HB1031enr 94TH GENERAL ASSEMBLY

HB1031 Enrolled LRB094 07832 RAS 38012 b

AN ACT concerning regulation.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 5. The Pharmacy Practice Act of 1987 is amended by changing Sections 14, 15, and 18 as follows:

(225 ILCS 85/14) (from Ch. 111, par. 4134)

(Section scheduled to be repealed on January 1, 2008)

Sec. 14. Structural and equipment requirements. No person shall establish or move to a new location any pharmacy unless the pharmacy is licensed with the Department and has on file with the Department a verified statement that:

(1) such pharmacy is or will be engaged in the practice of pharmacy; and

(2) other than a Division VI pharmacy, such pharmacy will have in stock and shall maintain sufficient drugs and materials as to protect the public it serves within 30 days after the issuance of the registration of the pharmacy.

Division I, II, III, IV, or V pharmacies shall be in a suitable, well-lighted and well-ventilated area with at least 300 square feet of clean and sanitary contiguous space and shall be suitably equipped for compounding prescriptions, storage of drugs and sale of drugs and to otherwise conduct the practice of pharmacy. The space occupied shall be equipped with a sink with hot and cold water or facilities for heating water, proper sewage outlet, refrigeration storage equipment, and such fixtures, facilities, drugs, equipment and material, which shall include the current editions of the United States Pharmacopoeia/DI, Facts and Comparisons, or any other current compendium approved by the Department, and other such reference works, as will enable a pharmacist to practice pharmacy, including this Act and the rules promulgated under this Act. Such pharmacy shall have the following items: accurate weights of 0.5 gr. to 4 oz. and 20 mg to 100 Gm; and a prescription balance equipped with balance indicator and with mechanical means of arresting the oscillations of the mechanism and which balance shall be sensitive to 0.5 grain (32 mg) or less or an alternative weighing device as approved by the Department, and such other measuring devices as may be necessary for the conduct of the practice of pharmacy.

The provisions of this Section with regard to 300 square feet of space shall apply to any pharmacy which is opened after the effective date of this Act. Nothing shall require a pharmacy in existence on the effective date of this Act which is comprised of less than 300 square feet to provide additional space to meet these requirements.

Any structural and equipment requirements for a Division VI pharmacy shall be set by rule.

(Source: P.A. 92-880, eff. 1-1-04.)

(225 ILCS 85/15) (from Ch. 111, par. 4135)

(Section scheduled to be repealed on January 1, 2008)

Sec. 15. Pharmacy requirements. It shall be unlawful for the owner of any pharmacy, as defined in this Act, to operate or conduct the same, or to allow the same to be operated or conducted, unless:

(a) It has a licensed pharmacist, authorized to practice pharmacy in this State under the provisions of this Act, on duty whenever the practice of pharmacy is conducted;

(b) Security provisions for all drugs and devices, as determined by rule of the Department, are provided during the absence from the licensed pharmacy of all licensed pharmacists. Maintenance of security provisions is the responsibility of the licensed registered pharmacist in charge; and

(c) The pharmacy is licensed under this Act to do business.

The Department shall, by rule, provide requirements for each division of pharmacy license and shall, as well provide guidelines for the designation of a registered pharmacist in charge for each division.

Division I. Retail Licenses for pharmacies which are open to, or offer pharmacy services to, the general public.

Division II. Licenses for pharmacies whose primary pharmacy service is provided to patients or residents of facilities licensed under the Nursing Home Care Act or the Hospital Licensing Act, or "An Act in relation to the founding and operation of the University of Illinois Hospital and the conduct of University of Illinois health care programs", approved July 3, 1931, as amended, and which are not located in the facilities they serve.

Division III. Licenses for pharmacies which are located in a facility licensed under the Nursing Home Care Act or the Hospital Licensing Act, or "An Act in relation to the founding and operation of the University of Illinois Hospital and the conduct of University of Illinois health care programs", approved July 3, 1931, as amended, or a facility which is operated by the Department of Human Services (as successor to the Department of Mental Health and Developmental Disabilities) or the Department of Corrections, and which provide pharmacy services to residents or patients of the facility, as well as employees, prescribers and students of the facility.

Division IV. Licenses for pharmacies which provide or offer for sale radioactive materials.

Division V. Licenses for pharmacies which hold licenses in Division II or Division III which also provide pharmacy services to the general public, or pharmacies which are located in or whose primary pharmacy service is to ambulatory care facilities or schools of veterinary medicine or other such institution or facility.

Division VI. Licenses for pharmacies that provide pharmacy services to patients of institutions serviced by pharmacies with a Division II or Division III license, without using their own supply of drugs. Division VI pharmacies may provide pharmacy services only in cooperation with an institution's pharmacy or pharmacy provider. Nothing in this paragraph shall constitute a change to the practice of pharmacy as defined in Section 3 of this Act. Nothing in this amendatory Act of the 94th General Assembly shall in any way alter the definition or operation of any other division of pharmacy as provided in this Act.

The Director may waive the requirement for a pharmacist to be on duty at all times for State facilities not treating human ailments.

It shall be unlawful for any person, who is not a licensed pharmacy or health care facility, to purport to be such or to use in name, title, or sign designating, or in connection with that place of business, any of the words: "pharmacy", "pharmacist", "pharmacy department", "apothecary", "druggist", "drug", "drugs", "medicines", "medicine store", "drug sundries", "prescriptions filled", or any list of words indicating that drugs are compounded or sold to the lay public, or prescriptions are dispensed therein. Each day during which, or a part which, such representation is made or appears or such a sign is allowed to remain upon or in such a place of business shall constitute a separate offense under this Act.

The holder of any license or certificate of registration shall conspicuously display it in the pharmacy in which he is engaged in the practice of pharmacy. The registered pharmacist in charge shall conspicuously display his name in such pharmacy. The pharmacy license shall also be conspicuously displayed.

(Source: P.A. 92-880, eff. 1-1-04.)

(225 ILCS 85/18) (from Ch. 111, par. 4138)

(Section scheduled to be repealed on January 1, 2008)

Sec. 18. Record retention.

(a) Except as provided in subsection (b), there There shall be kept in every drugstore or pharmacy a suitable book, file, or electronic record keeping system in which shall be preserved for a period of not less than 5 years the original of every written prescription and the original transcript or copy of every verbal prescription filled, compounded, or dispensed, in such pharmacy; and such book or file of prescriptions shall at all reasonable times be open to inspection to the pharmacy coordinator and the duly authorized agents or employees of the Department.

Every prescription filled or refilled shall contain the unique identifier of the person authorized to practice pharmacy under the provision of this Act who fills or refills the prescription.

Records kept pursuant to this Section may be maintained in an alternative data retention system, such as a direct digital imaging system, provided that:

(1) the records maintained in the alternative data retention system contain all of the information required in a manual record;

(2) the data processing system is capable of producing a hard copy of the electronic record on the request of the Board, its representative, or other authorized local, State, or federal law enforcement or regulatory agency; and

(3) the digital images are recorded and stored only by means of a technology that does not allow subsequent revision or replacement of the images.

As used in this Section, "digital imaging system" means a system, including people, machines, methods of organization, and procedures, that provides input, storage, processing, communications, output, and control functions for digitized representations of original prescription records.

Inpatient drug orders may be maintained within an institution in a manner approved by the Department.

(b) The record retention requirements for a Division VI pharmacy shall be set by rule.

(Source: P.A. 92-880, eff. 1-1-04.)

Section 99. Effective date. This Act takes effect upon becoming law.