Compound Pharmaceuticals

Extended synopsis/solicitation to answer Q & A. Extended until 24 September 2019, 12pm CT.

Question 1: Is this a brand new solicitation or is it a continuation of a similar solicitation from past years?

New

Question 2: If it is a continuation of a similar solicitation from past years, are you at liberty to divulge the name of the supplier from past years solicitation?

Not applicable

Question 3: Similar to Question 2, can you divulge information on the cost of goods for each item paid in past years for this type of solicitation?

Not applicable

Question 4: Can I request an extension on the deadline for submission of RFQ? Presently, the deadline is Sept 18, 2019, 3.00 PM CST? Is it possible to get an extension until Sept 20, 2019, 3:00 PM CST?

Extended until 24 September, 2019 at 12:00pm CT.

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This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and FAR Part 13 Simplified Acquisition Procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is W81K00-19-Q-0354 and is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-04 and Defense Federal Acquisition Regulation Supplement Publication Notice (DPN) 20190809.

This solicitation is for Compound Pharmaceuticals for Brooke Army Medical Center, JBSA Fort Sam Houston, TX. The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, with a size standard of 1,250 employees. This procurement is being conducted as a 100% Small Business Set Aside. All eligible businesses may submit an offer, which will be considered.

Quotes are due by 18 September 2019, at 3:00 PM, Central Standard Time. The point of contact is MAJ Stefanie Moore at stefanie.k.moore.mil@mail.mil, offers shall be submitted via e-mail. Questions shall be submitted via e-mail not later than 16 September 2019, at 12:00 PM, Central Standard Time. No questions will be entertained after this date.

Paper copies of this solicitation will not be physically issued, and telephone and faxed requests for the solicitation will not be honored.

Salient Characteristic:

CLIN 0001 Dexamethasone 24mg/mL 1mL Syringe PF 24mg/1mL(1mL Syringe)*Preservative Free
• Contain 24mg/ml of preservative free dexamethasone in 1 ml sterile
water for injection
• Will be packaged in 3 ml individually labeled luer lock syringes that are
sealed with a cap
• Must be stable for 90 days at room temperature

CLIN 0002 Dilating Ophthalmic drops 12mL of Tropicamide 1% and Phenylephrine 5% with Edetate Disodium as a buffer and Benzalkonium Chloride as a preservative. total of 15mL in a sterile eye dropper bottle"
• Will contain 12mL of compounded solution
• Will contain active ingredients Tropicamide 1% and Phenylephrine 5%
• Will contain inactive ingredients to buffer the solution, and benzalkonium
chloride as a preservative at 0.02%
• Will be packaged in a sterile eye dropper bottle
• Must be stable for 90 days at room temperature
CLIN 0003 Phenol 6% in Sterile Water for inj. 10mL 10 ml Phenol crystals In Sterile Water in 10mL vials or Syringe
• Will contain Phenol 6% QS to 10ml with sterile water for inj.
• Will be packaged in Vials or syringes
CLIN 0004 Tetracaine HCl 6% Topical Viscous Solution in Sterile Water Tetracaine HCL Hydroxyethyl Cellulose in sterile water
• Will contain tetracaine 6% in a viscous solution of hydroxyl cellulose in sterile water.
• Will be packaged in a 10 ml syringe
• Must be stable for 90 days at room temp

CLIN 0005 Glycerin 48%/Lido 1%/Epi 1:100,000 in 5ml Glycerin/Lidocaine/Epinephrine Will consist of 1.5ml of Lidocaine 1% with Epinephrine 1:100,000, and 3.5ml of Glycerin Injection 70%
• Will contain Glycerin/Lidocaine/Epinephrine Will consist of 1.5ml of
• Lidocaine 1% with Epinephrine 1:100,000, and 3.5ml of Glycerin Injection 70%
• Will be packaged in a syringe containing 5ml of product.
• Must be stable for 90 days at room temperature

CLIN 0006 BLT:Benzocaine/Lidocaine/Tetracaine/DMSO " Benzocaine 0.2 grams per gram(20%), Lidocaine 0.1 grams per gram(10%), Tetracaine 0.06 grams per gram(6%), and DMSO 0.2ml per gram or 10%, and packaged in a jar
• Will contain Benzocaine 0.2 grams per gram(20%), Lidocaine 0.1 grams per gram(10%), Tetracaine 0.06 grams per gram(6%), and DMSO 0.2ml per gram or 10% QS with a cream base
• Will be packaged with 30g in a small jar for dispensing with label affixed.
• Must be stable at room temperature for 90 days

