Sec. 21a-70h. Registration as pharmaceutical marketing firm. Definitions.
Sec. 21a-70k. Authority of commissioner re pharmaceutical marketing firms. Regulations.
Sec. 21a-65. (Formerly Sec. 19-209a). Sale of hypodermic needles and syringes restricted. Application to use secured machine. Destruction of used hypodermic needles and syringes. Penalty. (a) A licensed manufacturer or licensed wholesaler may sell hypodermic needles and syringes only to the following: (1) To a licensed manufacturer, licensed wholesaler or licensed pharmacy; (2) to a physician, dentist, veterinarian, embalmer, podiatrist or scientific investigator licensed to practice in this state; (3) to a person in charge of a care-giving institution, as defined in section 20-571, incorporated college or scientific institution, but only for use by or in such care-giving institution, college or institution for medical or scientific purposes; (4) to a person in charge of a licensed or registered laboratory, but only for use in that laboratory for scientific and medical purposes; (5) to a farmer but only for use on the farmer's own animals or poultry; (6) to a business authorized in accordance with the regulations adopted under section 21a-66 to purchase hypodermic needles and syringes but only for legitimate industrial or medical use within that business; and (7) to a syringe services program established pursuant to section 19a-124.
(b) Except as provided in subsection (a) of this section, no licensed manufacturer, licensed wholesaler or licensed pharmacist shall sell and no person shall buy a hypodermic needle or syringe except upon a prescription of a prescribing practitioner, as defined in section 20-571, in a quantity greater than ten. Any such prescription shall be retained on file by the seller for a period of not less than three years and shall be accessible to any public officer engaged in the enforcement of this section. Such a prescription shall be valid for one year from the date thereof and purchases and sales may be made thereunder during such period, provided the seller shall confirm the continued need for such sales with such practitioner at least every six months if sales continue to be made thereunder. Hypodermic needles and syringes in a quantity of ten or less without a prescription may be provided or sold at retail only by the following: (1) By a pharmacy licensed in accordance with section 20-594 and in such pharmacy only by a licensed pharmacist or under the pharmacist's direct supervision; (2) by a syringe service program established pursuant to section 19a-124; and (3) by a health care facility or a licensed health care practitioner for use by their own patients.
(c) A registered syringe service program established pursuant to section 19a-124 may apply to the Department of Consumer Protection for approval to provide access to not more than ten hypodermic needles and syringes per transaction to program participants authorized by said department, through a secured machine with the use of a patient-specific access number, personalized magnetic strip card or any technology that identifies an individual for the purpose of providing access to hypodermic needles and syringes. The secured machine shall prevent unauthorized access and be immobile. Any products provided by the secured machine shall provide information on access to treatment services to assist individuals obtaining products from the secured machine. The machine shall only be placed in an area where contents can be stored in accordance with the manufacturer's recommendation, unless the secured machine can provide adequate environmental controls independent of the external environment. A locked syringe disposal container to accept hypodermic needles and syringes that have already been used shall be available as part of the secured machine or in the area around the secured machine. Only authorized personnel of such program may collect the used syringes for proper disposal.
(d) Except as provided in subsection (c) of this section, at all locations where hypodermic needles and syringes are kept they shall be stored in a manner so as to be available only to authorized personnel and not be openly available to customers or patients. All used, disposable hypodermic needles and used, disposable syringes shall be destroyed. Destruction shall be conducted in a manner which renders such needles and syringes nonrecoverable. Used needles and syringes which have been discarded and are awaiting destruction shall be securely safeguarded or rendered nonreusable.
(e) Any person who violates any provision of this section shall be fined not more than five hundred dollars or imprisoned not more than one year or both.
(1971, P.A. 489, S. 1–3; P.A. 79-457, S. 2, 4; P.A. 83-115; P.A. 90-214, S. 1, 5; P.A. 92-185, S. 1, 6; May Sp. Sess. P.A. 92-11, S. 65, 70; P.A. 95-264, S. 53; P.A. 99-102, S. 31; P.A. 17-6, S. 5; July Sp. Sess. P.A. 20-4, S. 6; P.A. 21-192, S. 3; P.A. 23-19, S. 9.)
