~`w - california states pharmacopeia -national formulary {usp) , an industry standard...

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STkTEOFCALiPORNIA--OFFICEOFADMINIST :,i.:~ELF'.": - ' - ~ - ~S2~.It1Stt'llC~IOIIS Oh J~110TKE PUBLICATION/~tfCsU~r~~lii~f~S Slf$MiSSt~f~! reverse) Sl'D.400 (REV. 01-2013) QAL FILE NOTICE FILE NUMBER REGULATORY ACTION NUMBER ~ o EME72G~NC~ N~MER NUMBERS Z. 7 ~ ~ For use by Office of Administrative Law (OAL) only ~`w ~ ~, ~ _ ~~~'i . e t ~ ~ ~ ~ , ~ NOTICE AGENCY WITH RULEMAKING AUTHORITY Board of Pharmacy REGULATIONS For use by Secretary of State only t~. PUBLICATION OF NOTICE (Complete for publication in Notice Register) 1. SUBJECT OF NOTICE TITLES) FIRST: 3. NOTICE TYPE ~ 4. AGENCY CONTACT PERSON TELEPHONE NUMBER FAX NUMBER (Optional) Notice re Proposed Qe„~~i~+,,.,, e..r~,.., ~ Othef OAL USE A~ ~ `aN ON PROPOSED NOTICE NOT CE REGISTER'~UMBER PUBLICATION DA7E ~~~Y ~1 Approved as ~~;----~~' AnprnveC as Dieapui _e0~ ~ ~ Submrtte❑ I~ Medifieh ~ ~Nrthtlra~n -- ~ - ~ -- -- _ _ _ .i_r'. B. SUBMISSION OF REGULATIONS (Complete when submitting regulations) 1a. SUBJECT OF REGULATIONS) 1b. AlL PREVIOUS RELATED OAL REGULATORY ACTION NUMBER(Sj Compounded Drug Preparations 22013-1119-07,22014-0826-05, 22016 -0841-OS 2. SPECIFY CALIFORNIA CODE OF REGULATIONS TITI.E(S) AND SECTION(5) (Including title 26, if toxics related) SECTION(5) AFFECTED AooPr (List atl section numbers) individually. Attach AME"° additional sheet if needed.) 1735.2 TIT~E(S) 16 3. TYPE OF FILING Regular Rulemaking {Gov. ~ Certificate of Compliance: The agency officer named ~ Emergency Readopt (Gov. ❑Changes Without Regulatory Code 411346) below certifies that this agency complied with the Code, X71346.7 (hp Effect (Cal. Code Regs., title Resubmittal of disapproved or provisions of Gov. Code §71346.2-11347.3 either 1, §700) withdrawn nonernergency before the emergency regulation was adopted or filin (Gov. Code §§11349.3, ~ File &Print ~ Print Only 9 within the time eriod re wired b statute P 9 Y 7 1349.4) Emergency (Gov. Code, ~ Resubmittal of disapproved or withdrawn ~ Other (Specify) ~713 46.1( b)) emergency filing (Gov. Code, §71346.1) 4. ALL BEGINNING AND ENDING DATES OF AVAILABILITY OF MODIFIED REGULATIONS AND/OR MATERIAL ADDEDTO THE RULEMAKING FllE (Cal. Code Regs.title t, §44 and Gov. Code §7 7347.1) 5. EFFEGTNE GATE OF CHANGES (Gov. Code, §§ i 7343.4, i 7346.7 (d); CaI. Code Regs., title L §700 ) Effective January 1, April 1, Judy 1, or Effective on filing with §100 Changes Without Effective October 1 (Gov. Code §11343.4(aj) o Secretary of State ~ Regulatory Effect ~ other (Specify) 6. CHECK IF THESE REGULATIONS REQUIRE NOTICE TO, OR REVIEW, CONSULTATION, APPROVAL OR CONCURRENCE BY, ANOTHER AGENCY OR ENTITY Department of Finance (Form STD. 399) (SAM X6660) ~ Fair Political Practices Go iss n ~ State Fire Marshal ~( Other (Specify) Dean R. Grafilo, Director, Department of Consumer Affairs ,,r%Z'~'"~ 7. CONTACT PERSON TELEPHONE Nl1MBER FAX NUMBER (Optional) E-MAIL ADDRESS (Optional) Lori Martinez 916-574-7917 916-574-8617 [email protected] 8~ i certify that the attached copy of the regulations) is a true and correct copy ror use of the regulations) identified on this form, that the information specified on this form is true and correct, and that I am the head of the agency taking this action, or a des' nee of the h of the agency, and am authorized to make this certification. cicni i ioc nc non~ry ucnr no r_n~cc f)ATF l2~1~~201~ only Virginia Herold, Executive Officer

