update_Bupropion_XL_solicitation.docx
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- SPE2D2-15-R-0009
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SPE2D2-15-R-0009 Solicitation (Word Document)
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SOLICITATION NO. SPE2D2-15-R-0009 Page 4 of 62
19.
ITEM NO.
20.
SCHEDULE OF SUPPLIES/SERVICES
21.
QUANTITY
22.
UNIT
23.
UNIT PRICE
24.
AMOUNT
0001AA
0001AB
0001AC
0001AD
0001AE
0002AA
0002AB
0002AC
0002AD
0002AE
0003AA
0003AB
0003AC
0003AD
0003AE
0004AA
0004AB
0004AC
0004AD
0004AE
0005AA
0005AB
0005AC
0005AD
0005AE
0006AA
0006AB
0006AC
0006AD
0006AE
Bupropion XL 150MG 30 Count Bottle** National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4
90 Count Bottle** National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2
1000 Count Bottle National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4
Two bottles of 500ea are being accepted as an alternate to one bottle of 1000ea. For CLIN 0003 offers shall include pricing for 884 bottles of 1000ea or 1768 bottles of 500ea.
Bupropion XL 150MG 500 Count Bottle National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4
Bupropion XL 300MG 30 Count Bottle** National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2
Bupropion XL 300MG 90 Count Bottle** National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2
Bupropion XL 300MG 1000 Count Bottle National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2 Option Year 3 Option Year 4
Two bottles of 500ea are being accepted as an alternate to one bottle of 1000ea. For CLIN 0006 offers shall include pricing for 4,491 bottles of 1000ea or 8,982 bottles of 500ea.
Bupropion XL 300MG 500 Count Bottle National Drug Code (NDC) ____-___-__ Base Year Option Year 1 Option Year 2
*BT = One Bottle
** Package size is unit of use and is subject to Statement of Work - “Preparation for Delivery” requirement.
***The quantities specified in the Schedule are estimates only. Reference FAR 52.216-21 Requirements for additional details.
155,409
155,409
24,130
24,130
1,768
1,768
35,017
35,017
53,236
53,236
4,491
4,491
8,982
8,982
BT*
BT
BT
BT
BT
BT
BT
BT
BT
BT
Table of Contents
| CONTINUATION OF SF 1449 | 5 | |
| CAUTION NOTICE | 6 | |
| CONTRACT CLAUSES | 6 | |
| FAR 52.212-4 Contract Terms and Conditions—Commercial Items (DEC 2014) | 7 | |
| FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items (APR 2015) | 9 | |
| Contract Clauses Included by Reference | 9 | |
| STATEMENT OF WORK | 16 | |
| 1. | Background | 16 |
| 2. | Purpose and Objective | 16 |
| 3. | Purchase Compliance | 16 |
| 4. | Extent of Obligation | 17 |
| 5. | Contract Performance Date | 17 |
| 6. | Chargeback Agreements | 17 |
| 7. | Delivery | 17 |
| 8. | Transition Period | 17 |
| 9. | Contract Duration | 17 |
| 10. | Ordering and Acceptance of Orders | 17 |
| 11. | Initial Orders | 18 |
| 12. | National Contract Backorders | 18 |
| 13. | Product Registration | 18 |
| 14. | Preparation for Delivery | 18 |
| 15. | Labeling | 19 |
| 16. | Therapeutic Equivalence | 20 |
| 17. | Manufacturing Facilities | 20 |
| 18. | Recalls | 21 |
| 19. | Cost Recovery Fee and Submission of Quarterly Sales Reports | 22 |
| SOLICITATION PROVISIONS | 24 | |
| 52.212-1, Instructions to Offerors—Commercial Items (MAR 2015) | 24 | |
| FAR 52.212-2 Evaluation Commercial Items (October 2014) | 30 | |
| Appendix A: Pharmaceutical Prime Vendors | 60 |
CONTINUATION OF SF 1449
Block 9: Submission Instructions › Address and Submit “mailed” offers to:
Defense Logistics Agency Troop Support Post Office Box 56667 Philadelphia, PA 19111-6667 Solicitation Number: SPE2D2-15-R-0009 Opening/Closing Date and Time: 05/26/2015 / 06/25/2015 03:00PM EST
› Address and Deliver “hand carried” offers, including delivery by commercial carrier, to:
DLA Troop Support Business Opportunities Office Bldg. 36, 2nd Floor, Room 2035 700 Robbins Avenue Philadelphia, PA 19111-5092 Solicitation Number: SPE2D2-15-R-0009 Opening/Closing Date and Time: 05/26/2015 / 06/25/2015 03:00PM EST
Notes: 1. All hand carried offers are to be delivered to the Business Opportunities Office between 8:00 a.m. and 5:00 p.m., Monday through Friday, except for legal federal holidays as set forth in 5 USC 6103. Offerors using a commercial carrier service must ensure that the carrier service “hand carries” the package to the Business Opportunities Office specified above for hand carried offers prior to the scheduled opening/closing time. Package must be plainly marked ON THE OUTSIDE OF THE COMMERCIAL CARRIER’S ENVELOPE with the solicitation number, date, and time set forth for receipt of offers as indicated in Block 8 of the Standard Form 1449.
