3.04.00  COLORADO CANCER DRUG REPOSITORY PROGRAM.

3.04.10  A prescription drug outlet may accept donations of non-controlled cancer drugs and medical devices from cancer patients or the cancer patient’s family, provided the drugs or devices meet the following requirements:

a.  The drug is in the original, unopened, sealed, and tamper-evident unit-dose packaging, or if in a single unit dose package, the single unit dose package is unopened;

b.  The drug is not expired;

c.  The drug is not adulterated or misbranded as determined by the pharmacist; 

d.  The drug does not require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature; and

e.  The drug does not require patient registration with the drug manufacturer prior to dispensing.

3.04.20  The drugs and devices shall be stored in the compounding/dispensing area under manufacturer’s recommended storage conditions.  The drugs and devices shall be stored separately from the other drug stock.

3.04.30  Dispensing/distribution of repository drugs/devices.

3.04.31  The prescription drug outlet may distribute the donated drugs or devices to the following:

a.  A medical clinic, which is defined as a community health clinic required to be licensed or certified by the Colorado Department of Public Heath and Environment.  Such clinic must be registered with the board as an other outlet; or

b.  A registered prescription drug outlet.

3.04.32  The prescription drug outlet may dispense the drugs to eligible patients based on a valid order from a practitioner.  An eligible patient is defined as an uninsured or underinsured cancer patient who meets the eligibility criteria established in rule by the State Board of Health.  The pharmacy may only charge a handling fee for such dispensing.  This fee shall be determined by the State Board of Health.

3.04.40  Recordkeeping.

3.04.41  The prescription drug outlet shall retain separate records detailing the receipt and distribution/dispensing of repository drugs and devices.

3.04.42  Records of receipt shall include at least the following:

a.  Name and address of person donating the drug or device;

b.  Drug name and strength;

c.  Manufacturer of drug or device;

d.  Manufacturer’s lot number;

e.  Drug expiration date;

f.  Date received; and

g.  Quantity received.

3.04.43  Records or distribution shall include at least the following:

a.  Name and address of medical clinic or prescription drug outlet;

b.  Drug or device name;

c.  Drug strength;

d.  Dosage form, if appropriate;

e.  Quantity distributed;

f.  Identity of manufacturer of drug or device;

g.  Manufacturer’s lot number;

h.  Drug expiration date; 

i.  Date of distribution; and

j.  Name and address of distributing pharmacy.

3.04.44  Records of dispensing shall include at least the following;

a.  Patient name;

b.  Prescription number;

c.  Drug or device name and drug strength;

d.  Quantity dispensed;

e.  Practitioner’s name;

f.  Date dispensed;

g.  Identity of drug or device manufacturer; and

h.  Drug or device lot number.