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Page 1: ~`w - California States Pharmacopeia -National Formulary {USP) , an industry standard for-pharmaceutical compounding of non-sterile preparations, anticipates that the BUD

STkTEOFCALiPORNIA--OFFICEOFADMINIST :,i.:~ELF'.": - ' - ~ - ~S2~.It1Stt'llC~IOIIS OhJ~110TKE PUBLICATION/~tfCsU~r~~lii~f~S Slf$MiSSt~f~! reverse)Sl'D.400 (REV. 01-2013)

QAL FILE NOTICE FILE NUMBER REGULATORY ACTION NUMBER ~ o EME72G~NC~ N~MERNUMBERS Z. 7 ~ ~

For use by Office of Administrative Law (OAL) only

~`w ~ ~,~ _ ~~~'i . e t ~ ~ ~ ~ , ~

NOTICE

AGENCY WITH RULEMAKING AUTHORITY

Board of Pharmacy

REGULATIONS

For use by Secretary of State only

t~. PUBLICATION OF NOTICE (Complete for publication in Notice Register)1. SUBJECT OF NOTICE TITLES) FIRST:

3. NOTICE TYPE ~ 4. AGENCY CONTACT PERSON TELEPHONE NUMBER FAX NUMBER (Optional)Notice re ProposedQe„~~i~+,,.,, e..r~,.., ~ Othef

OAL USE A~ ~ ̀ aN ON PROPOSED NOTICE NOT CE REGISTER'~UMBER PUBLICATION DA7E~~~Y ~1 Approved as ~~;----~~' AnprnveC as Dieapui _e0~

~~ Submrtte❑ I~ Medifieh ~ ~Nrthtlra~n-- ~ - ~ -- -- _ _ _ .i_r'.

B. SUBMISSION OF REGULATIONS (Complete when submitting regulations)1a. SUBJECT OF REGULATIONS) 1b. AlL PREVIOUS RELATED OAL REGULATORY ACTION NUMBER(Sj

Compounded Drug Preparations 22013-1119-07, 22014-0826-05, 22016-0841-OS2. SPECIFY CALIFORNIA CODE OF REGULATIONS TITI.E(S) AND SECTION(5) (Including title 26, if toxics related)

SECTION(5) AFFECTED AooPr

(List atl section numbers)individually. Attach AME"°

additional sheet if needed.) 1735.2TIT~E(S)

16

3. TYPE OF FILING

Regular Rulemaking {Gov. ~ Certificate of Compliance: The agency officer named ~ Emergency Readopt (Gov. ❑Changes Without RegulatoryCode 411346) below certifies that this agency complied with the Code, X71346.7 (hp Effect (Cal. Code Regs., title❑ Resubmittal of disapproved or provisions of Gov. Code §71346.2-11347.3 either 1, §700)withdrawn nonernergency before the emergency regulation was adopted or

filin (Gov. Code §§11349.3, ~ File &Print ~ Print Only9 within the time eriod re wired b statuteP 9 Y7 1349.4)

Emergency (Gov. Code, ~ Resubmittal of disapproved or withdrawn ~ Other (Specify)~71346.1(b)) emergency filing (Gov. Code, §71346.1)

4. ALL BEGINNING AND ENDING DATES OF AVAILABILITY OF MODIFIED REGULATIONS AND/OR MATERIAL ADDEDTO THE RULEMAKING FllE (Cal. Code Regs.title t, §44 and Gov. Code §7 7347.1)