2. Examples of “hand carried” offers include: In-person delivery by contractor, Fed Ex, Airborne, UPS, DHL, Emery, other commercial carrier, USPS Express Mail, and USPS Certified Mail.
Block 17a: DUNS & CAGE › Offeror’s assigned Data Universal Numbering System (DUNS) Number:_______________ (If you do not have a DUNS number, contact the individual identified in Block 7a of the SF 1449 or see 52.212-1, Instructions to Offerors—Commercial Items (paragraph j) for information on contacting Dun and Bradstreet.)
› Offeror’s assigned Contractor and Government Entity (CAGE) Code:__________________
Block 17b: Remittance Address (if different from Contractor/Offeror address in block 17a of the SF 1449.)
CAUTION NOTICE
1. Reverse Auction Notification This solicitation contains DLAD provision 52.215-9023 for reverse auction (RA). The Government may activate this provision after timely offers have been received and evaluated. Prior to doing so, the contracting officer will establish a competitive range, decide whether or not an RA will be conducted, and determine which offerors will participate in this event. Firms removed from the competitive range will be notified in writing prior to the Government conducting the RA.
The reverse auction vendor provides the tool/software that allows for the reverse auction. By submitting an offer, the offeror consents that the reverse auction vendor may have access to its submitted data for the purpose of the reverse auction. Reverse auction vendors are bound by confidentiality agreements.
2. Subcontracting Plan All large business offerors must submit a subcontracting plan with their offer. Instructions for submitting the subcontracting plan are included in FAR 52.212-1. Contractors are required to report progress on subcontracting goals to the electronic Subcontracting Reporting System (eSRS) twice a year. eSRS is an internet-based tool that streamlines the process of reporting on subcontracting plans and provides agencies with access to analytical data on subcontracting performance. More information on eSRS can be found at DGPA 19.7: http://www.troopsupport.dla.mil/contract/dgpa/dgpa19.asp#dgpa19_705_7_p and www.esrs.gov.
CONTRACT CLAUSES
FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):
· FAR: https://www.acquisition.gov/far/index.html;
· DFARS: http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html
· DLAD: http://www.dla.mil/Acquisition/Documents/DLAD%20Rev%205.htm
The following additional clauses are incorporated by reference:
CLAUSE NUMBER
| TITLE |
| DATE |
FAR
| FAR 52.203-17 |
| Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights |
| APR 2014 |
| FAR 52.227-1 |
| Authorization and Consent |
| DEC 2007 |
| FAR 52.227-2 |
| Notice and Assistance Regarding Patent and Copyright Infringement |
| DEC 2007 |
| FAR 52.232-17 |
| Interest |
| MAY 2014 |
| FAR 52.242-13 |
| Bankruptcy |
| JUL 1995 |
| FAR 52.242-15 |
| Stop-Work Order |
| AUG 1989 |
| FAR 52.246-16 |
| Responsibility for Supplies |
| APR 1984 |
DFARS
| DFARS 252.203-7002 |
| Requirement to Inform Employees of Whistleblower Rights |
| SEP 2013 |
| DFARS 252.204-7003 |
| Control of Government Personnel Work Product |
| APR 1992 |
| DFARS 252.204-7004 |
| Alternate A, System for Award Management |
| FEB 2014 |
| DFARS 252.209-7004 |
| Subcontracting with Firms That Are Owned or Controlled by the Government of a Country That is a State Sponsor of Terrorism |
| DEC 2014 |
| DFARS 252.225-7002 |
| Qualifying Country Sources as Subcontractors |
| DEC 2012 |
DLAD
| DLAD 52.211-9014 |
| Contractor Retention of Traceability Documentation |
| AUG 2012 |
| DLAD 52.216-9023 |
| Additional Ordering Limitation |
| APR 2008 |
| DLAD 52.247-9012 |
| Requirements for Treatment of Wood Packaging Material (WPM) |
| FEB 2007 |
FAR 52.212-4 Contract Terms and Conditions—Commercial Items (DEC 2014) Incorporated in this solicitation by reference. Its full text may be accessed electronically at https://www.acquisition.gov/far/index.html. Text is available for viewing in Subpart 52.2 Text of Provisions and Clauses, through either the HTML or PDF Format links.
