Section 1330.99  Parenteral Product Standards

 

a)         This Section sets forth standards for Divisions I, II, III, IV and V pharmacies whose practice includes the preparation, labeling and distribution of parenteral products pursuant to prescriptions or drug orders, as defined in the Act.  These activities may include, but are not limited to:

 

1)         Sterile preparation of parenteral therapy, parenteral nutrition; and

 

2)         Sterile preparations of cytotoxic or antineoplastic agents.

 

b)         Definitions

 

Barrier Isolation Chamber – an apparatus designed to provide a Class 100 environment for preparation of sterile products using solid walls rather than air movement (laminar air flow) to create a critical zone for product handling, a HEPA filtration system that conditions the air flowing through the unit to remove initial particles and particles generated within the controlled environment, and a means by which products are introduced and people interact with the product being prepared within the unit.

 

Biological Safety Cabinet – containment unit suitable for the preparation of low to moderate risk agents when there is a need for protection of the product, personnel and environment, according to National Sanitation Foundation (NSF) Standard 49.

 

Cytotoxic – a pharmaceutical that has the capability of killing living cells.  These agents shall include, but are not limited to, agents classified as cancer chemotherapeutic, carcinogenic, mutagenic and antineoplastic.

 

Laminar Airflow Hood – apparatus designed to provide a Class 100 environment for preparation of sterile products using air circulation in a defined direction that passes through a HEPA filter to remove the initial particles and particles generated within the controlled environment.

 

Parenteral – sterile preparations of drugs for injection through one or more layers of the skin.

 

Terminal – a patient whose medical condition indicates his/her life expectancy to be 6 months or less.

 

c)         Physical Requirements of Pharmacies Preparing Sterile Parenteral Products

 

1)         The pharmacy shall have a designated area for preparing sterile parenteral products.  The area shall be designed to minimize outside traffic and airflow disturbances from activity within the facility.  It shall be of sufficient size to accommodate a laminar airflow hood, barrier isolation chamber or biological safety cabinet and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation and security.  It shall be ventilated in a manner not interfering with the proper operation of the parenteral products preparation apparatus.

 

2)         The licensed pharmacy preparing sterile parenteral products shall have the following:

 

A)        Laminar airflow hood

 

i)          Laminar airflow equipment shall be certified annually in accordance with Federal Standard 209E (for horizontal laminar airflow equipment) or National Sanitation Foundation Standard 49 (for vertical laminar airflow equipment).

 

ii)         In the event the preparation apparatus is moved from its site of certification, recertification shall occur.

 

iii)         Prefilters must be replaced or cleaned monthly and documentation of this maintained;

 

B)        Sink with hot and cold running water, which is convenient to the compounding area;

 

C)        Environmental Protection Agency approved disposal containers for used needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapy agents and infectious wastes;

 

D)        Biohazard cabinetry for environment control when cytotoxic drug products are prepared;

 

E)         Refrigerator and/or freezer with a thermometer;

 

F)         Temperature controlled container for off site deliveries.

 

3)         The following current resource materials and texts shall be maintained in the pharmacy:

 

A)        United States Pharmacopoeia/National Formulary (USP/NF);

 

B)        American Hospital Formulary Service;

 

C)        Copies of the Illinois Pharmacy Practice Act and this Part, the Illinois Controlled Substances Act [720 ILCS 570] and Rules, 21 CFR and the Illinois Hypodermic Syringes and Needles Act [720 ILCS 635];

 

D)        One compatibility reference such as:

 

i)          Trissel's Handbook on Injectable Drugs;

 

ii)         King's Guide to Parenteral Admixtures; or

 

iii)         Any other Division approved publication;

 

E)         A file on extended (more than 24 hours) stability data given to finished products.

 

d)         Staffing.  A pharmacist shall be accessible at all times at each licensed facility to respond to patients' and health professionals' questions and needs.  A 24-hour telephone number will be included on all labeling of compounded medication and medication infusion devices if off site.

 

e)         Drug Distribution and Control

 

1)         Patient Profile or Medication Record System.  A pharmacy generated patient profile or medication record system must be separate from the prescription file.  The patient profile or medication record system shall contain, at a minimum:

 

A)        Patient's full name;

 

B)        Date of Birth or Age;

 

C)        Sex;

 

D)        Sterile products dispensed;

 

E)         Date dispensed, if off site;

 

F)         Drug content and quantity;

 

G)        Patient directions, if off site;

 

H)        Identifying number;

 

I)          Identification of dispensing pharmacist and, if applicable, pharmacy technician;

 

J)         Other drugs patient is receiving;

 

K)        Known drug sensitivities and allergies to drugs and foods;

 

L)         Diagnosis; and

 

M)       Lot numbers of components or individual medicine if product is not used within 48 hours of preparation.

 

2)         Labeling.  Each parenteral product dispensed to patients shall be labeled with the following information with a permanent label:

 

A)        Name, address and telephone number of the licensed pharmacy, if not within facility;

 

B)        Administration date and identifying number if used on site, date dispensed and identifying number if used off site;

 

C)        Patient's full name and room number, if applicable;

 

D)        Name of each drug, strength and amount;

 

E)         Directions for use and/or infusion rate if used off site;

 

F)         Prescriber's full last name if used off premises;

 

G)        Required controlled substances transfer warnings, when applicable;

 

H)        Expiration date and expiration hour;

 

I)          Identity of pharmacist compounding and dispensing, or other authorized individual; and

 

J)         Auxiliary labels, storage requirements if applicable.

 

3)         The pharmacist-in-charge shall ensure that records are maintained for 5 years and are readily retrievable and in a format that provides enforcement agents an accurate and comprehensive method of monitoring distribution via an audit trail.  The records shall include at least the following information:

 

A)        Patient profile;

 

B)        Medication Record System;

 

C)        Purchase records; and

 

D)        Lot numbers of the components used in compounding sterile prescriptions/orders traceable to a specific patient, if not included on patient profile and if the product is not utilized within 48 hours after preparation.

 

f)          Delivery Service.  The pharmacist-in-charge shall assure the environmental control of all products shipped or delivered off site.  Therefore, any compounded, sterile pharmaceutical must be shipped or delivered to a patient in temperature controlled (as defined by USP Standards) delivery containers.

 

g)         Cytotoxic Drugs.  The following additional requirements are necessary for those licensed pharmacies that prepare cytotoxic drugs:

 

1)         Safety and containment techniques for compounding cytotoxic drugs shall be used.

 

2)         Disposal of cytotoxic waste shall comply with all applicable local, State and federal requirements.

 

3)         Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside and shipped in a manner to minimize the risk of accidental rupture of the primary container.

 

4)         Must have as a reference Procedures for Handling Cytotoxic Drugs/American Society of Hospital Pharmacists (ASHP).

 

(Source:  Amended at 29 Ill. Reg. 13639, effective August 25, 2005)