Question and Answer.pdf

Question #1: Couple of questions regarding this solicitation is this an all or none RFQ this a very sizable list of compounds. Also do you have any estimated quantities for this list? Please advise and thank you!

Answer #1: The attached document has the medications we will be primarily ordering.

Quantities depends on OR schedule. With Covid-19 among us it is hard to say how much.

It will range from 1 to 300 per month for example. See list below (we do not have an all-inclusive list of historical estimates for each drug).

Question #2: Is the Naval Medical Center San Diego the only site that orders will be shipped to?

Answer #2: Yes.

Question #3: Is there an estimate of volume by drug or historical volume data available for any products?

Answer #3: 1-300 approximately per month (primary meds to be ordered attached). Please keep in mind this is more or less, not exact. See list below (we do not have an all-inclusive list of historical estimates for each drug).

Question #4: For shipping purposes, is there an estimated quantity (eaches) which would be shipped with one order?

Answer #4: Orders will be placed as needed.

ITEM NO. DRUG NAME STRENGTH SIZE FORM

1 PHENYLEPHRINE 100MCG/ML 5ML FILL SYRINGE

2 EPHEDRINE 5MG/ML 5ML FILL SYRINGE

3 ROCURONIUM 10MG/ML 5ML FILL SYRINGE

4 GLYCOPYRROLATE 0.2MG/ML 2ML FILL SYRINGE

5 NEOSTIGMINE 1MG/ML 5ML FILL SYRINGE

6 SUCCINYLCHOLINE 20MG/ML 5ML FILL SYRINGE

7 ATROPINE SULFATE 0.4MG/ML 2.5ML FILL SYRINGE

8 EPINEPHRINE HCL PF 10MCG/ML 5ML FILL SYRINGE

9 MORPHINE SULFATE PF 5MG/ML in 0.9% sodium chloride 30ML MONOJECT BARREL

10 HYDROMORPHONE 1MG/ML in 0.9% sodium chloride 30ML MONOJECT BARREL

Question #5: What are the time frames for this contract?

a. Start and end dates

b. Contact length (is this an initial contract for 5 months, with 4 1-month renewals?)

Answer #5: We have updated the time frames for this contract. We will be only doing base plus 1 option quantity.

a. Estimated start date for Base: July 16, 2020- July 15, 2021 Option Quantity 1: July 16, 2021 – July 15, 2022

b. See “a.”

Question #6: Could you provide estimated monthly usage and ordering cadence for each product

(ex. 40 units per month, ordered at 10 /week)?

Answer #6: Here are the approximate quantities we may possibly order. See list below (we do not have an all-inclusive list of historical estimates for each drug).

Question #7: Several of the product descriptions include the terms "(S-S)" and "(API)" a.Please clarify what you mean by these abbreviations b.If a description says "(API)" and we have a "(S-S)" alternative, would you consider that substitution?

Answer #7:

a. and b.

API stands for Active Pharmaceutical Ingredients which are the base active component to make drug/medication.

Compounding that utilizes API as the starting material is commonly known as “non-sterile to sterile” compounding. Both processes produce a sterile product. In the API-based or “non-sterile to sterile” process, sterility is assured by the product being sterile filtered immediately prior to filling into sterile containers.

When a compounder produces a batch of a given drug product using “non-sterile to sterile compounding”, the end product is created from an API of defined quality. The API must be sourced from a FDA registered manufacturer and is tested to meet the compendial standards. This allows for robust control over variables such as pH, potency and impurities.

ITEM NO. DRUG NAME STRENGTH SIZE FORM

1 PHENYLEPHRINE 100MCG/ML 5ML FILL SYRINGE 1‐50/month approximately

2 EPHEDRINE 5MG/ML 5ML FILL SYRINGE 1‐300/month approximately

6 EPINEPHRINE HCL PF 10MCG/ML 5ML FILL SYRINGE 1‐60/month approximately

9 MORPHINE SULFATE PF 5MG/ML in 0.9% sodium chloride 30ML MONOJECT BARREL 1‐10/month approximately

10 HYDROMORPHONE 1MG/ML in 0.9% sodium chloride 30ML MONOJECT BARREL 1‐40/month approximately

‘Sterile to sterile compounding’ in contrast, is produced with batches of already manufactured product that are generally supplied in vials.

There has been a misconception that, because compounded products are not approved by the FDA, they are of lesser quality. However, the FDA inspects all 503B outsourcing facilities, and all bulk API used in non-sterile to sterile compounding must appear on the FDA’s 503B list of bulk drug substances, must have been made at an FDA-registered manufacturing facility, and must be accompanied by a Certificate of Analysis.

The 503b compounding pharmacy does not necessarily have to have API however they MUST have an FDA-approved drug source in the compounding process if they do not have API or both if NMCSD Command is going to accept any 503b compounding pharmacy on contract and accept their product for patient use.

S – S or Sterile to Sterile is a term stating the 503B compounding pharmacy is compounding the product originally from sterile base product to a final sterile compound product, i.e. in a sterile environment.

NS – S or Non-Sterile to Sterile is term stating the 503B compounding pharmacy is compounding the product originally from non-sterile base product to a final sterile compound product again in a sterile environment.