SNP DSCSA P&P version 2

Drug Supply Chain Security Act
(DSCSA)

Policies and Procedures

Version 2.0

Table of Contents

Receipt of Product ……………………………………………………………………. SNP-DSCSA-1010
Responding to Information Requests …………………………………………….. SNP-DSCSA-1020
Verification (Investigation) ………………………………………………………….. SNP-DSCSA-1030
Transfer of Medication ……………………………………………………………….. SNP-DSCSA-1040
Returns ………………………………………………………………………………….. SNP-DSCSA-1050
Third-Party Agreements ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,. SNP-DSCSA-1060
Record Keeping ………………………………………………………………………... SNP-DSCSA-1070
DSCSA Training ………………………………………………………………………,,, SNP-DSCSA-1080

Policy: Policy Number:
Receipt of Product SNP-DSCSA-1010

Type: Page :
Drug Supply Chain Security 1 of 2

1.0 Policy

1.1 Skilled Nursing Pharmacy shall only receive products from authorized trading partners (ATP).

1.2 Skilled Nursing Pharmacy (SNP) will only accept drug products provided that SNP has received
Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS).

2.0 Policy Definitions

2.1 Products: prescription drugs in finished dosage form for administration to a patient without
further manufacturing (i.e. capsules, tablets, lyophilized products prior to reconstitution).

2.2 Not Products: OTC, medical devices, API, or drugs indicated for animal use.

2.2.1 Radioactive drugs and radioactive biologics

2.2.2 Intravenous products

2.2.3 Homeopathic drugs

2.2.4 Compounded drugs

2.3 Transaction: when a product changes ownership

2.4 Traceability requirements

2.4.1 Transaction Information (TI): includes the name of the product; strength and dosage
form; NDC; container size; name and address of the seller and the purchaser; and other
DSCSA specified information.

2.4.2 Transaction History (TH): paper or electronic statement that includes the transaction
information for each prior transaction back to the manufacturer.

2.4.3 Transaction Statement (TS): paper or electronic attestation by the entity transferring
ownership of the product that it is authorized under the ACT; received the product from
an authorized party; and other DSCSA specified information.

2.4.4 Specific Patient Need: transfer of a product from one pharmacy to another (regardless of
affiliation) to fill an identified patient prescription.

2.4.4.1 Product tracing requirements NOT necessary.

Policy: Policy Number:
Receipt of Product SNP-DSCSA-1010

Type: Page :
Drug Supply Chain Security 2 of 2

3.0 Procedure

3.1 Ordering and Receiving Products

3.1.1 Skilled Nursing Pharmacy will only order/obtain and accept receipt of products from an
authorized trading partner.

3.1.2 Skilled Nursing Pharmacy will also require the receipt of Transaction History (TH),
Transaction Information (TI) , and Transaction Statement (TS) before accepting any
receipt of products.

3.2 Record Keeping

3.2.1 Skilled Nursing Pharmacy will maintain all Transaction History (TH), Transaction
Information (TI) and Transaction Statements (TS) in an electronic and/or paper format
for a period of no less than six (6) years from the receipt of the product.

3.2.2 Records may be maintained off-site or via third party (if SNP has entered into a written
agreement with the third-party). See Policy and Procedure: SNP-DSCSA-1060: Third-
Party Agreements.

Prepared by: Flynn Lew Effective Date: 06/21/2019
Chief Compliance Officer
Approved by: Ben Mandelbaum Approved Date: 06/21/2019

Revised: (dates) Approved: (dates) Implemented: (dates)
______________________________
______________________________ ________________________________ ____________________________

________________________________ ____________________________

Policy: Policy Number:
Responding to Information Request SNP-DSCSA-1020

Type: Page :
Drug Supply Chain Security 1 of 1

1.0 Policy

1.1 Skilled Nursing Pharmacy shall respond to requests for information related to the DSCSA (Drug
Supply Chain Security Act) within the timeframe required by the request, 2 (two) business days.

2.0 Procedure

2.1 Upon Receipt of an Information Request

2.1.1 The SNP Employee opening/receiving a request for information related to the DSCSA
will immediately provide the request to the Pharmacist-In-Charge (PIC) with a copy to
the Chief Compliance Officer.

2.1.2 The Pharmacist-In-Charge (PIC) will provide all of the information (in either a hardcopy
or an electronic format) required by the FDA or other governmental agency within two (2)
business days or within the timeframe requested.

If an investigation is needed, SNP will follow policy and procedure SNP-DSCSA-1030
Verification (Investigation).

