Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in ss.
15.08 (5) (b),
227.11 (2) and
450.02 (3) (a),
(b),
(d) and
(e), Wis. Stats., and interpreting s.
450.09 (7m), Wis. Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to amend Phar 7.04 (2) (intro.) and (b); and to create Phar 7.04 (1) (c) to (f), (2) (d) and (e), (3m), (5), and two Notes following Phar 7.04 (5), relating to the return of exchange of health items.
Hearing Date, Time and Location
Date: June 22, 2005
Time: 9:30 A.M.
Location: 1400 East Washington Avenue
Room 179A
Madison, Wisconsin
Appearances at the Hearing
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708. Comments must be received on or before July 6, 2005, to be included in the record of rule-making proceedings.
Analysis prepared by the Department of Regulation and Licensing.
Explanation of agency authority: The Wisconsin Pharmacy Examining Board is granted the authority to protect the public health, safety and welfare by establishing security standards for pharmacies, enforcing chapters 450 and 961, Stats, and establishing minimum standards for the practice of pharmacy and the dispensing of drugs. The return or exchange of health items is addressed specifically in the instance of state prisons, s.
450.09 (7m), Stats. The board also regulates this area of pharmacy practice in the non-state prison context in s.
Phar 7.04.
Related statute or rule: Cancer drug returns and redispensing are allowed provided the pharmacy follows the requirements in proposed ch.
HFS 148, which has not become final.
Plain language analysis: The Pharmacy Examining Board is amending the requirements of s.
Phar 7.04, pertaining to the return or exchange of health items, to allow for their return or exchange from community-based residential facilities (CBRFs), jails, and juvenile secured facilities. The amended rules set forth those circumstances under which a return or exchange of health items is allowed.
SECTION 1 adds new definitions for “original container," “resident health care patient," “secured institutional health care patient," and “tamper-resistant package."
SECTION 2 clarifies that health item returns may only be made to the pharmacy that dispensed them, and substitutes the term “beyond use date" for “expiration."
SECTION 3 lists the requirements for when health items may be returned to a pharmacy that dispensed them for the purpose of redispensing. The rule allows returns and redispensing of health items from secured institutional or resident health care patients, and for prepackaged non-narcotic, non-prescription drugs from any patient. Secured institutional patients include both jail inmates subject to the Department of Corrections approved policy and procedures manual for the control and administration of medications and juvenile patients residing in certain secured institutions whose health items are maintained by Department of Corrections staff.
For returns of health items from secured institutional health care patients, the rules also require those items to be segregated and prohibits the pharmacy from redispensing those items other than to a secured institutional health care patient.
Exempted from the definition of a “return" is the delivery to a pharmacy of a drug or device that was previously dispensed if the purpose of the delivery is for destruction at the pharmacy or by another authorized person or entity.
Also added are two notes referring to cancer drug returns and state prison pharmacy returns, which are governed by different statutory and rule authority.
Summary of, and comparison with, existing or proposed federal regulation: 21 U.S.C. § 360 (g) (1) (registration and manufacturers) provides: The foregoing subsections of this section shall not apply to-
(1) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail; (emphasis added)
2. Section 374(a)(2)(A) (inspection) (the Exemption) provides:
(2) The provisions of the third sentence of paragraph (1) shall not apply to-
(A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail; (emphasis added)
3. The Drug Enforcement Agency does not permit the return of controlled substances from non DEA registrants.
Comparison with rules in adjacent states
Minnesota
6800.2700 RETURN OF DRUGS AND DEVICES.
Subpart 1. Reuse. Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue, or resale any drugs, prescribed medications, chemicals, poisons, or medical devices; except that in a hospital with a licensed pharmacy, drugs, devices, or other items dispensed for hospital inpatient use may be returned to the pharmacy for disposition by a pharmacist in accordance with good professional practice.
