Section 80.71 - Practitioners; dispensing controlled substances

80.71 Practitioner; dispensing controlled substances.

(a) Practitioners, in good faith and in the course of their professional practice only, and as limited in this Part may dispense controlled substances.

(b) Except as provided in subdivision (c) of this section, the quantity of substances dispensed may not exceed a 30-day supply if the substances were used in accordance with the directions for use. No additional dispensing of a controlled substance may be made by a practitioner to an ultimate user within 30 days of the date of the previous dispensing unless and until the ultimate user has exhausted all but a seven days' supply of that controlled substance previously dispensed.

(c)(1) A practitioner may dispense up to a three month supply of a controlled substance, including chorionic gonadotropin, or up to a six month supply of an anabolic steroid if used in accordance with the directions for use, provided that such supply has been dispensed for the treatment of a condition specified in section 80.67(d) and 80.69(d) of this Part.

(d) No controlled substance shall be dispensed unless it is enclosed within a suitable and durable container upon which is indelibly typed, printed or otherwise legibly written upon an orange label affixed to such container, in a manner which would inhibit its removal, the following:

(1) name and address of the ultimate user for whom the substance is intended, or, if intended for use upon an animal, the species of such animal and the name and address of the owner or person having custody of such animal;

(2) name, address and telephone number of the dispensing practitioner;

(3) specific directions for use, including but not limited to the dosage and frequency of dosage, and the maximum daily dosage;

(4) the legend, prominently marked or printed in either boldface or upper case lettering: "CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED";

(5) the date of dispensing; and

(6) either the name of the substance or such code number assigned by the department for the particular substance pursuant to section 80.24 of this Part.

(e) The practitioner shall submit dispensing information, for all controlled substances dispensed, electronically to the department utilizing a transmission format acceptable to the department, not later than 24 hours after the substance was delivered. A waiver allowing a practitioner to make such filings within a longer period of time may be issued by the commissioner based upon a showing of economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner. Such waiver and any subsequent waiver shall be applied for in the same manner and shall be subject to the same requirements as specified in Section 80.63(c)(2)(x) of this Part and, if granted, such waiver shall not provide for a filing period longer than the 15th day of the next month following the month in which the substance was delivered. The information filed with the department shall include but not be limited to:

(1) dispenser identifier;

(2) patient name, in the case of an animal, the patient name field shall be filled with the name of the animal's owner;

(3) patient address, including street, city, state, ZIP code;

(4) patient date of birth;

(5) patient's sex;

(6) date controlled substance dispensed;

(7) metric quantity;

(8) national drug code number of the drug;

(9) number of days supply;

(10) prescriber's Drug Enforcement Administration (DEA) number;

(11) payment method;

(12) species code; and

(13) name of animal, if applicable.

When applicable, the practitioner shall file a zero report with the department as specified in Section 80.73(f)(2)(i) of this Part, or a practitioner may apply for a waiver of the requirement to file a zero report as specific in Section 80.73(f)(2)(ii) of this Part.

Effective Date: 
Tuesday, August 27, 2013
Doc Status: 
Complete