(1) it consists in whole or in part of any filth, putrid, or decomposed substance

(2) it has been produced, prepared, packed, or held under insanitary conditions whereby it has been contaminated with filfth, or whereby it has been rendered injurious to health

(3) good manufacturing practices aren't applied

(4) it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health

(5) it is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal act

(6) it is a color additive, the intended use of which in or on drugs is for purpose of coloring only, and is unsafe within the meaning of the federal act.

A drug or device shall be deemed to be adultereated if it purports to be or is represented as a drug the name of which is recognized in an official cmpendium, and its strength differs from, or it quality or purity falls below, the standard set forth in such compendium.

A drug or device shall be deemed to be adultered if it is a drug or any substance has been (1) mixed or packed with it so as to reduce its quality or strength or (2) substituted wholly or in part for it.

Name conditions in which a drug may be deemed misbranded?

(1) if its package does not bear a label containing the name and place of business of the manufacturer, packet, or distributor.

(2) required information isn't conspicious and easly readable by the public

(3) If its labeling is false or misleading in any particular

(4) Controlled substance must have the following words on it: "Warning - May Be Habit Forming"

(5) If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling or advertising.

Temperature range for a refrigerator.

2 - 8 degrees C (36 - 46 degrees F)

What is the temperature range for a freezer?

-20 to -10 degrees C (-4 to 14 degrees F)

Temperature range for controlled room temperature

20 to 25 degrees C (68 - 77 degrees F)

Temperature range for warm?

30 to 40 degrees C (86 - 104 degrees F)

Temperature range for excessive heat

Any temperature above 40 degrees C (104 degrees F)

Temperature range for cool?

8 to 15 degrees C (46 - 59 degrees F)

Define unit dose container?

single-unit container for articles intended for administration by other than the parenteral route as a single dose, direct from the container.

Define unit dose package

container that contains a particular dose ordered for a patient

multiple drugs in unit dose packaging are dispensed in a single container, such as a medication drawer or bin, labeled only with partient name and location. Directions for administration are not provided by the pharmacy on the drug packaging or container but are obtained by the person administering directly from a prescriber's order or medication administration record.

Define well-closed container?

container that protects the contents from extraneous solids and from loss of the drugs under the ordinary or customary conditions of handling, shipment, storate, and distribution.

Define compliance packaging?

Packaging for dispense drugs which is comprised of a series of containers for solid oral dosage forms and which is designed to assist the user in administering or serlf-administering the drugs in accordance with directions for use.

Define Beyond-use date?

The date beyond which the integrity of a compounded, repackaged, or dispensed drug can no longer be assured and as such is deemed to be adulterated or misbranded.

Define expiration date?

The date placed on a drug package by the manufacturer or repacker beyond which the product may not be dispensed or used.

In general, once a drug leaves the pharmacy, it can not be returned and redispensed. What are the exceptions?

(1) In an hospital with and on-site hospital pharmacy

(2) In such cases where official compendium storage requirements are assured and the drugs are in manufacturers' original sealed containers or in seald individual dose or unit dose packaging that meets official compendium class A or B container requirements.

(3) When a dispensed drug has not been out of the possession of a delivery agent of the pharmacy

Drugs may be transfered between the nursing home or the hospital and the pharmacy for re-dispensing to indigent patients, either through hospitals, or through clinics organized in whole or in part for the delivery of health care services without charge, provided that?

(1) physical transfer must be accompanied by a person authorized to do so by the pharmacy

(2) written consent must be provided by the one transfering

(3) person's name, prescription number, and any other patient identifying information, shall be obliterated from the packaging prior to removal from the licensed nursing home or hospital

(4) drug name, strength, and expiration date or beyond-use date shall remain on the medication package label

(5) an inventory list of the drugs shall accompany the drugs being transfered that shall include, but not be limited to, the medication names, strengths, expiration dates, and quantities

(6) outdated drugs shall not be transfered and shall be destroyed in accordance with regulations adopted by the board.

The PIC at the pharmacy shall be responsible for determining the suitability of the product for re-dispensing. A re-dispensed prescription shall not be assigned an expiration date beyond the expiration date or beyond-use date on the label from the first dispensing and no product shall be re-dispensed more than one time.

Can devices be returned to pharmacies?

Devices may be accepted for return or exchange provided the deviceis in the manufacturer's original sealed packaging.

What is to appear on any repackaged or reconstituted units?

Drug Name

Strength (if any)

Assigned lot number or control number or manufacturer's or distributor's name and lot number

appropriate expiration determined by the pharmacist

How long must records be maintained for bulk reconstituted drugs?

period of one year or until the expiration dated, whichever is greater!

