Combined_Synposis_and_Solicitation_Compound_Syringes.pdf

W91YTZ-19-R-0037

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued and is expected to result in the award of a firm-fixed price requirement type contract. The resulting award will be made on SF 1449, for commercial supplies and services. Solicitation number W91YTZ-19-R-0037 is issued as request for quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-01-97 and DPN 20181031 current as of 20 December 2018.

This acquisition is UNRESTRICTED, under size standard 1,250 employees and NAICS code 325413. The Government anticipates awarding a single award for a Compounded Syringe contract. The contractor shall supply a variety of high quality sterile pre-packaged syringes that comply with safety recommendation of the Institute of Safe Medication Practices (ISMP) as well as complying with the Food and Drug Administration (FDA) manufacturing practices:

Syringe Name

Annual Estimated Cases

Atropine 0.4mg/ml, 2.5ml 24 cases Dexamethasone Sodium Phosphate 4mg/ml, 2ml 96 cases Ephedrine Sulfate (PF) in 0.9% NaCl, 5ml 60 cases Esmolol HCI (PF), 10ml 48 cases Glycopyrrolate 0.2mg/ml, 3ml 60 cases Ketamine HCI in 0.9% NaCl, 5ml 48 cases Lidocaine 1% HCI (PF) in 0.9% NaCL, 1ml 276 cases Lidocaine 2% HCI (PF), 5ml 156 cases Phenylephrine HCI (PF) 100mcg/ml in 0.9% NaCl, 10ml 264 cases Rocuronium Bromide (PF) 0.5% in 15ml 108 cases Succinylcholine Chloride (Preserved) 20mg/ml, 10ml 132 cases Vecuronium Bromide 1mg/ml in Sterile Water, 10ml 36 cases

To be delivered FOB Destination to: Eisenhower Army Medical Center 300 East Hospital Road, Fort Gordon, Georgia 30905.

This requirement is for a base period and 4 option year periods. All responsible Small Businesses offers may submit a quotation which will be considered by the agency.

Item No. 0001: Sterile Pre-packaged Compounded Syringes 1 Job The contractor shall provide Dwight D. Eisenhower Army Medical Center (DDEAMC) with all necessary prefilled sterile pre-packaged compound syringes for use within the operating rooms and other procedural areas throughout the hospital in accordance with Attachment 1 Syringe List in the Statement of Work.

Billing shall occur monthly. Ordering Period: 15 June 2019 – 14 June 2020.

Unit Price: _______________________ Total: ______________________

Option Year 1

Item No. 1001: Sterile Pre-packaged Compounded Syringes 1 Job The contractor shall provide Dwight D. Eisenhower Army Medical Center (DDEAMC) with all necessary prefilled sterile pre-packaged compound syringes for use within the operating rooms and other procedural areas throughout the hospital in accordance with Attachment 1 Syringe List in the Statement of Work.

Billing shall occur monthly. Ordering Period: 15 June 2020 – 14 June 2021.

Option Year 2

Item No. 2001: Sterile Pre-packaged Compounded Syringes 1 Job The contractor shall provide Dwight D. Eisenhower Army Medical Center (DDEAMC) with all necessary prefilled sterile pre-packaged compound syringes for use within the operating rooms and other procedural areas throughout the hospital in accordance with Attachment 1 Syringe List in the Statement of Work.

Billing shall occur monthly. Ordering Period: 15 June 2021 – 14 June 2022.

Option Year 3

Item No. 3001: Sterile Pre-packaged Compounded Syringes 1 Job The contractor shall provide Dwight D. Eisenhower Army Medical Center (DDEAMC) with all necessary prefilled sterile pre-packaged compound syringes for use within the operating rooms and other procedural areas throughout the hospital in accordance with Attachment 1 Syringe List in the Statement of Work.

Billing shall occur monthly. Ordering Period: 15 June 2022 – 14 June 2023.

Option Year 4

Item No. 4001: Sterile Pre-packaged Compounded Syringes 1 Job The contractor shall provide Dwight D. Eisenhower Army Medical Center (DDEAMC) with all necessary prefilled sterile pre-packaged compound syringes for use within the operating rooms and other procedural areas throughout the hospital in accordance with Attachment 1 Syringe List in the Statement of Work.

