Policy, Practice, and Regulation

Question 1

Who is responsible for issues that pertain to taxation and health programs under Social Security Act, including Medicare, Medicaid, and CHIP?

Answer 1

Finance Committee

Question 2

Who has jurisdiction over FDA, NIH, CDC?

Answer 2

HELP Committee

Question 3

Who has oversight over DHHS?

Answer 3

House of Reps committee Energy and Commerce

Question 4

Who determines discretionary spending that is used to fund FDA?

Answer 4

Congress

Question 5

What agencies are part of DHHS?

Answer 5

FDA, Medicare, Medicaid and Chip, EHR Meaningful use incentive program

Question 6

Who has jurisdiction over the DEA?

Answer 6

DOJ

Question 7

Who is in charge of the Management Standards for Hazardous Waste Pharmaceuticals?

Answer 7

EPA

Question 8

If a study involves an investigational drug or device who has to approve the study?

Answer 8

IRB

Question 9

What is HIE defined as?

Answer 9

process for exchanging health information by directed exchange, query-based exchange, or consumer-mediated exchange

Question 10

What is the HITECH Act

Answer 10

Created to coordinated nationwide standards to increase interoperability and security of health information systems and support their meaningful use

Question 11

What are some big changes that ACA made to pharmacy practice?

Answer 11

-improve ACO quality goals
-participate In Medicare Annual Wellness Visit.

Question 12

The Safe and Secure Drug Disposal Act of 2010- what pharmacies can participate in the transfer of unwanted controlled substances?

Answer 12

hospitals and clinics with on-site pharmacies, and retail pharmacies, including long-term care facilities and specialty pharmacies

Question 13

FDA Safety and Innovation Act of 2012

Answer 13

-Establishing the “breakthrough therapy” drug approval pathway
-Permanently incentivizes pediatric drug studies
-Requiring a drug manufacturer to report permanent discontinuation

Question 14

The Drug Quality and Security Act (DQSA) of 2013

Answer 14

-allow a compounding facility to voluntarily register as an outsourcing facility with the FDA
- provide transaction details when pharmaceutical products change ownership

Question 15

Is a medication compounded for identified individual patients done by a Traditional Compounder or Outsourcing Facilities?

Answer 15

Traditional compounder (outsourcing facilities can receive individual prescriptions)

Question 16

Are Traditional Compounder or Outsourcing Facilities required to have FDA approval before marketing?

Answer 16

both

Question 17

Are Traditional Compounder or Outsourcing Facilities required to follow track-and-trace requirmeents

Answer 17

traditional compounder