SB 1006 — AN ACT CONCERNING REVISIONS TO THE PHARMACY AND DRUG CONTROL STATUTES.

General Assembly SubstituteRaised Bill No.

1006 January Session, 2019 ANLCO ACTNo. CONCERNING REVISIONS TO THE PHARMACY AND DRUG CONTROL STATUTES.

5194 Referred to Committee on GENERAL LAW Introduced by:

(GL) AN ACT CONCERNING REVISIONS TO THE PHARMACY AND DRUG CONTROL STATUTES.

Section 20-633b of the general statutes is repealed and the following is substituted in lieu thereof (Effective JanuaryOctober 1, 2020):2019):

[and]and (3) "Sterile pharmaceutical" means any dosage form of a drug, including, but not limited to, parenterals, injectables, surgical irrigants and ophthalmics devoid of viable microorganisms;microorganisms.

[.] and (4) "USP chapters" means chapters 797, 800 and 825 of the United States Pharmacopia that pertain to compounding sterile pharmaceuticals and their referenced companion documents, as LCO \\PRDFS1\SCOUSERS\FORZANOF\WS\2019SB-01006-R01 of 8 SB.docx Substitute Bill No.

10065194 1 of 9 Raised Bill No.1006 (b) (1) If an applicant for a new pharmacy license pursuant to section 20-594, as amended fromby timethis act, intends to time.compound sterile pharmaceuticals, the applicant shall file an addendum to its pharmacy license application to include sterile pharmaceutical compounding.

(b) (1) If an applicant for a new pharmacy license pursuant to section 20-594, as amended by this act, intends to compound sterile pharmaceuticals, the applicant shall file an addendum to its pharmacy license application to include sterile pharmaceutical compounding.

(4) If a nonresident pharmacy registered pursuant to section 20-627 intends to compound sterile pharmaceuticals for sale or delivery in this state for the first time on or after July 1, 2014, the nonresident LCOpharmacy {\\PRDFS1\SCOUSERS\FORZANOF\WS\2019SB-01002shall offile 8an R01-SB.docxaddendum }to Substituteits Billapplication No.to include sterile pharmaceutical compounding.

1006The nonresident pharmacy shall fileLCO anNo. addendum to its application to include sterile pharmaceutical compounding.

The5194 nonresident2 pharmacyof shall9 Raised Bill No.1006 provide the department with written proof it has passed inspection by the appropriate state agency in the state where such nonresident pharmacy is located.

(c) A sterile compounding pharmacy shall comply with the [mostmost recent version of the United States Pharmacopeia, Pharmaceutical Compounding - Sterile Preparations, and related chapters, as amended from time to time]time. USP chapters.

(d) An institutional pharmacy within a facility licensed pursuant to section 19a-490 that compounds sterile pharmaceuticals shall comply with the [mostmost recent version of the United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, and related chapters, as amended from time to time]time, USP chapters, and shall also comply with all applicable federal and state statutes and regulations.

Such institutional pharmacy may request from the Commissioner of Consumer Protection an extension of time, not to exceed six months, to comply, for state enforcement purposes, with any amendments to USP Chapter 797, for good cause shown.

(2) If a sterile compounding pharmacy provides sterile LCOpharmaceuticals {\\PRDFS1\SCOUSERS\FORZANOF\WS\2019SB-01003without ofa 8patient-specific R01-SB.docxprescription }or Substitutemedical BillLCO No.

10065194 pharmaceuticals3 withoutof a9 patient-specificRaised prescriptionBill orNo.1006 medical order, the sterile compounding pharmacy shall also obtain a certificate of registration from the Department of Consumer Protection pursuant to section 21a-70 and any required federal license or registration.

A sterile compounding pharmacy may prepare and maintain on-site inventory of sterile pharmaceuticals no greater than a thirty-day supply, calculated from the completion of compounding, which thirty- day period shall include the period required for third-party analytical testing, to be performed in accordance with the [mostmost recent version of the United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, and related chapters, as amended from time to time]time. USP chapters.

(f) (1) If a sterile compounding pharmacy plans to remodel a pharmacy clean room within the sterile compounding facility, relocate a pharmacy clean room within the facility or upgrade or conduct a nonemergency repair to the heating, ventilation, air conditioning or primary engineering controls for a pharmacy clean room within the facility,the sterile compounding pharmacy shall notify the Department of Consumer Protection,Protection in writing, not later than ten days prior to commencing such remodel, relocation, upgrade or repair.

(2) If the [Unitedmost recent version of the United States Pharmacopeia, Chapter[Chapter 797,797,] Pharmaceutical Compounding - Sterile Preparations, and related chapters, as amended from time to time, requires]requires USP chapters require sterile recertification after such remodel, relocation, upgrade or repair, the sterile compounding pharmacy shall provide a copy of its sterile recertification to the Department of Consumer Protection not later than five days after the sterile recertification approval.

(g) A sterile compounding pharmacy shall report, in writing, to the Department of Consumer Protection any known violation or LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2019SB-01004 of 8 R01-SB.docx } Substitute Bill No.

10065194 4 of 9 Raised Bill No.1006 noncompliance with viable and nonviable environmental sampling testing, as defined in the [mostmost recent version of the United States Pharmacopeia, Chapter[Chapter 797,797,] Pharmaceutical Compounding - Sterile Preparations, and related chapters, as amended from time to time]time, USP chapters, not later than the end of the next business day after discovering such violation or noncompliance.