Billing shall occur monthly. Ordering Period: 15 June 2023 – 14 June 2024.

Unit Price: _____________ Total: _______________________

Total Base Period Plus four (4) Option Periods:

The following FAR Clauses and Provisions in their latest editions apply to this solicitation.

52.212-1 Instructions to Offers –Commercial Items JAN 2017

Addendum to FAR 52.212-1 Instructions to Offerors—Commercial Items

FAR 52.212-1 is hereby amended to reflect the changes shown below:

Para (b) Submission of offers

All offerors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make an offer ineligible for award. Offerors may obtain information on registration Internet at https://www.sam.gov. Or the SAM Help desk at https://www.fsd.gov.

THE SOLICITATION MUST BE QUOTED ALL OR NONE.

All questions shall be submitted via email no later than 12:00PM EST June 3, 2019 to valerie.j.deveaux.civ@mail.mil and sebrena.l.lane.civ@mail.mil . Responses will be posted to the Federal Business Opportunities website. Proposals are being accepted via email only. All responsible sources should submit proposals to Valerie DeVeaux via e-mail:

valerie.j.deveaux.civ@mail.mil by June 7, 2019 12:00 PM EST. (n) the non-Far Part 12 discretionary FAR, DFARS, AFARS and MEDCOM provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 for locations where full text can be obtained.

Cover email shall include: Data Universal Numbering System (DUNS) / CAGE Code, Point of contact for individual authorized to enter in to discussions to include phone and email.

All offers must request verification by email to Valerie DeVeaux Email:

valerie.j.deveaux.civ@mail.mil to confirm receipt of their proposal was received by the time specified in the solicitation. The Government will not be responsible for any failure of transmission or receipt of the offer, or any failure of the offeror to verify receipt of the emailed offer.

https://www.sam.gov/ https://www.fsd.gov/ mailto:valerie.j.deveaux.civ@mail.mil mailto:sebrena.l.lane.civ@mail.mil mailto:valerie.j.deveaux.civ@mail.mil

Instructions for the Preparation of Proposals:

The proposal shall be prepared in two (2) separate volumes as indicated below.

• Volume I-Technical

• Volume II-Pricing

VOLUME I – TECHNICAL

The technical proposal, Volume I, shall be addressed in sufficient written detail for the Government to determine if the offeror understands this aspect of the Government’s requirement. The offeror shall address each factor separately, and shall provide sufficient narrative and supporting data for each factor. Lack of any of these significant capabilities shall be considered sufficient cause for the proposal to be determined unacceptable. The Technical Proposal shall provide sufficient detail for the Government to determine whether the proposal acceptably meets the requirements of the solicitation. Statements that the offeror understands, can or will comply with all specifications, or statements paraphrasing the specifications of parts thereof, or phrases such as “standard procedures will be used” or “well-known techniques will be used” will be considered unacceptable. The technical proposal shall provide a narrative and supporting data with the following sections organized separately so that the evaluation factors listed below are included.

VOLUME II – PRICING

Assessment of price reasonableness based on comparison to market prices.

a. The offeror shall submit proposed pricing for all subcontract Line Item Numbers (subCLINs) identified in the Request for Proposal, unless otherwise noted. The offeror shall limit their unit and extended prices to two (2) decimal places (example: $158.03).

b. The offeror shall submit pricing totals for the base period and option years individually, as well as a grand total.

CLAUSES INCORPORATED BY REFERENCE

52.203-2 Certificate of Independent Price Determination APR 1985 52.203-11 Certification and Disclosure Regarding Payment

To Influence Certain Federal Transactions

SEP 2007

52.204-7 System for Award Management OCT 2018 52.204-16 Commercial and Government Entity Code

Reporting

JUL 2016

52.222-22 52.222-46

Previous Contracts And Compliance Reports Evaluation of Compensation for Professional Employees

FEB 1999

FEB 1993

52.223-1 52.225-25

Bio Based Product Certification Prohibition on Contracting with Entities Engaging In Certain Activities or Transactions Relating to Iran-Representation and Certification