History: P.A. 79-457 referred to “licensed” manufacturers and wholesalers, replaced “physician licensed to practice medicine and surgery” with “practitioner, as defined in section 20-184a” and “pharmacist” with “pharmacy”, allowed sales to osteopaths, scientific investigators and those in charge of “care-giving institutions” as defined in Sec. 19-504a (formerly “hospitals”), added Subdiv. (6) allowing sales to businesses authorized to purchase needles and syringes “only for legitimate industrial or medical use within that business”, required confirmation of continued need for sales every six, rather than three, months in Subsec. (b) and added new Subsec. (c) re storage and disposal, redesignating former Subsec. (c) as Subsec. (d); Sec. 19-66a transferred to Sec. 19-209a in 1981; Sec. 19-209a transferred to Sec. 21a-65 in 1983; P.A. 83-115 required destruction of used syringes and needles, required that destruction render them nonrecoverable and required that they be safeguarded or rendered nonreusable while awaiting destruction, replacing provision which required only that they “not be disposed of until they have been rendered nonreusable”; P.A. 90-214 added Subdiv. (7) in Subsec. (a) re needle and syringe exchange program; P.A. 92-185 amended Subsec. (a) to delete provision re sale “without the prescription of a practitioner as defined in section 20-184a”, amended Subsec. (b) to limit the requirement of a prescription to the sale and purchase of hypodermic needles or syringes “in a quantity greater than eight” and to add provision that hypodermic needles and syringes in a quantity of eight or less may be provided or sold at retail without a prescription only by a licensed pharmacy, a needle exchange program and a health care facility or licensed health care practitioner, amended Subsec. (c) to require that hypodermic needles and syringes be stored in a manner “so as to be available only to authorized personnel and not be openly available to customers or patients” rather than “to prevent theft or diversion from their lawful use” and to delete provision that the purpose of requiring used needles and syringes awaiting destruction to be safeguarded or rendered nonreusable is “to prevent their theft”, and amended Subsec. (d) to delete from the applicability of the penalty “any person who forges or alters a prescription for the purpose of purchasing a hypodermic needle or syringe in violation of the provisions of this section”; May Sp. Sess. P.A. 92-11 amended Subsec. (b) to increase the quantity of needles or syringes that requires a prescription from “greater than eight” to “greater than ten” and to increase from “eight or less” to “ten or less” the quantity of needles or syringes which may be provided or sold at retail without a prescription by specified entities; P.A. 95-264 made technical changes (Revisor's note: The reference in Subsec. (b) to “prescribing practitioner, as defined in subdivision (21) of …” was changed editorially by the Revisors to “prescribing practitioner, as defined in subdivision (22) of …”); P.A. 99-102 amended Subsec. (a) by deleting an obsolete reference to osteopathy and making technical changes; P.A. 17-6 amended Subsec. (a)(7) by replacing “needle and syringe exchange program” with “syringe services program”, and amended Subsec. (b)(2) by replacing “needle exchange program” with “syringe services program”; July Sp. Sess. P.A. 20-4 amended Subsec. (b) by substituting reference to Sec. 20-571(24) for reference to Sec. 20-571(22), effective January 1, 2021; P.A. 21-192 amended Subsec. (a) by changing reference from Sec. 20-571(2) to Sec. 20-571(3), amended Subsec. (b) by changing reference from Sec. 20-571(24) to Sec. 20-571(28) and making technical changes, added new Subsec. (c) re application by registered syringe service program to use secured machine for access and provisions re disposal, redesignated existing Subsecs. (c) and (d) as Subsecs. (d) and (e) and amended redesignated Subsec. (d) to add “Except as provided in subsection (c) of this section, at”, effective July 13, 2021; P.A. 23-19 made technical changes in Subsecs. (a)(3) and (b), effective July 1, 2023.
