JP 7

under usp800: gloves must be changed in every ___ mins

30

NIOSH alert: the current version (2016) added ___ drugs to the list

34

If pharmacy located within a state that DOES NOT SIGN the MOU, distribution of compounded products in interstate commerce is restricted to not more than ___% of the total prescription orders dispensed/distributed in the pharmacy

5

If pharmacy is located within a state that SIGNS with the MOU, distribution of compounded products in interstate commerce MAY not exceed __ % of the total prescription orders dispensed/distributed by the pharmacy

50

Product tracing information: must be passed, received, and maintained for __years by each trading partner

6

Surface sampling (wipes) done initially and at least every __ months

6

Under the Prescription Drug Marketing Act it would be illegal for a hospital to resell prescription drugs that it purchases except: A. A pursuant to prescription B. To physicians in community practice on a regular basis C. To community pharmacies on a regular basis D. To drug wholesalers

A

What did the Drug Quality and Security Act of 2013 accomplish regarding the traditional compounding practice of community pharmacies pursuant to prescriptions? A. It reinstated the constitutional provisions of Section 503A enacted in 1997 by the FDAMA. B. It shifted enforcement authority from state pharmacy boards to the FDA. C. It established that pharmacy-compounded drugs are new drugs. D. It prohibits pharmacies from compounding in anticipation of prescriptions.

A

Which statement about the "beyond use date" on the label of a dispensed multiple-unit drug container by a pharmacy is correct? A. USP guidelines allow the earlier of the manufacturer's expiration date, or one year from the date of dispensing. B. FDA guidelines allow the earlier of the manufacturer's expiration date, or one year from the date of dispensing. C. All state laws mandate that the pharmacist must type the same date that is on the manufacturer's label. D. Most state laws do not mandate that an expiration or "beyond use" date be typed on the label.

A

A hospital has excess inventory of drug products. Local community pharmacies would like to purchase the excess inventory since they can buy the products for less from the hospital than from the wholesaler. The hospital: A. can sell inventory to the pharmacies, provided it charged the same amount as the wholesaler B. can sell inventory to the pharmacies for emergency reasons to alleviate a temporary shortage C. can sell inventory to the pharmacies without restriction D. cannot sell inventory to the pharmacies

B

FDA ensures the quality of drug products by carefully monitoring drug manufacturer's compliance with its ___ regulation

CGMP

Kefauver Harris amendment of 1962 transferred oversight of drug advertising from FTC to ___

FDA

MA distinction: MUST be inspected by ___ prior to distributing compounded drugs

FDA

MA distinction: outsourcing facilities: MUST register with ____

FDA

DQSA 2013: drug quality and security act: Amended which act with respect to human drug compounding and drug supply chain security?

Food, Drug and Cosmetic Act

Kefauver Harris amendment of 1962 established ___ requirement

GMP

FD&C act : 503B exemptions: list the two:

NDA, adequate directions for use labeling requirements

FD&C Act: 503A exemption: exemption from 3 provisions of the FD&C act: what are those?

NDA, cGMP requirements, adequate directions for using labeling requirement

_____: Special packaging of household products and drugs to protect children from serious injury or illness

PPPA 1970

____: prohibits the resale of a compounded drug labeled "not for resale", or the intentional falsification of a prescription for a compounded drug

Sec. 103

___: requires HHS to receive submission from state boards of pharmacy

Sec. 105

Compounding is performed by under the supervision of a licensed pharmacist pursuant to ___

USP

MA statues and regulations: Required adherence to all current chapters of ____

USP

____ is assigned by the pharmacy for a preparation that they compound. Determined by type of preparing, expiration date of ingredients and stability information of the compounded preparation

beyond use date

FDAMA 1997: created a special exemption to ensure continued availability of what types of drug?

compounded

____ is production of a drug preparation that meets the unique needs of an individual patient when a commercially available drug does not meet those needs.

compounding

Prescription drug marketing act: bans sale, trade and purchase of Rx ___ samples?

drug

____ established timeline for trading partners toward implementation of a track and trace system

drug supply chain security act

____ is identified by the product manufacturer. It is placed on the vial and in the package insert, and is dependent on the temperature and the appropriate storage of the unopened container

expiration date

T/F: ALL drugs need special packaging

false

T/F: Compound pharmacy can produced commercially available product

false

T/F: MA distinction: MAY receive patient specific prescription and have to in order to distribute

false

T/F: Prescription drug marketing act requires federal licensing of wholesalers

false

T/F: Provider can provide a "blanket" waiver for child resistant packaging

false

T/F: community pharmacies can receive drug samples

false

T/F: medical surveillance is REQUIRED

false

T/F: personnel training: antiseptic technique is a set of specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by pathogens

false

T/F: physicians are responsible to ensure packaging of required drugs is in child-resistant containers

false

T/F: surface sample is REQUIRED

false

T/F: the compounded drug product does not qualify for the exemption if the drug product is compounded

false

T/F: the compounding is not exempt from the provision of FD&C act under 503A

false

USP chapter 800 covers: ____

hazardous medication

___ required evidence of effectiveness for intended use (drug must be proven effective as well safe to be approved)

kefauver-harris amendment 1962

Prescription drug marketing act: Bans reimportation of Rx drugs EXCEPT by _____

manufacturer

____ is the production of FDA approved drug products pursuant to current CGMP

manufacturing

USP chapter 795 covers: ____

non-sterile compounding

_____ is responsible to ensure packaging of required drugs is in child resistant containers

pharmacist

What are the 3 things that the FDA consider insanitary conditions?: __,__ and __

staff related-aseptic practices, equipment and facilities, cleaning and disinfecting

USP chapter 797 covers: ____

sterile compounding

T/F: 503 exemptions if: pharmacy compounding of human drug products under section 503A of the federal food, drug and cosmetic act

true

T/F: Hospital patients are NOT required to receive child-resistant containers

true

T/F: K&H amendment of 1962 strengthened clinical trials by requiring informed consent of research subjects and adverse drug reaction reporting

true

T/F: Patient may provide a "blanket" waiver for child resistant packaging

true

T/F: USP compounding general principles: ONLY authorized personnel are allowed in the immediate vicinity of the drug compounding operations

true

T/F: in MA: if you are making morphine sulfate suppositories, diphenhydramine hydrochloride troches, you are subjected to a higher compounding inspections

true

T/F: outsourcing facilities are NOT exempt from CGMP requirements and will be inspected by FDA according to a risk based schedule

true

T/F: the prescriber's determination must be documented on the prescription

true

USP compounding general principles: T/F: ALL equipment used in compounding is CLENA, properly maintained and used appropriately

true

t/f: under usp800: all gloves must be tested to american socieity for testing and materials standard D6978

true