The policy and procedure manual shall comply with the [mostmost recent version of the United States Pharmacopeia, Chapter[Chapter 797,797,] Pharmaceutical Compounding - Sterile Preparations, and related chapters, as amended from time to time]time. USP chapters.

(j) Each sterile compounding pharmacy shall report to the Department of Consumer Protection any administrative or legal action commenced against it by any state or federal regulatory agency or accreditation entity not later than five business days after receiving noticeLCO ofNo. the commencement of such action.

LCO5194 {\\PRDFS1\SCOUSERS\FORZANOF\WS\2019SB-010055 of 89 R01-SB.docxRaised }Bill SubstituteNo.1006 Billnotice No.of the commencement of such action.

1006 (k) Notwithstanding the provisions of subdivisions (3) and (4) of subsection (b) of this section, a sterile compounding pharmacy that is a nonresident pharmacy shall provide the Department of Consumer Protection proof that it has passed an inspection in such nonresident pharmacy's home state, based on the [mostmost recent version of the United States Pharmacopeia, Chapter[Chapter 797,797,] Pharmaceutical Compounding - Sterile Preparations compliance standards, and related chapters, as amended from time to time]time. USP chapters.

If the state in which the nonresident pharmacy is located does not conduct inspections based on standards required in the [mostmost recent version of the United States Pharmacopeia, Chapter[Chapter 797,797,] Pharmaceutical Compounding, and related chapters, as amended from time to time]time, USP chapters, such nonresident pharmacy shall provide satisfactory proof to the department that it is in compliance with the standards required in the [mostmost recent version of the United States Pharmacopeia, Chapter[Chapter 797,797,] Pharmaceutical Compounding as amended from time to time]time. USP chapters.

(m) (1) For purposes of this subsection, a "designated pharmacist" means a pharmacist responsible for overseeing the compounding of sterile pharmaceuticals and the application of the USPmost chapters,recent version of the United States Pharmacopeia, as it pertains to sterile compounding.

(2) Any pharmacy licensed pursuant to section 20-594, as amended byLCO thisNo. act, or institutional pharmacy licensed pursuant to section 19a- 490, that provides sterile pharmaceuticals shall notify the department of its designated pharmacist.

LCO5194 {\\PRDFS1\SCOUSERS\FORZANOF\WS\2019SB-010066 of 89 R01-SB.docxRaised }Bill SubstituteNo.1006 Billby No.this act, or institutional pharmacy licensed pursuant to section 19a- 490, that provides sterile pharmaceuticals shall notify the department of its designated pharmacist.

1006 (3) The designated pharmacist shall be responsible for providingdemonstrating, proofin hea orform sheand hasmanner completedprescribed a program approved by the commissioner, that demonstrates the competence necessary for the compounding of sterile pharmaceuticals, in compliance with all applicable federal and state statutes and regulations.

(4) TheNo pharmacist shall be the designated pharmacist shallfor immediatelymore notifythan theone departmentlicensed wheneverlocation hewhere orsterile shepharmaceuticals ceasesare suchprepared designation.at the same time.

(5) NothingThe indesignated thispharmacist sectionshall immediately notify the department whenever he or she ceases such designation and shall preventimmediately anotify designatedthe department of the name and license number of the pharmacist fromwho beingassumes responsibility as the pharmacynew manager.designated pharmacist.

(6) Nothing in this section shall prevent a designated pharmacist from being the pharmacy manager.

Subsection (h) of section 21a-243 of the general statutes is repealed and the following is substituted in lieu thereof (Effective from passage):LCO No.

(h)5194 When7 a drug that is not a controlled substance in schedule I, II, III, IV or V, as designated in the Connecticut controlled substance scheduling regulations, is designated to be a controlled substance under the federal Controlled Substances Act, such drug shall be considered to be controlled at the state level in the same numerical schedule [for a period of two9 hundredRaised fortyBill days]No. from the effective date of the federal classification.

Nothing1006 inpassage): this section shall prevent the Commissioner of Consumer Protection from designating a LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2019SB-01007 of 8 R01-SB.docx } Substitute Bill No.

1006(h) When a drug that is not a controlled substance differentlyin schedule I, II, III, IV or V, as designated in the Connecticut controlled substance scheduling regulationsregulations, thanis suchdesignated controlledto substancebe isa designatedcontrolled insubstance under the federal Controlled Substances Act, assuch amendeddrug fromshall timebe considered to time.be controlled at the state level in the same numerical schedule for a period of two hundred forty days from the effective date of the federal classification.

Nothing in this section shall prevent the Commissioner of Consumer Protection from designating a controlled substance differently in the Connecticut controlled substance scheduling regulations than such controlled substance is designated in the federal Controlled Substances Act, as amended from time to time.

(e) Notwithstanding the provisions of subsections (a) to (d), inclusive, of this section, not later than January 1, 2013, the Commissioner of Consumer Protection shall submit amendments to sections 21a-243-7 and 21a-243-8 of the regulations of Connecticut state agencies to the standing legislative regulation review committee to reclassify marijuana as a controlled substance in schedule II under the Connecticut controlled substance scheduling regulations, except that for any marijuana product that has been approved by the federal Food and Drug Administration or successor agency to have a medical use and that is reclassified in any schedule of controlled substances or unscheduled by the federal Drug Enforcement Administration or successor agency the commissioner shall adopt the schedule designated by the Drug Enforcement Administration or successor agency.