Laws, Regulations, and Guidelines
37%of exam
Inventory Management, Documentation, and Recordkeeping
35%of exam
DEA Controlled Substance RecordsInventory MethodsContracts & SourcingTurns FormulaPar LevelJust-in-Time
Types of Suppliers and Supply Chain Entities
28%of exam
Quick Facts
- Exam
- PTCB Supply Chain Certificate
- Credential Type
- Assessment-Based Certificate (ABC)
- Questions
- 75 multiple-choice
- Exam Time
- 1h20m (1h30m total)
- Passing Score
- Scaled 300 of 0-400
- Exam Fee
- $89
- Renewal
- Not required (no expiration)
- Retake Wait
- None; ABCs have no wait
- Eligibility
- Active CPhT + REP program
T3 Data Memory Line
TI+TS required; TH sunset 2023
TI: product dataTS: seller attestationTH: no longer requiredSince Nov 27 2023
Transaction Info vs Statement
Transaction Information (TI)
- Product, lot, dates
- Data about the sale
Transaction Statement (TS)
- Seller's attestation
- Authorized, not altered, not suspect
Data vs sworn statement
Suspect Product Response
- Signs of counterfeit or diversion→Quarantine + investigate(Suspect product)
- Investigation confirms illegitimate→Notify immediate trading partners(Required step)
- Confirmed illegitimate product→Notify FDA within 24h(Section 582)
- Investigation clears the product→Return to saleable stock(Keep investigation records)
- Grey-market pricing spotted→Treat as suspect signal(Red flag)
- Poor package integrity→Quarantine before dispensing(Red flag)
FDA & DEA Roles
- FDA
- Drug safety, efficacy, security
- DEA
- Controlled substance safety, security
- State Board
- Licenses pharmacies, techs, in-state
- FDA Registration
- Register within 5 days
- FDA Annual Renewal
- Oct 1 to Dec 31
- DECRS
- Searchable, updated each business day
- WD State License
- State (or FDA) license required
- DEA Registration
- Per location, not company-wide
- PDMA (1987)
- State wholesaler licensing law
- Pedigree
- Drug's distribution history record
EDDS Phase-In Order
2023 legal; 2025 big; 2027 small
2023: legal effect date2024: stabilization period ends2025: mfr, wholesaler, dispenser2027: small dispensers
Form 222 vs CSOS
Form 222
- Paper order form
- Schedule I-II only
CSOS
- Digital certificate order
- Schedule I-V, broader scope
Paper vs electronic scope
T3 Receiving Picker
- Accepting ownership of product→Require TI + TS first(At or before sale)
- Seller offers only history→TH alone is not enough(TH sunset 2023)
- Choosing transmission method→Electronic; GS1 EPCIS standard(Not fax/spreadsheet)
- Storing received T3 data→Retain records 6 years(Produce on request)
- Verifying product identifier→Check NDC + lot + serial(2D barcode)
DSCSA Basics
- DSCSA
- 2013 track-and-trace drug law
- Product
- Finished-dose Rx drug only
- Product Exclusions
- Blood, radioactive, gases, compounded
- Transaction
- Ownership change between parties
- Transaction Exclusions
- Intracompany, emergency, minimal office use
- Serialization
- NDC, serial, lot, expiry
- Trading Partner
- Manufacturer, repackager, wholesaler, dispenser, 3PL
Domain Weight Order
Laws 37 > Inventory 35 > Suppliers 28
Laws: biggest domainInventory: second biggestSuppliers: smallest domain37 + 35 + 28 = 100
Suspect vs Illegitimate Product
Suspect Product
- Reason to investigate
- Counterfeit, diverted, grey market
Illegitimate Product
- Confirmed unfit for distribution
- Notify partners + FDA 24h
Suspicion vs confirmed finding
T3 Data & Suspect Products
- TI
- Product + lot + dates
- TS
- Seller's authorization attestation
- TH
- Sunset requirement Nov 2023
- Receiving Rule
- Need TI+TS at transaction
- Exchange Method
- Electronic; GS1 EPCIS standard
- Retention
- Keep T3 data 6 years
- Suspect Signs
- Counterfeit, diverted, grey market, misbranded
- Illegitimate Step
- Notify partners + FDA 24h
Wholesale Distributor vs 3PL
Wholesale Distributor
- Takes title to drug
- Subject to 582 tracing
3PL
- Warehouses; no title transfer
- Excluded from 582 tracing
Ownership vs logistics only
DSCSA EDDS Timeline
- Legal Effect Date
- Nov 27, 2023
- Stabilization End
- FDA discretion ended Nov 2024
- Mfr/Repackager Exemption
- Ended May 27, 2025
- Wholesaler Exemption
- Ended Aug 27, 2025
- Large Dispenser Exemption
- Ended Nov 27, 2025
- Small Dispenser Exemption
- Extended to Nov 27, 2027
- Small Dispenser Size
- ≤25 FT pharmacists + technicians
Inventory Method Continuum
Want book -> Par -> JIT -> Perpetual
Want book: manual notePar: target stock levelJIT: order just beforePerpetual: real-time count
Controlled Substance Recordkeeping Picker
- Ordering Schedule I or II→Form 222 or CSOS(CSOS covers I-V)
- Theft or loss discovered→Notify DEA in 1 day(Then file Form 106)
- Filing the loss report→Electronic Form 106, 45 days(Paper form retired)
- Counting Schedule I or II→Exact count required(Biennial minimum)
- Counting Schedule III-V stock→Estimate unless over 1,000 tablets(Then exact count)
- Returning drugs for disposal→Send to reverse distributor(CII needs Form 222)
DEA Controlled Substance Records
