Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy by pharmacists and pharmacy corporations in this state. That law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. That law requires a pharmacy to compound sterile products from one or more nonsterile ingredients in prescribed environments.

This bill would repeal that compounding environment provision and make conforming renumbering changes to other provisions.

Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy by pharmacists and pharmacy corporations in this state. That law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. That law requires a pharmacy to compound sterile products from one or more nonsterile ingredients in prescribed environments.

This bill would repeal that compounding environment provision and make conforming renumbering changes to other provisions.

Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy by pharmacists and pharmacy corporations in this state. That law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. That law requires a pharmacy to compound sterile products from one or more nonsterile ingredients in prescribed environments.

This bill would repeal that compounding environment provision and make conforming renumbering changes to other provisions.

SENATE THIRD READING

STR Bill Id:SB 510

Author:(Stone)

As Introduced Ver:February 16, 2017

Majority vote

SENATE VOTE: 37-0

SUMMARY: Deletes provisions of existing law that require specific environmental conditions for the compounding of sterile products from one or more nonsterile ingredients.

FISCAL EFFECT: None

COMMENTS:

Purpose. This bill is sponsored by the California State Board of Pharmacy (BOP). According to the author, "SB 510 is needed to remove the conflict between state and federal compounding standards, to ensure members of the board's regulated public have a clear understanding of the appropriate environments that must be used in compound sterile drug products."

Background. The BOP creates and regularly updates standards for pharmaceutical practice, including for compounding pharmacies. This bill repeals provisions in existing law that require compounding pharmacies to follow specific environmental requirements when compounding sterile products from one or more nonsterile ingredients. Under current law, pharmacies must operate within one of the following environments:

1. An International Organization for Standardization (ISO) class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.
2. An ISO class 5 cleanroom.
3. A barrier isolator that provides an ISO class 5 environment for compounding. (Business and Professions Code Section 4127.7)

Repealing the above requirements would mean that pharmacies would defer to regulations promulgated by the BOP on January 1, 2017. These regulations were created to ensure compliance with the United States Pharmacopeia and the National Formulary (USP-NF), the official standards established by the United States Federal Food, Drug, and Cosmetics Act for drugs marketed in the United States.

Prior Related Legislation. SB 1913 (Committee on Business and Professions) Chapter 695, Statutes of 2004 enacted a number of noncontroversial health-related statutory updates, including conditions under which sterile drugs must be compounded.

Analysis Prepared by: Jimmy Fremgen / B. & P. / (916) 319-3301 FN: 0001036

Date of Hearing: June 20, 2017

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

SBPCA Bill Id:

Author:() – As Ver:

SENATE VOTE:

SUBJECT:

SUMMARY: This bill repeals existing environmental requirements for the compounding of nonsterile ingredients by pharmacies.

EXISTING LAW:

1. Establishes the Board of Pharmacy (BOP) to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) Section 4001)
2. Requires a pharmacy compounding sterile drug products to obtain a sterile compounding pharmacy license from the BOP. (BPC Section 4127)
3. Requires the BOP to review any formal revision to General Chapter 797 of the United States Pharmacopeia and the National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary to governing law or regulations. (BPC Section 4127(c))
4. Requires a pharmacy compounding sterile products from one or more nonsterile ingredients to do so in one of the following environments:
   1. An International Organization for Standardization (ISO) class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.
   2. An ISO class 5 cleanroom.
   3. A barrier isolator that provides an ISO class 5 environment for compounding. (BPC Section 4127.7)
5. Establishes different facility and equipment standards for sterile compounding than exists in statute. (California Code of Regulations, Title 16, Section 1751.4)

THIS BILL:

1. Deletes provisions of existing law that require specific environmental conditions for the compounding of sterile products from one or more nonsterile ingredients.

FISCAL EFFECT: None

COMMENTS:

Purpose. This bill is sponsored by the California State Board of Pharmacy. According to the author, “SB 510 is needed to remove the conflict between state and federal compounding standards, to ensure members of the board’s regulated public have a clear understanding of the appropriate environments that must be used in compound sterile drug products.”

Background. The BOP creates and regularly updates standards for pharmaceutical practice, including for compounding pharmacies. This bill repeals provisions in existing law that require compounding pharmacies to follow specific environmental requirements when compounding sterile products from one or more nonsterile ingredients. Under current law, pharmacies must operate within one of the following environments:

• 1. An International Organization for Standardization (ISO) class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.
  2. An ISO class 5 cleanroom.
  3. A barrier isolator that provides an ISO class 5 environment for compounding. (BPC § 4127.7)

Repealing the above requirements would mean that pharmacies would defer to regulations promulgated by the BOP on January 1, 2017. These regulations were created to ensure compliance with the United States Pharmacopeia and the National Formulary (USP-NF), the official standards established by the U.S. Federal Food, Drug, and Cosmetics Act for drugs marketed in the United States.

Prior Related Legislation. SB 1913 (Committee on Business and Professions) Chapter 695, Statutes of 2004 enacted a number of noncontroversial health-related statutory updates, including conditions under which sterile drugs must be compounded.

ARGUMENTS IN SUPPORT:

The Board of Pharmacy writes, “As the compounding segment of pharmacy practice has evolved, so have the legal requirements, at both the state and federal levels. This ensures appropriate protections are in place for the patient as well as the staff who perform the compounding. Repeal of Business and Professions Code Section 4127.7 as proposed in SB 510 removes a significant conflict and is important in that it provides clarity to the board’s regulated public.”

