Chapter 2 (UMPJE) - FDCA, adulterated, recalls, books, etc

What is the FDCA?

• Food Drug and Cosmetic Act of 1938

• Authorizes the FDA to oversee the safety, manufacturing, & labeling of foods, drugs, medical devices, and cosmetics.

• It requires pre-market safety testing for drugs and prohibits false therapeutic claims

What is the Durham Humphrey Amendement of 1951?

• Defined boundry between prescription and OTC

• Required drug labels to have "RX only"

• Authorized verbal & prescription refills

What is the Kefauver Harris Amendment of 1962?

• Thalidomide tragedy & birth defects

• Increased safety requirements and established GMPs for drug manufacturing

What is the Prescription Drug Marketing Act (PDMA) of 1987?

• Ensure that prescription drugs are safe and effective, and to prevent the introduction of counterfeit, adulterated, or expired drugs into the supply chain

• Drug samples

Who can possess prescription drug samples? (3)

• Practitioners/prescribers

• Institutional pharmacies affiliated with a healthcare entity

• Community pharmacy only if affiliated with a healthcare entity (OP pharmacy at UCMC)

Who CANNOT have drug samples?

Regular retail/community pharmacy

T/F: Starter packs are equivalent to samples

FALSE - community pharmacies can have starter packs but cannot have samples

What is the only state that has been approved to allow drug importation from Canada?

Florida

What is the DQSA?

• Drug Quality and Security Act of 2013

• Title 1: the compounding quality act establishing oversight over compounding pharmacies (503A vs 503B)

• Title 2: DSCSA with the track and trace electronic system for RX monitoring

503A FACILITIES

• Traditional compounding (IV's at work)

• Must be compounded for A specific patient

Think A for A patient

503B FACILITIES

• Outsourcing facility

• Large scale compounding where they can make bulk medications without a prescription

• Regulated by FDA, required cGMP

Think B for Bulk

If the state does NOT have a MOU with the FDA, a 503A pharmacy cannot distribute >__% of compounded prescriptions interstate

>5%

So no more than 5% can leave the state

- MOU: memorandum of understanding

What is DSCSA?

Drug Supply Chain Security Act

• Provides for a uniform national framework for an electronic track and trace system for RX drugs as they move throughout the supply chain and set national standards for states to license drug wholesale distributors

_______ --> _______ --> pharmacy --> patient

Manufacturer

Wholesaler

Pharmacy

Patient

What are the 3 T's of Transaction Data?

• Transaction Information: drug name, strength, NDC, container size, number of containers, name & address of purchaser & seller

• Transaction History: a documented record of the chain of ownership back to the manufacturer

• Transaction Statement: basically a signed promise saying we followed DSCSA rules

HIS

With the new enhanced DSCSA system, what is not necessarily needed?

A. Transaction Information

B. Transaction History

C. Transaction Statement

B. Transaction History

idk if they will ask this, i think the DSCSA 2026 is like new

Transaction data must be maintained for ____ years by each supply chain partner!!

6

If the FDA requests transaction information from a pharmacy during an investigation, the pharmacy must provide it within ____ hours

48 hours

Pharmacies may only receive drugs with product identifiers. What are the 3 elements?

• NDC + unique alpha serial #

• Lot #

• Expiration date

During a suspect product investigation the pharmD must verify the product identifier of at least ......

3 packages or 10% of the quantity (whichever is greater)

You think something is wrong

A. Suspect

B. Illegitimate

A. Suspect

You have proof something is wrong

A. Suspect

B. Illegitimate

B. Illegitimate

What must you do if a product is illegitimate??

• Must notify FDA with form 3911

• Notify trading partners within 24 hours

FDA FORM 3911

• Drug notification form used by industry trading partners to notify FDA of illegitamate prescription drugs under the DSCSA within 24 hours

Authorized trading partners including pharmacies, must respond to a verification request from the FDA within ____ hours

24

FDA says prove that this lipitor bottle is legit

What are the exceptions to having a distribution license and passing transaction data (4)

• Internal distribution (between 2 entities that are affiliated or under common ownership)

• Providing product to another dispenser on a patient-specific basis

• Distributing under a medical response

• Distributing "minimal quantities" to a licensed practitioner for office use

DSCSA requires that all records related to the investigation of a suspect product must be maintained for ___ years

6

Transaction data (TI/TS) must be provided to the pharmacy in what format?

A. Paper invoices included in the tote

B. PDF files sent by email

C. Electronic, interoperable format at the package level

D. Verbal confirmation over the phone

C. Electronic, interoperable format at the package level

What is the DSCSA definition of a prescription drug product? What is exempt?