- Form 222
- Paper order; Schedule I-II
- CSOS
- Electronic order, Schedule I-V
- CSOS Certs
- 21 CFR 1311 Subpart B
- Theft/Loss
- Notify DEA 1 business day
- Form 106
- File electronically, 45-day deadline
- Biennial Inventory
- New count every 2 years
- Exact vs Estimate
- Schedule I-II exact; III-V estimate
- Estimate Exception
- Exact if over 1,000 tablets/capsules
- Five Percent Rule
- Transfers ≤5% of annual dosage units
- Reverse Distributor
- Takes back expired or recalled
Records Retention Memory
DEA records 2yr; DSCSA data 6yr
DEA: 2 years minimumDSCSA: 6 years minimumStates may require longerBiennial inventory: every 2yr
Inventory Methods
- Want Book
- Manual, low-tech reorder note
- Par Level
- Target stock; often the max
- Just-in-Time
- Order arrives right before need
- Perpetual Inventory
- Real-time count every transaction
- Formulary
- Pre-approved stocking list
- Non-Formulary
- Needs prior authorization or order
- Seasonal Forecasting
- Predictable demand swings, e.g. flu
- Emergency Forecasting
- Unpredictable surge, e.g. disaster
- Automation
- ADCs, carousels, barcode scanning
- Turns Formula
- COGS divided by avg inventory
- Days' Supply Formula
- 365 divided by turns
Contracts & Sourcing
- Individual Contract
- Direct pharmacy-supplier negotiation
- GPO
- Pools volume for pricing
- Buying Group
- Smaller, formal pooled buying
- Consignment
- Supplier owns stock until used
- 340B GPO Rule
- DSH, cancer, children's hospitals barred
- State Vaccine (VFC)
- Segregate public stock from private
- 503A Alternate Source
- Compounded, patient-specific prescriptions
- White Bagging
- Outside pharmacy ships to provider
- Brown Bagging
- Patient carries drug to provider
- Clear Bagging
- Health system's own specialty pharmacy
503A vs 503B
503A Compounding
- State-licensed pharmacist pharmacy
- Patient-specific prescription needed
503B Outsourcing Facility
- FDA-registered, follows cGMP
- No patient prescription needed
Pharmacy vs outsourcing facility
Supply Chain Entity Picker
- Never touches the drug→Virtual manufacturer or wholesaler(Uses a 3PL or contractor)
- Warehousing, no title transfer→3PL(Excluded from 582 tracing)
- Outsourced sterile compounding needed→503B outsourcing facility(cGMP, FDA-registered)
- Patient-specific shortage workaround→503A compounded product(Inventory domain)
- High-cost limited-distribution drug→Specialty wholesale distributor(Often a Big Three affiliate)
- Buying nonprescription stock only→OTC-only distributor(No Rx authority)
Supply Chain Entities
- Manufacturer
- Holds approved drug application
- Repackager/Relabeler
- Repacks into new container
- Primary Wholesaler
- Buys direct from manufacturer
- Secondary Wholesaler
- Buys from other wholesalers
- Specialty Wholesaler
- High-cost, limited-distribution drugs
- OTC-Only Distributor
- Distributes nonprescription drugs only
- Virtual Manufacturer
- Never holds product physically
- Virtual Wholesaler
- Never possesses drug physically
- 3PL
- Warehouses, ships; no title transfer
- 3PL Tracing Scope
- Trading partner, excluded from 582
Primary vs Secondary Wholesaler
Primary Wholesaler
- Buys direct from manufacturer
- Largest volume distributors
Secondary Wholesaler
- Buys from other wholesalers
- Resupply and gap-filling role
Source vs resupply channel
503B & Cross-Border
- 503B Facility
- FDA-registered; follows cGMP rules
- 503B Copy Limit
- No essentially-a-copy compounding allowed
- 503B Wholesaling Limit
- Buyers cannot resell its products
- 503A Domain Placement
- Placed in Inventory domain
- Foreign Sourcing
- Extra verification, import controls apply
- Drug Transfer
- Physical drug moves, not Rx
- Transfer Definition
- Pharmacy-to-pharmacy physical movement only
Virtual Manufacturer vs Wholesaler
Virtual Manufacturer
- Holds the drug application
- Never possesses product physically
Virtual Wholesaler
- Meets wholesaler definition
- Never possesses drug physically
Owns license vs resells drug
Common Traps
TH required?
TH sunset Nov 2023 ≠ TI + TS still required
Effective vs enforced
Legal date Nov 2023 ≠ Enforcement phased to 2027
Form 222 vs CSOS scope
222 is Schedule I-II ≠ CSOS spans Schedule I-V
3PL role vs tracing
3PL is a trading partner ≠ 3PL excluded from 582 tracing
503A vs 503B domain
503A sits in Inventory ≠ 503B sits in Suppliers
GPO prohibition scope
DSH, cancer, children's hospitals ≠ Not all 340B entities
Par level vs min-max
Par is the target max ≠ Min-max sets reorder point
Last Minute
- 1.75 questions, 1h20m testing time
- 2.Passing scaled score is 300
- 3.Laws domain 37%, the largest
- 4.ABC = no renewal ever
- 5.Retake: no wait period
- 6.TH sunset 2023; TI+TS required
- 7.EDDS legal 2023; small-dispenser 2027
- 8.Form 222 = Schedule I-II
- 9.CSOS = Schedule I-V electronic
- 10.Turns = COGS / avg inventory
- 11.503A = Inventory domain, not Suppliers
- 12.3PL excluded from 582 tracing
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