MAY 2012

OCT 2015

Incorporated by Full Text

52.209-2

52.209-7

Prohibition on Contracting with Inverted Domestic Corporations-Representations Information Regarding Responsibility Matters

NOV 2015

JUL 2013

52.209-11

52.215-20

Representation by Corporations Regarding Delinquent Tax Liability or A Felony Conviction Under Any Federal Law Requirements For Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Date (OCT 2010) Alternative IV (OCT 2010)

FEB 2016

52.216-1 Type of Contract: Firm Fixed Price APR 1984 52.222-25 52.233-2

Affirmative Action Compliance Service of Protest

APR 1984

SEP 2006

52.252-1 (FEB 1998), Solicitation Provisions Incorporated by Reference: The full text of a solicitation provision may be accessed electronically at this/these address (es):

www.farsite.hill.af.mil or www.arnet.gov/far.

52.252-5, Authorized Deviations in Provisions (APR 1984): (b) the use in this solicitation or contract of any DoD FAR Supplement (48 CFR Chapter 2) provision with an authorized deviation is indicated by the addition of “(DEVIATION)" after the name of the regulation.

252.203-7005 Representation Relating to Compensation of Former DOD

Officials

NOV 2011

252.204-7008

252.204-7011 252.213-7000

252.215-7007 252.215-7008 252.222-7007 252.225-7020 252.225-7035

Compliance With Safeguarding Covered Defense Information Controls Alternate Line-Item Structure Notice to Prospective Supplies on Use of Past Performance Information Retrieval System-Statistical Reporting in Past Performance Evaluations Notice of Intent to Resolicit Only One Offer Representation Regarding Combating Trafficking in Persons Trade Agreements Certificate Buy American Free Trade Agreements-Balance of Payments Program Certificate-Basic

OCT 2016

SEP 2011

JUN 2015

JUN 2012

OCT 2013

JAN 2015

NOV 2014

NOV 2014

252.247-7022 Reprensentation of Extent Of Transportation By Sea AUG 1992

52.212-2

Evaluation –Commercial Items

OCT 2014

Addendum 52.212-2 (LPTA):

Paragraph (a) replaced with the following:

http://www.farsite.hill.af.mil/ http://www.arnet.gov/far

Award will be made using the lowest price technically acceptable (LPTA) source selection process. Award will be made to the responsible offeror on the basis of the lowest evaluated price of proposals meeting or exceeding the acceptability standards for non-cost factors. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary.

The Government will award a Firm Fixed Price contract resulting from this solicitation to the responsible Offer whose offer conforming to the solicitation will be the most advantageous for the Government, price and other factors considered. In order to be considered for award, an Offeror must receive an Acceptable rating in all factors. The following factors shall be used to evaluate:

Technical and Price

Award will be made based on lowest price, technically acceptable proposal.

(a) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contractor without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

FACTOR: I TECHNICAL

Sub factor 1. Delivery – A plan for delivery of syringes found in Attachment 1 when severe or catastrophic events happen (i.e. severe weather)

Sub factor 2. Identification - Documentation of how your company meets the salient characteristics.

SALIENT CHARACTERISTICS

Compounded syringes shall be labeled with adequate identification of medications.

Syringes shall meet the minimum standard of shelf life as set by FDA, USP and other applicable guidelines

Compounded syringes shall have luer-lock connections and covers

Compounded syringes shall state: Medication concentrations will either be as indicated or be mixed in standard concentrations.

ACCEPTABLE: To be rated acceptable, the offeror's technical proposal must demonstrate it can meet all specifications and testing requirements.

UNACCEPTABLE: A technical proposal that fails to demonstrate it can meet one or more requirements will be determined unacceptable.

FACTOR II: PRICE

Price will be evaluated separately from Technical and will be evaluated for fairness and reasonability. The offeror shall complete the CLIN structure with a total cost covering a base period and four option years developed based upon the annual estimated cases required for compound syringes. This information will be used to assist in the price analysis as required by FAR 15.404-1(b).

