Chapter Med 17

Chapter Med 17

STANDARDS FOR DISPENSING AND PRESCRIBING DRUGS

Med 17.01   Authority and purpose.

Med 17.02   Definitions.

Med 17.03   Packaging.

Med 17.04   Labeling.

Med 17.05   Recordkeeping.

Med 17.06   Prescription orders by nurses and ancillary health care personnel.

Med 17.01 Med 17.01 Authority and purpose.

Med 17.01(1) (1) The rules in this chapter are adopted pursuant to authority in ss. 15.08 (5) (b), 227.11 and ch. 448, Stats.

Med 17.01(2) (2) The rules in this chapter are adopted to specify standards practitioners shall follow in dispensing prescription drugs for the protection of the public.

Med 17.01 History History: Cr. Register, September, 1982, No. 321, eff. 10-1-82; correction in (1) made under s. 13.93 (2m) (b) 7., Stats., Register, May, 1989, No. 401.

Med 17.02 Med 17.02 Definitions.

Med 17.02(1) (1) “Controlled substance” has the meaning under s. 961.01 (4), Stats.

Med 17.02(2) (2) “Practitioner” means a person holding a license to practice medicine and surgery.

Med 17.02(3) (3) “Prescription drug” has the meaning under s. 450.01 (20), Stats.

Med 17.02 History History: Cr. Register, September, 1982, No. 321, eff. 10-1-82; correction in (3) made under s. 13.93 (2m) (b) 7., Stats., Register, May, 1989, No. 401; correction in (1) made under s. 13.93 (2m) (b) 7., Stats., Register, February, 1997, No. 494; am. (2), Register, December, 1999, No. 528, eff. 1-1-00.

Med 17.03 Med 17.03 Packaging. A prescription drug dispensed by a practitioner shall be dispensed in a child-resistant container if it is a substance requiring special packaging under 16 CFR 1700.14 (1982) of the federal poison prevention packaging act.

Med 17.03 History History: Cr. Register, September, 1982, No. 321, eff. 10-1-82.

Med 17.04 Med 17.04 Labeling.

Med 17.04(1) (1) A prescription drug dispensed by a practitioner shall contain a legible label affixed to the immediate container disclosing:

Med 17.04(1)(a) (a) The name and address of the facility from which the prescribed drug is dispensed;

Med 17.04(1)(b) (b) The date on which the prescription is dispensed;

Med 17.04(1)(c) (c) The name of the practitioner who prescribed the drug or device;

Med 17.04(1)(d) (d) The full name of the patient;

Med 17.04(1)(e) (e) The generic name and strength of the prescription drug dispensed unless the prescribing practitioner requests omission of the name and strength of the drug dispensed; and,

Med 17.04(1)(f) (f) Directions for use of the prescribed drug and cautionary statements, if any, contained in the prescription or required by law.

Med 17.04(2) (2) Nonapplication of labeling requirements. The labeling requirement specified in sub. (1) does not apply to complimentary samples dispensed by a practitioner in original containers or packaging supplied to the practitioner by a pharmaceutical manufacturer or distributor.

Med 17.04 History History: Cr. Register, September, 1982, No. 321, eff. 10-1-82.

Med 17.05 Med 17.05 Recordkeeping.

Med 17.05(1) (1) Prescription drugs.

Med 17.05(1)(a) (a) A practitioner shall maintain complete and accurate records of each prescription drug received, dispensed or disposed of in any other manner.

Med 17.05(1)(b) (b) All prescription drugs dispensed by a practitioner shall be recorded in the patient record.

Med 17.05(2) (2) Controlled substances.

Med 17.05(2)(a) (a) Records required by the federal controlled substances act and ch. 961, Stats., shall be maintained at the location where the drug is received, distributed or dispensed and be available for inspection by authorized persons for at least 5 years from the date of such record.

Med 17.05(2)(b) (b) Controlled substances dispensed by a practitioner shall be recorded as follows:

Med 17.05(2)(b)1. 1. As provided in this section; and

Med 17.05(2)(b)2. 2. On a separate log, in a separate bound log book in which each schedule of controlled substances dispensed is recorded separately and in chronological order with the following information:

Med 17.05(2)(b)2.a. a. The name of the substance.

Med 17.05(2)(b)2.b. b. Dosage form and strength of the substance.

Med 17.05(2)(b)2.c. c. Name and address of the person for whom dispensed.

Med 17.05(2)(b)2.d. d. Date of dispensing.

Med 17.05(2)(b)2.e. e. Quantity dispensed.

Med 17.05(2)(b)2.f. f. Name or initials of practitioner who dispensed the substance.

Med 17.05 History History: Cr. Register, September, 1982, No. 321, eff. 10-1-82; correction in (2) (a) made under s. 13.93 (2m) (b) 7., Stats., Register, February, 1997, No. 494.

Med 17.06 Med 17.06 Prescription orders by nurses and ancillary health care personnel. Prescription orders prepared by professional nurses and ancillary health care personnel, as delegated and supervised by a practitioner under s. 448.03 (2) (e), Stats., shall contain in addition to other information required by this chapter, the name, address and telephone number of the delegating practitioner and the name, address and signature of the person preparing the prescription order.

Med 17.06 History History: Cr. Register, July, 1994, No. 463, eff. 8-1-94.