Subp. 2. Drugs from nursing homes. Drugs from nursing homes may be returned to the dispensing pharmacy if:
A. the consultant pharmacist can assure proper storage conditions for the drugs in the facility as specified in the United States Pharmacopeia, (United States Pharmacopeial Convention, Inc., Rockville, Maryland);
B. the drugs are returned to the pharmacy which dispensed the drugs;
C. the integrity of such packaging remains intact (no reconstituted drugs, drugs requiring refrigeration, or controlled substances may be so returned); and
D. the drugs are received by the pharmacy in the original manufacturer's packaging or pharmacist packager's unit-dose, unit-of-use, or strip packaging with each tablet or capsule individually wrapped and labeled, or in blister cards, which indicate the drug name and strength, the packager's name, and the manufacturer's or packager's lot or batch number. Drugs packaged by a pharmacy may be returned only if the pharmacy can demonstrate to the board that its packaging material and procedures will provide a package that will meet or exceed the criteria for class B packaging established by the United States Pharmacopeia, (United States Pharmacopeial Convention, Inc., Rockville, Maryland), and that procedures have been developed and implemented to prevent the commingling of dosage units of different lot numbers.
Subp. 3. Commingling. Commingling of returned medication or mixing of lot numbers of returned medication, upon or prior to repackaging, shall result in such medication being deemed misbranded and subject to embargo under Minnesota Statutes, section 151.38. This prohibition shall not apply to the return of medical devices provided that proper sanitary procedures are used prior to the reuse, resale, or rerent thereof.
HIST: 18 SR 1145
Current as of 10/27/03
Illinois:
Section 1330.91 Division I Pharmacies
a) Retail pharmacies which engage in general community pharmacy practice and are open to, or offer pharmacy service to, the general public shall, in addition to any other requirements of the Act and this Part, comply with Section 1330.91. A retail pharmacy which, in addition to offering pharmacy services to the general public, provides pharmacy services to an institution or facility listed in Sections 1330.92 (a) need not register as a Division II pharmacy if the sales do not exceed 49% of total sales, but the pharmacy shall comply with requirements of Sections 1330.92 (b), (c) and (d).
f) Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue or resale any dispensed medications, chemicals, poisons or medical devices except for:
1) Medical devices which can be properly sanitized prior to reuse, resale or rerent; and
2) Medications and medical devices that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by the current United States Pharmacopoeia (U.S.P.)/National Formulary or by the United States Pharmacopeial Convention, Inc.
Section 1330.92 Division II Pharmacies
a) Pharmacies which are not located in the facilities they serve and whose primary service is to provide services to patients or residents of facilities licensed under the Nursing Home Care Reform Act of 1979 or the Hospital Licensing Act, or the University of Illinois Hospital Act shall, in addition to any other requirements of the Act and this Part, comply with this Section.
f) Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue or resale any dispensed medications, chemicals, poisons or medical devices except for:
1) Medical devices which can be properly sanitized prior to reuse, resale or rerent; and
2) Medications and medical devices that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by the current United States Pharmacopoeia (U.S.P.)/National Formulary or by the United States Pharmacopoeial Convention, Inc.
Section 1330.93 Division III Pharmacies
a) Pharmacies which are located in facilities licensed under the Nursing Home Care Reform Act of 1979, the Hospital Licensing Act, or the University of Illinois Hospital Act, or are operated by the Department of Human Services or the Department of Corrections, and which provide pharmacy services to residents, patients, employees, prescribers and students of these facilities, shall, in addition to other requirements of the Act and this Part, comply with this Section.
d) Staffing of the Pharmacy
8) Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, or resale dispensed medications, chemicals, poisons or medical devices except for:
A) Medical devices which can be properly sanitized prior to reuse, resale or rerent; and
B) Medications that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by a current United States Pharmacopoeia/National Formulary published by the United States Pharmacopoeial Convention, Inc.