Addendum to 52.212-4:
The following paragraph of 52.212-4 is amended as indicated below:
Paragraph (m), Termination for Cause.
Delete paragraph (m) in its entirety and substitute the following:
(m) Termination for Cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If this contract is terminated in whole or in part for cause, and the supplies or services covered by the contract so terminated are repurchased by the Government, the Government will incur administrative costs in such repurchases. The Contractor and the Government expressly agree that, in addition to any excess costs of repurchase, or any other damages resulting from such default, the Contractor shall pay, and the Government shall accept, the sum of $1,350.00 as payment in full for the administrative costs of such repurchase. This assessment of damages for administrative costs shall apply for any termination for cause following which the Government repurchases the terminated supplies or services together with any incidental or consequential damages incurred because of the termination. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.
FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor at any time during the term of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years.
(End of clause)
FAR 52.212-9000 Changes – Military Readiness (NOV 2011)
The commercial changes clause at FAR 52.212-4(c) is applicable to this contract in lieu of the changes clause at FAR 52.243-1. However, in the event of a Contingency Operation or a Humanitarian or Peacekeeping Operation, as defined below, the Contracting Officer may, by written order, change 1) the method of shipment or packing, and 2) the place of delivery.
If any such change causes an increase in the cost of, or the time required for performance, the Contracting Officer shall make an equitable adjustment in the contract price, the delivery schedule, or both, and shall modify the contract. The Contractor must assert its right to an adjustment within 30 days from the date of receipt of the modification.
| “Contingency Operation” means a military operation that is designated by the Secretary of Defense as an operation in which members of the armed forces are or may become involved in military actions, operations, or hostilities against an enemy of the United States or against an opposing military force; or results in the call or order to, or retention on, active duty of members of the uniformed services under 10 United States Code (U.S.C.) 688, 12301(a), 12302, 12304, 12305, or 12406, chapter 15 of U.S.C., or any other provision of law during a war or during a national emergency declared by the President or Congress (10 U.S.C. 101(a)(13)). |
| “Humanitarian or Peacekeeping Operation” means a military operation in support of the provision of humanitarian or foreign disaster assistance or in support of peacekeeping operation under Chapter VI or VII of the Charter of the United Nations. The term does not include routine training, force rotation, or stationing. (10 U.S.C. 2302(8) and 41 U.S.C. 259(d)(2)(B)). |
FAR 52.216-21 Requirements (OCT 1995)
(a) This is a requirements contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the Government’s requirements do not result in orders in the quantities described as “estimated” or “maximum” in the Schedule, that fact shall not constitute the basis for an equitable price adjustment.
(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. Subject to any limitations in the Order Limitations clause or elsewhere in this contract, the Contractor shall furnish to the Government all supplies or services specified in the Schedule and called for by orders issued in accordance with the Ordering clause. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.
(c) Except as this contract otherwise provides, the Government shall order from the Contractor all the supplies or services specified in the Schedule that are required to be purchased by the Government activity or activities specified in the Schedule.
(d) The Government is not required to purchase from the Contractor requirements in excess of any limit on total orders under this contract.
(e) If the Government urgently requires delivery of any quantity of an item before the earliest date that delivery may be specified under this contract, and if the Contractor will not accept an order providing for the accelerated delivery, the Government may acquire the urgently required goods or services from another source.
(f) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period.
FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items (MAR 2015)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)
(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
[Contracting Officer check as appropriate.] _X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).
_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).
___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).
_X_ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).