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Sec. 21a-70. (Formerly Sec. 19-210). Registration of manufacturers and wholesalers of drugs. Sale of drugs limited. (a) Definitions. As used in this section: (1) “Drugs”, “devices” and “cosmetics” have the same meanings as defined in section 21a-92, “wholesaler” or “distributor” means a person, including, but not limited to, a medical device and oxygen provider, a third-party logistics provider, a virtual manufacturer or a virtual wholesale distributor, as such terms are defined in section 20-571, whether within or without the boundaries of the state of Connecticut, who supplies drugs, devices or cosmetics prepared, produced or packaged by manufacturers, to other wholesalers, manufacturers, distributors, hospitals, prescribing practitioners, as defined in section 20-571, pharmacies, federal, state or municipal agencies, clinics or any other person as permitted under subsection (h) of this section, except that: (A) A retail pharmacy or a pharmacy within a licensed hospital that supplies to another such pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or V controlled substance normally stocked by such pharmacies to provide for the immediate needs of a patient pursuant to a prescription or medication order of an authorized practitioner, (B) a pharmacy within a licensed hospital that supplies drugs to another hospital or an authorized practitioner for research purposes, (C) a retail pharmacy that supplies a limited quantity of a noncontrolled drug or of a schedule II, III, IV or V controlled substance for emergency stock to a practitioner who is a medical director of a chronic and convalescent nursing home, of a rest home with nursing supervision, of a hospice inpatient facility licensed pursuant to section 19a-491 or of a state correctional institution, and (D) a pharmacy within a licensed hospital that contains another hospital wholly within such licensed hospital's physical structure that supplies to such contained hospital a quantity of a noncontrolled drug or a schedule II, III, IV, or V controlled substance normally stocked by such hospitals to provide for the needs of a patient, pursuant to a prescription or medication order of an authorized practitioner, receiving inpatient care on a unit that is operated by the contained hospital, or receiving outpatient care in a setting operated by the contained hospital and such drug or substance is administered on-site by the contained hospital, shall not be deemed a wholesaler under this section; (2) “manufacturer” means (A) a person, whether within or without the boundaries of the state of Connecticut, who produces, prepares, cultivates, grows, propagates, compounds, converts or processes, directly or indirectly, by extraction from substances of natural origin or by means of chemical synthesis or by a combination of extraction and chemical synthesis, or who packages, repackages, labels or relabels a container under such manufacturer's own or any other trademark or label any drug, device or cosmetic for the purpose of selling such items, or (B) a sterile compounding pharmacy, as defined in section 20-633b, that dispenses sterile pharmaceuticals without a prescription or a patient-specific medical order; (3) “drug”, “device” and “cosmetic” have the same meanings as provided in section 21a-92; and (4) “commissioner” means the Commissioner of Consumer Protection or the commissioner's designee.
(b) Registration of wholesalers and manufacturers of drugs required. Exceptions. Fees. Expenses. No wholesaler or manufacturer shall operate as such until he has received a certificate of registration issued by the commissioner, which certificate shall be renewed annually, provided no such certificate shall be required of a manufacturer, except a sterile compounding pharmacy, as defined in subsection (a) of section 20-633b, whose principal place of business is located outside the state, who is registered with the federal Food and Drug Administration or any successor agency and who files a copy of such registration with the commissioner. A fee of one hundred ninety dollars shall be charged for each wholesaler's certificate and renewal thereof. A separate certificate and corresponding fee is required for each location existing in this state and for each location existing outside of this state that distributes products into this state. The fee for a manufacturer's certificate and renewal thereof shall be two hundred eighty-five dollars for manufacturers employing not more than five licensed pharmacists or qualified chemists or both; three hundred seventy-five dollars for manufacturers employing not more than ten licensed pharmacists or qualified chemists or both; and nine hundred forty dollars for manufacturers employing more than ten licensed pharmacists or qualified chemists or both. No such certificate shall be issued to a manufacturer unless such drugs, devices or cosmetics are manufactured or compounded under the direct supervision of a licensed pharmacist or a qualified chemist. No certificate of registration shall be issued under this section until the applicant has furnished proof satisfactory to the commissioner that the applicant is equipped as to facilities and apparatus to properly carry on the business described in his application and that the applicant conforms to chapter 418 and regulations adopted thereunder.
