Register September 2016 No. 729
Chapter Phar 8
REQUIREMENTS FOR CONTROLLED SUBSTANCES
Phar 8.01   Scope.
Phar 8.02   Records.
Phar 8.03   Filing prescription orders.
Phar 8.04   Purpose of issue of prescription order.
Phar 8.05   Dispensing.
Phar 8.06   Renewing prescriptions.
Phar 8.07   Partial dispensing.
Phar 8.08   Labeling prescriptions.
Phar 8.09   Emergency dispensing.
Phar 8.10   Disclosure of suspicious orders of controlled substances.
Phar 8.11   Controlled substances in emergency kits for long term care facilities.
Phar 8.12   Prescription orders transmitted by facsimile machine.
Phar 8.13   Identification card exception for a health care facility.
Phar 8.01 Phar 8.01Scope. Procedures governing the manufacture, distribution and dispensing of controlled substances pursuant to ch. 961, Stats., are set forth generally by that chapter and specifically by sections of this chapter and chs. Phar 12 and 13.
Phar 8.01 History History: Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. Register, August, 1991, No. 428, eff. 9-1-91; am. Register, December, 1998, No. 516, eff. 1-1-99.
Phar 8.02 Phar 8.02Records.
Phar 8.02(1) (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.
Phar 8.02(2) (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.
Phar 8.02(2m) (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.
Phar 8.02(3) (3) Required records shall be maintained as follows:
Phar 8.02(3)(a) (a) Records of schedule II controlled substances, other than prescription orders, shall be maintained separately from all other records.
Phar 8.02(3)(b) (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.
Phar 8.02(3)(c) (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.
Phar 8.02(3)(d) (d) Any person authorized to manufacture, distribute or dispense controlled substances shall maintain complete and accurate records with the following information:
Phar 8.02(3)(d)1. 1. The name of the substance.
Phar 8.02(3)(d)2. 2. The dosage form, strength and quantity of the substance.
Phar 8.02(3)(d)3. 3. The quantity and date of distribution as well as the name, address and DEA registration number of the person to whom distributed.
Phar 8.02(3)(d)4. 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.
Phar 8.02(3)(d)5. 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.
Phar 8.02(3)(e) (e) Records for dispensed schedule V substances shall be maintained as follows:
Phar 8.02(3)(e)1. 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.
Phar 8.02(3)(e)2. 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.
Phar 8.02(3)(f) (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.
Phar 8.02 Note Note: The Drug Enforcement Administration regional office is at 1800 Dirksen Federal Building, 219 S. Dearborn, Chicago, Illinois 60604.
Phar 8.02 History 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.
Phar 8.03 Phar 8.03Filing prescription orders.
Phar 8.03(1) (1) All controlled substance prescription orders shall be maintained on file, in chronological order, for a period of at least 5 years. The orders shall be readily accessible to enforcement personnel authorized by s. 961.51, Stats.
Phar 8.03(2) (2) Schedule II prescription orders may be filed separately from all other orders or they may be filed with those for schedule III, IV and V drugs provided all orders in the file for schedule III, IV and V drugs are stamped in red ink with the letter “C" one inch in height, in the lower right hand corner of the order. Under no circumstances may schedule II orders be filed together with those for non-controlled drugs.
Phar 8.03(3) (3) Schedule III, IV and V prescription orders may be filed with those for non-controlled drugs provided that orders for schedule III, IV and V drugs are stamped in red ink with the letter “C" one inch in height in the lower right hand corner of the order or orders for schedule III, IV and V substances may be filed separately. However, if a pharmacy employs an automated data processing system or other electronic recordkeeping system for prescription orders which permits identification by prescription order number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription order with a red ``C" is waived.
Phar 8.03 History History: Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. (2) and (3), Register, August, 1991, No. 428, eff. 9-1-91; am. (1) and (3), Register, December, 1998, No. 516, eff. 1-1-99.
Phar 8.04 Phar 8.04Purpose of issue of prescription order.
Phar 8.04(1)(1) Prescription orders for controlled substances shall be issued for a legitimate medical purpose by individual practitioners acting in the usual course of professional practice. Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who dispenses the prescription. An order purporting to be a prescription order not issued in the usual course of professional treatment or in legitimate and authorized research is not a prescription order within the meaning and intent of ss. 450.01 (21) and 961.38, Stats. The person knowingly dispensing pursuant to such a purported order, as well as the person issuing it, shall be subject to the penalties provided for violation of the provision of law relating to controlled substances.
