Ill. Admin. Code tit. 68, § 1330.500 - Community Pharmacy Services

a) Pharmacies that engage in general or specialty 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 this Section. A community pharmacy that, in addition to offering pharmacy services to the general public, provides institutional services shall also comply with Section 1330.520.

b) Staffing of the Pharmacy

1) Whenever the hours of the pharmacy differ from those of the establishment in which the pharmacy is located, the schedule during which pharmacy services are provided shall be conspicuously displayed.

2) Whenever a pharmacy is open and a pharmacist is not present and available to provide pharmacy services, a sign stating that situation shall be conspicuously displayed.

3) No prescription may be dispensed when a pharmacist is not physically present in the establishment.

c) Recordkeeping Requirements for Dispensing Prescription Drugs

1) For every prescription dispensed, the prescription record shall contain the name, initials or other unique identifier of the pharmacist who dispenses the prescription drugs. No prescription may be dispensed after 15 months from the date of the original issuance of the prescription by the prescriber.

2) Whenever a prescription is dispensed by a registered pharmacy technician or certified pharmacy technician under the supervision of a pharmacist, the prescription record shall contain the names, initials or other unique identifier of both the supervising pharmacist and the registered pharmacy technician or certified pharmacy technician who dispenses the prescription.

3) Refilling a Prescription

A) Each refilling of a prescription shall be entered on the prescription or on another appropriate, uniformly maintained, readily retrievable record that indicates, by the number of the prescription, the following information:

i) The name and dosage form of the drug;

ii) The date of each refilling;

iii) The quantity dispensed;

iv) The name or initials of the pharmacist and the pharmacy technician, if applicable, in each refilling; and

v) The total number of refills remaining for the prescription.

B) If the pharmacist does not otherwise indicate in a uniformly maintained record, the pharmacist shall be deemed to have dispensed a refill for the full face amount of the prescription.

4) Presentation of a written prescription copy or prescription label shall be for information purposes only and has no legal status as a valid prescription order. The recipient pharmacist of the copy or prescription label shall contact the prescribing practitioner to obtain a new prescription order.

5) Copies of prescriptions given to an ultimate consumer shall be marked "For Information Purposes Only".

6) Subject to Section 18 of the Act, any information required to be kept pursuant to that Section may be recorded and stored in a computerized pharmaceutical information system that meets the standards of performance stated in the regulations of the Drug Enforcement Administration ( 21 CFR 1306; 2014), except as provided in subsection (c)(7), and shall include the capability to:

A) Retrieve the original prescription order information for those prescription orders currently authorized for refilling;

B) Retrieve the current prescription orders, including, at a minimum, name of drug, date of refill, quantity dispensed, name and identification code of the manufacturer in the case of a generically written prescription or a generic interchange, name or initials of the dispensing pharmacist and technician for each refill, and the total number of refills dispensed to date;

C) Supply documentation of refill information entered by the pharmacist using the system through a hard copy printout of each day's refill data that has been verified for correctness. This printout must include for each prescription filled at least the following information:

i) The name and dosage form of the drug;

ii) The date of each refilling;

iii) The quantity dispensed;

iv) The name or initials of the pharmacist in each refilling and the pharmacy technician, if applicable;

v) The patient's name;

vi) The prescriber's name; and

vii) The prescription number for the prescription.

7) In lieu of the printout required by subsection (c)(6), the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in the dispensing shall sign a statement each day, attesting to the fact that the refill information entered into the computer that day has been reviewed and is correct as shown. The book or file must be maintained at the pharmacy employing the system for a period of 5 years after the date of dispensing the appropriately authorized refill.

8) All refill data shall be maintained by the pharmacy on the premises for 5 years, in accordance with Section 18 of the Act. The pharmacy shall have the appropriate equipment on the premises to provide readily retrievable information in the course of an on-site inspection. A hard copy printout shall be provided to the Division, upon request, within 48 hours.

d) Any drug that is dispensed pursuant to prescription, other than vaccinations administered in the pharmacy, shall have affixed to its container a label as provided in Section 22 of the Act.

e) No person shall establish or move to a new location any pharmacy unless the pharmacy is licensed with the Division and has on file with the Division a verified statement that:

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

2) The pharmacy will have in stock and will maintain sufficient prescription drugs and materials to protect the public it serves within 30 days after opening of the pharmacy.

f) Pharmacies have a duty to deliver lawfully prescribed drugs to patients and to distribute nonprescription drugs approved by the U.S. Food and Drug Administration for restricted distribution by pharmacies, or to substitute a generic drug as permitted in Section 25 of the Act in a timely manner, or to contact the prescriber to obtain authorization to dispense a different drug that produces a similar clinical effect in a timely manner, except for the following or substantially similar circumstances:

1) When, in the pharmacist's professional judgment, after screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions (including, but not limited to, serious interactions with nonprescription or over-the-counter drugs), drug-food interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, or clinical abuse or misuse, pursuant to Section 3(aa) of the Act, the pharmacist determines that the drug should not be dispensed due to one of the foregoing clinical reasons;

2) National or State emergencies or guidelines affecting availability, usage or supplies of drugs;

3) Lack of specialized equipment or expertise needed to safely produce, store or dispense drugs, such as certain drug compounding or storage for nuclear medicine;

4) Potentially fraudulent prescriptions;

5) Unavailability of drug; or

6) The drug is not typically carried in similar practice settings in the State.

g) Nothing in this Section requires pharmacies to dispense a drug without payment of their usual and customary or contracted charge.

h) All pharmacies shall be required to maintain the following current resource materials, either in hard copy or electronic format:

1) Copies of the Act and this Part;

2) Illinois Controlled Substances Act and 77 Ill. Adm. Code 3100;

3) Title 21 of the United States Code of Federal Regulations (Food and Drugs); and

4) Hypodermic Syringes and Needles Act [720 ILCS 635 ].

i) If the lawfully prescribed drug or nonprescription drug approved by the U.S. Food and Drug Administration for restricted distribution by pharmacies is not in stock or is otherwise unavailable, or the prescription cannot be filled pursuant to subsection (f)(1) or (f)(6), the pharmacy shall provide the patient or agent a timely alternative for appropriate therapy that, consistent with customary pharmacy practice, may include obtaining the drug. These alternatives include but are not limited to:

1) Contact the prescriber to address concerns such as those identified in subsection (f)(1);

2) If requested by the patient or the patient's agent, return unfilled lawful prescriptions to the patient or agent; or

3) If requested by the patient or the patient's agent, communicate or transmit, as permitted by law, the original prescription information to a pharmacy of the patient's choice that will fill the prescription in a timely manner.

j) Any mail order pharmacy that provides services in Illinois shall provide, during its regular hours of operation, but not less than 6 days per week for a minimum of 40 hours per week, a toll-free telephone service to facilitate communication between patients in this State and a pharmacist retained by the mail order pharmacy who has access to the patient's records. The toll free number must be disclosed on the label affixed to each container of drugs dispensed to residents of the State.

k) Engaging in or permitting any of the following shall constitute grounds for discipline or other enforcement actions:

1) Intentionally destroying unfilled lawful prescriptions;

2) Refusing to return unfilled lawful prescriptions;

3) Violating a patient's privacy;

4) Discriminating against patients or their agents in a manner prohibited by State or federal laws;

5) Intimidating or harassing a patient; or

6) Failing to comply with the requirements of this Section.

Notes

Ill. Admin. Code tit. 68, § 1330.500

Amended at 39 Ill. Reg. 6267, effective 4/23/2015 Amended at 47 Ill. Reg. 8352, effective 6/2/2023