Conn. Agencies Regs. § 20-576-30a

Current through December 4, 2024
Section 20-576-30a - Sale of Nonlegend Drugs
(a) A nonlegend drug permittee shall only purchase nonlegend drugs from a wholesaler or another nonlegend drug permittee.
(b) A nonlegend drug permittee 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) A nonlegend product, the sale of which is subject to quantity limitation, proof of identification, age verification, or other restriction pursuant to federal or state law, shall be stored and maintained by a nonlegend drug permittee in a manner accessible only to employees of the nonlegend drug permittee prior to purchase.
(d) It is the sole responsibility of each nonlegend drug permittee to ensure that all nonlegend products are not expired, and to take reasonable steps to ensure expired nonlegend products are promptly removed from retail display upon expiration.
(e) A nonlegend drug permittee shall, upon receiving a nonlegend product from a wholesaler or another nonlegend drug permittee, and prior to offering any nonlegend products for sale, inspect the expiration date of each nonlegend product offered for sale by authorized employees of such nonlegend drug permittee to ensure such product is not expired.
(f) A nonlegend drug permittee shall not sell or dispense at retail a recalled nonlegend product.
(g) It is the responsibility of each nonlegend drug permittee to prevent the retail sale of any nonlegend product that has been subject to a recall for any reason by the manufacturer, the federal government or the state of Connecticut.
(h) A nonlegend drug permittee shall have a written policy that sets forth a process to respond to recalls, which shall include, but not be limited to, a review of nonlegend products to identify if any nonlegend products offered for retail sale are subject to any such recall and a protocol to remove, return, destroy or sequester nonlegend products as applicable for each recall. The policy shall be electronically submitted to the department not later than forty-eight hours after a request from the department.
(i) Each nonlegend drug permittee shall maintain a record of all nonlegend products purchased from a wholesaler and other nonlegend drug permittees for individual retail sale.
(j) Each nonlegend drug permittee shall maintain a record of each received recall notice.
(k) Each nonlegend drug permittee shall maintain a record of each nonlegend product that was returned by a consumer, and denote on such record the reason for each return, including returns due to recall, damage, or other reason.
(l) All records required to be maintained under this section and section 20-576-31 of the Regulations of Connecticut State Agencies shall be maintained for a minimum of three years.
(m) The retail sale of any nonlegend products without a permit to sell nonlegend drugs pursuant to section 20-624 of the Connecticut General Statutes is prohibited.
(n) The retail sale of any nonlegend product that is commercially known or visually evident to be damaged, adulterated, misbranded, or expired is prohibited.
(o) Neither a nonlegend drug permit, nor a vending machine registration, shall be transferable from one place to another, or from one vending machine to another, without notice to the department, in a form and manner prescribed by the commissioner, at least thirty days prior to such transfer. Neither a nonlegend drug permit, nor a vending machine registration, shall be transferable to another person.

Conn. Agencies Regs. § 20-576-30a

Effective 11/7/2024