Frequently Asked Questions

• How much volume is needed for potency, micro or particulate matter?

• If I order a potency AND micro test, how many samples do I need to send?

• How long does it take to get my results?

• How is turnaround time calculated?

• Can ARL handle controlled substances? Is a 222 form required each time you send a controlled substance?

• Is ARL a FDA registered laboratory?

• How do I need to pack my sample when sending it to ARL for analysis?

• Why do we need a formulation sheet for HPLC analysis?

• If I do not find a sample in ARL's HPLC drug list, is ARL still capable to analyze it?

1. How much volume is needed for potency, micro or particulate matter?

• Minimum of: 1gm for Powders
• Minimum of: 10 Tablets or Capsules per sample
• Minimum of: 1mL for most samples
• Minimum of: 5--10gm for Creams or Lotions
• Minimum of: 3 Pellets or Suppositories per sample

2. If I order a potency AND micro test, how many samples do I need to send?

• Send 2 separate sample containers if requesting both Potency & Micro testing on same sample

3. How long does it take to get my results?

• Potency: Standard Turnaround time is 3 Business Days from receipt of samples (for most samples).
• Sterility: Standard Turnaround time is 3 Business Days from receipt of samples (for most samples).
• Endotoxin: Standard Turnaround time is 3 Business Days from receipt of samples (for most samples).
• Fungal: Standard Turnaround time is 4 Business Days from receipt of samples (for most samples).

4. How is turnaround time calculated?

• 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, the due date would be Thursday for standard turnaround time; for a rush the sample would be due on Tuesday.

5. Can ARL handle controlled substances? Is a 222 form required each time you send a controlled substance?

• ARL possesses a DEA license for Schedule I – V controlled substances
• No, a 222 form is not required each time you send in a controlled substance. See information below.

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:

(a) Distributions to persons exempted from registration under Part 1301 of this chapter.

(b) Exports from the United States that conform with the requirements of the Act.

(c) Deliveries to a registered analytical laboratory or its agent approved by DEA

(d) Delivery from a central fill pharmacy, as defined in 1300.01 (b) (44) of this chapter, to a retail pharmacy.

6. Is ARL a FDA registered laboratory?

• ARL is an FDA registered and audited laboratory

7. How do I need to pack my sample when sending it to ARL for analysis?

• Place an ice pack in the Shipping box to ensure that the sample does not get too hot during shipping. *It is recommended that the ice pack (s) be placed in side a bag that is sealable such as a zip lock bag.

8. Why do we need a formulation sheet for HPLC analysis?

• ARL needs to know what other ingredients are contained in the preparation, so that we can separate all the ingredients chromatographically.

9. If I do not find a sample in ARL's HPLC drug list, is ARL still capable to analyze it?

• Please contact ARL if a drug is not found on ARL's HPLC drug list. ARL frequently can handle requests for drugs not listed.