Question 1

In what year did the FDA take over biologics regulation?

Accepted Answer

C

Question 2

Which of the following would constitute short supply and an exemption from licensure?

Accepted Answer

Recovered plasma used in the manufacturing of factor VIII is considered short supply and exempt from licensure. This is because there is a high demand for factor VIII, which is used to treat hemophilia, and recovered plasma is one of the few sources for its production. The other options (A, B, and D) are not considered short supply and would require licensure.

Question 3

What is the primary focus of quality assurance?

Accepted Answer

The primary focus of quality assurance is to ensure that processes, systems, procedures, and standard operating procedures are effective and efficient. Therefore, if any of these components are deemed faulty, the primary focus of quality assurance is to amend them. Option A is incorrect because blaming employees for recurring errors does not fix the underlying problem, which lies in faulty processes, procedures, or systems. Option C is incorrect because post-market stability analysis is done during post-market surveillance and not part of quality assurance. Option D is incorrect because job descriptions are not within the scope of quality assurance.

Question 4

Biological products are defined as any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component (or derivative allergenic products), or analogous product applicable to the prevention, treatment, or cure of disease or injuries of man. Which specific product was missing in the original PHS statute?

Accepted Answer

All options listed in the question are included in the original PHS statute except for blood component or derivative allergenic products. Therefore, the missing product is B) Blood component.

Question 5

What is the function of the CBER?

Accepted Answer

The CBER (Center for Biologics Evaluation and Research) is a division of the FDA that is responsible for regulating biological products, such as vaccines, blood and blood products, and cellular and gene therapies. One of its main functions is to issue federal licenses to establishments that are manufacturing these products. Choices A and C are not accurate descriptions of the CBER's function.

Question 6

According to federal law, what organization must be contacted when a biological deviation occurs in a blood bank and the error has the potential to affect the safety of the product or patient?

Accepted Answer

The Center for Biologics Evaluation and Research (CBER) is the FDA organization responsible for regulating biological products, including blood and blood components. They must be notified when a biological deviation occurs in a blood bank that has the potential to affect the safety of the product or patient. The Joint Commission (A), AABB (B), and CAP (C) are organizations responsible for accrediting healthcare facilities and do not have regulatory authority over blood banks.

Question 7

What is contained in Form FDA-483?

Accepted Answer

Form FDA-483 contains objectionable conditions noted by an FDA inspector during an inspection of a facility.

Question 8

FDA proposed regulations are published in ________.

Accepted Answer

FDA proposed regulations are published in The Federal Register, which is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations, including the FDA.

Question 9

Why is the Center for Biologics Evaluation and Research (CBER) notified in the case of a transfusion-related fatality?

Accepted Answer

The CBER is notified in the case of a transfusion-related fatality to determine if appropriate corrective action has been taken to prevent recurrence. This allows for an investigation and potential improvements to the system to prevent future incidents. Recalling all banked units or disclosing the name of the deceased are not necessary for this purpose. Reporting all reagent lot numbers used in typing deceased patients may be helpful but is not the primary reason for notifying the CBER.

Question 10

Which of the following prevents interstate shipment of biological products by an establishment?

Accepted Answer

FDA suspension prevents interstate shipment of biological products by an establishment. A warning letter and form 483 are not as severe as a suspension and may not prevent interstate shipment. Short supply is unrelated to preventing interstate shipment.

Question 11

One change that occurred under the FDA for oversight of biologics was that the FD&C Act now labeled biologics as:

Accepted Answer

The FD&C Act now labeled biologics as drugs, which means that they are subject to regulation and oversight by the FDA, just like traditional pharmaceutical drugs. This change in classification allowed for more specific regulations to ensure the safety and efficacy of biologics, as they are complex and can sometimes be more difficult to manufacture and test than traditional drugs.

Question 12

Which of the following provides just cause for a product recall by the FDA?

Accepted Answer

Mislabeling blood products can lead to serious adverse reactions, including fatal ones, if patients receive blood of the wrong type. This constitutes a significant risk to patient safety, warranting a recall.

Question 13

Which part of quality assurance ensures that products are consistently manufactured according to, and controlled by, the quality standards appropriate for their intended use?

Accepted Answer

Good Manufacturing Practices (GMP) are a set of guidelines that ensure products are consistently produced and controlled according to quality standards. They are designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Question 14

The FDA-directed civil action that calls for removal of products from distribution channels is known as:

Accepted Answer

The FDA-directed civil action that calls for removal of products from distribution channels is known as seizure. An injunction is a court order to stop a certain action, prosecution refers to bringing criminal charges against someone, and quarantine is a period of isolation to prevent the spread of disease.

Question 15

The law that began and mandated regulation of biological products in the United States was called:

Accepted Answer

The Biologics Control Act of 1902 was the first law that began regulating biological products in the United States. It established licensing and inspection requirements for manufacturers of biological products, including vaccines and serums. The other options listed do not pertain to the regulation of biological products.

Question 16

Establishments that hold U.S. licenses for a biological product can:

Accepted Answer

Establishments that hold U.S. licenses for a biological product can ship products both interstate and internationally for sale or exchange. They can also market multiple trademarks for their product. Therefore, option D is also correct, but A is the best choice as it directly answers the question without any ambiguity.

Question 17

What protocol is followed for licensed products generated at a different site from the original licensed site or establishment?

Accepted Answer

An amendment is filed to the product license application to update the site information for the licensed product. This is necessary to ensure that the product is being manufactured, tested, and stored in compliance with the good manufacturing practices (GMP) filed in the original application. A separate product license is not required, but the amendment should be filed in a timely manner to avoid any regulatory or legal actions.

Question 18

All of the following is correct regarding recovered plasma except:

Accepted Answer

Recovered plasma is a licensed source material used in the manufacturing of licensed products. It is derived from single units of unexpired whole blood, not expired whole blood.

Question 19

In 1970, the Public Health Service Act was expanded to include:

Accepted Answer

The Public Health Service Act was expanded to include blood and blood components and derivatives in 1970. This was an important step in regulating the safety and quality of blood products in the United States.

Question 20

The short supply agreement is between the blood establishment and:

Accepted Answer

The short supply agreement is a contract between the blood establishment and the final product manufacturer. It outlines the specific quantities and types of blood products that the manufacturer will receive from the blood establishment. The agreement is designed to ensure that the manufacturer has a reliable source of blood products to meet its production needs, even in the event of fluctuations in donor availability or other factors that may impact the blood supply. The broker and donor are not parties to this agreement.

Quiz 24: Transfusion Safety and Federal Regulatory Requirements