5. EFFEGTNE GATE OF CHANGES (Gov. Code, §§ i 7343.4, i 7346.7 (d); CaI. Code Regs., title L §700 )Effective January 1, April 1, Judy 1, or Effective on filing with §100 Changes Without EffectiveOctober 1 (Gov. Code §11343.4(aj) o Secretary of State ~ Regulatory Effect ~ other (Specify)

6. CHECK IF THESE REGULATIONS REQUIRE NOTICE TO, OR REVIEW, CONSULTATION, APPROVAL OR CONCURRENCE BY, ANOTHER AGENCY OR ENTITY

Department of Finance (Form STD. 399) (SAM X6660) ~ Fair Political Practices Go iss n ~ State Fire Marshal

~( Other (Specify) Dean R. Grafilo, Director, Department of Consumer Affairs ,,r%Z'~'"~7. CONTACT PERSON TELEPHONE Nl1MBER FAX NUMBER (Optional) E-MAIL ADDRESS (Optional)Lori Martinez 916-574-7917 916-574-8617 [email protected]

8~ i certify that the attached copy of the regulations) is a true and correct copy ror useof the regulations) identified on this form, that the information specified on this formis true and correct, and that I am the head of the agency taking this action,or a des' nee of the h of the agency, and am authorized to make this certification.

cicni i ioc nc non~ry ucnr no r_n~cc f)ATF

l2~1~~201~

only

Virginia Herold, Executive Officer

Page 2: ~`w - California States Pharmacopeia -National Formulary {USP) , an industry standard for-pharmaceutical compounding of non-sterile preparations, anticipates that the BUD

Title 16. Board of Pharmacy

Changes made to the current regulation language are shown by strikethrough for deletedlanguage and underline for added language. Additionally, [Brackets] indicates language that isnot being amended.

Amend section 1?35.2, subdivision (i) in Article 4.5 of Division 17 of Title 16 CaliforniaCode of Regulations to read as follows:

1735.2. Compounding Limitations and Requirements; Self-Assessment.

(i) Every compounded drug preparation shall be given beyond use date representing the dateor date and time beyond which the compounded drug preparation should not be used,stored, transported or administered, and determined based on the professional judgment ofthe pharmacist performing or supervising the compounding.(1) For non-sterile compounded drug preparation(s), the beyond use date shall not exceed

any of the following:(A) the shortest expiration date or beyond use date of any ingredient in the compounded

__-__- drug preparation,{B) the chemical stability of any one ingredient in the compounded drug preparation;{C) the chemical stability of the combination of all ingredients in the compounded drug

preparation,(D) ~-~8-~a~s for non-aqueous formulations, 180 days or an extended date established

by the ~harmacis#'s research, analysis, and documentation.(E) ~-4-da~s for water-containing oral formulations, 14 days or an extended date

established by the pharmacist's research, analysis, and documentation, and(F) 38-dais for water-containing topical/dermal and mucosal liquid and semisolid

formulations, 30 days or an extended date established by the pharmacist's research,analysis, and documentation.

(GZA pharmacist, using his or her professional judgment may establish an extendeddate as provided in (D), (E~, and (F), if the eharmacist researches by consulting andapp~na drug-specific and general stability documentation and literature; analyzessuch documentation and literature as well as the other factors set forth in thissubdivision, and maintains documentation of the research, analysis andconclusion. The factors the pharmacist must analyze include:{i) the nature of the drug and its degradation mechanism,jii) the dosage form and its components,~iii1 the potential for microbial proliferation in the preparation,(iv) the container in which it is packaged,~vl the expected storage conditions, andjvij the intended duration of therapy,

Documentation of the pharmacist's research and analysis supporting an extension mustbe maintained in a readily retrievable format as part of the master formula.

Board of Pharmacy Emergency Regulation Text Page 1 of 216 CCR § 1735.2(i} Compounding {$.9.2017)

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r

(2) For sterile compounded drug preparations, the beyond use date shalt not exceed any of

the following:(A) The shortest expiration date or beyond use date of any ingredient in the sterile

compounded drug product preparation,

(B) The chemical stability of any one ingredient in the sterile compounded. drug

preparation,

(C) The chemical. stability of the combination of all ingredients in the sterile compounded

drug preparation, and

(D) The beyond use date assigned for sterility in section 1751.8.