Phar 8.04(2) (2) A prescription order issued by a practitioner to obtain controlled substances for the purpose of general dispensing or administration to patients by the practitioner is not valid.
Phar 8.04 History History: Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. Register, August, 1991, No. 428, eff. 9-1-91; am. (1), Register, December, 1998, No. 516, eff. 1-1-99.
Phar 8.05 Phar 8.05Dispensing.
Phar 8.05(1) (1) All controlled substance prescription orders shall be dated as of, and signed on, the day issued and shall contain the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address and registration number of the practitioner. Prescription orders shall be written with ink or indelible pencil or be typewritten and shall be signed by the practitioner. Orders for controlled substances may be issued only by individual practitioners who are authorized to prescribe controlled substances by the jurisdiction in which he or she is licensed to practice and registered or exempt from registration under the federal controlled substances act.
Phar 8.05(2) (2) A pharmacist may dispense a controlled substance listed in schedule II, III or IV only pursuant to a prescription order issued by an individual practitioner. The order shall be initialed and dated by the dispensing pharmacist as of the date the prescription is dispensed. If the person accepting the medication pursuant to any prescription order for a schedule II controlled substance, specified in s. 961.16, Stats., is not personally known to the pharmacist, there shall be written in ink, on the reverse side, the printed name, signature and address of the person.
Phar 8.05(3) (3) An individual practitioner may dispense directly a controlled substance listed in schedule II, III or IV provided that the prescription container is labeled and records are maintained in accordance with the requirements of this code.
Phar 8.05(4) (4) A prescription containing a controlled substance listed in schedule II may be dispensed only pursuant to a written hard copy or electronic order signed by the prescribing individual practitioner, except in emergency situations. A prescription for a controlled substance listed in schedule II may not be dispensed more than 60 days after the date of issue on the prescription order.
Phar 8.05(7) (7) A prescription order for a controlled substance may not be dispensed unless the prescription order contains all of the information required in sub. (1). For any controlled substance prescription order, a pharmacist may not add, modify or clarify the patient's name, the controlled substance prescribed, except for generic substitution as permitted by law, and the prescribing practitioner's signature. After consultation with the prescribing practitioner, a pharmacist may add, modify or clarify the strength, dosage form, quantity prescribed, date of issuance and directions for use for a schedule II controlled substance prescription order. For a schedule II controlled substance prescription order, a pharmacist may add, modify or clarify the registration number of the practitioner, and the address of the practitioner and the patient if that information is verifiable and retrievable from information maintained by the pharmacist or is obtained through consultation with the practitioner. A pharmacist may add, modify or clarify any information allowed in this subsection missing from a prescription order for a schedule III, IV or V controlled substance that is verifiable and retrievable from information maintained by the pharmacist or that is obtained through consultation with a practitioner. A patient may only provide information to a pharmacist to add, modify or clarify the patient's address. The prescription order shall be initialed and dated by the pharmacist and shall indicate the addition, modification or clarification of information and the manner by which the pharmacist obtained that information.
Phar 8.05 History History: Cr. Register, January, 1983, No. 325, eff. 2-1-83; am. (1), (2), (3) and (5), cr. (6), Register, August, 1991, No. 428, eff. 9-1-91; cr. (7), Register, January, 1996, No. 481, eff. 2-1-96; am. (4), Register, February, 1996, No. 482, eff. 3-1-96; am. (2), Register, December, 1998, No. 516, eff. 1-1-99; am. (1) and (7), r. (6), Register, February, 2001, No. 542, eff. 3-1-01; CR 01-154: am. (4), r. (5), Register 2002 No. 559, eff. 8-1-02; CR 13-075: am. (4) Register August 2014 No. 704, eff. 9-1-14.
Phar 8.06 Phar 8.06Renewing prescriptions.
Phar 8.06(1) (1) No prescription containing a schedule II substance may be renewed.
Phar 8.06(2) (2) The prescribing practitioner may authorize renewals of schedule III or IV controlled substances on the original prescription order or through an electronic or oral renewal authorization transmitted to the pharmacist. The following conditions must be met:
Phar 8.06(2)(a) (a) The pharmacist obtaining the electronic or oral authorization shall note on the prescription order, medication profile record or readily retrievable and uniformly maintained document the following information:
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.