Prepared by: Flynn Lew Pharm.D. Effective Date: 06/21/2019
Chief Compliance Officer
Approved by: Ben Mandelbaum Approved Date: 06/21/2019

Revised: (dates) Approved: (dates) Implemented: (dates)
______________________________
______________________________ ________________________________ ____________________________

________________________________ ____________________________

Policy: Policy Number:
Verification (Investigation) SNP-DSCSA-1030

Type: Page :
Drug Supply Chain Security 1 of 2

1.0 Policy

1.1 Skilled Nursing Pharmacy will perform verification/investigation of the authenticity of any
products that are suspected of being illegitimate and/or SNP has received notification via a
trading partner.

2.0 Policy Definition

2.1 Suspect Product: pharmacy has reason to believe:

2.1.1 Potentially counterfeit, diverted, or stolen

2.1.2 Subject of a fraudulent transaction.

2.1.3 Intentionally adulated or appears otherwise unfit for distribution such that would result in
serious adverse health consequences or death to humans.

2.2 Illegitimate Product: pharmacy has credible evidence that shows:

2.2.1 Product is counterfeit, diverted, or stolen.

2.2.2 Subject of a fraudulent transaction.

2.2.3 Intentionally adulterated or appears otherwise unfit for distribution such that would result
in serious adverse health consequences or death to humans.

3.0 Procedure

3.1 Quarantine of Suspect Products
3.1.1 All products to be verified will be placed in Quarantine in a box or tote labeled “DSCSA
Quarantine” immediately to prevent them from leaving the pharmacy.

3.2 Patient Safety

3.2.1 Skilled Nursing Pharmacy will notify skilled nursing facility and/or patients who received
the medication to discontinue use and return the medication back to the pharmacy for
replacement.

3.3 Investigation

3.3.1 Skilled Nursing Pharmacy will collect and review the Transaction Information,
Transaction History, and Transaction Statements, and lot number and product
identifier associated with the product.

Policy: Policy Number:
Verification (Investigation) SNP-DSCSA-1030

Type: Page :
Drug Supply Chain Security 2 of 2

3.3.2 Based on the information contained in the Transaction data, SNP will notify and
send all relevant documentation to the trading partners who sent the product to
the pharmacy.

3.4 Illegitimate Products

3.4.1 If a product is determined to be illegitimate, the pharmacy will:

3.4.1.1 Box the products up until it can be removed from the pharmacy.

3.4.1.2 Assist trading partners as appropriate.

3.4.1.3 Notify the FDA and trading partners within 24 hours, using FDA
3.4.1.4 form 3911 for determined illegitimacy.

(http://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm)

Provide samples as requested by the manufacturer or Secretary

3.5 Cleared Products

3.5.1 Once the product has been deemed a legitimate/cleared product, SNP will:

3.5.1.1 Place the Quarantined Product back in stock

3.5.1.2 Notify the FDA, if SNP was notified by the FDA, or if SNP
previously notified the FDA that the products were illegitimate

(http://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm).

3.6 Record Keeping

3.6.1 The Pharmacy will maintain records of any Investigations for a period of no less
than 6 years.

Prepared by: Flynn Lew Pharm.D. Effective Date: 06/21/2019
Chief Compliance Officer
Approved by: Ben Mandelbaum Approved Date: 06/21/2019

Revised: (dates) Approved: (dates) Implemented: (dates)
______________________________
_____________________________ ________________________________ ____________________________

________________________________ ____________________________

Policy: Policy Number:
Transfer of Medication SNP-DSCSA-1040

Type: Page :
Drug Supply Chain Security 1 of 1

1.0 Policy

1.1 Skilled Nursing Pharmacy shall provide/receive Transaction Information, Transaction History
and a Transaction Statement for all products that the pharmacy transfers to Pharmacies/Entities
from other pharmacies. The only exception to this are:

• Dispensing to the patient
• Sales to another dispenser (Pharmacy) to fulfill a specific patient need
• Provision to another pharmacy with common ownership
• Provision of Minimal Quantities to skilled nursing facilities in E-kits
• Returns of saleable products to wholesalers (See Policy and Procedure: SNP-DSCSA-

1050 Returns).
• Returns of non-saleable products to the manufacturer, re-packager, wholesale distributor

from whom the products were purchased, a returns distributor or person/entity acting on
behalf of one of these (See Policy and Procedure: SNP-DSCSA-1050 Returns).

Prepared by: Flynn Lew Pharm.D. Effective Date: 06/21/2019
Chief Compliance Officer
Approved by: Ben Mandelbaum Approved Date: 06/21/2019

Revised: (dates) Approved: (dates) Implemented: (dates)
______________________________
________________________________ ____________________________

______________________________ ________________________________ ____________________________

Policy: Policy Number:
Returns SNP-DSCSA-1050

Type: Page :
Drug Supply Chain Security 1 of 1

1.0 Policy

1.1 Skilled Nursing Pharmacy shall return products (saleable or non-saleable) and provide
information when necessary.

2.0 Procedure

2.1 Saleable Return

2.1.1 If the product(s) are being returned to the trading partner (typically a wholesaler) that the
product was obtained from, SNP will not provide Transaction Information, Transaction
History or a Transaction Statement.