What is to be recorded regaring record keeping of bulk reconstitution injectables?

Name of the drug(s) used

Strength (if any)

Date repackaged

Quantity prepared

Initials of the pharmacist verifying the process

assigned lot or control number

Manufacturer's or distributor's name and lot or control number

Expiration date

What are the requirements for pharamcy's useing automated counting dvices or dispensers in which drugs are removed from manufacturer's orginal packaging and placed in bulk bins?

(1) bin filling record shall be maintained, manually or in a computerized record for a period of one year from the date of filling from which information can be readily retrieved, for each bin including:

a. the drug name and strength, if any

b. the name of the manufacturer or distributor

c. manufacturer's control or lot number(s) and expiration date for all lots placed into the bin at the time of filling

d. any assinged lot number

e. an expiration date determined according to USP guidelines for repackaging

f. the date of filling

g. the pharmacist's initials verigying the accuracy of the process

(2) if more than one lot is added to the bin at the same time, the lot which expires first shall be used to determine the expiration date if shorter than a calculated date based on USP guidelines

(3) Each bin shall be labeled in such a manner as to cross-reference the information on the filling record with the correct expiration dte

(4) If only one lot is added to a bin at one time, but a subsequent lot may be added before the first has cleared, the automated device shall be constructed to reasonably dispense the first lot before the second lot is dispensed, the expiration date on the bin's label shall reflect the expiration date assigned to the earlier lot, and the bin shall be allowed to "run dry" where all product is completely removed prior to filling at least once every 60 days with a record made of the run dry dates.

The owner of any stocks of drugs included in Schedules II through V obtained in compliance with this chapter, upon discontinuance of dealing in such drugs, may dispose of such stocks only on an offical written order as follows:

(1) pharmacy or practitioner or an agent or agents of a pharmacy or practitioner under specific written authorization from the owner of such pharmacy or such practitioner, may dispose of such stocks to a manufacturer or wholesaler holding a valid license to deal in such drugs, or to another pharmacy or practitioner

(2) A manufacturer or wholesaler may dispose of such stocks only to a manufacturer or wholesaler holding a valid permit to deal in such drugs

What are the procedures for a PIC who wishes to dispose of unwanted drugs?

(1) transfer the drugs to another person or entity authorized to posses or provide for proper disposal of such drugs

(2) destroy the drugs by burning in an incinerator, or other board-approved method, in compliance with all applicable local, state, and federal laws and regulations.

What are the procedures for PIC wishing to destroy schedule II - V drugs?

a. at least 14 days prior to the destructiond ate, the PIC shall provide a written notice to the board office; the notice shall state the following:

(1) Date, time, manner, and place of destruction

(2) The names of the pharmacists who will witness the destruction process

b. if the destruction date is to be changed or the destruction does not occur, a new notice shall be provided to the board office as set forth above in subdivision 2 of thie section

c. the actual destruction shall be witnessed by the PIC and another pharmacist not employed by the pharmacy

d. the DEA drug destruction from shall be fully completed and used as the record of all drugs to be destroyed. A copy of the destruction form shall be retained at the pharmacy with other inventory records.

Record keeping for disposed drugs?

Records of all drugs sold, administered, dispensed, or otherwise disposed of, shall show the date of selling, administering, or dispensing, the name and address of the person to whom or for whose use, or the owner and the species of animal for which the drugs were sold, administered or dispensed, and the kind and quantity of drugs.

Can drugs be returned to pharmacies in long-term care facilities?

Yes.

"Discontinued drugs may be returned to the pharmacy for resale or transfered to another pharmacy for redispensing to the indegent if authorized or disposed of by appropriate means.

Who must witness drug destruction at a long-term care facility?

Drug destruction at the pharmacy shall be witnessed by the PIC and by another pharmacy employee.

Drug destruction at the facility shall be witnessed by the director of nursing or, if there is no director, then by the facility administrator and by a pharmacist providing pharmacy services to the facility or by another employee authorized to administer medication.

Record keeping regarding drug destruction at a long-term care facility?

A complete and accurate record of the drugs returned or destroyed or both shall be made. The original of the record of destruction shall be signed and dated by the persons witnessing the destruction and maintained at the long-term care facility for a period of two years.

A copy of the destruction record shall be maintained at the provider pharmcy for a period of two years.

Long term care facilities shall destroy discontinued or unused drugs or return them to the pharmacy within ___ days of the date the drug was discontinued.