Pentec’s Delivery Model Complies with DEA Guidance

Pentec Health, Inc. (Pentec) thanks you for the continued opportunity to provide industry-leading services for your patients with complex care challenges.

We write to address recent industry speculation that new United States Drug Enforcement Administration (DEA) guidance is forthcoming, and that this guidance will prohibit pharmacies like ours from providing home delivery services of intrathecal controlled substances — such speculation is completely unfounded, and more importantly, wrong to suggest that any adverse impact would result to our delivery model. We performed an exhaustive review of various regulatory databases and found nothing to indicate that any DEA guidance concerning Pentec Health’s home delivery model is forthcoming. Quite the opposite, our delivery model is in full compliance with the CSA and DEA regulations.¹

Background

Federal law requires close monitoring and accounting of controlled substances beginning with their manufacture through delivery to an ultimate user or their disposal. This close monitoring and accounting is accomplished by the Controlled Substance Act (CSA) and its implementing regulations administered by the DEA.  Specifically, the CSA and DEA regulations require entities involved with the manufacture or distribution of controlled substances to register with the DEA, although there are several exemptions from registration. An entity’s DEA-registration category determines how that entity must handle and secure controlled substances and which reporting and record keeping obligations it must meet. The CSA and DEA regulations also govern any movement of controlled substances between registered entities through a closed system of distribution so that a controlled substance is always under the control of a DEA-registered entity, or an entity specifically exempted from registration. Thus, the CSA and DEA regulations through the DEA’s closed distribution system ensure an accurate accounting of all controlled substances from manufacturing through dispensing to ultimate users or disposal.

 
Pentec’s Delivery Model Complies with CSA and DEA Regulations

Pentec’s delivery model is in full compliance with the CSA and DEA regulations. The CSA requires that pharmacies filling prescriptions for controlled substances deliver them directly to the ultimate user (i.e., the patient). Under the CSA’s current framework, pharmacies may utilize other employees including nurses acting on behalf of the pharmacy, in addition to pharmacists, in parts of the dispensing process that involve delivery of a prescription, or order, to an ultimate user under the CSA. To ensure that our dispensing and home delivery model complies with federal law while continuing to provide the best possible care to our patients, we have welcomed an open dialogue with the DEA over the past decade. The DEA has explained that a pharmacy’s employee or agent, such as a nurse, may hand deliver a prescribed controlled substance directly to the ultimate user, provided that state law permits it, and the pharmacy maintains the required records. The National Home Infusion Association agrees and per NHIA CEO, Connie Sullivan: “We have written to the DEA on behalf of our home infusion pharmacy members who provide sterile compounded controlled substances, explaining that home delivery to the ultimate user, utilizing employees (i.e. nurses or employed drivers) has been the standard practice in industry for decades. Any change to this long-standing policy would have a determinantal impact to patient access for patients receiving hospice and palliative care, or intrathecal pain management services.” 

Given the above, we harbor no concern that our dispensing practices run afoul of federal or state law. Further, we are mindful that ensuring the transfer of drugs to the ultimate user rests with the DEA registrant performing the regulated act of delivery, e.g., Pentec, and not with the prescriber, e.g., a physician. As a prescribing practitioner, we remind you that DEA regulations make it clear that the legal responsibility for issuing a valid prescription that “conform[s] in all essential respects to the law and regulations” rests upon the prescribing practitioner and Pentec and its pharmacists have a corresponding responsibility for proper prescribing and dispensing of controlled substances. Accordingly, we see no reason to change our dispensing practices at this time.

While others in the industry may have been operating a different model than Pentec Health’s that may have run afoul of DEA’s regulations, we have prided ourselves on establishing a compliant home delivery model to ensure yours and your patient’s needs continue to be met.

Staying on Mission

Our story began over 40 years ago.  We were founded as a small regional pharmacy addressing the needs of dialysis patients and patients with severe pain. Since then, we have grown to a team of over 350 clinicians treating 11,000 patients across the country. Although our size has changed, our mission to provide the highest quality of care to advance the outcomes for the patients we serve has not. 

Please feel free to reach out to us if you have any questions or require further clarification. We look forward to continuing to support you and the patients you serve. 

Sincerely,

Matthew Deans
President and Chief Executive Officer
Pentec Health, Inc.

References:

1. For a detailed, thoughtful analysis of the CSA, DEA regulations, and home delivery models, which explains why Pentec’s home delivery model is fully CSA and DEA regulation compliant, read the article, “Make No Mistake, Pharmacies Can Still Deliver Controlled Substances to Patients,” which is found here: https://www.bakerlaw.com/insights/make-no-mistake-pharmacies-can-still-deliver-controlled-substances-to-patients/. 
2. The records required are dictated by Title 21, Code of Federal Regulations, Part 1304.