSs used by prescribers to provide doses to emergency room patients under the existing authority to do so when the hospital pharmacy is closed, as specified, or under the authority proposed in this bill.

EXISTING LAW:

1. Regulates pharmaceutical professionals and premises under the Pharmacy Law. (Business and Professions Code (BPC) §§ 4000–4427.8)
2. Establishes the Board of Pharmacy (board) to administer and enforce the Pharmacy Law and delegates to the board the authority to adopt rules and regulations as may be necessary for the protection of the public. (BPC §§ 4001, 4005)
3. Defines “dangerous drug” or “dangerous device” as any drug or device unsafe for self-use in humans or animals and includes any drug or device that by federal or state law can be lawfully dispensed only on prescription. (BPC § 4022)
4. Defines “administer” as the direct application of a drug or device to the body of a patient by injection, inhalation, ingestion, or other means. (BPC § 4016)
5. Defines “dispense,” in relevant part, as the furnishing of drugs or devices directly to a patient by a physician or other healing arts professional acting within their scope of practice. (BPC § 4024(b))
6. Prohibits a prescriber from dispensing drugs or dangerous devices to patients in the prescriber’s office or place of practice unless all of the following conditions are met:
   1. The dangerous drugs or dangerous devices are dispensed to the prescriber’s own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant. (BPC § 4170(a)(1))
   2. The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient. (BPC § 4170(a)(2))
   3. The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons. (BPC § 4170(a)(3))
   4. The prescriber fulfills all of the labeling requirements imposed upon pharmacists, all of the recordkeeping requirements of the Pharmacy Law, and all of the packaging requirements of good pharmaceutical practice. (BPC § 4170(a)(4))
   5. The prescriber does not use a dispensing device unless the prescriber personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient. (BPC § 4170(a)(5))
   6. The prescriber, before dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy. (BPC § 4170(a)(6))
   7. The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient’s choice. (BPC § 4170(a)(7))
7. Defines “prescriber,” for purposes of prescriber dispensing, as a person who holds a physician’s and surgeon’s certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, a certificate to practice podiatry, a certificate to practice as an independent nurse practitioner, or a certificate to practice as a nurse-midwife, and who is duly registered by the Medical Board of California, the Osteopathic Medical Board of California, the California State Board of Optometry, the California Board of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, the Podiatric Medical Board of California, or the Board of Registered Nursing. (BPC § 4170(d))
8. Authorizes a prescriber to dispense a dangerous drug to an emergency room patient if all of the following apply:
   1. The hospital pharmacy is closed and there is no pharmacist available in the hospital. (BPC § 4068(a)(1))
   2. The dangerous drug is acquired by the hospital pharmacy. (BPC § 4068(a)(2))
   3. The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens. (BPC § 4068(a)(3))
   4. The hospital pharmacy retains the dispensing information and, if the drug is a controlled substance, reports the information to the Department of Justice. (BPC § 4068(a)(4))
   5. The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing. (BPC § 4068(a)(5))
   6. The quantity of drugs dispensed are limited to that amount necessary to maintain uninterrupted therapy while other pharmacies are not readily available or accessible, but shall not exceed a 72-hour supply. (BPC § 4068(a)(6))
   7. The prescriber ensures that the drug label contains all the information required for an ordinary prescription. (BPC § 4068(a)(7))
9. Defines “automated drug delivery system” (ADDS) as a mechanical system that performs operations relative to the storage, dispensing, or distribution of drugs and requires an ADDS to collect and maintain all transaction information to track the movement of drugs in and out of the system. (BPC § 4017.3(a))
10. Defines “automated unit dose system” (AUDS) as a subtype of ADDS used for the storage and retrieval of unit doses of drugs for administration to patients by authorized persons. (BPC § 4017.3(b))
11. Requires that an ADDS be licensed by the board, except as specified. (BPC § 4427.2(a))
12. Exempts an AUDS from licensure if (1) it is operated by a licensed hospital pharmacy, as specified, (2) used solely to provide doses administered to patients while in a licensed general acute care hospital facility, (3) the AUDS complies with all other safety, security, informational, and procedural requirements for an ADDS, and (4) the hospital pharmacy maintains a list of the locations of each AUDS it operates and makes the list available to the board upon request. (BPC § 4427.2(i))

THIS BILL:

1. Authorizes a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:
2. The dangerous drug is not a controlled substance.
3. The dangerous drug has been ordered and administered to the emergency room patient.
4. Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient.
5. Expands the existing AUDS licensure exemption for an AUDS used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility to exempt an AUDS used to provide doses to an emergency room patient when the hospital pharmacy is closed or under the authority created by this bill for prescribers to dispense unused portions of administered drugs.
6. FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

Purpose. This bill is sponsored by the California Chapter of the American College of Emergency Physicians (California ACEP). According to the author:

Whether due to financial barriers, difficulties reaching medical facilities, or limited time off work, many Californians struggle to obtain the care they need. [This bill] seeks to ease this burden by allowing emergency room patients to take home the remaining doses of non-narcotic medications they started during treatment. Under this bill, patients will no longer be forced to make an additional trip to a pharmacy to continue essential treatment—reducing both unnecessary expenses and delays in care. This policy will not only save patients time and money, but also help combat excessive medical waste in our healthcare system.

