reglab/statecodes huggingface dataset:
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Classes of Pharmacies › Section 20-576-57 - Designation of class

Current through July 10, 2024
(a) The commission
				shall, when approving a new pharmacy license application, designate the class
				or classes, as listed in section
				20-576-55
				of the Regulations of Connecticut State Agencies, in which the pharmacy is
				approved for licensure. The commission has complete discretion to determine in
				which class or classes a pharmacy shall be licensed. In making its
				determination, the commission shall take into consideration the proportion of
				the business that the class of service represents as it relates to the total
				business of the pharmacy.
(b) For
				pharmacies licensed prior to the adoption of sections
				20-576-54
				to
				20-576-59,
				inclusive, of the Regulations of Connecticut State Agencies, the commission
				shall review the operation of each such pharmacy and designate the class or
				classes in which it is approved for licensure not later than one hundred eighty
				days after the effective date of section
				20-576-56
				of the Regulations of Connecticut State Agencies.
(c) The licensing of a pharmacy in more than
				one class, simultaneously, shall not result in an increase in the licensing
				fee.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Classes of Pharmacies › Section 20-576-58 - Request for reconsideration. Modifications

Current through July 10, 2024
(a) A pharmacy
				may request the commission to reconsider the pharmacy's initial designation of
				class not later than thirty days after the notice of such
				classification.
(b) A pharmacy that
				is licensed to operate in a particular class or classes may apply to the
				commission for a modification of such status.
(c) No fee shall be charged for a request for
				reconsideration or modification.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Classes of Pharmacies › Section 20-576-59 - Waivers and modifications

Current through July 10, 2024
(a) Upon written
				request, the commission may grant a waiver or modification of any regulation
				pertaining to the operation of a pharmacy within a designated class or classes.
				The commission may approve such a request if it finds that:
(1) The waiver or modification will not
				adversely affect the health, safety or welfare of the public;
(2) The basis for the request has been
				clearly substantiated; and
(3)
				Compliance with the particular regulation is, or will be, impractical or unduly
				burdensome.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Nuclear Pharmacies › Section 20-576-60 - Definitions

Current through July 10, 2024
As used in sections 20-576-60 to
				  20-576-63,
				  inclusive, of the Regulations of Connecticut State Agencies:
(1) "Agreement state" means any state that
				has entered into an agreement with the United States Nuclear Regulatory
				Commission or the Atomic Energy Commission under
				42 U.S.C. §
										2021;
(2) "Commission" means the Commission of
				Pharmacy;
(3) "Component" means any
				active or non-active ingredient of a drug product;
(4) "Department" means the Department of
				Consumer Protection;
(5) "Nuclear
				pharmacist" or "authorized nuclear pharmacist" means a pharmacist who holds a
				current pharmacist license issued by the commission, and who meets the
				following standards:
(A) has a current board
				certification as a nuclear pharmacist by the Board of Pharmaceutical
				Specialties; or
(B) is identified
				as an authorized nuclear pharmacist on a United States Nuclear Regulatory
				Commission or agreement state license that authorizes the use of radioactive
				material in the practice of nuclear pharmacy;
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Nuclear Pharmacies › Section 20-576-61 - General requirements for pharmacies providing radiopharmaceutical services

Current through July 10, 2024
(a) A license to
				operate a nuclear pharmacy shall only be issued to a person who is, or who
				employs, a nuclear pharmacist.
(b)
(1) A nuclear pharmacist shall:
(A) be responsible for all operations of the
				nuclear pharmacy;
(B) supervise the
				operation of only one nuclear pharmacy; and
(C) be present at all times that
				radiopharmaceutical services are being performed and at all times that the
				nuclear pharmacy is open for business.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Nuclear Pharmacies › Section 20-576-62 - Records and labeling

Current through July 10, 2024
(a) Upon receiving
				an order for a radiopharmaceutical, a nuclear pharmacy shall immediately reduce
				the prescription to writing or record the order in an automated data processing
				system. The written or electronic record shall contain at least the following:
(1) the name of the institution and
				prescribing practitioner or the practitioner's agent;
(2) the requested date of dispensing and the
				calibration time of the radiopharmaceutical;
(3) the name of the procedure;
(4) the name of the
				radiopharmaceutical;
(5) the dose
				or quantity of the radiopharmaceutical;
(6) the prescription number assigned to the
				order;
(7) any specific
				instructions;
(8) the identity of
				the person who dispenses the prescription or medication order; and
(9) the patient's name if the prescription or
				medication order is for a therapeutic or blood-product
				radiopharmaceutical.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Nuclear Pharmacies › Section 20-576-63 - Minimum equipment and supplies

