Section 1330.570  Outpatient Clinic Pharmacy Services

a)         Outpatient Clinic Pharmacies are defined as those pharmacies not located in or servicing patients of a facility licensed as defined in Section 1330.520(a), whether located in a health care facility or another location that provides outpatient treatment or care.

1)         An outpatient is an ambulatory patient who comes to an outpatient clinic to receive health care services related to the objectives of the outpatient clinic and departs within 24 hours.

2)         An outpatient drug order is defined as an order written by a medical practitioner engaged in the practice of that clinic and ordered for services received in that clinic in conjunction with health care services related to the objectives of that clinic.

b)         Contracting Services. Outpatient clinic pharmacies may contract with outpatient clinics to provide pharmacy services.  The contract must define the scope of pharmacy services to be provided and delineate the specific duties and responsibilities of each party.

c)         Investigational new drugs, authorized by the U.S. Food and Drug Administration, shall be dispensed pursuant to a valid drug order of the principal physician-investigator or the principal physician-investigator's authorized clinician.  All investigational drugs shall be stored in and dispensed from the pharmacy and shall be identified with the following information:

1)         Name of drug and strength (if applicable);

2)         Beyond use date;

3)         Reference code to identify source and lot number;

4)         A label indicating "For Investigational Use Only"; and

5)         Name and location of the patient.  Those institutions or facilities utilizing a unit-dose and medication cart system may identify the name of the patient and the patient's location on the outside of the bin of the medication cart, when those carts are filled by the pharmacy.

d)         The pharmacist-in-charge of the outpatient clinic pharmacy or their pharmacist designee may, in the best interest of the patients served, establish one or more lists of the kind and quantity of drugs to be kept in one or more automatic dispensing machines at all times within the outpatient clinic.  A copy of the list of items stored in automatic dispensing machines must be kept by the pharmacist-in-charge or his/her pharmacist designee.

e)         Staffing of the Pharmacy

1)         Each outpatient clinic pharmacy shall be directed by a pharmacist-in-charge, who is knowledgeable in and thoroughly familiar with the specialized functions of outpatient clinic pharmacy.

2)         The pharmacist-in-charge shall ensure that all staff shall be adequately trained.  The pharmacist-in-charge shall develop and implement written policies and procedures to specify the duties to be performed by each employee.

3)         All functions and activities of pharmacy technicians shall be personally and directly supervised by an adequate number of licensed pharmacists to ensure that all such functions and activities are performed competently.

4)         The pharmacist-in-charge shall meet the requirements of Section 1330.660 in addition to the following:

A)        The pharmacist-in-charge of an outpatient clinic pharmacy shall be assisted by a sufficient number of additional pharmacists and personnel, as may be required to operate the pharmacy competently, safely, and to meet the needs of the patients of the clinic facility.

B)        Establishment and supervision of the method and manner for storage, dispensing and safekeeping of pharmaceuticals in all areas of the outpatient clinic, including maintenance of security provisions to be used when the pharmacy is closed.

C)        The development and implementation of a procedure to be utilized in the event of a drug recall that can be readily activated to assure that all drugs included on the recall are returned to the pharmacy for proper disposition.

f)         Recordkeeping Requirements

1)         Every drug order filled shall contain the name, initials or other unique identifier of the pharmacist (and pharmacy technician if one is used) who fills or refills the drug order, or the name, initials or other unique identifier may be recorded on another appropriate, uniformly maintained and readily retrievable record that indicates, at least, the following information:

A)        The  name and dosage form of the drug;

B)        The date of filling or refilling; and

C)        The quantity dispensed.

2)         The pharmacist-in-charge shall maintain or have access to the following records for at least 5 years or as otherwise required by law:

A)        Records of drug orders;

B)        Records of packaging, bulk compounding or manufacturing; and

C)        Records of actions taken pursuant to drug recalls.

g)         Labeling Requirements

1)         All medication repackaged by the pharmacy for future use inside the institution or facility and not intended for immediate dispensing to a specific patient shall be identified as follows:

A)        Single dose or multi-dose drugs, except sterile solutions to which a drug has been added, shall be labeled with:

i)          Brand and/or generic name;

ii)         Strength (if applicable);

iii)        Beyond use date; and

iv)        Reference code to identify source and lot number.

B)        Sterile solutions to which drugs have been added shall contain on the outer label:

i)          Name, concentration and volume of the base sterile solution;

ii)         Name and strength of drugs added;

iii)        Beyond use date and time of the admixture; and

iv)        Reference code to identify source and lot number of drugs added.

2)         All medication prepared by the pharmacy for immediate dispensing to a specific patient or resident in the institution or facility shall be identified as follows:

A)        Single dose or multi-dose drugs, except parenteral solutions to which a drug has been added, shall be identified with:

i)          Brand and/or generic name; and

ii)         Strength (if applicable).

B)        Sterile solutions to which drugs have been added shall be identified with:

i)          Name, concentration and volume of the base sterile solution;

ii)         Name and strength of drugs added; and

iii)        Beyond use date and time of the admixture.

3)         All medication dispensed to a specific patient in the institution shall be dispensed in a container identified with the name of the patient and the patient's location.  Those outpatient clinics utilizing a unit-dose and medication cart system may identify the name of the patient and the patient's location on the outside of the bin of the medication cart, when those carts are filled by the pharmacy.

h)         Storage. Pharmacies licensed under this Part shall comply with Sections 1330.600, 1330.610, 1330.630, and 1330.680.

(Source:  Added at 50 Ill. Reg. 610, effective December 30, 2025)