(3) For sterile compounded drug preparations, ~-extension of a beyond use date is only

allowable when supported by the following:

(A) Method Suitability Test,

(B) Container closure integrity Test, and

(C) Stability Studies

(4) In addition to the requirements of paragraph three (3), the drugs or compounded drug

preparations tested and studied shah be identical in ingredients, specific and essential

compounding steps, quality reviews, and packaging as the finished drug or compounded

drug preparation.

(5) Shorter dating than set forth in this subsection may be used if it is deemed appropriate in

the professional judgment of the responsible pharmacist.

Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections

4005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code.

Board of Pharmacy Emergency Regulation Text Page 2 of 2

16 CCR § 1735.2(1) Compounding (8.9.2017)

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• • • f

On January 1; 2017, following three years of discussion and development, the CaliforniaState Board of Pharmacy's. (board} regulations related to compounded drugpreparations were extensively amended. Following implementation of the amendedregulations, stakeholders expressed concern that some of the new requirements werehaving a significant unintended impact on .patients' ability to receive their medications.The board held. two. public committee meetings to discuss the issue and. received.comments from stakeholders. After considering public impact, the board finds that thereis a significant adverse impact to patients related to the. current requirements forestablishing beyond use dates (BUDS) for non-sterile compounded drug preparations.Each day that the board's existing regulations are in place, there is a significant risk thatpatients. will be .deprived access. to needed medications. In addition, the board finds thatit is necessary to clarify the requirements to extend the BUDs for sterile compoundeddrug preparations in order to allow for the BUDs of non-sterile to be emended. Becauseof the immediate need for relief from the board's existing regulations that restrictpatients'. access. to drugs, the board is adopting these changes on an emergency basis.

Section 1735.2, subdivision (i), of title 16, California Code of Regulations (section.1735.2), as currently written, establishes the BUDs of compounded. drug preparations.Subdivision (i)(2) of that section does not include an option to emend the BUD specificto non-sterile compounded drug preparations. Each,BUD exists for public protectionbecause. it represents the date. after which the preparation should not be used —eitherbecause. it may no longer be effective {or as effective) as a medication ar because thepreparation .may. develop impurities. United States Pharmacopeia -National Formulary{USP) <795>, an industry standard for-pharmaceutical compounding of non-sterilepreparations, anticipates that the BUD of non-sterile compounded drug preparationsmay be determined using stability information that. is applicable.#o a specific drug andpreparation, which may include drug-specific. information as well as generaldocumentation and literature.

The board .received significant testimony from the public that patients were not able toreceive timely access to medications because of the restrictive BUD for non-sterilecompounded. preparations. The most notable. example of direct patient impact was.. inthe area of pediatric oral suspensions, where the board's current BUD requirements areimpacting patient access to and ability to maintain appropriate drug therapy. Accordingto the. United .Network of Organ Sharing (LINOS) .online database system (UNet), there.

- were over 1,800 transplants in patients under the age of 18 in 2016 nationwide (basedon Organ Procurement and Transplantation Network data as of November 24, 2017).Pediatric patients who have undergone an organ transplant use a compoundedmedication to prevent the body from rejecting the transplant. Failure to have timely andconsistent access to .this medication may result in transplant rejection.

Further, for pediatrcpatients with .autism, compounded medications play a vital role.When nutritional therapy is required, pharmacies combine vitamins, minerals and

Board of Pharmacy Finding of Emergency Page 1 of 716 CCR section 1735.2(1)

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supplements in specific dosage forms for such patients. Further, according to theProfessional Compounding Centers of America, children affected by autism often haveunique physical or psychological challenges that can be exacerbated by ingredientsfound in food and medicine. Compounded medications are necessary to overcomethese challenges.

Compounding pharmacists work directly with prescribers, including physicians, nursepractitioners and veterinarians to create customized medication solutions for patients(humans and animals) whose health care needs cannot be met by manufacturedmedications. Compounding preserves the prescribers' ability to prescribe medicationsthat best fit the needs of their patients. Without this regulatory change, patients maysuffer due to increased prices and restricted access to necessary medications. In thecontext of less risky, non-sterile compounded drugs, the consequences of thedecreased access to compounded medications far outweigh the minimal additionalpublic protections that come with the more restrictive BUD.