Current through July 10, 2024
(a) Each nuclear
				pharmacy shall have the following equipment and supplies:
(1) radiation detection and measuring
				instruments capable of accurately measuring quantities of radioactivity and
				radiation;
(2) radiation
				shielding;
(3) appropriate supplies
				and equipment for performing quality assurance testing;
(4) a refrigerator;
(5) materials for decontamination of
				accidental spills of radioactive materials; and
(6) appropriate supplies and equipment
				necessary for compounding and dispensing sterile parenteral
				radiopharmaceuticals.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Sterile Compounding › Section 20-576-64 - Definitions

Current through July 10, 2024
As used in sections 20-576-64 to
				  20-576-68,
				  inclusive, of the Regulations of Connecticut State Agencies:
(1) "Sterile compounding pharmacy" means a
				pharmacy licensed pursuant to section
				20-594
				of the general statutes that dispenses sterile pharmaceutical products, but
				does not include a pharmacy that is part of a licensed hospital; and
(2) "Sterile pharmaceutical" means any dosage
				form of a drug, including, but not limited to, parenterals (e.g., injectables,
				surgical irrigants, and ophthalmics), devoid of viable
				microorganisms.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Sterile Compounding › Section 20-576-65 - Purpose

Current through July 10, 2024
The purpose of sections
				  20-576-64
				  to
				  20-576-68,
				  inclusive, of the Regulations of Connecticut State Agencies is to ensure
				  positive patient outcomes through the provision of standards for (1) pharmacist
				  care; (2) the preparation, labeling, and distribution of sterile
				  pharmaceuticals by pharmacies licensed pursuant to section
				  20-594
				  of the general statutes; and (3) product quality and
				  characteristics.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Sterile Compounding › Section 20-576-66 - Standards

Current through July 10, 2024
(a) Sections
				20-576-64
				to
				20-576-68,
				inclusive, of the Regulations of Connecticut State Agencies shall apply to all
				sterile pharmaceuticals, notwithstanding the location of the patient (e.g.,
				home, hospital, nursing home, hospice, doctor's office).
(b) A sterile compounding pharmacy shall
				comply with sections
				20-576-64
				to
				20-576-68,
				inclusive, of the Regulations of Connecticut State Agencies, and the current
				United States Pharmacopeia, Revised General Chapter 797, Pharmaceutical
				Compounding-Sterile Preparations. The United States Pharmacopeia, Revised
				General Chapter 797, Pharmaceutical Compounding-Sterile Preparations may be
				obtained via the Internet at the following location:
				http://www.usp.org/products/797Guidebook/.
(c) A sterile compounding pharmacy may
				provide compounded products to practitioners of medicine, osteopathy, podiatry,
				dentistry, or veterinary medicine to administer to their patients in the course
				of their professional practice, either personally or under their direct and
				immediate supervision, except that the quantity of such compounded products
				shall be limited to a two-week supply.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Sterile Compounding › Section 20-576-67 - Policy and procedure manual

Current through July 10, 2024
A sterile compounding pharmacy shall prepare and maintain a
				  policy and procedure manual for the compounding, dispensing, delivery,
				  administration, storage and use of sterile pharmaceuticals. The policy and
				  procedure manual shall be in compliance with the United States Pharmacopeia,
				  Revised General Chapter 797, Pharmaceutical Compounding-Sterile
				  Preparations.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Sterile Compounding › Section 20-576-68 - Hours

Current through July 10, 2024
A sterile compounding pharmacy shall be open at least
				  thirty-five (35) hours per week unless granted a waiver by the Commission of
				  Pharmacy pursuant to section
				  20-576-59
				  of the Regulations of Connecticut State Agencies.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Non-Sterile Compounding › Section 20-576-69 - Definitions

Current through July 10, 2024
As used in sections 20-576-69 to
				  20-576-73, inclusive, of the
				  Regulations of Connecticut State Agencies:
(1) "Commission" means the Commission of
				Pharmacy;
(2) "Non-sterile
				compounding pharmacy" means a pharmacy licensed pursuant to section
				20-594
				of the General Statues that dispenses non-sterile compounded pharmaceutical
				products, but does not include a pharmacy that is part of a licensed hospital;
				and
(3) "Non-sterile compounded
				pharmaceutical product" means a drug dosage form, a dietary supplement or a
				finished device made from the preparation of one or more substances.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Non-Sterile Compounding › Section 20-576-70 - Purpose

Current through July 10, 2024
The purpose of sections
				  20-576-69 to
				  20-576-73, inclusive, of the
				  Regulations of Connecticut State Agencies is to ensure positive patient
				  outcomes through the provision of standards for (1) pharmacist care; (2) the
				  preparation, labeling, and distribution of non-sterile compounded
				  pharmaceutical products by pharmacies licensed pursuant to section
				  20-594
				  of the General Statutes; and (3) product quality and
				  characteristics.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Non-Sterile Compounding › Section 20-576-71 - Standards

