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Compliance Programs

Overview

Letco® Medical (Letco®) shares a mission and responsibility with all health care professionals to continuously maintain and monitor the integrity of the supply chain for pharmaceutical products.

Frequently Asked Questions

Q) What is required to order controlled substances from Letco®?

Title 21, CFR part 1300 to 1316 and Sections 823 (b) and (d) of the Controlled Substance Act call for the maintenance of effective controls against diversion of controlled substances. To adequately satisfy 21 CFR, Letco® has developed a “Know Your Customer” program. The program requires a complete due diligence package from every customer that intends to purchase controlled drugs and List 1 chemicals from Letco®. This package includes: 1) copies of the customer’s state board license and DEA registration; 2) a properly completed questionnaire; and 3) a properly completed affidavit. Some customers are also required to complete a successful onsite inspection prior to being quali­fied for controlled drug purchases.

Q) I sent in a copy of my online State Board License Verification and was told that Letco® needed a copy of my original license. Why can’t Letco® accept online state licenses?

The Letco® Regulatory group is required to follow specific Standard Operating Procedures (SOP). These procedures comply with Healthcare Distribution Management Association (HDMA) guidelines derived and interpreted from the Drug Enforcement Agency (DEA) requirements. The current SOP — detailing minimum requirements for doing business with Letco® — requires an actual copy of your state board license. Please send us a photocopy of the state board license that is on display at your facility.

Q) I filled out a customer questionnaire and received a follow-up call informing me that I needed to disclose all wholesalers I currently work with. Why does Letco® need this information?

Knowing a customer’s current wholesaler(s) and the percentage of purchases being made with each wholesaler allows Letco® to better understand your ordering quantities and patterns. This is a part of our “Know Your Customer” program.

Q) I just recently opened an account with Letco® to purchase controlled substances. Why do I need to update my due diligence paperwork after 6 months?

Letco® requires this information from new facilities that have been open for less than 6 months. Obtaining this information helps us to determine whether or not any Letco® changes have taken place in that 6 month period. For example, a change of ownership, a new PIC or physician joining your facility, or a change in the quantity or type of controlled drug that you wish to purchase in this time period may require additional due diligence documents.

Q) I just received a call from your Customer Care department informing me that Letco® is sending a representative to conduct an onsite inspection of my pharmacy. Why is this necessary?

Our “Know Your Customer” program complies with the Healthcare Distribution Management Associ­ation (HDMA) guidelines. The guidelines recommend that we verify the information we have on file. An onsite inspection of the facility enables us to confirm the information we have received via other due diligence documents.

Q) I have an account with Letco® and am approved to order controlled substances but have not purchased any for a few months. I tried to place an order for a controlled substance and was told that my account was inactive. I purchase other products from Letco® on a regular basis. How can my account be inactive?

Accounts that have not ordered controlled substances for 180 days are considered “inactive.” Letco® requires refreshed paperwork to identify if any Letco® changes have taken place during the inactive period. It is very easy to complete a reactivation form; once completed and reviewed, the account is normally able to order controlled substances.

Q) I completed all of my due diligence paperwork 3 years ago. Why is Letco® asking me to do it again?

All customer due diligence must be kept up to date. It is generally acceptable to allow up to a 3 year period prior to expiry. Updated due diligence is a way to ensure Letco® is staying current with the pertinent data related to your business.

Q) I received a call from Letco® requesting additional information regarding my controlled substance order. Why is Letco® asking me questions about my controlled substance purchases?

In accordance with CFR 1301.74 (b), when controlled substance orders deviate substantially from normal size, frequency, or pattern — and often for first time orders — Letco® requires additional information to update our files and better understand ordering changes. This will help us continue to keep your controlled substance orders on schedule.

Website Suggestions

National Association of Boards of Pharmacy
Drug Enforcement Agency
Drug Enforcement Agency
Health Care Distribution Management Association
Food and Drug Administration
National Association of State Controlled Substance Authorities
National Association of Chain Drug Stores
National Association of Drug Diversion Investigators
National Coalition of Pharmaceutical Distributors
National Council for Prescription Drug Programs
National Community Pharmacists Association
(INDUSTRY NEWS): Drug Store News
(INDUSTRY NEWS): Drug Channels (Expert Insights on Pharmaceutical Economics and the Drug Distribution System)