CLIN 0007 Boric Acid (ear Capsule) Boric Acid 150mg per cap and packaged in #4 size clear gelatin caps
• Will contain Boric Acid 150mg per cap packaged in #4 size clear gelatin caps
• Must have a stability of 60 days at room temperature and packaged in an amber vial

CLIN 0008 CASH Capsules (Chloramphenical 50mg/ Amphotercin 5mg/Sulfacetamide 0.05gm/Hydrocortisone Acetate 0.001gm)
• Chloramphenicol 0.05gm or 5% per cap, Sulfacetamide 0.05gm or 5% per cap, Amphotericin B 0.005gm or 0.5%,Hydrocortisone Acetate 0.001gm or 0.1% per cap packaged in #3 white capsules
• Will contain Chloramphenicol 0.05gm or 5% per cap, Sulfacetamide 0.05gm or 5% per cap, Amphotericin B 0.005gm or 0.5%,Hydrocortisone Acetate 0.001gm or 0.1% per cap packaged in #3 or #4 white capsules
• Must be stable for 90 days at room temperature

CLIN 0009 Naloxone 1mg/ml 2ml Oral Syringe
• Will contain a solution of Naloxone 1mg/ml Will be 2mls in volume
• Will be packaged in an oral syringe with a tamper evident cap
• Will not have a luer lock tip
• Will be labeled for oral use only
• Must have a Beyond Use Date of no less than 30 days

CLIN 0010 Ketamine 2500mg/250mL 0.9% Normal Saline 2500mg/250mL in Normal Saline
• Will contain ketamine 2500mg packaged in a 250 ml bag of 0.9% NaCl
• Will have a label affixed to each bag specifying the contents
• Must be stable for 45 days at room temperature

VENDOR REQUIREMENTS

1. This is a list of the Brooke Army Medical Center (BAMC) Department of Pharmacy
minimum requirements for commercially prepared products.
2. The minimum requirements for commercially prepared products have been
established based on the Department of Pharmacy's mission and best pharmacy practices.
3. The Contractor must deliver orders to BAMC within 3-4 business days, preferred 2-3 business
days, Monday through Friday not including Federal Holidays from receiving the order.
a. The Contractor shall have at a minimum one year of experience in Compound Pharmaceutical manufacturing.
b. The Contractor shall provide compounded pharmaceuticals meeting the minimum shelf-life and potency within +/- 10% of the medication label.
c. The Contractor shall be in compliance with the Trade Agreements Acts (ingredients supplied from authorized sources).
d. The Contractor shall be in compliance with Compounding Quality Act Title I of the
Drug Quality and Security Act of 2013.
e. The Contractor shall be in compliance with Current Good Manufacturing Practices (cGMPs) requirements under section 501(a)(2)(B).
f. The Contractor shall label the product with adequate directions for use (cGMPs requirements under section 502(f)(1)) and make any modification to the packaging and labeling of product if BAMC requests due to patient safety concerns.
g. The Contractor shall label the product with appropriate drug labeling as per NPSG
03.04.01 for labeling of all medications to be in compliance with The Joint Commission.
h. The Contractor shall be in compliance with all of the requirements for facilities that compound drugs (cGMP requirements under section 5038).
i. The Contractor shall have Food and Drug Administration (FDA) approval prior to marketing (cGMP requirements under section 505).
j. The Contractor shall provide Quality Improvement/Quality Assurance (QI/QA) certification on every batch regardless of size.
k. The Contractor must comply with all DEA licensing requirements for the manufacturing and distribution of controlled substances to the facility.
l. Documented proof for item (1) listed below must accompany the Request for Quote, in order to be considered for award; additionally the vendor must be in compliance with items (2) and
(3) below:
(1) Certification/Accreditation: 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.
(2) USP Chapter : The compounding pharmacy must be compliant with ongoing changes and keeping up to date with requirements imposed by USP Chapter . Products made are prepared under the guidance set forth by this organization.
(3) 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.

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