Section 8.02. Records.  


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  • (1)  Any pharmacy, practitioner, or other federal drug enforcement administration registrant, as referenced in ch. 961 , Stats. , shall maintain complete and accurate records of each controlled substance received, manufactured, distributed, dispensed or disposed of in any other manner.
    (2)  Records required by the federal controlled substances act and ch. 961 , Stats. , shall be maintained at the location where the drug is received, manufactured, distributed or dispensed, and be available for inspection by authorized persons for at least 5 years from the date of such record. Financial and shipping records such as invoices and packing slips, but not executed order forms, may be kept at a central location. A complete and accurate biennial physical inventory of all schedule II, III, IV and V controlled substances pursuant to ss. 961.16 , 961.18 , 961.20 and 961.22 , Stats., and ch. CSB 2 on hand shall be made in conformance with all applicable federal and state laws.
    (2m)  Records required under s. 450.11 (1b) (bm) , Stats., shall be maintained for at least 5 years from the date the drug was dispensed, or, for a record that is subject to s. 961.385 , Stats., until the name of a person to whom a drug is dispensed is delivered to the controlled substances board under s. 961.385 , Stats., whichever is sooner.
    (3)  Required records shall be maintained as follows:
    (a) Records of schedule II controlled substances, other than prescription orders, shall be maintained separately from all other records.
    (b) Records of schedule III, IV and V controlled substances shall be maintained either separately or in such form that the information required is readily retrievable from the registrant's ordinary records.
    (c) The official drug enforcement administration order forms, DEA form 222, used in the procurement and distribution of schedule II substances shall be maintained at the locations from which the drug was distributed and where it is received.
    (d) Any person authorized to manufacture, distribute or dispense controlled substances shall maintain complete and accurate records with the following information:
    1. The name of the substance.
    2. The dosage form, strength and quantity of the substance.
    3. The quantity and date of distribution as well as the name, address and DEA registration number of the person to whom distributed.
    4. The number of units and date of receipt as well as the name, address and DEA registration number of the person from whom received.
    5. The name and address of the person for whom dispensed, date of dispensing, quantity dispensed and name or initials of the individual who dispensed the substance.
    (e) Records for dispensed schedule V substances shall be maintained as follows:
    1. If a schedule V drug is dispensed pursuant to the prescription order of a practitioner, the prescription shall be labeled properly and the order filed in accordance with the requirements for schedule III and IV orders.
    2. If a schedule V drug is dispensed other than pursuant to a prescription order, the dispenser shall make the record required by s. 961.23 , Stats., in a bound controlled substance V register at the time of the transaction.
    (f) In any instance that a pharmacy, practitioner or other DEA registrant authorized to possess controlled substances is required to file with the DEA a report of theft or loss of controlled substances, the pharmacy, practitioner or other DEA registrant shall also send a copy to the board within 2 weeks of filing with the DEA.
History: Cr. Register, January, 1983, No. 325 , eff. 2-1-83; am. (3) (f), r. (4) (a) and (b), Register, August, 1991, No. 428 , eff. 9-1-91; am. (1), (2) and (3) (e) 2., Register, December, 1998, No. 516 , eff. 1-1-99; CR 06-052 : am. (3) (f) Register October 2006 No. 610 , eff. 11-1-06; CR 16-018 : cr. (2m) Register September 2016 No. 729 , eff. 10-1-16; correction in (2m) made under s. 35.17 , Stats., Register September 2016 No. 729 .

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The Drug Enforcement Administration regional office is at 1800 Dirksen Federal Building, 219 S. Dearborn, Chicago, Illinois 60604. Microsoft Windows NT 6.1.7601 Service Pack 1