Current through July 10, 2024
(a) Sections
				20-576-69 to
				20-576-73, inclusive, of the
				Regulations of Connecticut State Agencies shall apply to all non-sterile
				compounded pharmaceutical products, notwithstanding the location of the
				patient, including, for example: Home, hospital, nursing home, hospice, or
				doctor's office.
(b) A non-sterile
				compounding pharmacy shall comply with sections
				20-576-69 to
				20-576-73, inclusive, of the
				Regulations of Connecticut State Agencies, and the current United States
				Pharmacopeia, Revised General Chapter 795, Pharmaceutical Compounding:
				Non-Sterile Preparations. The United States Pharmacopeia, Revised General
				Chapter 795, Pharmaceutical Compounding: Non-Sterile Preparations may be
				obtained at http://www.pharmacopeia.cn/v29240/usp29nf24s0_c795.html.
(c) A non-sterile compounding pharmacy may
				provide non-patient specific non- sterile compounded pharmaceutical products to
				practitioners of medicine, osteopathy, podiatry, dentistry, or veterinary
				medicine to administer to their patients in the course of their professional
				practice, either personally or under their direct and immediate supervision,
				except that the quantity shall be limited to a thirty day supply.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Non-Sterile Compounding › Section 20-576-72 - Policy and procedure manual

Current through July 10, 2024
A non-sterile compounding pharmacy shall prepare and maintain
				  a policy and procedure manual for the compounding, dispensing, delivery,
				  administration, storage, and use of non-sterile compounded pharmaceutical
				  products. The policy and procedure manual shall be in compliance with the
				  United States Pharmacopeia, Revised General Chapter 795, Pharmaceutical
				  Compounding: Non-Sterile Preparations.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Non-Sterile Compounding › Section 20-576-73 - Hours

Current through July 10, 2024
A non-sterile compounding pharmacy shall be open at least
				  thirty-five hours per week unless granted a waiver by the commission pursuant
				  to section
				  20-576-59
				  of the Regulations of Connecticut State Agencies.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Shared Pharmacy Services › Section 20-576-75 - Minimum Requirements

Current through July 10, 2024
(a) Each pharmacy
				performing shared pharmacy services shall be a licensed pharmacy;
(b) A licensed pharmacy may dispense a
				prescription at the request of an originating pharmacy and return the dispensed
				prescription to the originating pharmacy for delivery to a patient or patient's
				representative, or if requested by the originating pharmacy, direct delivery to
				a patient or patient's representative;
(c) Each licensed pharmacy shall have a
				dispensing process in which order entry verification is separate and
				distinguishable from final prescription verification;
(d) Each licensed pharmacy shall have a
				secure and confidential mechanism with a licensed pharmacy or other authorized
				user, including pharmacy personnel, for the provision of patient demographics,
				prescription images, drug utilization reviews, and any other information
				necessary to appropriately perform order entry, order entry verification, and
				final prescription verification;
(e) Each licensed pharmacy shall have the
				ability to scan, with a minimum of a 1:1 ratio and a minimum of 200 pixels per
				inch, any prescription that is not electronically-transmitted to such pharmacy.
				Any licensed pharmacy that lacks the ability to scan with a minimum of a 1:1
				ratio and a minimum of 200 pixels per inch shall only utilize shared pharmacy
				services for electronically-transmitted prescriptions and prescription refills
				pursuant to subsection (c) of this section; and
(f) Each licensed pharmacy that performs
				shared pharmacy services shall have prescription processing software that is
				capable of maintaining an audit trail that identifies, at a minimum, each
				pharmacy personnel or any other pharmacy staff who entered, modified, or
				verified a prescription during the dispensing process; approved or rejected a
				drug utilization review; or modified or verified a prescription after final
				prescription verification.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Shared Pharmacy Services › Section 20-576-77 - Central Dispensing Pharmacy