Another impact described was on the compounded medications that available forprescriber office use. Under board regulations, a pharmacy may provide a reasonablequantity of a medication to a prescriber for office use. Specific to veterinary practices,most non-sterile compounded medications for animals are aqueous, or water-containing, oral formulations. Currently, such medications have a BUD of 14 days.Because the patient population in a veterinary practice ranges in species and sizes(from birds to horses), the reasonable quantity a veterinarian might need on a given dayvaries greatly and the supply cannot easily be managed without the ability of thecompounder to extend the BUD of non-sterile compounded products beyond 14 days.Without the appropriate supply, the veterinarian cannot easily provide sufficientmedication to the animal patient until the regular prescription can be filled.

Under the existing regulation, the restrictive BUDs mean that the medication is lessaccessible for patients because (1) patients can obtain only a limited quantity and mustreturn to the pharmacy more frequently for refills, (2) the expense required to extendBUDs makes drugs prohibitively expensive for patients, or (3) the expense required toextend BUDs will mean that fewer pharmacies will compound and patients will have aharder time finding a pharmacy from which to obtain medications. The patients'restricted access, in turn, directly impacts patients' medication adherence. Patientmedication adherence, where the patient takes medication in the dosage and in thepattern prescribed, is necessary for patient health. The lack of ready access tomedications decreases patient medication adherence and, consequently, patient health.The inability of patients to timely receive non-sterile compounded medication poses aserious threat to public health, safety, and welfare.

The board is proposing an emergency action to amend its regulations related to theestablishment of beyond use dates for compounded drug preparations to allow for anextension of the beyond use date of non-sterile compounded drug preparations and toclarify that method suitability tests, container closure integrity tests, and stability studies

Board of Pharmacy Finding of Emergency Page 2 of 716 CCR section 1735.2(1)

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are only required to emend the beyond use date of sterile compounded drugpreparations.

The Board will also pursue the non-emergency rulemaking process. However, topreserve the peace, health, safety and general welfare of the residents of the State ofCalifornia, the board will adopt these amendments to existing regulation on anemergency basis.

INFORMATIVE DIGEST

Summary of Existing Laws and Regulations

The Pharmacy Law provides for the licensure and regulation of pharmacists andpharmacies in this state.by the California.State Board of Pharmacy. Existing lawrequires the board to adopt regulations establishing standards for compounding drugproducts in a pharmacy. Existing law requires licensure to operate as a .pharmacy,subject to annual renewal. Existing law requires pharmacies to obtain a license from theboard in .order to compound sterile drug preparations, which is also subject to annualrenewal Similar licensing requirements apply to nonresident pharmacies shipping drugproducts (compounded or otherwise) into California. Existing law subjects pharmacieswho compound sterile products to a cease and desist order issued by the board as wellas other enforcement or disciplinary actions.

There are compounding professional standards that are used across the nation knownas the .United States Pharmacopeia and the National Formulary (USP—NF). USP-NF isa book of pharmacopeia) standards. USP—NF is a combination of two compendia, theUnited States Pharmacopeia (USP) and the National Formulary (NF). Monographs fordrug substances, dosage forms, and compounded preparations are featured in theUSP. As it pertains to this rulemaking, it contains standards for compoundedpreparations, for both sterile and non-sterile. The U.S. Federal Food, Drug, andCosmetics Act designates the USP—NF as official compendia for drugs marketed in theUnited States. A drug product in the U.S. market must conform to the standards inUSP—NF; failure to do so may result in adulteration and misbranding of the drugs.

Business and Professions Code (B&P) section 4005 generally authorizes the board toadopt and amend rules and regulations pertaining to the practice of pharmacy and theadministration of Chapter 9 of Division 2 of that code. B&P section 4127 generallyauthorizes the board to adopt and amend regulations establishing standards forcompounding sterile drug products in a pharmacy.

