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 Phar 8 NoteNote: Chapter Phar 8 as it existed on September 30, 2022, was repealed and a new chapter Phar 8 was created Register September 2022 No. 801, effective October 1, 2022.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 8.04Phar 8.04Notification 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(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 8.07(2)(a)(a) The partial dispensing of a prescription containing a controlled substance listed in schedule II is permissible, if one of the following conditions applies:
Phar 8.07(2)(a)1.1. If the pharmacist is unable to supply the full quantity called for in a written, electronic, or emergency oral prescription order, and the pharmacist makes a notation of the quantity supplied on the face of the written hard copy prescription order or written record of the electronic or emergency oral prescription order.
Phar 8.07(2)(a)3.3. If the prescribing practitioner requests partial dispensing.
Phar 8.07(2)(b)(b) The remaining portion of any partially dispensed prescription under this subsection may be dispensed within 72 hours of the first partial dispensing. If the remaining portion is not dispensed within the 72 hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond the 72 hours without a new prescription order.
Phar 8.07(3)(3)Prescription orders for schedule II controlled substances written for patients in long-term care facilities (LTCF) or for patients with a medical diagnosis documenting a terminal illness may be dispensed in partial quantities to include individual dosage units. The prescribing practitioner may document a terminal illness by writing upon the face of the prescription order the phrase “terminal illness” or words of similar meaning. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the prescribing practitioner prior to partially dispensing the prescription. Documentation of a terminal illness, whether substantiated by the presence of an appropriate phrase written upon the face of the prescription order or through pharmacist contact with the prescribing practitioner, shall be placed within the individual medication profile record maintained under s. Phar 7.07. The pharmacist shall record on the prescription order whether the patient is “terminally ill” or an “LTCF patient.” A prescription order that is partially dispensed and does not contain the notation “terminally ill” or “LTCF patient” shall be deemed to have been dispensed in violation of this subsection. For each partial dispensing, the dispensing pharmacist shall record on the back of the prescription order or on another appropriate record, uniformly maintained and readily retrievable, the date of the partial dispensing, quantity dispensed, remaining quantity authorized to be dispensed and the identification of the dispensing pharmacist. Subsequent partial dispensing is not permitted under this section if the patient becomes deceased, or is no longer diagnosed as terminally ill, or no longer resides within an LTCF. The total quantity of a schedule II controlled substance dispensed by partial dispensing may not exceed the total quantity prescribed. Prescription orders for schedule II controlled substances for patients in an LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless terminated earlier by the discontinuance of medication.
Phar 8.07(4)(4)Information pertaining to current prescription orders for schedule II controlled substances for patients in an LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if the system has the capability to permit:
Phar 8.07(4)(a)(a) Display or printout of: the original prescription order designation; date of issue; identification of prescribing practitioner; identification of patient; name and address of the LTCF or name and address of the hospital or residence of the patient; identification of medication authorized, including dosage form, strength and quantity; listing of partial quantities that have been dispensed under each prescription order and the information required in sub. (3).
Phar 8.07(4)(b)(b) Immediate (real time) updating of the prescription order record each time there is partial dispensing of the prescription.
Phar 8.07(4)(c)(c) Retrieval of partially dispensed schedule II prescription information identical to that required by s. Phar 7.05 (2) for all prescription renewal information.
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.