Current through July 10, 2024
(a) A central
				dispensing pharmacy shall maintain a mechanism for tracking each step of the
				dispensing process performed by an originating pharmacy for each
				prescription;
(b) A central
				dispensing pharmacy shall label each prescription or include with the dispensed
				prescription the name, address, and telephone number of the originating
				pharmacy and the central dispensing pharmacy along with all information
				required in section 20-617 of the Connecticut General Statutes;
(c) A central dispensing pharmacy shall
				ensure that each prescription dispensed and returned to an originating pharmacy
				is shipped in accordance with manufacturer labeling;
(d) A central dispensing pharmacy shall
				provide security mechanisms that protect the confidentiality and integrity of
				patient information;
(e) A central
				dispensing pharmacy shall provide all information required by this section,
				sections 20-576-75, 20-576-78 and 20-576-79 of the Regulations of Connecticut
				State Agencies, to the Department of Consumer Protection, Drug Control
				Division, within 48 hours of said department's request;
(f) A central dispensing pharmacy shall
				provide a shipping record to an originating pharmacy listing each prescription
				a central dispensing pharmacy places in each container shipped to an
				originating pharmacy;
(g) A central
				dispensing pharmacy shall maintain a list of up-to-date information of all
				pharmacy personnel including, but not limited to, pharmacy personnel names,
				contact information, and credential information for the jurisdiction in which a
				central dispensing pharmacy is primarily licensed;
(h) A central dispensing pharmacy shall
				maintain and utilize adequate containers and processes to ensure drug stability
				and potency during storage and shipping of dispensed prescriptions. Such
				processes shall include, but are not limited to, (1) utilizing appropriate
				packaging and devices to ensure each dispensed prescription is maintained
				within an appropriate temperature range throughout the shipping process and (2)
				utilizing packaging that is tamper-evident; and
(i) Nothing in this section shall prevent a
				central dispensing pharmacy from shipping or delivering a prescription directly
				to a patient or patient's representative at a patient's or patient's
				representative's request after final prescription verification by a central
				dispensing pharmacist.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Shared Pharmacy Services › Section 20-576-78 - Remote Order Entry

Current through July 10, 2024
(a) Remote order
				entry shall only be performed by pharmacy personnel;
(1) For the purposes of this section, direct
				supervision by a licensed pharmacist of a registered pharmacy technician or
				pharmacy intern performing remote order entry, from a location other than the
				physical premises of an originating pharmacy, is permitted;
(2) A registered pharmacy technician's
				performance regarding remote order entry, from a location other than the
				physical premises of an originating pharmacy, shall be evaluated at least
				quarterly by the pharmacist manager at the licensed pharmacy at which such
				pharmacy technician is registered, to determine if such remote order entry work
				is suitable for such pharmacy technician. A pharmacist manager's quarterly
				evaluation, to determine if remote order entry work is suitable for the
				registered pharmacy technician, shall be documented in such pharmacy
				technician's training record as required by section
				20-576-37
				of the Regulations of Connecticut State Agencies;
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576 - The Practice of Pharmacy › Shared Pharmacy Services › Section 20-576-79 - Remote Order Entry Verification

Current through July 10, 2024
(a) Remote order
				entry verification shall only be performed by a licensed pharmacist;
(b) Each licensed pharmacist who performs
				remote order entry verification shall have the ability to refuse a prescription
				for dispensing and the refused prescription shall be returned to the
				originating pharmacy;
(c) Each
				licensed pharmacist that performs remote order entry verification, from a
				location other than the physical premises of an originating pharmacy, shall
				make efforts to prevent disclosure of confidential information in accordance
				with section 20-626 of the Connecticut General Statutes; and
(d) Nothing in this section shall prevent a
				licensed pharmacist from working at a location other than the physical premises
				of an originating pharmacy.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576a › Section 20-576a-2 - Authorized collector

Current through July 10, 2024
(a) A pharmacy may
			 operate a collection receptacle if the pharmacy:
(1) meets the requirements specified in 21
			 CFR 1307 and 21 CFR 1317;
(2)
			 meets the requirements set forth in sections 20-576a-1 to 20-576a-7, inclusive,
			 of the Regulations of Connecticut State Agencies; and
(3) registers with the department as an
			 authorized collector.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576a › Section 20-576a-3 - Collection receptacles

Current through July 10, 2024
(a) Collection
			 receptacles shall be lockable, sturdy, and securely fixed within the authorized
			 collector's registered location, and shall have a one-way access point to allow
			 ultimate users to deposit drugs.
(b) The collection receptacle shall have two
			 locking mechanisms for access to the inner liner, and these locking mechanisms
			 shall have different keys for operating the locks for simultaneous use by two
			 different authorized employees. The one-way access point shall have a locking
			 mechanism to prevent the acceptance of drugs when the pharmacy is closed or the
			 inner liner is full. Locks shall be kept in good working order with keys
			 removed therefrom. Keys to the locks shall not be left in a location accessible
			 to anyone other than specifically authorized employees.
(c) If it is necessary to unlock the
			 collection receptacle and view the contents of the rigid container in order to
			 determine the drug fill level and avoid overfill, two authorized employees
			 shall perform this check, at an interval determined by the authorized
			 collector. One such authorized employee shall be a Connecticut licensed
			 pharmacist. If the drug fill level of the rigid container has reached a point
			 where overfill is imminent, the collection receptacle shall be locked to
			 prevent ultimate users from depositing any drugs. The authorized collector
			 shall commence disposal of the rigid container within forty-eight hours,
			 pursuant to section 20-576a-5 of the Regulations of the Connecticut State
			 Agencies. The date of the rigid container check, the names of the authorized
			 employees performing the check and the approximate drug fill level of the rigid
			 container shall be entered in the record log maintained by the authorized
			 collector.
(d) The collection
			 receptacle shall be located in the immediate proximity of a designated area
			 where controlled substances are stored and at which an authorized employee is
			 present and the collection receptacle is visible to such authorized
			 employee.
(e) The collection
			 receptacle shall accept drugs only when the authorized collector is open for
			 business and an authorized employee is present.
(f) The collection receptacle shall be
			 secured pursuant to section
			 20-576-18
			 of the Regulations of Connecticut State Agencies when the pharmacy is
			 closed.
(g) The outside of each
			 collection receptacle shall prominently display a sign indicating:
(1) the types of drugs permitted for deposit;
(2) the prohibited items; and
(3) that no drugs intended for
			 return are to be left in the vicinity of the collection receptacle at any
			 time.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576a › Section 20-576a-4 - Inner liners and rigid containers