52.212-3 Offeror Representations and Certifications--Commercial Items (JAN 2017) Alternate I OCT 2014

52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017

52.212-4 ADDENDUM

(w) the non-FAR Part 12 discretionary FAR, DFARS, AFARS, and Local clauses herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found.

52.203-3 Gratuities APR 1984 52.203-6 Restrictions on Subcontractor Sales to the

Government-Alternate I

SEP 2006

52.203-12 Limitation on Payments to Influence Certain Federal Transactions

OCT 2010

52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights

APR 2014

52.204-4 Printed or Copied on Double-sided Post Consumer Fiber Content Paper

MAY 2011

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards

OCT 2018

52.204-13 System for Award Management Maintenance OCT 2018 52.204-18 Commercial and Government Entity Code

Maintenance

JUL 2016

52.209-6

52.209-9

52.219-9

Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment Updates of Publically Availability Information Regarding Responsibility Matters Small Business Subcontracting Plan

OCT 2018

JAN 2017

52.219-6 Notice of Total Small Business Set-Aside NOV 2011

52.219-8 Utilization of Small Business Concerns OCT 2011

52.219-14 Limitations on Subcontracting JAN 2017

52.219-16 Liquidated Damages—Subcontracting Plan JAN 1999 52.222-3 52.222-19

Convict Labor Child Labor-Cooperation With Authorities and Remedies

JUN 2003

JAN 2014

52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity APR 2015 52.222-35 Equal Opportunity For Veterans OCT 2015 52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-37 Employment Reports on Veterans OCT 2015 52.222-50 Combating Trafficking in Persons MAR 2015 52.223-2 Affirmative Procurement of Bio based Products

Under Service and Construction Contracts

SEP 2013

52.223-3 Hazardous Material Identification and Material Safety Data

JAN 1997

52.223-5 Pollution Prevention and Right-to-Know Information

MAY 2011

52.223-18 Encouraging Contractor Policies To Ban Text Messaging While Driving

AUG 2011

52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.228-5 Insurance—Work on A Government Installation JAN 1997 52.232-33 Payment by Electronic Funds Transfer--System for

Award Management

OCT 2018

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.237-2 Protection Of Government Buildings, Equipment, And Vegetation

APR 1984

52.242-5 52.242-13

Payment to Small Business Subcontractors Bankruptcy

JAN 2017

JUL 1995

52.244-2 Subcontracts OCT 2010 52.246-16 Responsibility for Supplies APR 1984

252.203-7000 Requirements Relating to Compensation of Former

DoD Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights

SEP 2013

252.204-7003

252.209-7004

252.219-7003

Control Of Government Personnel Work Product

Subcontracting With Firms That Are Owned Or Controlled By the Government of A Country That is A State Sponsor of Terrorism Small Business Subcontracting Plan (DOD Contracts)

APR 1992

MAR 2016

252-225-7002 252.225-7012 252.225-7021

Qualifying Country Sources as Subcontractors Preference for Certain Domestic Commodities Trade Agreements

AUG 2016

DEC 2017

DEC 2017

252.225-7048 252.226-7001

Export-Controlled Items Utilization of Indian Organizations, Indian-Owned Economic Enterprises, And Native Hawaiian Small Business Concerns

JUN 2013

SEP 2004

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

JUN 2012

252.232-7006 Wide Area Workflow Payment Instructions MAY 2013 252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustments DEC 2012

Incorporated in Full Text

52.209-10 Prohibition On Contracting With Inverted Domestic

Corporations

NOV 2015

(End of clause)

52.217-7 Option for Increased Quantity—Separately Priced Line Item MAR 1989

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days before the contract expires. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

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 within 30 days (insert the period of time within which the Contracting Officer may exercise the option); provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 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 60 months

52.219-28 Post Award Small Business Program Re-representation JUL 2013 52.222-40

Notification of Employee Rights Under the National Labor Relations Act

DEC 2010

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):

www.farsite.hill.af.mil.

