Section 1330.670  Compounded Sterile Preparation Standards

 

a)         This Section sets forth standards for pharmacies whose practice includes the preparation, labeling and distribution of compounded sterile preparations pursuant to prescriptions or medication orders, as defined in the Act.  These activities may include, but are not limited to:

 

1)         Sterile preparation of parenteral therapy and parenteral nutrition;

 

2)         Sterile preparations of cytotoxic or antineoplastic agents; and

 

3)         Other sterile preparations to be used topically or internally by humans or animals.

 

b)         Definitions

 

1)         "Barrier Isolation Chamber" means an apparatus designed to provide a Class 5, 6 or 7 environment, as spelled out in ISO (International Organization for Standardization) 14644-1, for  preparation of sterile preparations using solid walls rather than air movement (laminar air flow) to create a critical zone for preparation handling, a high efficiency particulate air (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 preparations are introduced and people interact with the preparation being prepared within the unit.

 

2)         "Biological Safety Cabinet" or "BSC" means a containment unit suitable for the preparation of low to moderate risk agents when there is a need for protection of the preparation, personnel and environment, according to ISO 14644-1.

 

3)         "Compounded Sterile Preparation" or "CSP" means a sterile pharmaceutical that has been prepared by a pharmacist, or under the supervision of a pharmacist. It shall be a preparation prepared for or in anticipation of a specific patient prescription or medication order issued by a prescribing practitioner.  The preparation may include commercially available dosage forms that may need to be altered by the pharmacist to meet a specific patient's need.

 

4)         "Cytotoxic" means 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.

 

5)         "Laminar Airflow Hood" means an apparatus designed to provide a Class 5, 6 or 7 environment, as spelled out in ISO 14644-1 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.

 

6)         "Parenteral" means sterile preparations of drugs for injection through one or more layers of the skin.

 

7)         "Terminal" means a patient whose medical condition indicates his or her life expectancy to be 6 months or less.

 

c)         Physical Requirements of Pharmacies Preparing Compounded Sterile Preparations

 

1)         The pharmacy shall have a designated area for preparing compounded sterile preparations.  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 (LAF), barrier isolation chamber or BSC 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 so as not to interfere with the equipment specified in this subsection (c)(1).

 

2)         The licensed pharmacy preparing compounded sterile preparations shall have the following:

 

A)        LAF workstation

 

i)          LAF shall be certified annually in accordance with ISO 14644-1;

 

ii)         In the event the preparation apparatus is moved from its site of certification, recertification shall occur prior to resumption of use for compounding sterile preparations;

 

iii)        Prefilters shall be inspected, replaced or cleaned per manufacturer specifications monthly and documentation of this maintained;

 

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

 

C)        National Institute for Occupational Safety and Health (NIOSH) approved disposal containers for used needles, syringes, etc., and, if applicable, cytotoxic waste from the preparation of chemotherapy agents;

 

D)        Biohazard cabinetry for environment control when cytotoxic compounded sterile preparations are prepared;

 

E)        Refrigerator and/or freezer with a thermometer or temperature recording device; and

 

F)         Temperature controlled containers for off site deliveries.

 

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

 

A)        American Hospital Formulary Service;

 

B)        Copies of the Act and this Part, the Illinois Controlled Substances Act and 77 Ill. Adm. Code 3100, 21 CFR and the Illinois Hypodermic Syringes and Needles Act [720 ILCS 635];

 

C)        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;

 

D)        A file or reference on extended (more than 24 hours) stability data given to finished preparations.

 

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 used off site.

 

e)         Drug Distribution and Control

 

1)         Patient Profile or Medication Record System.  A pharmacy generated patient profile or medication record system shall be maintained in addition to 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)        Gender;

 

D)        Compounded sterile preparations dispensed;

 

E)        Date dispensed, if off site;

 

F)         Drug content and quantity;

 

G)        Patient directions, if preparation being administered off site;

 

H)        Identifying number;

 

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

 

J)         Other drugs or supplements the patient is receiving, if provided by the patient or his or her agent;

 

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

 

L)        Diagnosis; and

 

M)       Lot numbers of components or individual medicine if the compounded sterile preparation is not used within 48 hours after preparation.

 

2)         Labeling.  Each compounded sterile preparation dispensed to patients shall be labeled with the following information, using a permanent label:

 

A)        Name, address and telephone number of the licensed pharmacy, if not used 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 name if used off site;

 

G)        Required controlled substances transfer warnings, when applicable;

 

H)        Beyond use date and time;

 

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 preparation is not utilized within 48 hours after preparation.

 

f)         Delivery Service.  The pharmacist-in-charge shall assure the environmental control of all preparations 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 or devices 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 shall 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)         The pharmacy must have as a reference Safe Handling of Hazardous Drugs Video Training Program and Workbook (American Society of Health-System Pharmacists (ASHP), 7272 Wisconsin Avenue, Bethesda MD 20814, (301)657-3000, http://www.ashp.org).

 

h)         Emergency Medications.  Pharmacies that dispense compounded sterile preparations to patients in facilities off site or in the patient's residence shall stock supplies and medications appropriate for treatment of allergic or other common adverse effects, to be dispensed upon the prescription or order of an authorized prescriber.