DSCSA: DRUG SUPPLY CHAIN SECURITY ACT AND IMPLEMENTATION. Chris Smith, R.Ph. Director, Pharmacy Business Intelligence Inmar

Transcription

1 DSCSA: DRUG SUPPLY CHAIN SECURITY ACT AND IMPLEMENTATION Chris Smith, R.Ph Director, Pharmacy Business Intelligence Inmar

2 AGENDA CONTENTS History and key provisions Important concepts Timeline Meaningful provisions-retailer Meaningful provisions-other stakeholders Suspect and illegitimate product Saleable and nonsaleable returns Special situations What s next? Q&A 2

3 History Law passed and signed in 2013 First effective January 1, 2015 Pre-empts the need for 50 individual state laws and the confusion that scenario would generate Works to reduce the possibility of stolen, tainted, or counterfeit drugs of entering the Supply Chain 10 year implementation phase-in Touches all stakeholders in the drug supply chain-manufacturers, wholesalers, 3PLs, and distributors 3

4 Key provisions of act Product identification Product tracing Product verification Detection and response Notification Wholesaler licensing Third-party logistics provider licensing Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically. Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market. Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages. Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous. Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found. Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database. Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license. 4

5 Important concepts-ti/ts/th Transaction information Transaction statement TI TS Details about the product itself, including but not limited to product description, NDC, lot number, etc. Statement attesting to transaction containing correct and accurate information Transaction history TH Details about which organizations have owned the product Cannot accept product without TI/TS/TH 5

6 Important concepts Verification and serialization Verification Manufacturers, wholesaler drug distributors, repackagers and many dispensers shall establish systems and processes to be able to comply with the verification requirements. Verification requirements change once product is serialized. Serialization Manufacturers, followed by repackagers shall place a unique product identifier on certain prescription drug packages 2D Product identifier National Drug Code Serial number Lot number Expiration date 6

7 Important concepts Verification and serialization Verification Manufacturers, wholesaler drug distributors, repackagers, and many dispensers shall establish systems and processes to be able to comply with the verification requirements. Verification requirements change once product is serialized. Serialization Manufacturers, followed by repackagers shall place a unique product identifier on certain prescription drug packages 2D Product identifier National Drug Code Serial number Lot number Expiration date 7

8 Important concepts Scope Product What s covered: Prescription drug in finished dosage form for administration to a patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution) What s not covered: Blood or blood components intended for transfusion Radioactive drugs or biologics Imaging drugs Certain IV products Medical gas Homeopathic drugs Lawfully compounded drugs Transaction Transfer of product where a change of ownership occurs Exempt - Intercompany distributions - Distribution among hospitals under common control - Public health emergencies - Dispensed pursuant to a prescription - Product sample distribution - Blood and blood components for transfusion - Minimal quantities by a licensed pharmacy to a licensed practitioner - Charitable organizations - Distributions pursuant to a merger or sale - Certain combination products - Certain medical kits - Certain IV products - Medical gas distribution - Approved animal drugs 8

9 Timeline 9

10 Meaningful provisions: Retailer Manufacturer and distributors must send and receive TI/TS/TH. Most big Jan 1, 2015 wholesalers and distributors made them available to all trading partners. All participants must have a policy and procedure to identify and report suspect and illegitimate products. July 15, 2015 Nov 27,2015 Nov 27,2017 Nov 27,2018 Nov 27,2019 Nov 27,2020 Nov 27,2023 Dispensers must receive and retain TI/TS/TH. Must retain for six years and is responsibility of the buyer. Standards issued for grandfathering and product identifier exceptions Manufacturers must serialize product. Repackagers must serialize product. Distributor lot-level traceability Pharmacy lot-level traceability Unit level traceability 10

