Overview

---

Online Services

---

Test Services

---

API-Potency List

---

CQI Partnership

---

Sample Submission

---

Customer Service

Sample Submission

Guidelines:

• Sample Submission: Once your pharmacy has been registered, please log into www.dynalabs.us and fill out the “Test Request” form.
  

• Packaging Samples: If the sample is sensitive to heat and/or needs to be kept refrigerated or frozen, we ask that it be shipped with “cold packs” or “dry ice,” whichever is more appropriate. Please pack the samples and cold packs in separate zip-lock baggies to prevent moisture condensing on the cold packs from affecting the sample, paperwork and/or labels. Please pack samples appropriately to prevent breakage.
  

• Shipping Samples: Please send your sample to DYNALABS via traceable means, such as FedEx, UPS, USPS or courier to the Sample Receiving Department of DYNALABS. Samples are received Monday through Friday (excluding holidays). Samples received after 1pm may not be tested until the next business day, if it is important that the sample be tested on the day it is received, please note that on the test request form. There may be additional charges for same day testing.
  

• Sample Quantity: Table 1 contains the standard quantities necessary for DYNALABS to perform the corresponding tests. For expensive and/or rare materials, please contact DYNALABS for absolute minimum quantities necessary. The sampling list below was not intended to meet any statistical criteria. For customers that wish to sample according to the USP, please refer to the appropriate monograph and/or chapter.

TABLE 1: Sample Quantity Requirements
Potency *		Microbiology
Aliquots / Powders	1 gram	Sterility	2 mL
Capsules, Tablets, Pellets	20 or more	Endotoxin	1 mL
Liquid samples	1 mL	Particulates (Laser) USP <788>	25 mL
Suppositories, Troches, Lollipops	5 or more	Particulates (Visual) USP <797>	1 mL
Creams, Lotions, Gels	5 grams	pH	2 mL
T3/T4 (no porcine)	10 mcg per capsule in avicel
	200 mcg per capsule in methocel
Notes: Please send 2 separate sample containers if requesting both Potency and Microbiology testing on same sample * Per active, per time point.

• Turn Around Time: Table 2 outlines Standard and Rush turnaround times for common tests.

TABLE 2: Standard and Rush turnaround times for common tests
	Standard (business days)	Rush* (business days)	Comments
Potency	3	1	In calculating turnaround time, the day the sample is received is not taken into consideration. For example: If a sample was received for potency on Monday; a “standard sample” would be due back Thursday (3 business days) and a “rush sample” would be due on Tuesday (1 day).
Sterility	Daily Update	No Rush	Sterility is started the day the sample is received (unless after 1pm) and incubates 14 business days. Suspensions need an additional transfer and 4 day incubation.
Endotoxin	3	1	n/a
Particulate Matter	3	1	USP <788>
		No Rush	USP <797> Visual Inspection
* For most Rush testing, there is an additional $50 fee per sample
* If there is an unforeseen issue/delay, the customer will be notified with a call and/or by email if the results cannot be posted within the turnaround time listed.
* When submitting drugs for potency testing that are not on our current drug list we ask that you please call in advance to verify testing capability.

Confidentiality

DYNALABS maintains strict confidentiality with its customers. Formal Confidentiality agreements may be initiated by the customer or by DYNALABS.

Retention and Disposal

Samples are retained for 3 weeks after receipt. Prior arrangements must be made to retain samples under other conditions or to return samples. Unless alternate arrangements have been made, raw data will be retained for 3 years plus the current year after report date.

Controlled Substance - 222 Form

DYNALABS possesses a DEA license for Schedules II – V controlled substances.

A DEA 222 form is not always required each time you send in a controlled substance.

TITLE 21 -- FOOD and DRUGS
CHAPTER II -- DRUG ENFORCEMENT ADMINISTRATION
DEPARTMENT OF JUSTICE
PART 1305 -- ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

Subpart A -- General Requirements

Sec. 1305.03 Distributions requiring a Form 222 or a digitally signed electronic order.

Either a DEA Form 222 or its electronic equivalent as set forth in subpart C of this part and Part 1311 of this chapter is required for each distribution of a Schedule I or II controlled substance except for the following:

1. Distributions to persons exempted from registration under Part 1301 of this chapter.
2. Exports from the United States that conform with the requirements of the Act.
3. Deliveries to a registered analytical laboratory or its agent approved by DEA.*
4. Delivery from a central fill pharmacy, as defined in 1300.01 (b) (44) of this chapter, to a retail pharmacy.

* NB: Drug manufacturers, drug repackagers and drug distributors are required to complete and submit a DEA Form 222 or its electronic equivalent when sending Schedule I and II controlled substances for testing. Please contact us regarding any DEA Form 222 requirements questions you may have.

Financial Information:

• Payment in advance may be required for customers whose credit has not been established with DYNALABS.
• Purchase orders or valid credit card information are required, unless other credit options have been approved by DYNALABS. Contracts for Services without this information may cause delay in testing.
• Payment terms are “Net 15” from date of invoice unless otherwise stated differently in a quote. Client agrees to pay all costs, including, but not limited to, attorney and accounting fees and other expenses of collection resulting from any default by client under any terms of this contract.
  
• For third party billing, a signed purchase order must be received from the party being billed for the service.
  
• Published pricing is designed for single samples. Project or volume discounts may be available.
• Quotations will be provided upon request by the client.
  
• Additional charges may be assessed (i.e. hazardous samples) with client approval.
  
• Liability of DYNALABS is limited to an amount no greater than the amount invoiced. This document supersedes any other arrangements with regards to financial liability.