PTCB Supply Chain cheat sheet

Reorder point = (average daily usage x lead time in days) + safety stock; an order is triggered when on-hand plus on-order quantity falls to this level.

Min/max system: min equals the reorder point, max equals min plus the typical order quantity; ordering up to max restores the par level.

A three-way match compares the purchase order, the receiving document, and the supplier invoice; any quantity or price mismatch must be resolved before the invoice is approved for payment.

DEA Form 222 is required to purchase Schedule II controlled substances; it allows no more than 10 line items, permits no alterations or erasures, and CSOS is its electronic equivalent.

A DEA power of attorney names the employees authorized to sign Schedule II order forms for the registrant and must be kept with the executed order records.

Group purchasing organizations pool member volume to negotiate contract pricing; a prime vendor agreement designates one wholesaler as the primary supplier with defined pricing, delivery, and service terms.

A 503B outsourcing facility may ship compounded sterile products without a patient-specific prescription but must comply with current good manufacturing practice and DSCSA requirements.

Formulary decisions are made by the pharmacy and therapeutics committee; the formulary is the list of drug products approved for routine purchasing and dispensing.

Backorder = temporarily unavailable at the supplier but still expected; shortage = a regional or national supply disruption; discontinuation = permanent stop in manufacture.

Controlled room temperature is 20 to 25 degrees C (68 to 77 degrees F); brief excursions between 15 and 30 degrees C are acceptable if the label permits.

Refrigerated storage is 2 to 8 degrees C (36 to 46 degrees F); freezer storage is minus 25 to minus 10 degrees C (minus 13 to 14 degrees F).

FEFO (first expired, first out) rotates stock so the earliest expiration date is picked first; FIFO rotates by date of receipt.

Perpetual inventory keeps a running balance updated at every receipt, dispensing, and return; periodic inventory establishes the balance only at set counting intervals.

Cycle counting verifies a rotating subset of items on a schedule, so errors surface continuously without shutting down operations for a full wall-to-wall count.

ABC analysis ranks items by annual dollar usage; A items, roughly 10 to 20 percent of items but 70 to 80 percent of value, receive the tightest control and most frequent counting.

Inventory turnover = cost of goods sold divided by average inventory value; a falling ratio signals overstock, slow movers, or over-ordering.

Schedule II drugs are stored in a locked, substantially constructed cabinet or safe, or dispersed through stock with limited access; Schedules III through V require locked storage or limited access.

High-alert medications and look-alike/sound-alike pairs are stored apart and flagged with auxiliary warning labels to reduce selection errors.

Receiving sequence: match product to the purchase order, count, inspect packaging and temperature indicators, check expiration dates, sign and date the delivery receipt, then date-stamp the invoice.

Shortages, overages, wrong items, and damage are noted on the delivery receipt at the time of delivery and reported to the supplier within its claim window, commonly 24 to 48 hours.

Class I recall: reasonable probability that use will cause serious adverse health consequences or death; action is immediate and includes notifying patients who received the product.

Class II recall: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote.

Class III recall: use is unlikely to cause adverse health consequences; typically involves labeling or packaging violations.

Recall workflow: identify all affected lot numbers, segregate and label product in quarantine, notify recipients, return or destroy per the manufacturer's instructions, then document completion.

A reverse distributor is a DEA-registered entity that receives expired, damaged, or recalled controlled substances from a pharmacy and arranges lawful return or destruction.

DEA Form 41 documents destruction of controlled substances and requires the signature of the person destroying the drugs plus an authorized witness.

A saleable return may be resold by a wholesaler only after the product identifier is verified under DSCSA; non-saleable returns are quarantined and destroyed or sent back to the manufacturer.

DSCSA requires an interoperable, electronic, package-level trace of prescription drugs, exchanged as Transaction Information, Transaction History, and a Transaction Statement (T3).

The product identifier carries the NDC, serial number, lot number, and expiration date in both human-readable and machine-readable (2D data matrix) form.

DSCSA records must be retained for 6 years and provided within 24 hours of a request from FDA or a state authority.

Suspect product is quarantined and investigated; illegitimate product is reported to FDA and to trading partners within 24 hours.

DEA records are kept 2 years, must be readily retrievable, and must be available at the registered location for inspection.

Biennial inventory is taken every 2 years: exact count for Schedule II; estimated count for Schedules III through V, unless a container holds more than 1,000 units, which requires an exact count.

DEA Form 106 reports theft or significant loss in writing to the DEA field office within one business day of discovery.

DEA registrations are renewed every 3 years; a wholesaler must also hold a state license in each state into which it ships.

Temperature logs, cleaning records, and compounding documentation must be contemporaneous, legible, and retained according to USP and state requirements.