(c) Commissioner's right to deny certificate. The commissioner shall have the right to deny a certificate of registration if he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the commissioner shall consider, at a minimum, the following factors:
(1) Any convictions or regulatory actions involving the applicant under any federal, state or local law relating to drug samples, wholesale or retail drug distribution, or distribution or possession of drugs including controlled substances;
(2) Any felony convictions of the applicant under federal, state or local laws;
(3) The applicant's past experience in the manufacture or distribution of drugs;
(4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;
(5) Suspension, revocation or other sanction by federal, state or local government of any license or registration currently or previously held by the applicant for the manufacture or distribution of any drugs;
(6) Compliance with licensing or registration requirements under previously granted licenses or registrations;
(7) Compliance with requirements to maintain or make available to the commissioner or to federal, state or local law enforcement officials those records required by any federal or state statute or regulation;
(8) Failure to provide adequate control against the diversion, theft and loss of drugs;
(9) Provision of required security for legend drugs and, in the case of controlled substances, compliance with security requirements for wholesalers set forth in regulations adopted under chapter 420b; and
(10) Compliance with all regulations adopted to enforce the provisions of this section.
(d) Suspension, revocation or refusal to renew registration. The commissioner may suspend, revoke or refuse to renew a registration, or may issue a letter of reprimand or place a registrant on probationary status, for sufficient cause. Any of the following shall be sufficient cause for such action:
(1) The furnishing of false or fraudulent information in any application or other document filed with the commissioner;
(2) Any criminal conviction of the registrant under any federal or state statute concerning drugs;
(3) The suspension, revocation or other restriction or penalty issued against a license or registration related to drugs;
(4) Failure to provide adequate control against the diversion, theft and loss of drugs; or
(5) A violation of any provision of any federal or state statute or regulation concerning drugs.
(e) Compliance with applicable laws. Wholesalers and manufacturers shall operate in compliance with applicable federal, state and local statutes, regulations and ordinances, including any applicable laws concerning controlled substances, drug product salvaging or reprocessing.
(f) Inspections and audits. Wholesalers and manufacturers shall permit the commissioner, or his authorized representatives, to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, at reasonable times and in a reasonable manner.
(g) Hearings. Before denying, suspending, revoking or refusing to renew a registration, or before issuing a letter of reprimand or placing a registrant on probationary status, the commissioner shall afford the applicant or registrant an opportunity for a hearing in accordance with the provisions of chapter 54. Notice of such hearing may be given by certified mail. The commissioner may subpoena witnesses and require the production of records, papers and documents pertinent to such hearing.
(h) Sale of drugs limited. Regulations. No wholesaler or manufacturer shall sell any drugs except to the state or any political subdivision thereof, to another manufacturer or wholesaler, to any hospital recognized by the state as a general or specialty hospital, to any institution having a full-time pharmacist who is actively engaged in the practice of pharmacy in such institution not less than thirty-five hours a week, to a chronic and convalescent nursing home having a pharmacist actively engaged in the practice of pharmacy based upon the ratio of one-tenth of one hour per patient per week but not less than twelve hours per week, to a practicing physician, podiatrist, dentist, optometrist or veterinarian, to a licensed pharmacy or a store to which a permit to sell nonlegend drugs has been issued as provided in section 20-624 or to an authorized entity that has established a medical protocol with a prescribing practitioner pursuant to section 19a-909, provided drugs sold to an authorized entity shall be limited to epinephrine cartridge injectors. The commissioner may adopt such regulations as are necessary to administer and enforce the provisions of this section.