2.1.2 If the product(s) are being provided (returned) to a trading partner whom SNP did not
obtain the products from, SNP will provide Transaction Information, Transaction History
or a Transaction Statement. See Policy and Procedures SNP-DSCSA-1040 Transfer of
Medication.

2.2 Non-Saleable Returns

2.2.1 If the product(s) are being returned to the manufacturer, re-packager, wholesale
distributor from whom the products were purchased, or a returns distributor or
person/entity acting on behalf of one of these, SNP will not provide Transaction
Information, Transaction History or a Transaction Statement.

Prepared by: Flynn Lew Pharm.D. Effective Date: 06/21/2019
Chief Compliance Officer
Approved by: Ben Mandelbaum Approved Date: 06/21/2019

Revised: (dates) Approved: (dates) Implemented: (dates)
______________________________
________________________________ ____________________________

______________________________ ________________________________ ____________________________

Policy: Policy Number:
Third-Party Agreements SNP-DSCSA-1060

Type: Page :
Drug Supply Chain Security 1 of 1

1.0 Policy

1.1 Skilled Nursing Pharmacy may enter into written agreements with third-parties to house the
required Transaction Information, Transaction History and Transaction Statements.

1.2 Written Agreements shall be written to ensure the third-party is complying with the
responsibilities of the pharmacy and can maintain and respond to requests for information as
required.

2.0 Procedure

2.1 Skilled Nursing Pharmacy Compliance Officer will ensure that all third-party documentation
agreements are written to ensure the required DSCSA record keeping timeframes (see the table
below) are maintained and accessible within 2 (two) business days.

Type of Documentation Length of Time
Transaction Information At least 6 years from the transaction
Transaction History At least 6 years from the transaction
Transaction Statement At least 6 years from the transaction
Documentation related to the Investigation of At least 6 years from the conclusion of the
a Products authenticity investigation

2.2 Agreements will be stored for a period of no less than 6 years from the date it was last in effect.

Prepared by: Flynn Lew Pharm.D. Effective Date: 06/21/2019
Chief Compliance Officer Approved Date: 06/21/2019
Approved by: Ben Mandelbaum

Implemented by: Pharmacist In Charge Implementation Date: 6/21/2019

Revised: (dates) Approved: (dates) Implemented: (dates)
______________________________
______________________________ ________________________________ ____________________________

________________________________ ____________________________

Policy: Policy Number:
Record Keeping SNP-DSCSA-1070

Type: Page :
Drug Supply Chain Security 1 of 1

1.0 Policy

1.1 Skilled Nursing Pharmacy shall maintain records as required by the Drug Supply Chain Security
Act (DSCSA): 6 years for all transactional information and investigatory information.

2.0 Procedure

2.1 The Pharmacist-In-Charge will ensure that the documentation required by the DSCSA (see
table below) is maintained in a hardcopy and/or electronic form for the period of time required.

Type of Documentation Length of Time
Transaction Information At least 6 years from the transaction
Transaction History At least 6 years from the transaction
Transaction Statement At least 6 years from the transaction
Documentation related to the Investigation of At least 6 years from the conclusion of the
a Products authenticity investigation

Prepared by: Flynn Lew Pharm.D. Effective Date: 06/21/2019
Chief Compliance Officer Approved Date: 06/21/2019
Approved by: Ben Mandelbaum

Implemented by: Pharmacist In Charge Implementation Date: 06/21/19

Revised: (dates) Approved: (dates) Implemented: (dates)

______________________________ ________________________________ ____________________________

______________________________ ________________________________ ____________________________

Policy: Policy Number:
DSCSA Training SNP-DSCSA-1080

Type: Page :
Drug Supply Chain Security 1 of 1

1.0 Policy
1.1 Skilled Nursing Pharmacy shall ensure all pharmacy personnel directly involved with acquiring,
purchasing, or transferring products are trained on processes related to DSCSA.

2.0 Procedure
2.1 Initial Training
2.1.1 At the time of hire, the direct product handling employees will be trained DSCSA.
2.2. Annual and Updated Training
2.2.1 Annually, the direct product handling employees will be trained on DSCSA.
2.3 Documentation
2.3.1 Documentation of DSCSA Training can be found in the Human Resource Department d
in each employee’s personnel file.

Prepared by: Flynn Lew Pharm.D. Effective Date: 06/21/2019
Chief Compliance Officer Approved Date: 06/21/2019
Approved by: Ben Mandelbaum

Implemented by: Pharmacist In Charge Implementation Date: 06/21/2019

Revised: (dates) Approved: (dates) Implemented: (dates)

______________________________ ________________________________ ____________________________

______________________________ ________________________________ ____________________________