Current through July 10, 2024
(a) All inner
			 liners shall have a permanent unique identification number, and the authorized
			 collector shall track and maintain a record log to track all inner liners used
			 in the collection receptacle and their unique identification numbers. Such
			 record log shall be the same record log required for use in sections
			 20-576a-5(a) and (b) of the Regulations of Connecticut State
			 Agencies.
(b) All inner liners
			 shall contain an absorbent material sufficient to prevent leakage of any drugs
			 deposited in a collection receptacle.
(c) All inner liners shall be placed in or a
			 part of a rigid container prior to use and placement inside a collection
			 receptacle. Prior to placement inside a collection receptacle, the permanent
			 unique identification number of the inner liner shall be marked, in a clear and
			 permanent manner, on the rigid container. The inner liner shall remain in side
			 the rigid container from the point of placement in the collection receptacle to
			 the time of destruction. Rigid containers shall be leak resistant, and have
			 sealable openings.
(d) All inner
			 liners used in collection receptacles shall meet the requirements of 21 CFR
			 1317.60 and sections 20-576a-1 to 20-576a-7, inclusive, of the Regulations of
			 Connecticut State Agencies.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576a › Section 20-576a-5 - Disposal

Current through July 10, 2024
(a) To dispose of inner liners and rigid
			 containers:
(1) the reverse distributor shall
			 be present and ready to receive the inner liner;
(2) two authorized employees shall be present
			 and performing the removal and replacement of the rigid container and inner
			 liner, and one such authorized employee shall be a Connecticut licensed
			 pharmacist;
(3) the rigid container,
			 including the inner liner, shall be removed from the collection receptacle
			 together and the inner liner shall be immediately sealed and replaced with a
			 new rigid container and inner liner;
(4) the rigid container shall then be sealed at all
			 openings with tamper evident tape and display the unique identification number
			 of the inner liner contained therein;
(5)
			  the rigid container shall not have any outer markings that would
			 indicate the nature of its contents;
(6) the authorized employees present during the
			 disposal shall record all required information and perform all actions
			 necessary to record log entries pursuant to this section;
(7) the authorized employees shall provide
			 the sealed rigid container that contains the sealed inner liner to a registered
			 reverse distributor for destruction, who shall sign the authorized collector's
			 log book; and
(8) the entire process
			 shall be monitored and recorded by video camera, pursuant to section 20-576a-3
			 of the Regulations of Connecticut State Agencies.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 576a › Section 20-576a-6 - Reverse distributors

Current through July 10, 2024
(a) No reverse
			 distributor shall operate as such until it has registered with the department,
			 which registration shall be renewed annually on or before January 31.
(b) A reverse distributor application for
			 registration shall either be received by the department in conjunction with a
			 new wholesale or distributor registration application, or as an amendment to an
			 existing wholesale or distributor registration held by the reverse distributor
			 applicant pursuant to section 21a-70 of the Connecticut General
			 Statutes.
(c) Upon annual renewal,
			 the reverse distributor shall provide information related to the amount of
			 drugs destroyed and any additional information required by the
			 department.
(d) A reverse
			 distributor applicant shall submit an application and all other documentation
			 required by the commissioner on forms prescribed by the commissioner. No
			 registration shall be approved under this section until the applicant has
			 furnished proof satisfactory to the commissioner that the applicant has
			 adequate facilities and apparatus to properly carry on the business described
			 in their application and that the applicant conforms to and is in compliance
			 with federal and state requirements, including 21 CFR 1317 and sections
			 20-576a-1 to 20-576a-7, inclusive, of the Regulations of Connecticut State
			 Agencies.
(e) The commissioner
			 shall have the right to deny a reverse distributor registration if the
			 commissioner determines that the issuance of such registration is inconsistent
			 with the public interest. In determining the public interest, the commissioner
			 shall consider, among others, the factors enumerated in section 21a-70(c) of
			 the Connecticut General Statutes and any potential negative impact on public
			 health and safety.
(f) A reverse
			 distributor shall maintain record logs, which contain the following information
			 for each transaction:
(1) the name and
			 address of the authorized collector from whom the reverse distributor collected
			 the rigid container;
(2) the date
			 of collection of the rigid container from the authorized collector;
(3) the date of delivery of the rigid
			 container to the reverse distributor or the date the reverse distributor
			 obtained possession of the rigid container;
(4) the inner liner unique identification
			 number marked on the outside of the rigid container;
(5) the destruction date of each rigid
			 container and its contents; and
(6)
			 the names of the reverse distributor employees or representatives who performed
			 each function.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 614 - Electronic Data Intermediaries › Section 20-614-1 - Definitions