ARGUMENTS IN OPPOSITION:

None on file

REGISTERED SUPPORT:

California State Board of Pharmacy

REGISTERED OPPOSITION:

None on file

Analysis Prepared by: Jimmy Fremgen / B. & P. / (916) 319-3301

 CONSENT  

Bill No: SB 510

Author:

:

Vote:

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 3/27/17

AYES: Hill, Bates, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk

SUBJECT:

SOURCE: California State Board of Pharmacy

DIGEST: This bill deletes current law relating to sterile compounding environments that conflict with recently adopted regulations.

ANALYSIS:

Existing law:

1. Establishes the Board of Pharmacy (BOP) to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) Section 4001)
2. Requires a pharmacy compounding sterile drug products to obtain a sterile compounding pharmacy license from the BOP. (BPC § 4127)
3. Requires BOP to review any formal revision to General Chapter 797 of the United States Pharmacopeia and the National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary to governing law or regulations. (BPC § 4127 (c))
4. Requires a pharmacy compounding sterile products from one or more nonsterile ingredients to do so in one of the following environments:
   1. An International Organization for Standardization (ISO) class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.
   2. An ISO class 5 cleanroom.
   3. A barrier isolator that provides an ISO class 5 environment for compounding. (BPC § 4127.7)
5. Establishes different facility and equipment standards for sterile compounding than exists in statute. (California Code of Regulations, Title 16, § 1751.4)

This bill deletes provisions of law describing the appropriate environment in which to compound sterile products from one or more nonsterile ingredients.

Background

The BOP establishes standards for the creation of sterile drug products. This bill updates current law to defer to regulations promulgated by the BOP that took effect on January 1, 2017. These regulations were developed in part to ensure compliance with the USP-NF, a publication of public pharmacopeial standards, which were last updated in 2008.

The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as the official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

SUPPORT: (Verified 3/29/17)

California State Board of Pharmacy (source)

OPPOSITION: (Verified 3/29/17)

None received

ARGUMENTS IN SUPPORT: The Board of Pharmacy writes, “As the compounding segment of pharmacy practice has evolved, so have the legal requirements, at both the state and federal levels. This ensures appropriate protections are in place for the patient as well as the staff who perform the compounding. Repeal of Business and Professions Code Section 4127.7 as proposed in SB 510 removes a significant conflict and is important in that it provides clarity to the board’s regulated public.”

Prepared by:

3/29/17 15:42:37

**** END ****

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2017 - 2018 Regular

Bill No: Hearing Date: March 27, 2017

Subject:

SUMMARY:

This bill deletes current law relating to sterile compounding environments that conflict with recently adopted regulations.

Existing law:

1. Establishes the Board of Pharmacy (BOP) to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) Section 4001)
2. Requires a pharmacy compounding sterile drug products to obtain a sterile compounding pharmacy license from the BOP. (BPC § 4127)
3. Requires BOP to review any formal revision to General Chapter 797 of the United States Pharmacopeia and the National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary to governing law or regulations. (BPC § 4127 (c))
4. Requires a pharmacy compounding sterile products from one or more nonsterile ingredients to do so in one of the following environments:
   1. An International Organization for Standardization (ISO) class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas.
   2. An ISO class 5 cleanroom.
   3. A barrier isolator that provides an ISO class 5 environment for compounding. (BPC § 4127.7)
5. Establishes different facility and equipment standards for sterile compounding than exists in statute. (California Code of Regulations, Title 16, § 1751.4)

This bill: deletes provisions of law describing the appropriate environment in which to compound sterile products from one or more nonsterile ingredients.

FISCAL EFFECT:

This bill is not keyed fiscal by Legislative Counsel.

COMMENTS:

1. Purpose. The Board of Pharmacy is the Sponsor of this bill. According to the Author’s office, “This bill is needed to remove the conflict to ensure members of the board’s regulated public have a clear understanding of the appropriate environments that must be used in compound sterile drug products.”

1. Background. The BOP establishes standards for the creation of sterile drug products. This bill updates current law to defer to regulations promulgated by the BOP that took effect on January 1, 2017. These regulations were developed in part to ensure compliance with the USP-NF, a publication of public pharmacopeial standards, which were last updated in 2008.

The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as the official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.

1. Related Legislation. SB 351 (Roth) would authorize the BOP to issue a license to a hospital satellite compounding pharmacy meeting specified requirements and would make the license subject to annual renewal. The bill would define a hospital satellite compounding pharmacy as an area licensed by the BOP to perform sterile compounding that is separately licensed by the BOP to perform that compounding and located outside of the hospital in another physical plant that is regulated as a general acute care hospital. (Status: This bill is currently pending in this Committee.)
2. Prior Related Legislation. SB 1913 (Committee on Business and Professions, Chapter 695, Statutes of 2004) enacted a number of noncontroversial health-related statutory updates, including conditions under which sterile drugs must be compounded.
3. Arguments in Support. The Board of Pharmacy writes, “As the compounding segment of pharmacy practice has evolved, so have the legal requirements, at both the state and federal levels. This ensures appropriate protections are in place for the patient as well as the staff who perform the compounding. Repeal of Business and Professions Code Section 4127.7 as proposed in SB 510 removes a significant conflict and is important in that it provides clarity to the board’s regulated public.”

SUPPORT AND OPPOSITION:

Support:

California State Board of Pharmacy

Opposition:

None on file as of March 21, 2017

-- END --