Existing regulations establish standards and expectations for pharmacies compoundingdrug preparations. Existing regulations specify the beyond use dates (BUD) that applyto sterile and non-sterile compounded drug preparations. Subdivision (i)(3) of section1735.2 specifies a method to extend BUDs for all compounded drugs.

Board of Pharmacy Finding of Emergency Page 3 of 716 CCR section 1735.2(1)

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Policy Statement Overview

This regulation will revise and specify new requirements for a pharmacist establishingbeyond use dates (BUDs) for non-sterile compounded drug preparations. In addition, itclarifies that an existing provision that permits e~ctending the BUD will only apply tosterile compounded drug preparations.

Specific Changes

The specific changes, which are all to section 1735.2, subdivision (i), are as follows:

Subdivision (i)(1)(D) will be amended from "180 days for non-aqueous formulations," to"for non-aqueous formulations, 180 days or an e~ctended date established by thepharmacist's research, analysis, and documentation." This change permits apharmacist, using professional judgment, to extend the BUD for anon-aqueousformulation beyond 180 days, based on the pharmacist's research, analysis anddocumentation. The nature of the research, analysis, and documentation is furtherclarified in subdivision (G). A pharmacist's ability to extend the BUD for the specifiedformulation makes will make the drug preparations more readily available to public. Thepharmacist's exercise of professional judgment under the circumstances shouldadequately protect the public from any risks associated with the emended BUD.

Subdivision. (i)(1) (E) will be amended from "14 days for water-containing oralformulations, and" to "for water-containing oral formulations, 14 days or an extendeddate established by the pharmacist's research, analysis, and documentation." Thischange permits a pharmacist, using professional judgment, to extend the BUD far awater-containing oral formulation, beyond 14 days based on the pharmacist's research,analysis and documentation. The nature of the research, analysis, and documentation isfurther clarified in subdivision (G). A pharmacist's ability to e~ctend the BUD for thespecified formulation makes will make the drug preparations more readily available topublic. The pharmacist's exercise of professional judgment under the circumstancesshould adequately protect the public from any risks associated with the extended BUD.

Subdivision (i)(1) (F) was amended from "30 days for water-containing topical/dermaland mucosal liquid and semisolid formulations" to "for water-containing topical(dermaland mucosal liquid and semisolid formulations, 30 days or an extended date establishedby the pharmacist's research, analysis, and documentation." This change permits apharmacist, using professional judgment, to extend the BUD for a water containingtopical/dermal and mucosal liquid and semisolid formulations beyond 30 days based onthe pharmacist's research, analysis and documentation. The nature of the research,analysis, and documentation is further clarified in subdivision (G). A pharmacist's abilityto e~ctend the BUD for the specified formulation makes will make the drug preparationsmore readily available to public. The pharmacist's exercise of professional judgmentunder the circumstances should adequately protect the public from any risks associatedwith the extended BUD.

Board of Pharmacy Finding of Emergency Page 4 of 716 CCR section 17352(1)

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Subdivision (i)(1) (G) was added and reads as follows:

"A pharmacist, using his or her professional judgment may establish an extendeddate as provided in (D), (E), and (F), if the pharmacist researches by consultingand applying drug-specific and general stability documentation and literature;analyzes such documentation and literature as well as the other factors set forthin this subdivision, and maintains documentation of the research, analysis andconclusion. The factors the pharmacist must analyze include:

(i) the nature of the drug and i#s degradation mechanism,(ii) the dosage form and its components;.(iii) the potential for microbial proliferation in the preparation,(iv) the container in which it is packaged,(v) the expected storage conditions, and(vi) the intended duration of therapy.

Documentation of the pharmacist's research and analysis supporting ane~ension must be maintained in a readily retrievable format as part of the masterformula."