Current through July 10, 2024
(1) "Commission" means the Commission of
			 Pharmacy;
(2) "Department" means
			 the Department of Consumer Protection; and
(3) "Electronic data intermediary" means
			 "electronic data intermediary" as defined by section
			 20-614
			 of the Connecticut General Statutes.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 614 - Electronic Data Intermediaries › Section 20-614-2 - Application for approval

Current through July 10, 2024
(a) Each electronic
			 data intermediary shall file an application for approval of its system with the
			 commission on a form prescribed by the department. The form shall include but
			 not be limited to the following information:
(1) the name and address of the applicant;
			 and
(2) the business status of the
			 applicant (sole proprietorship, partnership, corporation, limited liability
			 company, etc.); and
(3) a
			 description of the type of electronic data intermediary system to be used that
			 describes:
(A) the security
			 safeguards;
(B) the retention and
			 retrieval capabilities of the system; and
(C) the safeguards designed to protect
			 patient confidentiality.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 614 - Electronic Data Intermediaries › Section 20-614-3 - Procedures for transmission of prescription information

Current through July 10, 2024
Each electronic data intermediary system shall have security
				and system safeguards designed to prevent and detect unauthorized access,
				modification, or manipulation of prescription information in accordance with
				current electronic transmission standards. Each system established by an
				electronic data intermediary shall include procedures to:
(1) select and execute security
			 measures;
(2) establish physical
			 safeguards to protect computer systems and other pertinent equipment from
			 intrusion;
(3) protect and control
			 confidential patient information;
(4) prevent unauthorized access to the data
			 when transmitted over communication networks or when data physically moves from
			 one location to another using media such as magnetic tape, removable drives, CD
			 media or any other means of data storage; and
(5) authenticate the sender's authority and
			 credentials to transmit a prescription.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 614 - Electronic Data Intermediaries › Section 20-614-4 - Retention of information

Current through July 10, 2024
Each system established by an electronic data intermediary
				shall provide an audit trail of all prescriptions electronically transmitted
				that documents for retrieval all actions and persons who have acted on a
				prescription, including the authorized delegation of a transmission. Such audit
				trail shall be maintained for three years from the date of last activity and
				made available for review by investigators of the department.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 614 - Electronic Data Intermediaries › Section 20-614-5 - Mechanisms for confidentiality of prescription information

Current through July 10, 2024
Each electronic data intermediary system shall maintain the
				confidentiality of patient information in accordance with any applicable
				federal or state statute or regulation, including but not limited to 45 C.F.R.
				Part 160 and Part 164. Each electronic data intermediary system shall establish
				mechanisms in accordance with current electronic transmission standards that
				contain:
(1) encryption technology to
			 maintain security;
(2) controls on
			 employee access;
(3) protections
			 against unauthorized access by outsiders;
(4) procedures for the permanent deletion of
			 patient information.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 631 - Collaborative Drug Therapy Management › Section 20-631-1 - Competency requirements

Current through July 10, 2024
To qualify for participation in a collaborative drug therapy
				management agreement, a pharmacist shall be licensed in this state and shall
				meet at least one of the following qualifications:
(1) Bachelor of Science degree in pharmacy
			 with 10 years of clinical experience, or a Pharm.D. degree;
(2) Certification by the Board of
			 Pharmaceutical Specialties;
(3)
			 Certification by the Commission for Certification in Geriatric
			 Pharmacy;
(4) A credential in
			 disease state management from the National Institute for Standards in
			 Pharmacist Credentialing;
(5)
			 Pharmacy residency accredited by the American Society of Health-System
			 Pharmacists; or
(6) Completion of a
			 disease state management certification program approved by the Accreditation
			 Council for Pharmacy Education.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 631 - Collaborative Drug Therapy Management › Section 20-631-2 - Content of a collaborative drug therapy management agreement