11 Meaningful provisions: Wholesaler / distributor Jan 1, 2015 Manufacturer and distributors must send and receive TI/TS/TH. Must report state licenses to FDA FDA database of wholesalers/distributors to be published Nov 27,2015 Nov 27,2017 Nov 27,2018 Nov 27,2019 Nov 27,2020 Nov 27,2023 National standards issued for wholesaler distributor licenses National standards issued for 3PLs TI/TS/TH waiver guidance issued Manufacturers must serialize product. National wholesale license standard take effect. Repackagers must serialize product. Distributor lot-level traceability Pharmacy lot-level traceability Unit-level traceability 11

12 Suspect and illegitimate product Signs of suspect drug Product labeling that contains misspelled words or looks different from the standard labeling The finished product is a different shape or color from the standard product or has an unusual odor. The packaging is missing identifying information such as the lot number or expiration date. The original packaging seals have been opened, damaged, repaired or altered. Actions that could increase risk Purchasing drugs from a new source Responding to an unsolicited offer, usually with a significantly lower price, that comes through an advertisement, , fax or telephone call Purchasing a product on the Internet from an unknown source Purchasing a product that is in high demand or one that is on the drug shortage list 12

13 Saleable returns Beginning January 1, 2015, until November 27, 2019, a wholesale distributor may accept a return from a dispenser or repackager pursuant to the terms and conditions of an agreement between the parties. The parties may agree that the dispenser or repackager does not need to provide TI, TH and/or TS with the returns it makes to its wholesale distributor supplier. The wholesale distributor may resell the returned product without providing TH that reflects the prior sales. For any subsequent resale of the returned product, the TH begins with the wholesale distributor that accepted the return. 582(c)(1)(B)(i)(I). Many wholesalers are requiring attestation. After November 27, 2019, a wholesale distributor may accept returned product from a dispenser or repackager only if it can associate the returned product with the TI and TS associated with the original sale of that product to the dispenser/repackager. For all transactions after that date, the TH shall begin with the wholesale distributor that accepted and verified the returned product. However, the TH need not include transaction dates if it is not reasonably practicable to obtain those dates. 582(c)(1)(B)(i)(II). 13

14 Returns providers The DSCSA defines returns processors (or reverse logistics provider ) as a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsalable product received from an authorized trading partner such that the product may be processed for credit or disposed of for no further distribution. 581(17). Thus, the returns processor is allowed to handle both saleable product and nonsaleable product under the DSCSA. However, there is no provision that permits a returns processor to sell the returned product. As a result, if the returns processor sells the returned goods, it would be acting as a wholesale distributor and would have to comply with the traceability and licensure requirements applicable to a wholesale distributor (including receiving and passing full TI/TH/TS and including TH for the product s prior transactions). 14

15 Nonsaleable returns Under the DSCSA, a wholesale distributor may return a nonsaleable product to the manufacturer or repackager, to the wholesale distributor from whom such product was purchased, or to a person acting on behalf of such a person, such as a returns processor, without providing TI/TH/TS. Further, the DSCSA does not require a dispenser to provide TI/TH/TS when it returns nonsaleable product to the wholesale distributor from whom it acquired the product. Implicitly, this means that the wholesale distributor is relieved of any requirement to receive TI/TH/TS when accepting the nonsaleable returned goods from the dispenser. Further, we believe this transfer may be outside the scope of the DSCSA because when a drug is nonsaleable, it is not for administration to a patient. If a drug is not for administration to a patient, it does not meet the definition of product under the DSCSA in 581(13). 15

16 Special situations Drop ship Seller/shipper supplies TI/TS/TH records. Self-warehousing pharmacies must supply TI/TS/TH records for those entities not under common ownership. Lot number direct purchase wholesaler distributors do NOT need to include lot number in TI/TS/TH. Request for information Manufacturers, wholesale distributors, repackager: Shall provide applicable TI, TH, and TS, not later than one business day, not to exceed 48 hours after receiving request. Dispensers: Shall provide applicable TI, TH, TS not later than two business days after receiving request. 16

17 Next up Should be planning for the July 1 requirements System testing Training Implement business practices 17

18 Questions 18

19 Chris Smith, R.Ph

20 Click the survey button found on the session page.

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