Customer Control Substance Questionnaire

Controlled Substance Order Monitoring Program

Title 21 Code of Federal Regulations Part 1301 Section 1301.74

One of the top priorities of Lifeline Pharmaceuticals is to prevent diversion and abuse of controlled substances. It is a federal mandate that all distributors of controlled substances "design and operate a system to disclose to the registrant suspicious orders for controlled substances." The DEA defines a suspicious order as an order of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

In response to the DEA requirement, Lifeline Pharmaceuticals, LLC has implemented an Order Monitoring Program that provides effective controls to detect and prevent diversion. Under this program, we will use a set of rules and a review of customer purchase history and submitted compliance documents. If the program finds any anomalies in the order, the order is flagged and held for review by our Compliance Team. We will continuously modify and enhance the program to ensure compliance with DEA regulations while providing exceptional customer service.

Title 21 Code of Federal Regulations Part 1301 Section 1301.74 can be viewed in its entirety at http://www.deadiversion.usdoj.gov/21cfr/cft/1301/1301_74.htm.

Below are excerpts from the regulation that relate directly to the Suspicious Order Monitoring requirements.

Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the Administration or with the appropriate State controlled substances registration agency, if any, to determine that the person is registered to possess the controlled substance.
The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances. The registrant shall inform the Field Division Office of the Administration in his area of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
The registrant shall notify the Field Division Office of the Administration in his area, in writing, of any theft or significant toss of any controlled substances within one business day of discovery of the theft or loss. The supplier is responsible for reporting all in-transit losses of controlled substances by the common or contract carrier selected pursuant to paragraph (e) of this section, within one business day of discovery of such theft or loss. The registrant shall also complete and submit to the Field Division Office in his area, DEA Form 106 regarding theft or loss. Thefts and significant losses must be reported whether or not the controlled substances are subsequently recovered, or the responsible parties are identified, and action taken against them. When determining whether a loss is significant, a registrant should consider, among others, the following factors:

The actual quantity of controlled substances lost in relation to the type of business.
The specific controlled substances lost.
Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substance.
A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, whether the specific controlled substances are likely candidates for diversion.
Local trends and other indicators of the diversion potential of the missing controlled substance

DEA "Know Your Customer" Policy

In addition to the requirements listed in Title 21 Code of Federal Regulations Part 1301 Section 1301.74, all distributors of schedule II-V controlled substances and list I chemicals are required by the DEA to comply with the "Know Your Customer" Policy. Per the DEA "Know Your Customer" Policy, “It is fundamental for sound operations that handlers take reasonable measures to identify their customers, understand the normal and expected transactions typically conducted by those customers, and, consequently, identify those transactions conducted by their customers that are suspicious in nature.”

In order to assist us in complying with the "Know Your Customer" Policy, the DEA published a list of 48 suggested questions that we should ask our customers prior to shipping controlled substances to them. These questions were used to help Lifeline Pharmaceuticals, LLC develop the questionnaires and lists of required documents used in our "Know Your Customer" Policy.

Please assist us in complying with these DEA requirements by completing the requested questionnaire thoroughly with all applicable details and submitting all requested documentation. Additionally, we ask that you cooperate with any on-site inspections or telephone interviews.

If you have questions or concerns, please feel free to contact Ms. Vanessa Santodomingo or Ms. Erika Reyna at (305) 643-8841 or (877) 430-6337.

Respectfully,

Richard O. Mitchell

Chief Compliance Officer

Date Questionnaire Completed*

Date

Person Completing Questionnaire*

First NameLast Name

Title of Person Completing Form*

Sales Representative Name (if known)

Business Name:*

DBA:

Address*

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code

Phone Number*

Please enter a valid phone number.

Fax

Please enter a valid fax number.

1) Medical Director / Practitioner / Pharmacist in Charge or Person (s) (responsible / authorized for controlled substance purchases):*

2) Enter Medical Practitioner Licenses Below*

3) Business Classification (please check all that apply)*

4) Facility Licenses (must be for the ship-to address)*

In the case where the Registration is in the business name, we would need a copy of the DEA Registration Receipt which shows who the Registrant for the facility is. Please follow the instructions below and provide us with a copy of the receipt once you get it. Additionally, if you have a Power of Attorney associated with the DEA Registration, please also provide us a copy.

https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e2s1

Choose option # 6 for registration receipt

Upload DEA Registration Receipt if Above applies to you

1) Ownership Type:*

Sole ProprietorPartnershipCorporation

If Corporation, please enter State of Inc. below

2) Has any owner been convicted or charged with a felony or any other crime related to fraud/controlled substances?*

If yes please explain:

3) Has your DEA registration ever been suspended, revoked, placed on probation or subject of disciplinary action?*

If yes please explain:

4) Has a state license ever been suspended, revoked or subject of disciplinary action?*

If yes please explain:

5) Has any previous wholesaler ceased shipping or restricted purchases of controlled substances?*

If yes please explain:

6) Do you conduct criminal background checks on all employees involved in controlled substance operations?*

7) Do you conduct random drug testing on employees?*

1) List ALL wholesale distributors used in last 24 months and indicate whether they are a primary or secondary source of controlled substances:*

2) Select the reasons why this facility is interested in purchasing controlled substances from Lifeline Pharmaceuticals:*

3) If a physician practice/clinic, how is business received? (Please list percent):
Walk-in* %. Appointment * %

4) Is practice/clinic located within a strip mall or shopping center?*

5) What is the average distance that your patients travel to reach your facility? *Miles

6) What is the longest distance for a patient to travel? *Miles

7) What is the average number of patients per day per doctor?*

8) Clearly define the scope of your medical practice including but not limited to: information on any areas of specialty, the type of procedures that take place on site and the patient population served.*

9) Does this facility utilize physician assistants or nurse practitioners?*

If yes how many and what are their duties:

10) Does this facility allow out-of-state residents to receive services at this facility?*

11) List all persons that have Power of Attorney of this facility or any of the facilities registrants DEA license (provide copy of the POA).