Current through July 10, 2024
A collaborative drug therapy management agreement shall
				include:
(1) The types of prescriptive
			 authority decisions the pharmacist may make (e.g., initiation, continuation or
			 modification);
(2) Patients who are
			 eligible for treatment;
(3) The
			 types of diseases, drugs, or drug categories involved (there are no limitations
			 on disease states or conditions);
(4) The procedures, decision criteria, plans,
			 or guidelines the pharmacist is to follow when making therapeutic decisions,
			 particularly when initiating or modifying drug therapy;
(5) Required training;
(6) A plan for periodic review, feedback and
			 quality assurance; and
(7)
			 Procedures for documenting prescribing decisions.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 631 - Collaborative Drug Therapy Management › Section 20-631-3 - Content of patient protocol

Current through July 10, 2024
A written protocol for a specific patient established pursuant
				to a collaborative drug therapy management agreement shall include, but need
				not be limited to, the following:
(1)
			 The specific drug or drugs to be managed by the pharmacist;
(2) The terms and conditions under which drug
			 therapy may be implemented, modified or discontinued;
(3) The conditions and events that the
			 pharmacist is required to report to the physician;
(4) The laboratory tests that may be ordered
			 by the pharmacist; and
(5) The
			 drugs that may be administered by the pharmacist.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 633 - Administration of Vaccine by Pharmacists › Section 20-633-1 - Definitions

Current through July 10, 2024
As used in sections 20-633-1 to
				20-633-5,
				inclusive, of the Regulations of Connecticut State Agencies:
(1) "Administer" means "administer" as
			 defined in section
			 20-571
			 of the Connecticut General Statutes; and
(2) "Health care provider" means a licensed
			 practitioner authorized to order or prescribe legend drugs.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 633 - Administration of Vaccine by Pharmacists › Section 20-633-2 - General requirements

Current through July 10, 2024
A licensed pharmacist may administer a vaccine authorized by
				section
				20-633(a)
				of the Connecticut General Statutes to an adult if:
(a) The administration of the vaccine is
			 conducted pursuant to an order of a licensed health care provider;
			 and
(b) the pharmacist has
			 successfully completed an immunization training program that complies with the
			 requirements of section
			 20-633-3
			 and section
			 20-633-4
			 of the Regulations of Connecticut State Agencies.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 633 - Administration of Vaccine by Pharmacists › Section 20-633-4 - Requirements of training programs

Current through July 10, 2024
(a) The course of
			 study for the immunization training program shall include current guidelines
			 and recommendations of the Department of Health and Human Services Centers for
			 Disease Control and Prevention for vaccination of adult patients accredited by
			 the Accreditation Council for Pharmacy Education.
(b) The course of study shall include, but
			 not be limited to, the following:
(1)
			 Mechanisms of action for vaccines, contraindications, drug interactions, and
			 monitoring after vaccine administration;
(2) subcutaneous and intramuscular
			 injections;
(3) immunization
			 screening questions, informed consent forms, recordkeeping, registries and
			 reporting mechanisms;
(4) vaccine
			 storage;
(5) biohazard waste
			 disposal and sterile techniques;
(6) establishing protocols;
(7) immunization coalitions and other
			 community resources available;
(8)
			 mechanisms for reporting adverse events to the Vaccine Adverse Event Reporting
			 System (VAERS);
(9) reimbursement
			 procedures and vaccine coverage by federal, state and local entities;
(10) administration techniques;
(11) current cardiopulmonary resuscitation
			 certification; and
(12) annual
			 continuing education in immunizations.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 633 - Administration of Vaccine by Pharmacists › Section 20-633-5 - Systems for control and reporting

Current through July 10, 2024
(a) A health care
			 provider shall establish a protocol with a pharmacist or a pharmacy. The
			 protocol shall establish which vaccines may be administered, recordkeeping and
			 reporting requirements, and emergency procedures.
(b) Written protocols shall include, but not
			 be limited to, the following:
(1) The name of
			 the health care provider authorized to order or prescribe drugs;
(2) the name of the pharmacist or pharmacists
			 authorized to administer the vaccine;
(3) the types of vaccines that the pharmacist
			 or pharmacists are authorized to administer;
(4) the procedures, decision criteria or plan
			 the pharmacist or pharmacists shall follow when exercising the administration
			 authority, including when to refer the patient to the physician;
(5) the procedures for emergency situations;
			 and
(6) record keeping and
			 documentation procedures, which shall include a requirement that the name of
			 the pharmacist who administered the vaccine be recorded.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 635 - Quality Assurance Programs for Pharmacies › Section 20-635-1 - Definitions

Current through July 10, 2024
As used in section 20-635-1 to section
				20-635-6,
				inclusive, of the Regulations of Connecticut State Agencies:
(1) "Department" means the Department of
			 Consumer Protection;
(2) "Pharmacy
			 personnel" means pharmacist, pharmacy intern, pharmacy technician, and pharmacy
			 support personnel; and
(3)
			 "Prescription error" means "prescription error" as defined by section
			 20-635
			 of the Connecticut General Statutes.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 635 - Quality Assurance Programs for Pharmacies › Section 20-635-2 - Quality assurance program

