DEPARTMENT OF REGULATORY AGENCIES
State Board of Pharmacy
PHARMACY RULES AND REGULATIONS
3 CCR 719-1

[PUBLICATION INSTRUCTIONS: ********** INDICATE UNCHANGED RULE TEXT]

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3.04.10	A prescription drug outlet may accept donations of non-controlled cancer drugs and medical devices (prescription drugs and devices that are used to treat cancer or the side effects of cancer) from cancer patients or the cancer patient’s family, provided the drugs or devices meet the following requirements:
a.	The drug or device 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 or device is not expired;
c.	The drug or device is not adulterated or misbranded as determined by the pharmacist;
d.	The drug or device does not require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature; and
e.	The drug or device does not require patient registration with the drug manufacturer prior to dispensing.
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3.04.32	The prescription drug outlet may dispense the drugs or devices to eligible patients based on a valid order from a practitioner. The prescription drug outlet shall establish criteria for individuals to receive donated cancer drugs or devices. The pharmacy may only charge a handling fee for such dispensing. This fee shall be determined by the State Board of Health.
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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 or device name and strength;
c.	Manufacturer of drug or device;
d.	Manufacturer’s lot number;
e.	Drug or device expiration date, if Applicable;
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 or device expiration date, if applicable;
i.	Date of distribution; and
j.	Name and address of distributing pharmacy.
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