Background.

Dispensing Unused Medications. Ordinarily, hospital emergency room (ER) personnel may not dispense medication to patients for use outside the ER, except under certain circumstances. One such exception authorizes a prescriber (e.g., a physician) to dispense medication to an ER patient when the hospital pharmacy is closed and there is no pharmacist available in the hospital. When dispensing medication pursuant to this authority, the quantity of medication provided may not exceed a 72-hour supply, the prescriber must reasonably believe there is no local pharmacy accessible at the time, and the medication must be labeled with all the information required of a typical pharmacy-issued prescription.

This bill would create an additional authority for prescribers to dispense medication to an ER patient for use outside the hospital. Specifically, it would authorize a prescriber to dispense the unused portion of a medication that was administered to the patient in the ER, provided the medication remains necessary for treatment following discharge.

Because of the existing limitations on prescribers’ authority to dispense medication, any unused portion of a multi-use medication must be disposed of when the patient is discharged, even if the medication is necessary for the patient’s continued treatment. Instead of allowing the ER patient to take home the unused medication, the prescriber who administered the drug will issue a prescription to be filled at an external pharmacy. According to the author and sponsor, this process causes hospitals to unnecessarily waste usable medication and creates additional inconvenience and expense for patients.

The authority created by this bill is designed specifically for medications contained in multi-use packaging that are difficult or impossible to separate into discrete doses. For example, an inhaler may come in an aerosol container with 30 doses, but an ER patient may only require 3 doses during their ER stay. However, unlike with pills or capsules, there is no way for the hospital pharmacy to separate out 3 aerosol doses to administer to one ER patient and save the remaining 27 doses for other patients. Nor can a prescriber measure out a 72-hour supply of aerosol doses and dispense it to the patient upon discharge under the existing prescriber authority. This bill, therefore, creates a novel pathway for prescribers and hospital pharmacies to dispense portions of necessary medication that would otherwise be disposed of.

Expansion of AUDS Licensure Exemption. To help streamline the processing and distribution of drugs throughout the facility, hospital pharmacies often maintain an automated drug delivery system, or ADDS. An ADDS is an automated cabinet that securely stores medications for ready access by authorized employees. Hospitals may also use a subtype of ADDS known as an automated unit dose system, or AUDS, which specifically dispenses individually-packaged doses for hospital personnel to administer to patients. By packaging and dispensing drugs in single doses, the use of an AUDS can help reduce human error and expedite delivery of medications.

All operators of an ADDS must obtain a license for the system from the Board of Pharmacy (board). However, if an ADDS is an AUDS operated by a licensed hospital pharmacy and is used solely to administer doses to patients in an acute care hospital, the ADDS is exempt from the licensure requirement. This licensure exemption does not exempt the hospital pharmacy from following all other safety, recordkeeping, reporting, and inspection requirements under the Pharmacy Law—it merely exempts the hospital pharmacy from obtaining a separate license and paying the licensing fee. In Question #22 of its Frequently Asked Questions for ADDSs, the board explains its interpretation that an ADDS is not exempt from licensure if the ADDS is used by a prescriber to dispense medication to an ER patient under the existing prescriber dispensing authority (i.e., when the pharmacy is closed, up to a 72-hour supply). An ADDS used for this purpose, the board states, is not exempt even when it is primarily used for the type of in-hospital administration that would ordinarily render it exempt. The board contends that, because the exemption only applies to ADDSs used solely for administration, any use of an ADDS to dispense medication will require the machine to be licensed.

To address the board’s interpretation, this bill would expand the licensure exemption to expressly exempt AUDSs used to provide medication to ER patients under existing prescriber dispensing authority or under the proposed authority in this bill.

ARGUMENTS IN SUPPORT:

The sponsor of this bill, the California Chapter of the American College of Emergency Physicians, writes in support:

Patients often present to the emergency department (ED) with conditions that require prescription treatments. These treatments are dispensed from the hospital pharmacy containing more doses than will be used during the ED visit. Frequently, one dose of a multi-use medication, including eye drops, inhalers and liquid antibiotics [is] administered and then the remainder must be disposed of. Under existing law, the remaining doses cannot be sent home with the patient they were prescribed for, and they cannot be used for other patients.