(i) System to identify suspicious orders of controlled substances. Reports. (1) Each registered manufacturer or wholesaler of drugs shall operate a system to identify suspicious orders of controlled substances and shall immediately inform the Director of the Drug Control Division of suspicious orders. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern and orders of unusual frequency. Each registered manufacturer or wholesaler of drugs shall also send the Drug Control Division a copy of any suspicious orders submitted to the federal Drug Enforcement Administration pursuant to 21 CFR 1301.74.
(2) Each registered manufacturer or wholesaler of drugs that, based on concerns of potential diversion, ceases or declines distribution of any schedule II, III, IV or V controlled substance to a pharmacy, as defined in section 20-594, or to a practitioner, as defined in section 21a-316, in the state of Connecticut shall report the name of the pharmacy or practitioner, location of the pharmacy or practitioner and the reasons for ceasing or declining distribution of such controlled substance in writing to the Director of the Drug Control Division, or to an electronic system designated by the Drug Control Division, not later than five business days after ceasing or declining distribution of such controlled substance.
(j) Penalty. Any person who violates any provision of this section shall be fined not more than five hundred dollars or imprisoned not more than six months, or both.
(1949 Rev., S. 3925–3928; 1951, S. 2089d; 1959, P.A. 412, S. 38, 42; 593, S. 1; February, 1965, P.A. 519; 1971, P.A. 115; P.A. 74-298, S. 1, 2; P.A. 75-279, S. 1, 2; P.A. 76-228, S. 1, 2; P.A. 77-73; 77-170; P.A. 78-53, S. 2; 78-310, S. 1, 4; P.A. 79-13; P.A. 84-194, S. 1; P.A. 86-13, S. 1, 4; P.A. 89-251, S. 152, 203; P.A. 92-181, S. 2, 3; P.A. 93-55, S. 8; P.A. 95-264, S. 54; June Sp. Sess. P.A. 00-2, S. 14, 53; June Sp. Sess. P.A. 01-9, S. 25, 131; June 30 Sp. Sess. P.A. 03-6, S. 146(c); P.A. 04-189, S. 1; June Sp. Sess. P.A. 09-3, S. 282; P.A. 10-117, S. 72; P.A. 13-196, S. 36; P.A. 14-122, S. 124; 14-224, S. 5; P.A. 17-77, S. 8; P.A. 18-16, S. 3; P.A. 19-19, S. 2; 19-191, S. 4; July Sp Sess. P.A 20-4, S. 7; P.A. 21-37, S. 48; P.A. 21-192, S. 6; P.A. 23-19, S. 10.)
History: 1959 acts created distinction between fees for wholesalers' and manufacturers' certificates in Subsec. (b), adding provisions re manufacturers' certificates; 1965 act deleted “manufacturers” from wholesaler's activities, changed “medical devices” to “proprietary medicines,” extended wholesaler to mean person within or without the state, limited reselling to “within the state”, confined the meaning of “manufacturer” to a person “within the state” and replaced commissioner of food and drugs with commissioner of consumer protection; 1971 act deleted provision prohibiting issuance of certificate to wholesaler unless drugs, etc. dispensed under direct supervision of licensed pharmacist or qualified chemist; P.A. 74-298 redefined “wholesaler” and “manufacturer” to replace references to bottling, packing and purchase or manufacture of drugs, medicine, cosmetics, etc.; P.A. 75-279 revised sale prohibition in Subsec. (c) to except other manufacturers and wholesalers and podiatrists and to delete dispensary reference and to add provision re adoption of necessary regulations; P.A. 76-228 increased fees in Subsec. (b): For wholesalers, from $50 to $75, for manufacturers, from $75 to $112.50 for those employing not more than five licensed pharmacists or chemists or both, from $100 to $150 for those employing not more than ten and from $250 to $375 for those employing more than ten; P.A. 77-73 included manufacturers outside Connecticut as well as those within in Subsec. (a), added proviso re exemption from certificate requirements for those whose principal place of business is outside the state and required proof of proper facilities and equipment and of conformity with chapter 342 in Subsec. (b) and qualified sales to institutions with full-time pharmacists in Subsec. (c) by requiring that pharmacist practice at least 35 hours per week; P.A. 