(End of clause)

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any DoD FAR Supplement (48 CFR Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

OCT 2016

252.204-7015 Disclosure of Information to Litigation Support Contractors

MAY 2016

252.216-7006 Ordering MAY 2011

252.244-7000 Subcontracts for Commercial Items and Commercial Components

JUN 2013

252.247-7023 252.247-7024

Transportation of Supplies by Sea-Basic Notification of Transportation of Supplies By Sea

APR 2014

MAR 2000

End of Additional FAR and DFARS clauses

Incorporated in Full Text http://www.farsite.hill.af.mil/

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Deviation 2013-O0019)

JAN 2017

HIPPA-Health Insurance Portability and Accountability Act (7 July 2014)

TFMC-Tobacco Free Medical Campus

LEIE (October 2015)

Wide Area Work Flow - Instructions

WAWF is the authorized method to electronically process vendor request for payment. This application allows DOD vendors to submit and track Invoices and Receipt/Acceptance documents electronically. Contractor shall (i) register to use WAWF at https://wawf.eb.mil and

(ii) ensure an electronic business point of contract (POC) is designated in the System for Award Management at https://www.sam.gov within ten (10) calendar days after award of this contract/order.

WAWF Instructions:

Questions concerning payments should be directed to the Defense Finance and Accounting Service (DFAS) location listed in Block 18a of your purchase order/contract. Please have your purchase order/contract number ready when calling about payments.

You can easily access payment and receipt information using the DFAS web site at http://www.dfas.mil/dfas/contractorsvendors/poemail.html. Your purchase order/contract number or invoice number will be required to inquire status of your payment.

The following codes and information will be required to assure successful flow of WAWF documents.

Foreign Vendors will submit banking information in the Comments Tab of the WAWF invoice.

TYPE OF DOCUMENT [X the appropriate block]

___ Invoice (Contractor Only)

_X__ Invoice and Receiving Report (COMBO)

___ Invoice as 2-in-1 (Services Only)

___ Receiving Report (Government Only)

CAGE CODE:

ISSUE BY DODAAC: W91YTZ

ADMIN BY DODAAC: W91YTZ

https://wawf.eb.mil/ https://www.sam.gov/ http://www.dfas.mil/dfas/contractorsvendors/poemail.html https://wawf.eb.mil/SUM%20RoboHelp%20Web%20Help/Detailed_Document_Information/Scribble550.htm https://wawf.eb.mil/SUM%20RoboHelp%20Web%20Help/Detailed_Document_Information/Scribble560.htm https://wawf.eb.mil/SUM%20RoboHelp%20Web%20Help/Detailed_Document_Information/Scribble570.htm https://wawf.eb.mil/SUM%20RoboHelp%20Web%20Help/Detailed_Document_Information/Scribble620.htm

INSPECT BY DODAAC:

ACCEPT BY DODAAC:

SHIP TO DODAAC:

PAYMENT OFFICE FISCAL STATION CODE: HQ0490

EMAIL POINTS OF CONTACT LISTING: (Use Group e-mail accounts if applicable)

INSPECTOR Primary:

Alternate:

ACCEPTOR Primary:

Alternate:

RECEIVING OFFICE POC: Primary:

Alternate:

CONTRACT ADMINISTRATOR/ SPECIALIST: valerie.j.deveaux.civ@mail.mil DSN: 389- Comm: - Fax:

CONTRACTING OFFICER:

ADDITIONAL CONTACT: Customer Service, PH:

Any modification requests must be in writing and submitted to: ADMIN DODAAC.

(End)

STATEMENT OF WORK

Dwight D. Eisenhower Army Community Hospital

Pharmaceutical Compounding Performance Requirements Fort Gordon, GA

1. The minimum requirements for commercially prepared products have been established based on the DDEAMC Department of Pharmacy’s mission and best pharmacy practices.

2. The Contractor must deliver orders to DDEAMC within 14 days, Monday through Friday, not including Federal Holidays, from receiving the order. The Contractor shall provide procedures for placement of emergency orders to be delivered within 5 business days. Additionally, the Contractor shall provide a plan for delivery when severe or catastrophic events happen (e.g., severe weather).

3. The Contractor shall have at a minimum of one year experience in compound pharmaceutical manufacturing.

4. The Contractor shall provide the shelf life for each compounded pharmaceuticals proposed.

Pharmaceutical shelf life shall meet the minimum standard as set forth by FDA, USP, and other applicable guidelines.

