MSL-BC Exam UPDATED QUESTIONS AND
CORRECT ANSWERS
PhRMA Code - CORRECT ANSWER 1. voluntary code
2. last revised 2021
3. Ensure industry interactions with HCPs are professional exchanges designed to benefit patients and
to enhance the practice of medicine
4. Based on the principle that a HCPs care of pts should be based solely on each pt's medical needs
and the HCP's medical knowledge and experience.
PhRMA's Goals - CORRECT ANSWER 1. Inform HCPs about risks/benefits of products for
appropriate pt use
2. Provide scientific and educational info
3. Support medical research and education
4. Obtain feedback and advice via consultation with medical experts
PhRMA Code Section 2: Meals - CORRECT ANSWER (a) modest as judged by local
standards; (b) not part of an entertainment or recreational event; (c) provided in a manner conducive
to informational communication.
**should also be limited to in-office or in-hospital settings, significant others/guests are not
appropriate.
Can't just Drop off food or give grab-and-go.
Dinner programs okay if location is conducive to education, not too fancy, meal is modest and
incidental to informational session
No meals directly provided at CME events - however 3rd party conferences/prof meetings where
CME is only part of the meeting- company can sponsor meal/reception
PhRMA Section 3: Entertainment & Recreation - CORRECT ANSWER Companies shouldn't
provide any entertainment or recreational items (i.e. tickets to the theater or sporting events, sporting
equipment, or leisure or vacation trips) to any HCP who is not a salaried employee of the company.
Shouldn't be offered regardless of (1) the value of the items; (2) whether the company engages the
HCP as a speaker or consultant; or (3) whether the entertainment or recreation is secondary to an
educational purpose.
,PhRMA Code Dont's - CORRECT ANSWER 1. no physical gifts - focus on education
2. no pens, mugs, product brochures, etc
3. occasionally items designed to help educate patients OR HCP if <$100 (medical book) or "starter
kits"
4. Products of non-educational use are not allowed (pedometers, etc)
Nothing that does not advance disease tx or edu, nothing of personal benefit (gas in car)
OIG - CORRECT ANSWER Office of Inspector General
OIG Compliance Program Guidance (CPG) for Pharmaceutical Manufacturers - CORRECT
ANSWER Compliance Program Guidance (CPG) was developed with goal of preventing and
reducing fraud and abuse in federal health care programs.
The purpose of the compliance program guidance is to encourage the use of internal controls to
efficiently monitor adherence to applicable statutes, regulations and program requirements
*set of guidelines only published in 2003
OIG Recommended Elements for Pharma CPG - CORRECT ANSWER • Implementing written
policies and procedures; - Code of Conduct
• Designating a compliance officer and compliance committee;
• Conducting effective training and education; • Developing effective lines of communication;
• Conducting internal monitoring and auditing;
• Enforcing standards through wellpublicized disciplinary guidelines; and
• Responding promptly to detected problems and undertaking corrective action.
*CPG = Compliance Program Guidance
FDA's mission - CORRECT ANSWER To Protect and promote public health. It is a consumer
protection agency AND a regulatory agency.
Assuring safety, efficacy, and security
Advancing public health
Speeding innovation
,Assuring accurate, science-based information
What does the FDA not do? - CORRECT ANSWER •Regulate physician or healthcare provider
practice
•Make recommendations for individuals (doctors, clinics, care facilities). Dictate the prices of
medications.
What does the FDA not regulate? - CORRECT ANSWER Advertising (except Rx-only drugs
and medical devices)
alcohol
Meat and poultry
herbal and dietary supplements
drugs of abuse
health insurance
grocery store water
What does the FDA regulate? - CORRECT ANSWER food (including infant formula), drugs,
cosmetics and since 2009: cigarettes
MedWatch - CORRECT ANSWER FDA's medical safety reporting program for medical
professionals and consumers
MedWatch Safety Alerts - CORRECT ANSWER The FDA publishes safety alerts for FDA-
regulated products: Rx and OTC medications, Biologics (aka blood), medical devices, combination
products (nasal spray), infant formulas, special nutrition products, cosmetics, food
FDA 3500 - CORRECT ANSWER Med Watch program reporting form for healthcare
professionals
FDA 3500b - CORRECT ANSWER MedWatch program reporting form for consumers
The Center for Devices and Radiological Health (CDRH) - CORRECT ANSWER The FDA
center responsible for for overseeing the medical device program. The FDA monitors reports of
, adverse events and other problems with medical devices and when needed, alerts patients, health care
providers, industry, and the public.
