REQUIREMENTS FOR CONTROLLED SUBSTANCES
Phar 8.01 Federal registration and compliance with federal, state, and local laws and regulations. (1) FEDERAL REGISTRATION REQUIRED. To possess, manufacture, distribute, dispense, or conduct research with controlled substances in this state, pharmacies and pharmacists shall register with the drug enforcement administration as required under federal law.
(2) CONTROLLED SUBSTANCES AUTHORIZATION UNDER FEDERAL REGISTRATION. As provided under s. 961.32 (1m) (a), Stats., pharmacies and pharmacists registered under federal law to manufacture, distribute, dispense, or conduct research with controlled substances may possess, manufacture, distribute, dispense, and conduct research with those substances in this state to the extent authorized by their federal registration and in conformity with the provisions of ch. 961, Stats. (3) COMPLIANCE WITH LAWS AND REGULATIONS. Failure to register with the drug enforcement administration or otherwise comply with applicable federal, state, and local laws and regulations relating to possessing, manufacturing, distributing, dispensing, or conducting research with controlled substances constitutes unprofessional conduct for purposes of s. 450.10, Stats. Phar 8.02 Purpose of issue of prescription order. 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.
Phar 8.03 Valid prescription requirements. (1) A pharmacist may not dispense controlled substances for a prescription the pharmacist knows, or reasonably should know, is not a valid prescription under applicable federal, state, and local laws and regulations.
(2) 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 valid prescription order within the meaning and intent of ss. 450.01 (21) and 961.38, Stats. 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. A pharmacist knowingly dispensing pursuant to such a purported order, as well as the practitioner issuing it, shall be subject to the penalties provided for violation of the provision of law relating to controlled substances. (3) As provided under s. 961.38 (4r), Stats., a pharmacist is immune from any civil or criminal liability and from discipline under s. 450.10, Stats., for any act taken by the pharmacist in reliance on a reasonable belief that an order purporting to be a prescription was issued by a practitioner in the usual course of professional treatment or in authorized research. Phar 8.04 Notification of suspicious orders for and theft or loss of controlled substances. A pharmacy or pharmacist shall notify the board of a suspicious order or series of orders for controlled substances or the theft or loss of controlled substances on the same day notification is required to be provided to the drug enforcement administration. Notification to the board shall include all information required to be provided in the notification to the drug enforcement administration.
Phar 8.05 Recordkeeping. Records required by the federal controlled substances act, ch. 961, Stats., and s. 450.11 (2), Stats., shall be maintained for at least 5 years from the date the drug was received, manufactured, distributed, or 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. Records shall be readily retrievable, easily readable, and available for inspection by authorized persons for at least 5 years from the date of such record. An electronic recordkeeping system shall have the capability of producing a printout of records as required under this section. The pharmacist-in-charge shall oversee monthly inspections, maintenance, and reconciliation of all controlled substances, including maintaining a perpetual inventory for all Schedule II controlled substances.
Phar 8.06 Identification card requirement under s. 450.11 (1b), Stats. (1) DEFINITION. In this section and s. 450.11 (1b) (e) 3., Stats., “health care facility” means a facility, as defined in s. 647.01 (4), Stats.; any hospital, nursing home, community−based residential facility, county home, county infirmary, county hospital, county mental health complex, or other place licensed or approved by the department of health services under s. 49.70, 49.71, 49.72, 50.03, 50.032, 50.033, 50.034, 50.35, 51.08, or 51.09, Stats.; a facility under s. 45.50, 51.05, 51.06, 233.40, 233.41, 233.42, or 252.10, Stats.; and a hospice facility under s. 50.90 (1) (c), Stats. (2) IDENTIFICATION CARD REQUIREMENT. As provided under s. 450.11 (1b) (b) and (e), Stats., a controlled substance included in schedule II or III of ch. 961, Stats., may not be dispensed, and may not be delivered to a representative of the ultimate user, without an identification card belonging to the person to whom the drug is being dispensed or delivered. An identification card is not required if any of the following applies: (a) The drug is administered or dispensed directly to the ultimate user by a practitioner.
(b) The pharmacist or other person dispensing or delivering the drug has personal knowledge of the person to whom the drug is dispensed or delivered, and that the person is the ultimate user or the ultimate user’s authorized representative.
(c) The drug is delivered to a health care facility to be administered in the health care facility.
Phar 8.07 Dispensing schedule II controlled substances in emergency situations under s. 961.38 (2), Stats. (1) DEFINITION. For purposes of dispensing a schedule II controlled substance under s. 961.38 (2), Stats., “emergency situation" means a situation in which the prescribing practitioner determines all of the following: (a) Immediate administration of the schedule II controlled substance is necessary for proper treatment of the patient.
(b) No appropriate alternative treatment is available, including the administration of a drug that is not a schedule II controlled substance.
(c) It is not reasonably possible for the prescribing practitioner to provide a written prescription order to be presented to the pharmacist prior to dispensing.
(2) REQUIRED NOTIFICATION. A dispensing pharmacist shall notify the board of the failure of a prescribing practitioner to deliver a written prescription within 7 days after authorizing an emergency oral prescription for a schedule II controlled substance. The notification shall be provided to the board on the same day notification is required to be provided to the drug enforcement administration and shall include all information required to be provided in the notification to the drug enforcement administration.
Phar 8.08 Dispensing and sale of pseudoephedrine products. The dispensing and sale of pseudoephedrine products shall meet all applicable federal, state, and local laws and regulations relating to schedule V controlled substances, including all the following requirements:
(1) The requirements under ss. 961.23 and 961.38 (4), Stats., for dispensing schedule V controlled substances. (2) The requirements under s. 961.235, Stats., for records relating to sales of pseudoephedrine products. Section 2. EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats. ---------------------------------------------------------------------------------------------------------------------
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