File Upload

12) Does the practice/clinic dispense controlled substance for the patient take home?*

13) Does the practice/clinic administer controlled substances to patients for in-office/facility procedures?*

If yes, what is the percentage of the patient total? %

14) Is there a prescription filling pharmacy in-house or a Retail Pharmacy in the same building?*

15) Does the practice/clinic provide minimum doses of controlled substances as a convenience until the patient can fill a prescription?*

16) Do you treat weight loss or have a weight loss program?*

17) What measures does the facility and DEA Registrant employ to identify drug abusers or doctor shoppers and / or diversion of controlled substances?*

18) Are you treating for opiate dependency?*

If yes attach Substance Abuse Clinic registration and list of staff members who are authorized to sign 222 forms:

19) Detail the security measures that are in place at this facility to deter theft, diversion and other illicit activities that may occur on the premises, i.e. security guard, safes, inventory counts, alarm system, cameras, exterior doors security etc:*

1) Total estimated monthly purchases of all items (i.e. Devices, OTC Products, and Supplies) $ *

2) Total estimated monthly Rx drug purchases (including controlled substances): $ *

3) Purchase breakdown:
a. Rx Drugs*%
b. Controlled Substances * %
c. All Other Items * %

4) Number of prescriptions filled per day*/ per month *

5) Method of payment by your patients/customers:
Private insurance:*% Medicare/Medicaid: *%
Cash:*% Credit Card:*%
Other: *%

1) Estimate dose units (tablets/capsules) dispensed per month for each of the following Controlled Substances.*

2) Estimate dose units (tablets/capsules) administered per month for each of the following Controlled Substances.*

3) List other controlled substances that your business dispenses:

4) List other controlled substances that your business administers:

Required Documentation
1.) Completed questionnaire affidavit.
2.) DEA and State Controlled Substance Registration.
3.) Any Letters of Admonition, Orders to Show Cause or Memorandum of Agreement with the DEA that are
currently in effect or issued in the previous 5 years. Include any responses to these letters/documents.
4.) Disciplinary documents from local, state or federal agencies.
5.) Copies of all DEA Form 106 submitted to the DEA in the prior 36 months.
6.) Customer marketing materials and website Information.
7.) Most recent 90 days controlled substance dispensing records.
8.) Most recent 30 days controlled substance purchasing records.
9.) Photographs of the interior and exterior of the facility and security features to include photo of Narcotic cabinet/safe open and closed.
10.) Copies of any Power of Attorney documents in effect over the DEA Controlled Substance Registration.

Please answer each question completely and include all supporting documentation that may assist us in determining your eligibility to purchase controlled substances and the proper allocations necessary to best serve your facilities within the limits of all applicable laws (i.e., licenses, questionnaires, inspection reports, policy and procedures, etc.). Your failure to do so will delay our approval process.

Please upload all necessary files required above here.

Please List the Top Controlled Substances you purchase per month*

Estimated doses (tablets/capsules) administered per month, for each of the following List I Chemicals.

Ephedrine Quantity Per Month: Quantity Per Month
Pseudoephedrine(PSE) Quantity Per Month: Quantity Per Month
Guaifenesin/PSE Quantity Per Month: Quantity Per Month
Lugol's Iodine Quantity Per Month: Quantity Per Month

List other List I Chemicals that your business will administer to patients forin-office procedures/treatments:

Estimated vials of Testosterone purchased per month to be administered in office.
Testosterone Quantity Per Month: Quantity Per Month

Additional Comments:

Name of Pharmacist In Charge

First NameLast Name

Signature of Pharmacist In Charge

DECLARATIONS/AFFIDAVIT OF APPLICANT(S)
(The person completing this form and the Medical Director or Owner must initial and sign this page)

I hereby attest that I am an authorized representative of the below-listed facility and have the authority to bind the facility to the terms of this affidavit. I further attest that all the statements of fact are true and accurate to the best of my knowledge and certify that I have made sufficient inquiry to be able to make this declaration.
Initial   Inital*

I declare that this facility fully complies with all federal, state and local laws and regulations on the dispensing and administration of controlled substances.
Initial   Inital*

I hereby attest that this facility or any of the owners, management, staff or its contractors have not been issued any warning notice, notice of violation and are not knowingly under investigation by any regulatory authority. I further agree to notify Lifeline Pharmaceuticals within 5 business days of any warning notice, notice of violation or investigative proceedings by any regulatory authority issued upon this facility or any of the owners, management, staff or its contractors.
Initial   Inital*

By executing this affidavit, this facility and all representatives agree that all controlled substances distributed to this facility by Lifeline Pharmaceuticals, LLC, shall only be dispensed / administered at the address of record and shall not be dispensed, sold or transferred off-site. Initial   Inital*

By executing this affidavit, this facility and all representatives agree to inform Lifeline Pharmaceuticals, LLC in writing, within 5 business days of any changes affecting ownership, physical location, license status, and/or key employees including but not limited to: Medical Director, Buyer, Pharmacy Manager, and Staff Doctors.
Inital*

Person completing the form:*

Signature*

Signature

Medical Director/Owner DEA Registrant responsible for signing DEA form 222:*

Signature*

“Please ensure all answers are correct before submitting.”

.

Controlled Substance Customer Questionnaire and Declaration

General information and Licensing

Ownership / Business History

Business Information

Purchasing Information

Controlled Substance Purchases