Phar 8.08Controlled substances in emergency kits for long-term care facilities.
Ch. Phar 8 NoteNote: Chapter Phar 8 as it existed on September 30, 2022, was repealed and a new chapter Phar 8 was created Register September 2022 No. 801, effective October 1, 2022.
Phar 8.01Phar 8.01Federal registration and compliance with federal, state, and local laws and regulations.
Phar 8.01(1)(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.
Phar 8.01(2)(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.
Phar 8.01(3)(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 8.01 NoteNote: The United States Department of Justice Drug Enforcement Administration has published a pharmacist’s manual, which provides an informational outline of the federal Controlled Substances Act. It can be found online at: https://www.deadiversion.usdoj.gov/pubs/manuals/index.html.
Phar 8.01(4)(4)Emergency kits in long-term care facilities. Nothing in these rules shall prohibit long-term care facilities from obtaining an emergency kit, from a DEA registered pharmacy, in compliance with federal law.
Phar 8.01(5)(5)Remote dispensing sites. For the purposes of this chapter and pursuant to s. 450.09 (1) (a), Stats., pharmacies shall include remote dispensing sites.
Phar 8.02Phar 8.02Purpose 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(1)(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.
Phar 8.03(2)(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.
Phar 8.03(3)(3)A pharmacist may use professional judgment to contact prescribers for changes to controlled substances prescriptions as needed and in accordance with federal law and s. Phar 7.02 (5).
Phar 8.04Phar 8.04Notification of theft or loss of controlled substances.A pharmacy or pharmacist shall notify the board of a 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 of the information required to be provided in the notification to the drug enforcement administration.
Phar 8.05(1)(1)Records shall be maintained as required by the federal controlled substances act, ch. 961, Stats., and s. 450.11 (2), Stats.
Phar 8.05(2)(2)The managing pharmacist shall oversee quarterly inspections, maintenance, and reconciliation of all controlled substances, including maintaining a perpetual inventory for all Schedule II controlled substances.
Phar 8.06Phar 8.06Identification card requirement under s. 450.11 (1b), Stats.
Phar 8.06(1)(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.
Phar 8.06(2)(2)Exemption. There shall be an exemption to the requirement for an identification card when the drug is lawfully delivered to the patient’s home, or any address requested by the patient, through mail, common carrier or delivery service. A valid signature is required upon delivery.
Phar 8.08Phar 8.08Controlled substances in emergency kits for long-term care facilities.long-term care facilities which are not registered with the DEA shall meet all of the following requirements regarding emergency kits containing controlled substances:
Phar 8.08(1)(1)The source of supply must be a DEA registered hospital, pharmacy or practitioner.
Phar 8.08(2)(2)The pharmaceutical services committee of the facility shall establish security safeguards for each emergency kit stored in the LTCF which shall include the designation of individuals who may have access to the emergency kits and a specific limitation of the type and quantity of controlled substances permitted to be placed in each emergency kit.
Phar 8.08(3)(3)A pharmacist shall be responsible for proper control and accountability for such emergency kits within the LTCF which includes the requirement that the LTCF and the providing DEA registered hospital, pharmacy or practitioner maintain complete and accurate records of the controlled substances placed in the emergency kits, the disposition of those controlled substances, plus the requirement to take at least monthly physical inventories.
Phar 8.08(4)(4)The pharmaceutical services committee will establish the emergency medical conditions under which the controlled substances may be administered to patients in the LTCF which shall include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual DEA registered practitioner and in compliance with all applicable federal and state laws.
Phar 8.08(5)(5)Noncompliance with this section may result in revocation, denial or suspension of the privilege of having or placing emergency kits, containing controlled substances, in LTCF.
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.