5. The contractor shall be compliant with the Regulations, Guidelines and Certification standards;

a. The Contractor shall be compliant with Trade Agreements Act (ingredients supplied from authorized sources).

b. The Contractor shall be compliant with Compounding Quality Act Title I of the Drug Quality and Security Act of 2013.

c. The Contractor shall be compliant with Current Good Manufacturing Practices (CGMP) requirements under section 501(a) (2) (B).

d. The Contractor shall label the product with adequate directions for use (CGMP requirements under section 502(f) (1)) and make any modification to the packaging and labeling of the product if DDEAMC requests due to patient safety concerns.

e. The Contractor shall be compliant with all the requirements for facilities that compound drugs (CGMP requirements under section 503B).

f. The Contractor shall have Food and Drug Administration (FDA) approval prior to marketing (CGMP requirements under section 505).

g. The Contractor shall comply with all DEA licensing requirements for the manufacturing and distribution of controlled substances prepared and shipped to the government facility.

h. FDA or Pharmacy Compounding Accreditation Board (PCAB) certification. The company will have an active certification which will be maintained annually to ensure the products are conducted with strict adherence to quality standards and principles of professional compounding.

i. USP Chapter 797: The compounding pharmacy must be compliant with ongoing changes and keep up to date with requirements imposed by USP Chapter 797. Products made are performed under the guidance set forth by this organization.

j. Quality Control: A system of quality checks which include environmental monitoring, raw material testing, in-process testing, endotoxin testing, product sterility and fungal testing as well as potency and stability testing of finished preparations. Vendor shall provide QI/QA certification on every batch regardless of size.

6. Contractor shall provide formal procedures for conducting recalls of any of its compounded preparations.

ATTACHMENT 1

ITEM NO: SUPPLY/SERVICE PROJECTED

USAGE PER

MONTH

UNIT COST

PER

CASE

BASE

YR

TOTAL

COSTS

01 2% Lidocaine preservative free

14 CASE

02 Atropine 2 CASE 03 Dexamethasone 8 CASE 04 Ephedrine 6 CASE 05 Esmolol 4 CASE 06 Glycopyrrolate 6 CASE 07 Ketamine 4 CASE 08 Phenylephrine 24 CASE 09 Rocuronium 9 CASE 10 Succinylcholine 12 CASE 11 Vecuronium 3 CASE

MONTH

UNIT COST

PER

CASE

OY 1

TOTAL

COSTS

01 2% Lidocaine preservative free

14 CASE

02 Atropine 2 CASE 03 Dexamethasone 8 CASE 04 Ephedrine 6 CASE 05 Esmolol 4 CASE 06 Glycopyrrolate 6 CASE 07 Ketamine 4 CASE 08 Phenylephrine 24 CASE 09 Rocuronium 9 CASE

MONTH

UNIT COST

PER

CASE

OY 2

TOTAL

COSTS

01 2% Lidocaine preservative free

14 CASE

02 Atropine 2 CASE

03 Dexamethasone 8 CASE 04 Ephedrine 6 CASE 05 Esmolol 4 CASE 06 Glycopyrrolate 6 CASE 07 Ketamine 4 CASE

08 Phenylephrine 24 CASE 09 Rocuronium 9 CASE

MONTH

UNIT COST

PER

CASE

OY3

TOTAL

COSTS

01 2% Lidocaine preservative free

14 CASE

02 Atropine 2 CASE 03 Dexamethasone 8 CASE 04 Ephedrine 6 CASE 05 Esmolol 4 CASE 06 Glycopyrrolate 6 CASE 07 Ketamine 4 CASE 08 Phenylephrine 24 CASE 09 Rocuronium 9 CASE

MONTH

UNIT COST

PER

CASE

OY 4

TOTAL

COSTS

01 2% Lidocaine preservative free

14 CASE

02 Atropine 2 CASE 03 Dexamethasone 8 CASE 04 Ephedrine 6 CASE 05 Esmolol 4 CASE 06 Glycopyrrolate 6 CASE 07 Ketamine 4 CASE 08 Phenylephrine 24 CASE 09 Rocuronium 9 CASE