77-170 excepted retail pharmacies and pharmacies within licensed hospitals from definition of “wholesaler” in certain specified circumstances; P.A. 78-53 included schedule III, IV or V controlled substances in exception for retail pharmacies and pharmacies within licensed hospitals added in 1977 act; P.A. 78-310 referred to “manufacturer's certificate” rather than “drug manufacturer's certificate” in Subsec. (b); P.A. 79-13 applied definition of “wholesaler” to “distributor” as well; Sec. 19-210 transferred to Sec. 21a-70 in 1983; P.A. 84-194 amended Subsec. (a) to specifically exclude from the definition of “wholesaler” or “distributor” a retail pharmacy which supplies certain controlled and noncontrolled drugs to medical directors of convalescent nursing homes or rest homes; P.A. 86-13 amended Subsec. (c) to authorize sales to optometrists; P.A. 89-251 amended Subsec. (b) to increase fee for a wholesaler's certificate from $75 to $150, for a manufacturer employing not more than five pharmacists or chemists from $112.50 to $225, for a manufacturer employing not more than ten pharmacists or chemists, from $150 to $300, and for a manufacturer employing more than ten pharmacists or chemists from $375 to $750; P.A. 92-181 amended Subsec. (a) to define “commissioner”, inserted a new Subsec. (c) re commissioner's right to deny a certificate and grounds for denying certificate, new Subsec. (d) re commissioner's other powers and what would constitute “sufficient cause” for the commissioner to exercise those powers and new Subsecs. (e), (f) and (g) re duties of wholesalers and the right of the commissioner to enter and inspect premises and delivery vehicles and to audit records and the commissioner's duties with regard to affording the applicant with proper notice and hearing, relettering former Subsecs. (c) and (d) accordingly; P.A. 93-55 made technical change in Subsec. (a); P.A. 95-264 changed “licensed” practitioner to “prescribing” practitioner in Subsec. (a) and changed “proprietary and patent medicines” to “nonlegend drugs” in Subsec. (i) (Revisor's note: The reference in Subsec. (a) to “prescribing practitioner, as defined in subdivision (21) of …” was changed editorially by the Revisors to “prescribing practitioner, as defined in subdivision (22) of …”); June Sp. Sess. P.A. 00-2 amended Subsec. (h) to authorize sales of drugs to certain chronic and convalescent nursing homes, effective July 1, 2000; June Sp. Sess. P.A. 01-9 amended Subsec. (a) to add provision re state correctional institution to the definition of “wholesaler” and to make a technical change for purposes of gender neutrality, effective July 1, 2001; June 30 Sp. Sess. P.A. 03-6 replaced Commissioner of Consumer Protection with Commissioner of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004; June Sp. Sess. P.A. 09-3 amended Subsec. (b) to increase fees and made a technical change in Subsec. (i); P.A. 10-117 redefined “wholesaler” or “distributor” in Subsec. (a)(1); P.A. 13-196 amended Subsec. (b) to add provision requiring separate certificate and corresponding fee for each location in state and for each location outside state that distributes products into the state, effective June 21, 2013; P.A. 14-122 made technical changes in Subsec. (a); P.A. 14-224 amended Subsec. (a)(2) to redefine “manufacturer” by inserting Subpara. (A) designator and adding Subpara. (B) re sterile compounding pharmacy that dispenses sterile pharmaceuticals without prescription or patient-specific medical order, amended Subsec. (b) by adding exception re sterile compounding pharmacy, amended Subsec. (e) by adding “and manufacturers”, and made technical changes, effective July 1, 2014; P.A. 17-77 amended Subsec. (a)(1) by adding definitions of “drugs”, “devices” and “cosmetics”, redefining “wholesaler” or “distributor” and replacing “medical devices” with “devices”, and amended Subsec. (b) by replacing “medical devices” with “devices”, effective July 1, 2017; P.A. 18-16 added Subsec. (i) re operation of system to identify suspicious orders of controlled substances, and redesignated existing Subsec. (i) as