SOURCES SOUGHT
99 -- Compound Pharmaceuticals
- Notice Date
- 1/22/2020 11:17:54 AM
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- W40M USA HLTH CONTRACTING ACT JBSA FT SAM HOUSTON TX 78234-0000 USA
- ZIP Code
- 78234-0000
- Solicitation Number
- 27-January-2020
- Response Due
- 1/27/2020 7:00:00 AM
- Archive Date
- 02/11/2020
- Point of Contact
- Donald Sanders, Phone: 254-287-8881, Fax: 254-553-3906
- E-Mail Address
-
donald.d.sanders6.civ@mail.mil
(donald.d.sanders6.civ@mail.mil)
- Description
- This is a Sources Sought Notice announcement; market survey for information only, to be used for preliminary planning purposes. ��No proposals are being requested or accepted with this synopsis. �THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE.� Any requests for a solicitation in response to this notice will not be honored.� The Regional Health Contracting Office - Central, has a requirement for Compounded Pharmaceuticals with delivery to Fort Hood, TX 76544.� It is anticipated that the proposed award will result in a Firm Fixed-Priced contract.� Anticipated Requirement for Compounded Pharmaceuticals: Ephedrine Sulfate PF 25 mg (5 mg/ml) 5 ml in 0.9% SodiumChloride solution in 5 ml BD syringe Phenylephrine HCL 1 mg (100 mcg/ml) 10 ml in 0.9% Sodium Chloride solution 10 ml BD syringe * The vendor must be able to provide all of the above compounded pharmaceuticals. In order to meet and maintain the high quality standards of Carl R. Darnall, a list of the necessary elements of compliance have been compiled. The requirements for patient specific prescriptions such as those compounded by local pharmacies do not meet specifications required for bulk compounds. Below are the various qualities that will meet the rigorous compounding requirements for those bulk sterile products unavailable by commercial means. a. The Contractor shall deliver orders to CRDAMC within four (4) business days (Monday through Friday not including Federal Holidays) from receiving the order. b. The Contractor shall have at a minimum one (1) year experience in Compound Pharmaceutical manufacturing. c. The Contractor shall provide compounded pharmaceuticals meeting or exceeding the minimum shelf life listed in the below Pharmaceutical Drug List while stored at specified room temperature or refrigerated. d. The Contractor shall be in compliant with Trade Agreements Act (TAA) (ingredients supplied from authorized sources). e. FDA allows +/- 15%, however, the Contractor shall delivery pharmaceuticals within +/- 10%. f. The Contractor shall be in compliant with Compounding Quality Act Title I of the Drug Quality and Security Act of 2013. g. The Contractor shall be in compliant with Current Good Manufacturing Practices (CGMP) (section 501(a)(2)(B). h. The Contractor shall Label with adequate directions for use (CGMP) requirements under (section 502(f)(1) and make any modification to the packing and labeling of product if CRDAMC requests due to patient safety concerns. i. The contractor shall comply with all the requirements for facilities that compound drugs (cGMPs requirement under section 503B). j. The Contractor shall have Food and Drug Administration (FDA) approval prior to marketing (CGMP) (section 505). k. The Contractor shall provide QI/QA certification on every batch regardless of size. l. The contractor must comply with all DEA Licensing requirements for the manufacturing and distribution of controlled substance to the facility. The type of solicitation issued will be based upon the responses to this synopsis.� Contact with Government Personnel, other than the Contract Specialist identified at the bottom of this notice, by any potential offeror, or their employees�, regarding this requirement is strictly prohibited. The purpose of this synopsis is to gain knowledge of interest, capabilities and qualifications of various members of the Small Business Community to include Section 8(a), Historically Underutilized Business Zones (HUB-Zone), Women-Owned Small Business, and Service-Disabled Veteran-Owned Small Business (SDVOSB), as well as the interest, capabilities and qualifications of various members of the Large Business community, to compete and perform a Firm Fixed Price Contract for these services.� The type of solicitation to issue will depend upon the responses to this sources sought synopsis.� The Government must ensure there is adequate competition among the potential pool of responsive contractors. The North American Classification System (NAICS) code for this requirement is 325412 � �Pharmaceutical Preparation Manufacturing�.� The Small Business Size Standard is 1,250 employees. Responses to this Sources Sought Notice should demonstrate the firm�s ability, capability, and responsibility to deliver the supplies listed above.� In response to this notice, interested parties shall submit a written Statement of Capability limited up to five (5) pages and shall include the following information: �Offeror�s name, address, point of contact, phone number, and e-mail address. �Offeror�s interest in providing a proposal/quote on the solicitation when it is issued. �Offeror�s capability to meet the requirements. �Offeror�s type of small business and Business Size (Whether 8(a), HUB Zone, Women-Owned Small Business, Service Disabled Veteran Owned Small Business, etc.), or Large Business Status, should be documented in the Statement of Capability. Interested parties are responsible for marking information that is proprietary in nature.� No reimbursement will be made for any costs associated with providing information in response to this notice or any follow up information requests.� The Government is not obligated to, nor will it, pay for or reimburse any costs associated with responding to this sources sought notice.� This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.� No subcontracting opportunity is anticipated.� A determination by the Government to not compete this proposed contract action based on the responses to this notice is solely within the discretion of the Government. Interested Offerors shall respond to this Sources Sought Notice no later than 27 January 2020 at 9:00 A.M. Central Standard Time. All interested businesses must be registered in the Central Contractor�s Registration (CCR) through the System for Award Management (SAM) at www.sam.gov to be eligible for award of Government contracts. Fax or email your response Don Sanders, Contract Specialist to FAX # 254-553-3906 or email: donald.d.sanders6.civ@mail.mil. Telephonic inquiries will not be honored.� EMAIL IS THE PREFERRED METHOD.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/f5fb22c4e8db4504a50ed4913ed6be08/view)
- Place of Performance
- Address: Fort Hood, TX 76544, USA
- Zip Code: 76544
- Country: USA
- Zip Code: 76544
- Record
- SN05541014-F 20200124/200122230154 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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