Patients who receive these types of treatments leave the ED with a prescription for the same medication that they must pick up at an outpatient pharmacy to continue treating their condition. In areas where there are no 24-hour pharmacies, this can mean waiting until business hours start and potentially missing treatment doses. Even when readily available, it is an unnecessary, duplicate expense.

Prescription drugs account for approximately 10% of healthcare costs in the U.S. and policies that prevent patients from taking home multiuse drugs contribute to these costs. While emergency department specific data isn’t currently available, studies of other care settings have found that as much as 50% of prepared multiuse drugs, including eye drops and inhalers, are discarded instead of being used again or [dispensed] to the patient.

Current California law results in redundant prescriptions, increased cost to the health system, and increased medical waste. [This bill] would allow providers to dispense remaining doses of non-narcotic prescriptions to emergency room patients. Allowing patients to take home the remaining doses of their multiuse medication will reduce unnecessary spending, medical waste, and guarantee timely access to necessary prescriptions.

The California State Association of Psychiatrists writes in support:

[This bill] . . . provides a pragmatic approach to ensuring continuity of care for emergency room patients by allowing the dispensing of unused portions of dangerous drugs upon discharge, under specified conditions.

This bill addresses a critical gap in patient care by authorizing prescribers to dispense non-controlled dangerous drugs acquired by the hospital pharmacy when it is necessary to continue treatment. This is particularly important for vulnerable patients who may face barriers to accessing a pharmacy immediately upon discharge, potentially leading to treatment interruptions and negative health outcomes.

[This bill] maintains appropriate safeguards by excluding controlled substances and ensuring that the prescriber is responsible for any errors or omissions. This balanced approach promotes patient safety while enhancing access to necessary medications, aligning with the goals of improving public health and reducing hospital readmissions.

The California Medical Association writes in support:

This bill addresses flaws in California law which currently result in redundant prescriptions, increased healthcare costs, and excessive medical waste. Allowing patients to take home the remaining doses of their prescribed multi-use medications would reduce unnecessary spending, decrease medical waste, and ensure timely access to necessary treatments. Important safeguards are kept in place, ensuring that a drug must have been ordered and administered to the emergency room patient and that it is required for continued treatment of the patient.

This bill seeks to implement a structured program that allows for the redistribution of certain medications, while ensuring compliance with safety and regulatory standards. This measure will improve health care efficiency, support vulnerable populations, and reduce financial burdens on patients and our health care delivery system.

ARGUMENTS IN OPPOSITION:

There is no opposition on file.

IMPLEMENTATION ISSUES:

Expansion of AUDS Licensure Exemption. This bill is intended to exempt AUDSs that either provide doses for dispensing to ER patients under the existing prescriber authority, or under the new prescriber authority that this bill would create. However, this bill’s expanded exemption may not function as intended, as there is an inherent tension between the existing, unchanged exemption language and that of the two prescriber dispensing provisions at issue.

The exemption statute requires, as a threshold matter, that the exempted machine be an AUDS. An AUDS, in turn, is defined as a machine used for storage and retrieval of “unit doses” of drugs for “administration to patients.” However, the existing prescriber authority allows a prescriber to dispense medication. Because an AUDS is defined as a machine used for administration, a machine used to occasionally dispense drugs to ER patients may not be classified as an AUDS, and therefore may not qualify for the AUDS exemption.

Under the proposed authority to dispense the unused medication in this bill, the medication must first be administered, which satisfies the “administration” prong of the AUDS definition. However, this bill’s provisions specifically contemplate dispensing multi-use medications, while the definition of AUDS is a machine that provides unit doses, which are single-use. So, a machine used to provide medication under the proposed authority in this bill may not fit within the definition of an AUDS, and therefore may not qualify for the AUDS licensure exemption. If this bill passes this committee, the author may wish to resolve the tension between the exemption language and the prescriber dispensing authorities both in existing law and within this bill.

AMENDMENTS:

1. To clarify the meaning of “unused portion of a dangerous drug,” amend the bill as follows:

On page 3, between lines 5 and 6, insert:

(3) The dangerous drug was administered from multi-use packaging and can be self-administered by the patient, including but not limited to, an inhaler, eye drop, ear drop, nose drop or spray, topical product, or liquid product.

1. To standardize labeling requirements with those of an ordinary prescription, amend the bill as follows:

On page 3, between lines 7 and 8, insert:

(5) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.

REGISTERED SUPPORT:

California Chapter of the American College of Emergency Physicians (sponsor)

California State Association of Psychiatrists

California Medical Association

California Emergency Nurses Association

California Hospital Association (if amended)

REGISTERED OPPOSITION:

There is no opposition on file.

Analysis Prepared by: Alexander Diehl / B. & P. / (916) 319-3301