___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).
___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).
___ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note).
_X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).
___ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).
___ (ii) Alternate I (Nov 2011) of 52.219-3.
___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).
___ (ii) Alternate I (Jan 2011) of 52.219-4.
___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).
___ (ii) Alternate I (Nov 2011).
___ (iii) Alternate II (Nov 2011).
___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).
___ (ii) Alternate I (Oct 1995) of 52.219-7.
___ (iii) Alternate II (Mar 2004) of 52.219-7.
_X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).
_X_ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637 (d)(4)).
___ (ii) Alternate I (Oct 2001) of 52.219-9.
_X_ (iii) Alternate II (Oct 2001) of 52.219-9.
___ (iv) Alternate III (Oct 2014) of 52.219-9.
___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).
___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).
_X_ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).
_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).
___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).
___ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).
_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).
_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).
_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
_X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).
_X_ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).
_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
_X_ (31) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).
_X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
_X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).
___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).
___ (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)
___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
___ (36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Jun 2014) of 52.223-13.
___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).
___ (ii) Alternate I (Jun 2014) of 52.223-14.
___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).
___ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514).
___ (ii) Alternate I (Jun 2014) of 52.223-16.
_X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).
___ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).
___ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).
___ (ii) Alternate I (May 2014) of 52.225-3.
___ (iii) Alternate II (May 2014) of 52.225-3.
___ (iv) Alternate III (May 2014) of 52.225-3.
___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
_X_ (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).
_X_ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
_X_ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).
___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).
___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).
___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
_X_ (50) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).
___ (51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).
___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
___ (54) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).
___ (ii) Alternate I (Apr 2003) of 52.247-64.
(c) Deleted – applicable to service contracts only. [
(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).
(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.
(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(v) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).
(vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).
(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
(viii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).
(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.
(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).
(xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).
___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).
(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)
(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)
(xiv) 52.222-54, Employment Eligibility Verification (Aug 2013).
(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658).
(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.
(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.
Contract Clauses Included by Reference
252.225-7012, Preference for Certain Domestic Commodities (FEB 2013) (10 U.S.C. 2533a).
Administration Costs for Reprocurement after Termination for Cause