Subsec. (j), effective January 1, 2019; P.A. 19-19 amended Subsec. (h) to add provision allowing sale of epinephrine cartridge injectors to authorized entity that has established a medical protocol and made technical changes, effective June 13, 2019; P.A. 19-191 amended Subsec. (i) by designating existing provisions re system to identify suspicious orders as Subdiv. (1), changing “activity reporting” to “orders” and adding Subdiv. (2) re report to Director of the Drug Control Division; July Sp. Sess. P.A. 20-4 amended Subsec. (a)(1) by substituting reference to Sec. 20-571(24) for reference to Sec. 20-571(22), effective January 1, 2021; P.A. 21-37 amended Subsec. (a)(1)(C) by adding “of a hospice inpatient facility licensed pursuant to section 19a-491” and amended Subsec. (a)(1)(D) by adding provision re receiving outpatient care in contained hospital setting and administering the drug or substance on-site, effective July 1, 2021; P.A. 21-192 amended Subsec. (a)(1) by substituting reference to Sec. 20-571(28) for reference to Sec. 20-571(24), effective July 13, 2021; P.A. 23-19 amended Subsec. (a) by making technical changes in Subdivs. (1), (1)(D) and (3), effective July 1, 2023.
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Sec. 21a-70h. Registration as pharmaceutical marketing firm. Definitions. For the purposes of this section and sections 21a-70i to 21a-70k:
(1) “Commissioner” means the Commissioner of Consumer Protection;
(2) “Contact” means any communication transmitted in person or by telephone, electronic mail, text message or other electronic means between a pharmaceutical representative and a prescribing practitioner or pharmacist, to promote or provide information relating to a legend drug;
(3) “Department” means the Department of Consumer Protection;
(4) “Legend drug” has the same meaning as provided in section 20-571;
(5) “Pharmaceutical manufacturer” means a (A) person, whether within or without the boundaries of the state of Connecticut, that produces, prepares, cultivates, grows, propagates, compounds, converts or processes a drug, device or cosmetic, directly or indirectly, by extraction from substances of natural origin, by means of chemical synthesis or by a combination of extraction and chemical synthesis, or that packages, repackages, labels or relabels a container under such manufacturer's own trademark or label or any other trademark or label, or a drug, device or cosmetic for the purpose of selling the drug, device or cosmetic, or (B) sterile compounding pharmacy, as defined in section 20-633b that dispenses sterile pharmaceuticals without a prescription or a patient-specific medical order intended for use in humans;
(6) “Pharmaceutical manufacturer” includes a virtual manufacturer, as defined in section 20-571;
(7) “Pharmaceutical marketing firm” means a pharmaceutical manufacturer that employs pharmaceutical representatives;
(8) “Pharmaceutical representative” means any person, including, but not limited to, a sales representative, who markets, promotes or provides information regarding a legend drug for human use to a prescribing practitioner and is employed or compensated by a pharmaceutical manufacturer;
(9) “Pharmacist” has the same meaning as provided in section 20-571; and
(10) “Prescribing practitioner” has the same meaning as provided in section 20-571.
(P.A. 23-171, S. 3.)
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Sec. 21a-70i. Registration of pharmaceutical manufacturer as pharmaceutical marketing firm. Fees. List of employees. Reports. (a) On and after October 1, 2023, a pharmaceutical manufacturer that employs an individual to perform the duties of a pharmaceutical sales representative shall register annually with the department as a pharmaceutical marketing firm, in a form and manner prescribed by the commissioner. No pharmaceutical manufacturer shall authorize an individual to perform such duties on such manufacturer's behalf unless such manufacturer has obtained a registration from the department pursuant to this section. Registrations issued pursuant to this section shall expire annually on June thirtieth.