Section 1330.94 Division IV Pharmacies
a) Pharmacies which provide and/or offer for sale radiopharmaceuticals shall in addition to any other requirements of the Act and this Part comply with this Section 1330.94.
(NONE)
Section 1330.95 Division V Pharmacies
a) Pharmacies Required to Hold Division V Licenses
1) Pharmacies which are located in or provide service to ambulatory care facilities, schools of veterinary medicine or other institutions or facilities. In addition to other requirements of the Act and this Part, these pharmacies shall comply with this Section.
2) Pharmacies that hold Division II licenses and provide pharmacy services to the general public. In addition to other requirements of the Act and Rules, these pharmacies shall comply with Section 1330.92 and this Section.
3) Pharmacies that hold Division III licenses and provide pharmacy services to the general public. In addition to other requirements of the Act and Rules, these pharmacies shall comply with Section 1330.93 and this Section.
f) Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, or resale any dispensed medications, chemicals, poisons or medical devices except for:
1) Medical devices that can be properly sanitized prior to reuse, resale or rerent; and
2) Medications and medical devices that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by the current United States Pharmacopoeia (U.S.P.)/National Formulary or by the United States Pharmacopoeial Convention, Inc.
IOWA:
657—6.15(124,126) Return of drugs and other items. For the protection of the public health and safety, prescription drugs and devices, controlled substances, and items of personal contact may be returned to the pharmacy for reuse or resale only as herein provided:
6.15(1) Integrity maintained. Prescription drugs and devices may be returned, exchanged, or resold only if, in the professional judgment of the pharmacist, the integrity of the prescription drug has not in any way been compromised.
6.15(2) Controlled substances. Under no circumstances shall pharmacy personnel accept from a patient or a patient's agent any controlled substances for return, exchange, or resale except to the same patient.
6.15(3) Noncontrolled substance returns. Prescription drugs, excluding controlled substances, may be returned and reused as authorized in 657—subrule 11.1(6).
6.15(4) Personal contact items. Pharmacy personnel shall not accept for reuse or resale any items of personal contact nature that have been removed from the original package or container after sale.
Indiana-returns
856 IAC 1-21 Resale of returned substances
Authority: IC 25-26-13-4
Affected: IC 25-26-13-25
Sec. 1. (a) This section implements and interprets IC 25-26-13-15(h) concerning the resale or redistribution of medications.
(b) For a medication to have been properly stored and securely maintained according to sound pharmacy practices, the storage and administration of medications in the institutional facility must be under the immediate control of licensed nursing personnel.
(c) If the medication was originally packaged by the dispensing pharmacy, it cannot be resold or redistributed unless:
(1) the medication has been repackaged into unit-dose packaging using packaging materials that meets Class A or Class B standards, found in the United States Pharmacopeia (U.S.P.), page 1574, published by the United States Pharmacopeia, 22nd Revision, January 1, 1990, United States Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway, Rockville, Maryland 20852, which standards are incorporated herein by reference; and
(2) the repackaging process complies with the standards as found in the “Proper Treatment of Products Subjected to Additional Manipulations, Section 1191" of the United States Pharmacopeia, page 1705, 22nd Revision, 1990, which section is incorporated herein by reference.
(d) A medication repackaged under the provisions of subsection (c) shall be labeled with an expiration date of not greater than one (1) year until the manufacturer's expiration date, whichever is earlier. (Indiana Board of Pharmacy; Reg 21, Sec 1; filed Jun 18, 1962, 10:00 a.m.: Rules and Regs. 1963, p. 128; filed Mar 31, 1992, 5:00 p.m.: 15 IR 1391; readopted filed Dec 2, 2001, 12:35 p.m.: 25 IR 1334)
Michigan-returns
R 338.472 Prescription drugs and devices; returns or exchange for resale prohibited,
Rule 2. For the protection of the public health and safety, prescription drugs or devices which have been dispensed and which have left the control of the pharmacist shall not be returned or exchanged for resale.