If this contract is terminated in whole or part for cause pursuant to Paragraph (m) of the clause included in this contract entitled “Contract Terms and Conditions - Commercial Items”, and the supplies or services covered by the contract so terminated are repurchased by the Government, the Government will incur administrative costs in such repurchases. The Contractor and Government expressly agree that in addition to any excess costs of repurchase, or any other damages resulting from the Contractor’s default, the Contractor shall pay, and the Government shall accept, the sum of $1,350.00 as payment in full for the administrative costs of such repurchase. The assessment of damages for administrative costs shall apply for any termination for cause for which the Government repurchases the terminated supplies or services, regardless of whether any other damages are incurred and/or assessed.
DLAD 52.212-9002 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items (NOV 2014) The Contractor shall comply with any clause that is checked on the following list which, if checked, is included in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items or components.
1. __X__FAR 52.203-3, Gratuities (APR 1984)
2. __X__DFARS 252.203-7000, Requirements Relating to Compensation of Former DoD Officials (SEP 2011)
3. __X__DFARS 252.203-7003, Agency Office of the Inspector General (DEC 2012)
4. _____ DFARS 252.203-7005, Representation Relating to Compensation of Former DoD Officials (NOV 2011)
5. _____ DFARS 252.204-7011, Alternative Line Item Structure (SEP 2011)
6. _____ DFARS 252.204-7012, Safeguarding of Unclassified Controlled Technical Information (NOV 2013)
7. _____ DFARS 252.204-7013, Limitations on the Use or Disclosure of Information by Litigation Support Solicitation Offerors (FEB 2014)
8. _____ DFARS 252.204-7014, Limitations on the Use or Disclosure of Information by Litigation Support Contractors (FEB 2014)
9. _____ DFARS 252.204-7015, Disclosure of Information to Litigation Support Contractors (FEB 2014)
10. __X__ DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders (DEC 1991)
11. _____ DFARS 252.209-7001, Disclosure of Ownership or Control by the Government of a Terrorist Country (JAN 2009)
12. _____ DFARS 252.211-7003, Item Unique Identification and Valuation (DEC 2013)
13. __X__ DFARS 252.211-7006, Passive Radio Frequency Identification (SEP 2011)
14. _____ DFARS 252.211-7007, Reporting of Government-Furnished Property (AUG 2012)
15. _____ DFARS 252.215-7003, Requirements for Submission of Data Other Than Certified Cost or Pricing Data—Canadian Commercial Corporation (JUL 2012)
16. _____ DFARS 252.215-7004, Requirement for Submission of Data other Than Certified Cost or Pricing Data—Modifications—Canadian Commercial Corporation (OCT 2013)
17. _____ DFARS 252.215-7007, Notice of Intent to Resolicit (JUN 2012)
18. _____ DFARS 252.215-7008, Only One Offer (OCT 2013)
19. __X__ DFARS 252.219-7003, Small Business Subcontracting Plan (DoD Contracts) (OCT 2014)
20. _____ DFARS 252.219-7004, Small Business Subcontracting Plan (Test Program) (OCT 2014)
21. _____ DFARS 252.223-7008, Prohibition of Hexavalent Chromium (JUN 2013)
22. _____ DFARS 252.225-7000, Buy American—Balance of Payments Program Certificate (JAN 2014)
a. _____Alternate I (DEC 2010) of 52.225-7000
23. _____ DFARS 252.225-7001, Buy American and Balance of Payments Program (DEC 2012)
a. _____Alternate I (JAN 2014) of 252.225-7001
24. _____ DFARS 252.225-7008, Restriction on Acquisition of Specialty Metals (MAR 2013)
25. _____ DFARS 252.225-7009, Restriction on Acquisition of Certain Articles Containing Specialty Metals (OCT 2014)
26. _____ DFARS 252.225-7010, Commercial Derivative Military Article—Specialty Metals Compliance Certificate (JUL 2009)
27. _____ DFARS 252.225-7012, Preference for Certain Domestic Commodities (FEB 2013)
28. _____ DFARS 252.225-7015, Restriction on Acquisition of Hand or Measuring Tools (JUN 2005)
29. _____ DFARS 252.225-7016, Restriction on Acquisition of Ball and Roller Bearings (JUN 2011)
30. _____ DFARS 252.225-7017, Photovoltaic Devices (JAN 2014)
31. _____ DFARS 252.225-7018, Photovoltaic Devices—Certificate (JAN 2014)
32. _____ DFARS 252.225-7020, Trade Agreements Certificate (JAN 2005)
a. _____Alternate I (DEC 2010) of 252.225-7020
33. __X__ DFARS 252.225-7021, Trade Agreements—Basic (NOV 2014)
a. _____Alternate II (OCT 2011) of 252.225-7021
34. _____ DFARS 252.225-7023, Preference for Products or Services from Afghanistan (SEP 2013)
35. _____ DFARS 252.225-7024, Requirement for Products or Services from Afghanistan (SEP 2013)
36. _____ DFARS 252.225-7026, Acquisition Restricted to Products or Services from Afghanistan (SEP 2013)
37. _____ DFARS 252.225-7027, Restriction on Contingent Fees for Foreign Military Sales (APR 2003)
38. _____ DFARS 252.225-7028, Exclusionary Policies and Practices of Foreign Governments (APR 2003)
39. _____ DFARS 252.225-7029, Acquisition of Uniform Components for Afghan Military or Afghan National Police (SEP 2013)
40. _____ DFARS 252.225-7031, Secondary Arab Boycott of Israel (JUN 2005)
41. _____ DFARS 252.225-7035, Buy American—Free Trade Agreements—Balance of Payments Program Certificate (NOV 2012)
a. _____Alternate I (OCT 2013) of 252.225-7035
b. _____Alternate II (NOV 2012) of 252.225-7035
c. _____Alternate III (JUN 2012) of 252.225-7035
d. _____Alternate IV(NOV 2012) of 252.225-7035
e. _____Alternate V (NOV 2012) of 252.225-7035
42. _____ DFARS 252.225-7036, Buy American --Free Trade Agreements--Balance of Payment Program (DEC 2012)