Subdivision (i) (1) (G) was added to clarify how the pharmacist must use professionaljudgment to research, analyze and document his or her findings in extending a BUDpursuant to one of the identified subdivisions. It requires the pharmacist to research, ata minimum, by consulting and applying drug-specific and general stabilitydocumentation and literature. It requiresthe pharmacist, at a minimum, to analyze theidentified documentation .and literature, as well as items. (i) — (vi) above, :before. reachinga conclusion. The board determined that items (i) — (vi) were the appropriate standardsbased on the factors specified in USP <795> for determining BUDs. The board requiresthe pharmacist to exercise professional judgment in these ways because it is less likelyunder these circumstances that the public will be harmed by an emended BUD. Thesection also requires that the pharmacist maintain documentation of his or her research,analysis and conclusion, and to maintain such documents as part of the master formulain a readily retrievable format. The board requires the documentation and maintenanceso that the board can readily inspect and verify whether the pharmacist complied withthe regulation, and so that the board can take action if it finds that any non-complianceposes a risk to the public.

Subdivision (i)(3) was amended to add "For sterile compounded drug preparations," tothe beginning of the subdivision. This was done to clarify that, with the changesdescribed above, this .section, which specifies a different method for e~ctending a BUD,will only apply to sterile compounded drug preparations, and will not apply to non-sterilecompounded drug preparations. The standards in the existing regulation are moreappropriate to, and are practically feasible only for, sterile compounded preparations..The board determined that without making this change, the changes the board isproposing to subdivision (i}(1) would create confusion about the means to emend a BUD#or both sterile and non-sterile compounded drug preparations.

Board of Pharmacy Finding of Emergency Page 5 of 716 CCR section 1735.2(1)

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Consistency and Compatibility with Existing. Regulations

The. board conducted a search of the California Code of Regulations and determinedthat the proposed regulation is neither inconsistent nor incompatible with existing stateregulations.

Underl~nq Data

1. Relevant Meeting Materials and Minutes from Board Meeting held January 24-25, 2017

2. Relevant Meeting Materials and Minutes from Board Enforcement CommitteeMeeting held April 18, 2017

3. Relevant Meeting Materials and Minutes from Board Enforcement CommitteeMeeting held June 2, 2017

4. Relevant Meeting Materials and Minutes from Board Enforcement CommitteeMeeting held July 12, 2017

5. Relevant Meeting Materials and Minutes from Board Meeting held July 25-26,2017

6. Chapter <795> of the United States Pharmacopeia -National Formulary (USP37NF32 through 2nd Supplement) (37th Revision, Effective December 1, 2014).

7. Chapter <797> of the United States Pharmacopeia -National Formulary (USP37- NF32 through 2nd Supplement) (37th Revision, Effective December 1, 2014).

8. United Network for Organ Sharing (LINOS) Organ Procurement andTransplantation Network (OPTN) as of November 24, 2017(https://optn.transplant. h rsa.gov/data(view-data-reports/national-datal#)

Authority and Reference

Authority: Sections 4005 and 4127, Business and Professions Code. Reference:Sections 4005, 4036, 4037, 4051, 4052, 4126.9, 4127, 4127.1, 4127.2, 4127.3, and4127.9 Business and Professions Code.

Fiscal.lmpact Estimates

Cost to Any Local Agency or School District for Which Government CodeSections 1 7500 —1 7630 Require Reimbursement: None

Fiscal Impact on Public Agencies Including Costs or Savings to State Agenciesor Costs/Savings in Federal Funding to the State: Minimal

Nondiscretionary Costs/Savings to Local Agencies: None

Effect on Housing Costs: None

Local Mandate: None

Board of Pharmacy Finding of Emergency Page 6 of 716 CCR section 1735.2(1)

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Mandate on Local Agencies or School DistrictsThis regulatory action does not impose a mandate on local agencies or schooldistricts.

Contact Person

Inquiries or comments concerning the proposed rulemaking action may be addressedto:

Name:Address:

Telephone No.:Fax No.:E-Mail Address:

The backup contact person is:

Name:Address:

Telephone No.:Fax No..E-Mail Address:

Lori Martinez1625 N. Market Blvd., N219Sacramento, CA 95834(916) 574-7917(91 fi) [email protected]

Anne Sodergren1625 N. Market Blvd., N219Sacramento, CA 95834(916) 574-7910(916) [email protected]

Website Access: Materials regarding this proposal can be found. atwww. pharmacy.ca.gov.

Board of Pharmacy Finding of Emergency Page 7 of 716 CCR section 1735.2(1)