Current through December 4, 2024
Section 20-576-31 - Storage, Sale and Acquisition of Nonlegend Drugs in Vending Machines(a) A vending machine registrant shall only purchase nonlegend drugs from a wholesaler or another nonlegend drug permittee.(b) A vending machine registrant shall ensure all nonlegend products purchased from a wholesaler or other nonlegend drug permittee are labeled for individual sale in accordance with the requirements of the federal Food and Drug Administration or successor agency.(c) All nonlegend products sold in a vending machine shall be:(1) Stored in accordance with manufacturer recommendations, including, but not limited to, temperature conditions; and(2) Sold only in the manufacturer's clearly labeled, original, unbroken, tamper-proof and expiration-dated packaging.(d) A nonlegend product subject to any sale restriction pursuant to state or federal law shall not be contained in a vending machine. Such restricted products shall include, but not be limited to, products requiring age verification or proof of identity or subject to a quantity limitation.(e) No expired nonlegend products shall be sold from a vending machine. Such products shall be removed by the vending machine registrant from the vending machine on or before the manufacturer's expiration date.(f) A nonlegend drug permittee shall have a written policy to review expiration dates of nonlegend products contained in the vending machine at least monthly. The policy shall be made available to the department not later than forty-eight hours after a request from the department.(g) Vending machines shall be in good working order. Should a machine become inoperable, the vending machine registrant shall, not later than twenty-four hours after being made aware of the vending machine's inoperability, affix a sign indicating to consumers that the vending machine is not in working order. The vending machine registrant shall arrange for the vending machine to be serviced so that it can return to operation as soon as is commercially reasonable. If the vending machine does not return to operation on or before the seventh calendar day after the vending machine registrant is made aware of the vending machine's inoperability, the vending machine registrant shall notify the department, in a form and manner prescribed by the commissioner, that the vending machine is inoperable and include the following information: (1) Vending machine registration number;(2) Serial number of the vending machine;(3) Vending machine location;(4) Date vending machine became inoperable;(5) Date vending machine registrant was made aware that the vending machine became inoperable;(6) Contents of the vending machine;(7) A description of why the vending machine is inoperable;(8) Whether any contents of the vending machine have been damaged or compromised as a result of the vending machine's inoperability;(9) Whether and when the vending machine is expected to return to operation; and(10) A contact name and the phone number for the company servicing the vending machine.(h) Each vending machine registrant shall maintain a record of each service. Such record shall include the date the vending machine was serviced, the company servicing the vending machine and the purpose of the service, and shall be either: (1) Affixed to the interior of the vending machine, in a manner visible from the exterior of the vending machine; or(2) Maintained electronically in a manner that the vending machine registrant can provide the records required pursuant to this subsection not later than one business day after a request for such information from the department.(i) The vending machine shall be securely constructed and either weigh a minimum of seven hundred and fifty pounds or be physically affixed to the building.(j) Vending machines shall be serviced at least once per year to ensure proper operation.(k) Any vending machine containing a nonlegend product shall be protected from the elements through internal systems or an external enclosure, which shall be: (5) Protected from direct sunlight; and(6) Capable of maintaining storage conditions consistent with the manufacturer's recommendations for each nonlegend product at all times.(l) When a vending machine is relocated inside the authorized premises of a vending machine registrant, the vending machine registrant shall notify the department in writing not later than five calendar days after such relocation. When a vending machine is relocated to the exterior of an authorized premises or another location on such premises where the climate or other elements may impact the vending machine or nonlegend products therein, the vending machine registrant shall request authorization from the department prior to such relocation. Such a request for authorization shall be submitted to the department, in a form and manner prescribed by the commissioner, at least thirty days prior to such proposed relocation and shall describe the reason for the request and provide a description of quality controls to ensure the protection of the vending machine and the nonlegend products contained therein.(m) In the event that a vending machine has been tampered with or otherwise damaged, or the vending machine's contents have been forcibly removed, stolen or otherwise compromised, the vending machine registrant shall notify the department not later than twenty-four hours after discovering the event. Not later than five days after discovering the event, the vending machine registrant shall submit a written description of the event, including, but not limited to, steps taken by the vending machine registrant to resolve the event and prevent such occurrences from happening again. During such five-day period, the vending machine registrant shall evaluate nonlegend products remaining within the vending machine to determine if the nonlegend products are adulterated or are damaged products. If any such nonlegend product is adulterated or is a damaged product, the vending machine registrant shall not offer such product for sale and such product shall be immediately removed from the vending machine.(n) The department may inspect vending machines and the contents thereof. The department's inspection may include, but is not limited to, the following: (1) Verifying that the owner of the vending machine has the required registration and permit pursuant to section 20-623 of the Connecticut General Statutes; and(2) Verifying that the vending machine: (A) Is located where indicated on the registration;(B) Is in good working order;(C) Contains required notices and signage;(D) Has been serviced in accordance with subsection (j) of this section;(E) Is protected from the elements in accordance with subsection (k) of this section; and(F) Contains products that are not (i) expired, (ii) subject to a recall, (iii) showing evidence of being tampered with, (iv) damaged, or (v) prohibited for sale within a vending machine.(o) If the vending machine registrant decides to permanently cease offering nonlegend products at a vending machine, the vending machine registrant shall notify the department in writing not less than five calendar days before nonlegend products will permanently cease to be offered at the vending machine. A sign shall be affixed to the vending machine informing customers of the last date of offering nonlegend products at the vending machine not less than five calendar days before the vending machine will cease offering nonlegend products. All nonlegend products shall be removed from the vending machine by 11:59 p.m. of the last day of offering such products at the vending machine. If such vending machine exclusively offered nonlegend products, the vending machine registrant shall ensure a sign remains affixed to the vending machine, at all times when such machine is accessible to consumers, indicating that the machine is no longer operational.Conn. Agencies Regs. § 20-576-31
Adopted effective January 11, 1999; amended 11/7/2024