a. _____Alternate I (JUN 2012) of 252.225-7036
b. _____Alternate II (NOV 2012) of 252.225-7036
c. _____Alternate III (JUN 2012) of 252.225-7036
d. _____Alternate IV (NOV 2012) of 252.225-7036
e. _____Alternate V (NOV 2012) of 252.225-7036
43. _____ DFARS 252.225-7037, Evaluation of Offers for Air Circuit Breakers (JUN 2005)
44. _____ DFARS 252.225-7038, Restriction on Acquisition of Air Circuit Breakers (JUN 2005)
45. _____ DFARS 252.225-7040, Contractor Personnel Authorized to Accompany U.S. Armed Forces Deployed Outside the United States (MAY 2014)
46. _____ DFARS 252.225-7043, Antiterrorism/Force Protection Policy for Defense Contractors Outside the United States (MAR 2006)
47. __X__ DFARS 252.226-7001, Utilization of Indian Organizations, Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns (SEP 2004)
48. _____ DFARS 252.227-7013, Rights in Technical Data – Noncommercial Items (FEB 2014)
49. _____ DFARS 252.227-7015, Technical Data -- Commercial Items (FEB 2014b)
50. _____ DFARS 252.227-7037, Validation of Restrictive Markings on Technical Data (JUN 2013),
51. __X__ DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports (JUN 2012)
52. _____ DFARS 252.232-7009, Mandatory Payment by Governmentwide Commercial Purchase Card (DEC 2006)
53. __X__ DFARS 252.232-7010, Levies on Contract Payments (DEC 2006)
54. _____ DFARS 252.232-7011, Payments in Support of Emergencies and Contingency Operations (MAY 2013)
55. _____ DFARS 252.237-7010, Prohibition on Interrogation of Detainees by Contractor Personnel (JUN 2013)
58. _____ DFARS 252.237-7019, Training for Contractor Personnel Interacting with Detainees (JUN 2013)
57. _____ DFARS 252.239-7017, Notice of Supply Chain Risk (NOV 2013)
58. _____ DFARS 252.239-7018, Supply Chain Risk (NOV 2013)
59. __X__ DFARS 252.243-7002, Requests for Equitable Adjustment (DEC 2012)
60. _____ DFARS 252.244-7000, Subcontracts for Commercial Items (JUN 2013)
61. _____ DFARS 252.246-7003, Notification of Potential Safety Issues (JUN 2013)
62. _____ DFARS 252.246-7004, Safety of Facilities, Infrastructure, and Equipment for Military Operations (OCT 2010)
63. _____ DFARS 252.247-7003, Pass-Through of Motor Carrier Fuel Surcharge Adjustment to the Cost Bearer (JUN 2013)
64. _____ DFARS 252.247-7022, Representation of Extent of Transportation by Sea (AUG 1992)
65. __X__ DFARS 252.247-7023, Transportation of Supplies by Sea (APR 2014).
a. _____Alternate I (APR 2014) of 252.247-7023.
b. _____Alternate II (APR 2014) of 252.247-7023
66. __X__ DFARS 252.247-7024, Notification of Transportation of Supplies by Sea (MAR 2000)
67. _____ DFARS 252.247-7025, Reflagging or Repair Work (JUN 2005)
68. _____ DFARS 252.247-7026, Evaluation Preference for Use of Domestic Shipyards – Applicable to Acquisition of Carriage by Vessel for DoD Cargo in the Coastwise or Noncontiguous Trade (NOV 2008)
69. _____ DFARS 252.247-7027, Riding Gang Member Requirements (OCT 2011)
70. _____ DFARS 252.247-7028, Application for U.S Government Shipping Documentation/Instructions (JUN 2012) In addition to the clauses listed in paragraph (e) of FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, the Contractor shall include the terms of the following clauses, if applicable, in subcontracts for commercial items or commercial components, awarded at any tier under this contract:
1. DFARS 252.227-7013, Rights in Technical Data – Noncommercial Items (FEB 2014)
2. DFARS 252.227-7015, Technical Data – Commercial Items (FEB 2014)
3. DFARS 252.227-7037, Validation of Restrictive Markings on Technical Data (JUN 2013)
4. DFARS 252.237-7010, Prohibition on Interrogation of Detainees by Contractor Personnel (JUN 2013)
5. DFARS 252.237-7019, Training for Contractor Personnel Interacting with Detainees (JUN 2013)
6. DFARS 252.247-7003, Pass-Through of Motor Carrier Fuel Surcharge Adjustment to the Cost Bearer (JUN 2013)
7. DFARS 252.247-7023, Transportation of Supplies by Sea (APR 2014)
8. DFARS 252.247-7024, Notification of Transportation of Supplies by Sea (MAR 2000)
STATEMENT OF WORK
1. Background The Defense Logistics Agency (DLA), Directorate of Medical Materiel provides pharmaceutical products for the Department of Defense (DoD) to their customers through the Pharmaceutical Prime Vendor program. The Department of Veterans Affairs (VA) provides pharmaceutical products to their customers as well as the Indian Health Service (IHS) and the Bureau of Prisons (BoP) through the VA Pharmaceutical Prime Vendor Program. Hereafter these programs are collectively referred to as the PPV. A prime vendor is an independent business concern that functions as a purchaser's primary source for specified classes of products and is responsible for the delivery of goods produced by various suppliers. As a part of the Pharmaceutical Prime Vendor Program, this solicitation will establish a national contract for the items listed in the schedule. The awardee consents to allow VA and DLA prime vendors to distribute the listed products at the prices established in a contract resulting from this solicitation.