Drugs for human use in finished dosage form

EXEMPT:

- Blood

- Radioactive/imaging

- Certain IV products for fluid replacement

- Dialysis solutions

- Medical gases (oxygen)

- Compounded drugs

- Sterile water

A small dispenser is defined as ≤ ____ full time pharmacists/techs employed and is exempt from full electronic interoperaple tracing requirements

≤25

Adulterated vs. Misbranded

• Adulterated = the drug itself is bad (contaminated, expired, poor storage, etc)

• Misbranded = the labeling/info is wrong or misleading

Failure to provide a PPI for oral contraceptives

A. Adulterated

B. Misbranded

C. Both

B. Misbranded

Pills counted with residue from another drug

A. Adulterated

B. Misbranded

C. Both

A. Adulterated

Dispensed without a valid prescription

A. Adulterated

B. Misbranded

C. Both

B. Misbranded

Wrong strength

A. Adulterated

B. Misbranded

C. Both

C. Both

No child resistant container when required

A. Adulterated

B. Misbranded

C. Both

B. Misbranded

Drug approval process pathway (6) **

Animal Studies

IND

Clinical trials (phases 1-3)

NDA

FDA approval/marketing

Post marketing (phase 4)

Phases of clinical trials (4)

• PHASE 1: healthy volunteers, is it safe??

• PHASE 2: pts with condition/disease, does it work??

• PHASE 3: can it work with lots of people

• PHASE 4: long term safety, problems found after millions use it

Permission to study in humans

A. IND

B. IRB

C. NDA

D. ANDA

A. IND

Approval to market

A. IND

B. IRB

C. NDA

D. ANDA

C. NDA

Generic approval

A. IND

B. IRB

C. NDA

D. ANDA

D. ANDA

What is ANDA?

• Abbreviated New Drug Application

• Provides review & ultimate approval of a generic drug product

• Must be BIOEQUIVALENT (performs in same manner as the innovator)

OTC products must be tamper evident! What are the 4 exceptions to this ***

• Dermatologics

• Dentifrices (toothpaste)

• Insulin

• Lozenges

CLASS I-III RECALL

What drugs must patient package insert (PPI) be required?

• Oral contraceptives

• Estrogen containing products

FOR ALL NEW & REFILL

For institutional patients taking OC, how often do they need to get a PPI? (2)

• Prior to first administration

• Every 30 days thereafter

When are medguides required? (3)

• Patient labeling could prevent serious AE

• Product has serious risks

• Patient adherence to directions is cruical

Ex: anticoags, ADHD, benzos, HIV, etc.

What is medwatch?

Voluntary reporting system for health care professionals and consumers to report AE

FDA ORANGE BOOK

• Approved drug products with therapeutic equivalence evaluations

• A = Pharmaceutically equivalent and therapeutically equivalent

• B = NOT pharmaceutically equivalent and therapeutically equivalent

Pharmaceutically equivalent vs. therapeutically equivalent

• Pharm equiv: drug looks the same on paper with same API, strength, dose, etc but we dont know if it behaves the same in the body

• Thera equiv: means they are pharm equiv and work the same clinically, therefore bioequivalence is proven

FDA PURPLE BOOK

Lists of licensed biological products that are considered biosimilar and provide interchangeability

What does biosimilar mean?

The biological product is highly similar to the reference product

• Biosimilar does not mean automatic substitution like interchangeables do

T/F: Interchangeable biosimilars can have automatic substitution allowed

True

CLASS I-III MEDICAL DEVICE

• CLASS I: deemed to be low risk and therefore subject to the least regulatory controls

-- Ex: dental floss

• CLASS II: higher risks and require greater regulatory controls

-- Ex: syringes

• CLASS III: subject to the highest level of regulatory control, and those that pose a significant risk of illness or injury require premarket approve by FDA

-- Ex: replacement heart valves

Dental floss

A. Class I medical device

B. Class II medical device

C. Class III medical device

A. Class I medical device

syringes

A. Class I medical device

B. Class II medical device

C. Class III medical device

B. Class II medical device

Replacement heart valve

A. Class I medical device

B. Class II medical device

C. Class III medical device

C. Class III medical device

Do OTC products have an NDC number?

NO - this would be considered misbranded

Breakdown the components of an NDC

• First 4-5 digits is the labeler code

• Next 3-4 digits is the specific drug, strength, dosage

• Last 1-2 digits is the package size

Unique 10-11 digits that identifies a drug

iPLEDGE REMS max ___ day supply

30

What is PPPA?

• Posion Prevention Packaging Act of 1970

• Required child resistant containers for all RX's and some OTC drugs

What are some OTC drugs must have child resistant containers per PPPA?

• Aspirin

• Iron

• Methanol

• APAP, IBU, naproxen

• Lidocaine

• Benadryl

ETC.......

Who can request to not have child resistant pill bottles?

Patient or prescriber

CMS requires LTC patients medications to be reviewed every ___ days

30