Salients and Items.pdf
PDF 104 KB Posted
- Attached to
- Compound Pharmaceuticals for Dept of Pharmacy, Carl R. Darnall Army Medical Center, Fort Hood, Tx.
- Solicitation number
- 0012380812
- Issued by
-
Department of the Army Medical Command
About this file
This document is a Statement of Objectives (SOO) for compounded pharmaceutical supply services for the Carl R. Darnall Army Medical Center (CRDAMC). The solicitation requires contractors to supply four specific compounded pharmaceutical products in bulk quantities: Succinylcholine Chloride 100 mg (2,640 units), Oxytocin 30 Units in 500 ml solution bags (2,400 units), L.E.T. Solution in topical syringes (1,200 units), and Phenylephrine HCl 1 mg in syringes (1,500 units). All products must maintain a minimum shelf life of 45 days at room temperature. The solicitation explicitly states that partial quantities or partial listed items will not be technically acceptable, and offerors unable to provide the entirety of requested compounds are ineligible for award.
Contractors must comply with comprehensive quality and regulatory requirements including FDA or Pharmacy Compounding Accreditation Board (PCAB) certification, USP Chapter compliance, and Current Good Manufacturing Practices (cGMP) under section 503b. Quality control systems must encompass environmental monitoring, raw material testing, in-process testing, endotoxin testing, sterility and fungal testing, and potency and stability testing with QI/QA certification provided on every batch. Additional contractor requirements include: delivery within four business days of order receipt, minimum one year experience in compound pharmaceutical manufacturing, use of only FDA-approved drugs and containers from authorized sources, Trade Agreements Act (TAA) compliance, delivery within ±10% per USP standards, Drug Quality and Security Act of 2013 compliance, Joint Commission-compliant product labeling, and DEA licensing for controlled substance manufacturing and distribution. The contractor must also provide 24/7 customer service.
View the file
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
To meet and maintain the high-quality standard of the Carl R. Darnall Army Medical Center (CRDAMC), a list of the necessary elements of compliance has been compiled. The requirement for patient specific prescriptions such as those compounded by local pharmacies do not meet specification required for bulk compounds. Below are the items and quantities required:
*NOTE Partial quantities or partial listed items will not be technically acceptable.
ITEM QTY
Succinylcholine Chloride 100 mg (20 mg/ml) 5 ml syringe 2640
Oxytocin 30 Units added to 500 ml 0.9% Sodium Chloride solution bag 2400
L.E.T. (Lidocaine, Epinephrine, Tetracaine) Solution 3 ml in 5 ml Topical Syringe 1200
Phenylephrine HCl 1 mg (100 mcg/ml) 10 ml in 0.9% Sodium Chloride solution 10ml syringe 1500
Minimum Shelf Life and Storage requirements
Succinylcholine Chloride 100 mg (20 mg/ml) 5 ml syringe, (minimum shelf life: 45 days, at room temperature)
Oxytocin 30 Units added to 500 ml 0.9% Sodium Chloride solution bag, (minimum shelf life: 45 days, at room temperature)
L.E.T. (Lidocaine, Epinephrine, Tetracaine) Solution 3 ml in 5 ml Topical Syringe, (minimum shelf life: 45 days, at room temperature)
Phenylephrine HCl 1 mg (100 mcg/ml) 10 ml in 0.9% Sodium Chloride solution 10ml syringe, (minimum shelf life: 45 days, at room temperature)
MUST be able to provide the ENTIRETY of the requested compound pharmaceuticals. If not able to provide the entirety of the items, the offeror is ineligible for award.
Provide documented proof and compliance with the following:
a) Certification/Accreditations: 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. Provide copy in response.
b) USP Chapter: The pharmacy must be compliant with ongoing changes and keeping up to date with requirements imposed by USP Chapter. Products made are performed under the guidance set forth by this organization.
c) 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. May conduct studies to verify and potentially extend stability and use-by dating on all preparations. Vendor shall provide QI/QA certification on every batch regardless of size.
d. In addition to providing the entirety of the requested compound pharmaceuticals the offeror shall meet the following:
o The Contractor shall deliver orders to CRDAMC Ordering Officer within four (4) business days (Monday through Friday, not including Federal Holidays) upon receipt of order.
o The Contractor shall have a minimum of one (1) year experience in Compound Pharmaceutical manufacturing.
o The Contractor shall provide compounded pharmaceuticals meeting or exceeding the minimum shelf life listed in Pharmaceutical Drug List while stored at specified room temperature or refrigerated.
o The Contractor shall use only FDA approved drugs, containers, and diluents (e.g.
ingredients supplied from authorized sources).
o The Contractor shall be in compliant with Trade Agreements Act (TAA) (ingredients supplied from authorized sources).
o The Contractor shall delivery pharmaceuticals within +/- 10% per USP standards.
o The Contractor shall be in compliant with Compounding Quality Act Title I of the
Drug Quality and Security Act of 2013.
o The Contractor shall be in compliant with Current Good Manufacturing Practices
(cGMP) (section 503b).
o The Contractor shall label the product with appropriate drug labeling as per
NPSG.03.04.01 for labeling of all medications to follow Joint Commission.
o The contractor shall comply with all the requirements for facilities that compound drugs (cGMPs requirement under section 503b).
o The Contractor shall provide QI/QA certification on every batch regardless of size.
o The Contractor shall provide 24/7 customer service.
o The contractor must comply with all DEA Licensing requirements for the manufacturing and distribution of controlled substances to the facility.
File details come from the government source that posted it. Updated .