2. Purpose and Objective A contract resulting from this solicitation will establish a national supply source, in accordance with FAR 52.216-21 Requirements, to provide the drugs listed in the schedule for purchase by DLA and VA customers through the PPV. The annual usage for DLA, VA, BoP and IHS customers served through the Prime Vendor Programs is estimated in the Schedule of Supplies. The objective of the contract is to ensure availability and consistency of product and to obtain volume-based, committed use pricing.
3. Purchase Compliance When placing orders with DLA, BoP, IHS or the VA, ordering activities will purchase their requirements from the selected contract holder for the items listed in the Schedule of Supplies section of this Solicitation through the DLA or VA prime vendors except when: (1) the contracted items is/are unavailable to meet the needs of the Government, (2) an alternate is requested by the prescribing healthcare provider, or (3) the contract holder does not participate in third party reimbursement programs, such as the Medicaid Rebate Program (#3 applies to IHS requirements only)
4. Extent of Obligation The contractor shall provide the products specified in the schedule at the prices established to all eligible DoD, VA, BoP and IHS ordering activities.
5. Contract Performance Date The contract performance date shall be 30 days (or sooner upon mutual agreement) after the date of contract award. This is the date the contractor shall be ready to fill PPV orders.
The contract prices shall be effective 15 days after the contract performance date. Before the contract performance date, the PPVs will begin placing orders with the contractor for delivery to multiple PPV distribution centers for distribution to the participants under this contract. See Appendix A for the current list of PPVs. The contractor shall ensure that sufficient inventory of contract items awarded under this solicitation is available to ensure delivery to the PPV distribution centers within 15 days of the contract performance date. The national contractor will establish a business relationship with the PPVs to facilitate the sale of the items at a unit price no higher than the established contract price. The national contractor will notify the Contracting Officer within 10 days from receipt of award if an agreement cannot be reached.
6. Chargeback Agreements Chargeback arrangements shall be coordinated between the prime vendors and the successful contractor. The Government is not obligated to become involved in or assume any responsibility for any financial disputes involved with such arrangements.
7. Delivery The complete order quantity shall be delivered to the PPV within 15 days after receipt of order.
Other delivery requirements including but not limited to product quantities, time and place of delivery and method of delivery for products awarded as a result of this procurement action will be determined by the contract awardee and the prime vendors.
8. Transition Period After the effective date a short phase-in period may be needed to convert patients and medical centers to the awarded products. Every effort will be made to begin transitioning as many patients as possible by the contract performance date.
9. Contract Duration The contract resulting herein will be for a one year base and include four option years for a maximum of five years. The contract will not exceed five years.
10. Ordering and Acceptance of Orders The contractor agrees to accept orders and provide items at the prices agreed to under this contract that are placed by Pharmaceutical Prime Vendors (PPVs) for use by medical treatment facilities, formularies, and eligible beneficiaries served by the DLA and VA PPVs. The Government reserves the right to delete ordering sites/activities which are current prime vendor customers during the effective period of this contract. In addition, the Government reserves the right to add Government pharmacies and ordering activities of agencies, which are not current PPV customers, during the effective period of this contract.