(b) The nonrefundable fee for registration as a pharmaceutical marketing firm and for annual renewal of such registration shall be one hundred fifty dollars. Any pharmaceutical marketing firm that fails to renew its registration on or before June thirtieth shall pay a late fee of one hundred dollars for each year that such firm did not renew, in addition to the annual renewal fee required under this section.
(c) On the date of its initial registration, and annually thereafter, each pharmaceutical marketing firm shall provide to the department a list of all individuals employed by such firm as a pharmaceutical sales representative. Each pharmaceutical marketing firm shall notify the department, in a form and manner prescribed by the commissioner, of each individual who is no longer employed as a pharmaceutical sales representative or who was hired after the date on which such firm provided such annual list, not later than two weeks after such individual leaves employment or was hired.
(d) The department shall prominently post on its Internet web site the most recent list provided by each pharmaceutical marketing firm pursuant to subsection (c) of this section.
(e) Any person who is not identified to the department pursuant to subsection (c) of this section shall not perform the duties of a pharmaceutical sales representative on behalf of the pharmaceutical marketing firm for any prescribing practitioner in this state.
(f) Not later than July 1, 2024, and annually thereafter, each pharmaceutical marketing firm shall provide the commissioner with the following information regarding the performance for the previous calendar year of each of its pharmaceutical sales representatives identified to the department pursuant to subsection (c) of this section at any time during the previous calendar year, in a form and manner prescribed by the commissioner:
(1) The aggregate number of contacts such pharmaceutical sales representative had with prescribing practitioners and pharmacists;
(2) The specialty of each prescribing practitioner and pharmacist with whom such pharmaceutical sales representative made contact;
(3) Whether product samples, materials or gifts of any value were provided to a prescribing practitioner or such practitioner's staff in a prescribing practitioner's office or to a pharmacist; and
(4) An aggregate report of all free samples, by drug name and strength, in a form and manner prescribed by the commissioner.
(g) The department shall annually analyze the information submitted pursuant to this section and compile a report on the activities of pharmaceutical sales representatives in the state. Not later than December 1, 2024, and annually thereafter, the department shall post such report on its Internet web site and submit such report to the Secretary of the Office of Policy and Management.
(P.A. 23-171, S. 4.)
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Sec. 21a-70j. Disclosure by pharmaceutical sales representative engaged in legend drug marketing to prescribing practitioner or pharmacist. Each pharmaceutical representative engaged in legend drug marketing in this state shall disclose, in writing, to a prescribing practitioner or pharmacist, at the time of each contact with such prescribing practitioner or pharmacist, the following information:
(1) The list price of a legend drug when such pharmaceutical representative provides information concerning such legend drug to the prescribing practitioner or pharmacist based on the dose and quantity of such legend drug as described in the medication package insert; and
(2) Information on the variation efficacy of the legend drug marketed to different racial and ethnic groups, if such information is available.
(P.A. 23-171, S. 5.)
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Sec. 21a-70k. Authority of commissioner re pharmaceutical marketing firms. Regulations. (a) The commissioner may (1) refuse to authorize the issuance or renewal of a registration to operate as a pharmaceutical marketing firm, (2) revoke, suspend or place conditions on a registration to operate as a pharmaceutical marketing firm, and (3) assess a penalty of up to one thousand dollars for each violation of any provision of section 21a-70i or 21a-70j, or take other action permitted by subdivision (7) of subsection (a) of section 21a-7, if the applicant or holder of the registration fails to comply with the requirements set forth in section 21a-70i or 21a-70j.
(b) The commissioner may adopt regulations, in accordance with chapter 54, to implement the provisions of this section.
(P.A. 23-171, S. 6.)
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