Current through July 10, 2024
(a) Each pharmacy
			 shall implement a quality assurance program to detect, identify and prevent
			 prescription errors. The quality assurance program shall document and assess
			 prescription errors to determine the cause and an appropriate
			 response.
(b) The primary purpose
			 of the quality assurance program shall be to advance error prevention by
			 analyzing, individually and collectively, investigative and other pertinent
			 data collected in response to a prescription error to assess the cause and any
			 contributing factors such as system or process failures.
(c) Each pharmacy shall use the findings of
			 its quality assurance program to develop pharmacy systems and workflow
			 processes designed to prevent prescription errors.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 635 - Quality Assurance Programs for Pharmacies › Section 20-635-3 - Notification to patient and prescribing practitioner

Current through July 10, 2024
(a) Unless informed of a prescription error
			 by the prescribing practitioner or the patient, a pharmacist who has discovered
			 or been informed of a prescription error, shall immediately notify the patient
			 and the prescribing practitioner that a prescription error has occurred. If the
			 patient is deceased or unable to fully comprehend the notification of the
			 error, the pharmacist shall notify the patient's caregiver or appropriate
			 family member.
(b) The pharmacist
			 shall communicate to the patient and prescribing practitioner the methods for
			 correcting the error and reducing the negative impact of the error on the
			 patient.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 635 - Quality Assurance Programs for Pharmacies › Section 20-635-4 - Review of prescription errors

Current through July 10, 2024
(a) Each pharmacy
			 shall perform a quality assurance review for each prescription error. This
			 review shall commence as soon as is reasonably possible, but no later than two
			 business days from the date the prescription error is discovered.
(b) Each pharmacy shall create a record of
			 every quality assurance review. This record shall contain at least the
			 following:
(1) the date or dates of the
			 quality assurance review and the names and titles of the persons performing the
			 review;
(2) the pertinent data and
			 other information relating to the prescription error reviewed;
(3) documentation of the patient and
			 prescribing practitioner contact required by section
			 20-635-3
			 of the Regulations of Connecticut State Agencies;
(4) the findings and determinations generated
			 by the quality assurance review; and
(5) recommended changes to pharmacy policy,
			 procedure, systems, or processes, if any.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 635 - Quality Assurance Programs for Pharmacies › Section 20-635-5 - Records

Current through July 10, 2024
(a) Each pharmacy shall maintain a written
			 copy of the quality assurance program on the pharmacy premises. This copy shall
			 be readily available to all pharmacy personnel and the department.
(b) Each pharmacy shall maintain a record of
			 the quality assurance review for all prescription errors for a minimum of three
			 years. These records shall be maintained in an orderly manner and filed by
			 date. These records, which may be stored outside of the pharmacy, shall be made
			 available for inspection by the department within forty-eight (48) hours of
			 request.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 635 - Quality Assurance Programs for Pharmacies › Section 20-635-6 - Notice to pharmacy personnel

Current through July 10, 2024
(a) A pharmacy
			 shall make available a copy of its quality assurance program to each pharmacist
			 employed at the pharmacy.
(b) Each
			 pharmacy shall notify all pharmacy personnel that the discovery or reporting of
			 a prescription error shall be relayed immediately to a pharmacist on
			 duty.
(c) Each pharmacy shall
			 inform pharmacy personnel of changes to pharmacy policy, procedure, systems, or
			 processes made as a result of recommendations generated by the quality
			 assurance program.
Connecticut Administrative Code › Title 20 - Professional and Occupational Licensing, Certification › 636 - Opioid Warning Labels › Section 20-636-1 - Definitions

Current through July 10, 2024
In addition to the defined terms set forth in section 20-571 of
				the Connecticut General Statutes, as used in this section and sections 20-636-2
				to 20-636-4, inclusive, of the Regulations of Connecticut State
				Agencies:
(1) "Container" means the
			 receptacle that holds the legend drug, labeled with information required by
			 federal and state law for dispensing;
(2) "Controlled substance" means an opioid
			 drug, as defined in section 20-14o of the Connecticut General Statutes, or a
			 controlled substance in schedule II, III, IV or V;
(3) "Fluorescent orange" means the
			 hexadecimal color #ff6700 with RGB values of R:255, G:103, B:0, and CMYK values
			 of C:0, M:60, Y:100, K:0;
(4)
			 "Packaging" means the bag, box, wrapping, or other material used to contain or
			 enclose the container for delivery to a patient; and
(5) "Label or sticker" means symbols,
			 graphics or other information about the controlled substance, either directly
			 on the container or packaging, or affixed to the container or packaging on
			 separate material such as paper or film.