What is a medical device? - CORRECT ANSWER any instrument, apparatus, implement,
machine, IMPLANT, etc...that is intended for the use in diagnosis of disease or other conditions, or in
the cure, mitigation, treated, or prevention of disease
What is a "counterfeit medical device" - CORRECT ANSWER a fake medical device that is a
"copy cat" such as:
a container, package, or label that bears an unauthorized trademark, trade name, or other identifying
mark or imprint, or any likeness thereof.
Or a device that is manufactured using a design, of a device manufacturer, processor, packer, or
distributor other than the person or persons who in fact manufactured, processed, packed, or
distributed such device
Medical Device Classifications - CORRECT ANSWER Currently medical devices fall into one
of three medical device classifications: Class I, Class II, and Class III. Class I includes devices with
the lowest risk and Class III includes those with the greatest risk.
Regulatory control increases from Class I to Class III. The device classification regulation defines the
regulatory requirements for a general device type. Most Class I devices are exempt from Premarket
Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III
devices require Premarket Approval.
Combination products - CORRECT ANSWER Combination products are therapeutic and
diagnostic products that combine drugs, medical devices, and/or biological products. Based on
primary mode of action, a combination product is assigned to a "lead-center" that has primary
jurisdiction for its regulation
Medical Device - basic regulatory requirements - CORRECT ANSWER 1. Establishment
registration (manufacturer and distributors must register with FDA)
2. Medical Device Listing (manufacturers must list their devices with FDA)
3. Premarket Notification 510(k), unless exempt (most class 1 and II devices are exempt), or
Premarket Approval (PMA)
4. Investigational Device Exemption (IDE) for clinical studies
5. Quality System (QS) regulation (requirements for methods/facilities: designing, purchasing,
manufacturing, packaging, labeling, storing, installing and servicing)
CORRECT ANSWERS
PhRMA Code - CORRECT ANSWER 1. voluntary code
2. last revised 2021
3. Ensure industry interactions with HCPs are professional exchanges designed to benefit patients and
to enhance the practice of medicine
4. Based on the principle that a HCPs care of pts should be based solely on each pt's medical needs
and the HCP's medical knowledge and experience.
PhRMA's Goals - CORRECT ANSWER 1. Inform HCPs about risks/benefits of products for
appropriate pt use
2. Provide scientific and educational info
3. Support medical research and education
4. Obtain feedback and advice via consultation with medical experts
PhRMA Code Section 2: Meals - CORRECT ANSWER (a) modest as judged by local
standards; (b) not part of an entertainment or recreational event; (c) provided in a manner conducive
to informational communication.
**should also be limited to in-office or in-hospital settings, significant others/guests are not
appropriate.
Can't just Drop off food or give grab-and-go.
Dinner programs okay if location is conducive to education, not too fancy, meal is modest and
incidental to informational session
No meals directly provided at CME events - however 3rd party conferences/prof meetings where
CME is only part of the meeting- company can sponsor meal/reception
PhRMA Section 3: Entertainment & Recreation - CORRECT ANSWER Companies shouldn't
provide any entertainment or recreational items (i.e. tickets to the theater or sporting events, sporting
equipment, or leisure or vacation trips) to any HCP who is not a salaried employee of the company.
Shouldn't be offered regardless of (1) the value of the items; (2) whether the company engages the
HCP as a speaker or consultant; or (3) whether the entertainment or recreation is secondary to an
educational purpose.
,PhRMA Code Dont's - CORRECT ANSWER 1. no physical gifts - focus on education
2. no pens, mugs, product brochures, etc
3. occasionally items designed to help educate patients OR HCP if <$100 (medical book) or "starter
kits"
4. Products of non-educational use are not allowed (pedometers, etc)
Nothing that does not advance disease tx or edu, nothing of personal benefit (gas in car)
OIG - CORRECT ANSWER Office of Inspector General
OIG Compliance Program Guidance (CPG) for Pharmaceutical Manufacturers - CORRECT
ANSWER Compliance Program Guidance (CPG) was developed with goal of preventing and
reducing fraud and abuse in federal health care programs.
