Section 22-B412. LABELING, HANDLING, STORAGE, AND RECORDKEEPING STANDARDS

 

412.1Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

 

412.2Any drug whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such and shall be quarantined and physically separated from other drugs until they are either destroyed or returned to their supplier.

 

412.3If the conditions under which a drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity, then the drug shall be destroyed or returned to the supplier, unless examination, testing or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity, the drug supplier shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.

 

412.4All facilities at which drugs are stored, warehoused, handled, held, offered, marketed or displayed shall meet the following minimum requirements:

 

(a)Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

 

(b)Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

 

(c)Have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or that are in sealed, secondary containers that have been opened;

 

(d)Be maintained in a clean and orderly condition; and

 

(e)Be free from infestation by insects, rodents, birds, or vermin of any kind.

 

412.5All drugs shall be stored at appropriate temperatures and under conditions in accordance with requirements, if any, in the labeling of such drugs, or according with the requirements in the current edition of an official compendium:

 

(a)If no storage requirements are established for a drug, the drug may be held at “controlled” room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected; and

 

(b)Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of drugs.

 

412.6Manufacturers, wholesalers, and distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs. These records shall include the following information:

 

(a)The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;

 

(b)The identity and quantity of the drugs received and distributed or disposed of; and

 

(c)The dates of receipt and distribution or other disposition of the drugs.

 

412.7Inventories and records shall be made available for inspection and photocopying by the Director for a period of two (2) years following disposition of drugs.

 

412.8Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for inspection during the retention period. Records kept at a central location apart from the inspection site and are not electronically retrievable shall be made available for inspection within two (2) business days of a request by the Director.

 

source

Final Rulemaking published at 39 DCR 7729, 7736 (October 16, 1992).