11. Initial Orders Each ordering agency (DoD, VA, IHS, and BoP) may place initial orders with their respective PPV contractors totaling up to 30% of the agency's stated estimated annual contract quantities, located in Appendix B: Agency Annual Demand Projections, immediately upon the contract effective date. Initial orders totaling up to 30% of each agency's stated estimated annual contract quantities may be placed by the PPV contractors with the national contract awardee of this solicitation to fulfill the initial order requirements.
12. National Contract Backorders The ability of the DoD, VA, BoP, and IHS to provide quality healthcare to the patient population is severely impaired when a national contract product is not available due to backorders.
For purposes of this contract a backorder occurs when the PPV issues an order with the contractor and the complete order quantity is not delivered to the PPV within 15 days after receipt of order.
The contract awardee shall inform the contracting officer within four calendar days after a backorder occurs or is foreseen. In addition to informing the contracting officer of the backorder, the contractor shall provide an estimated date when the backordered product will be shipped, and may propose a solution to satisfy the Government’s needs for the contract items until the backorder is resolved.
If a backorder occurs, the Government may be required to acquire the same or similar items from other readily available sources and seek reimbursement for excess costs in accordance with FAR 52.233-1, Disputes or the remedies available under FAR 52.212-4 (m), Termination for cause.
13. Product Registration Product information pertaining to all items offered under this solicitation must be registered with RXNorm, First Data Bank and Medispan prior to the effective date of contract performance. Details on submitting this information can be found at the following links:
http://www.nlm.nih.gov/research/umls/rxnorm/ http://www.medispan.com/manufacturers-exchange.aspx http://www.fdbhealth.com/solutions/manufacturer-relations/
14. Preparation for Delivery Preservation and packaging shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc., involving shipment from the supply source to and from the receiving activity and shall conform to the applicable carrier’s rules and regulations.
All unit of use packaging (identified in schedule of supplies beginning on Page 2) must contain a child proof closure (safety cap) and a bottle with a minimum required size of 100cc volume. The safety cap must not exceed the diameter of the bottle. The bottle must have a cylindrical body and minimum of 5.75” circumference. The bottle must fit a label with dimensions of 5.25” x 2”. The 0.5” additional space is required to keep the bar code exposed and/or allow for the display of the expiration date and lot number. Sample pictures (bar code exposed) of how the label must fit the offered bottle are below:
Glass bottles are not acceptable.
Tablets/capsules must be compatible with automated dispensing units (Baxter ATC Canisters, OptiFill, etc.).
15. Labeling All pharmaceutical products provided under this contract shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GSI or HIBCC parameters including, but not limited to: symbology type or encoded pattern, bar and space dimensions and tolerances and allowable ratio of wide to narrow elements.
The bar code may be any linear bar code symbology such as GS1-128 (formerly EAN.UCC), GS1 DataBar (formerly RSS) or Universal Product Code (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 data structure (Global Trade Item Number (GTIN)).
The bar code printing must be American National Standards Institute (ANSI) / International Organization for Standardization (ISO) / IEC quality grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this clause prior to shipping pharmaceutical products to any government prime vendor or authorized ordering activity under this contract.
The bar code must be on the outside container or wrapper of the medication as well as on the immediate container, unless the bar code is readily visible and machine readable through the outside container or wrapper. When the bar code is not easily machine readable through the over-wrap, the over-wrap should contain the bar code. The bar code must go on each cell of a blister pack. Furthermore, the bar code must remain intact under normal conditions of use; thus it should not be printed across the perforations of a blister pack.
When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in “ladder orientation” on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging.
It is required that bar code labeling also include the lot number and expiration date. If two separate distinctive bar codes are used, one for NDC and the other for lot number/expiration date; the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code. When applicable, all Healthcare Distribution Management Association (HDMA) guidelines shall be followed.
16. Therapeutic Equivalence Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. Only FDA approved products with therapeutic equivalence evaluations that resulted in a FDA Therapeutic Equivalence Code (TE Code) of “A” will be considered, unless all drugs in the family group are “B” rated. If all products in a family group have a “B” TE Code, no award will be made to other than the innovator unless the non-innovator vendor submits acceptable data demonstrating bioequivalence.
17. Manufacturing Facilities If at any time during the life of the contract, the contractor’s facility or the source from which the contractor obtains any of the products offered on this contract is informed in a FDA “warning letter” that it fails to meet FDA current good manufacturing practices (cGMP) (21 CFR Part 210 and 211), and/or a facility’s unacceptable FDA…
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