The purpose of the compliance program guidance is to encourage the use of internal controls to
efficiently monitor adherence to applicable statutes, regulations and program requirements
*set of guidelines only published in 2003
OIG Recommended Elements for Pharma CPG - CORRECT ANSWER • Implementing written
policies and procedures; - Code of Conduct
• Designating a compliance officer and compliance committee;
• Conducting effective training and education; • Developing effective lines of communication;
• Conducting internal monitoring and auditing;
• Enforcing standards through wellpublicized disciplinary guidelines; and
• Responding promptly to detected problems and undertaking corrective action.
*CPG = Compliance Program Guidance
FDA's mission - CORRECT ANSWER To Protect and promote public health. It is a consumer
protection agency AND a regulatory agency.
Assuring safety, efficacy, and security
Advancing public health
Speeding innovation
,Assuring accurate, science-based information
What does the FDA not do? - CORRECT ANSWER •Regulate physician or healthcare provider
practice
•Make recommendations for individuals (doctors, clinics, care facilities). Dictate the prices of
medications.
What does the FDA not regulate? - CORRECT ANSWER Advertising (except Rx-only drugs
and medical devices)
alcohol
Meat and poultry
herbal and dietary supplements
drugs of abuse
health insurance
grocery store water
What does the FDA regulate? - CORRECT ANSWER food (including infant formula), drugs,
cosmetics and since 2009: cigarettes
MedWatch - CORRECT ANSWER FDA's medical safety reporting program for medical
professionals and consumers
MedWatch Safety Alerts - CORRECT ANSWER The FDA publishes safety alerts for FDA-
regulated products: Rx and OTC medications, Biologics (aka blood), medical devices, combination
products (nasal spray), infant formulas, special nutrition products, cosmetics, food
FDA 3500 - CORRECT ANSWER Med Watch program reporting form for healthcare
professionals
FDA 3500b - CORRECT ANSWER MedWatch program reporting form for consumers
The Center for Devices and Radiological Health (CDRH) - CORRECT ANSWER The FDA
center responsible for for overseeing the medical device program. The FDA monitors reports of
, adverse events and other problems with medical devices and when needed, alerts patients, health care
providers, industry, and the public.
What is a medical device? - CORRECT ANSWER any instrument, apparatus, implement,
machine, IMPLANT, etc...that is intended for the use in diagnosis of disease or other conditions, or in
the cure, mitigation, treated, or prevention of disease
What is a "counterfeit medical device" - CORRECT ANSWER a fake medical device that is a
"copy cat" such as:
a container, package, or label that bears an unauthorized trademark, trade name, or other identifying
mark or imprint, or any likeness thereof.
Or a device that is manufactured using a design, of a device manufacturer, processor, packer, or
distributor other than the person or persons who in fact manufactured, processed, packed, or
distributed such device
Medical Device Classifications - CORRECT ANSWER Currently medical devices fall into one
of three medical device classifications: Class I, Class II, and Class III. Class I includes devices with
the lowest risk and Class III includes those with the greatest risk.
Regulatory control increases from Class I to Class III. The device classification regulation defines the
regulatory requirements for a general device type. Most Class I devices are exempt from Premarket
Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III
devices require Premarket Approval.
Combination products - CORRECT ANSWER Combination products are therapeutic and
diagnostic products that combine drugs, medical devices, and/or biological products. Based on
primary mode of action, a combination product is assigned to a "lead-center" that has primary
jurisdiction for its regulation
Medical Device - basic regulatory requirements - CORRECT ANSWER 1. Establishment
registration (manufacturer and distributors must register with FDA)
2. Medical Device Listing (manufacturers must list their devices with FDA)
3. Premarket Notification 510(k), unless exempt (most class 1 and II devices are exempt), or
Premarket Approval (PMA)
4. Investigational Device Exemption (IDE) for clinical studies
5. Quality System (QS) regulation (requirements for methods/facilities: designing, purchasing,
manufacturing, packaging, labeling, storing, installing and servicing)
