Our pharmacy will be closed on Thursday, Nov. 28 in observance of Thanksgiving.

Compounded Semaglutide and Tirzepatide: What Patients Should Know

For the past year or more, public interest in a group of medications called GLP-1 agonists or “Glucagon-like Peptide-1 agonists” has reached an incredible level. Discussions about Semaglutide (brand names Ozempic®, Wegovy® and Rybelsus®) and Tirzepatide (brand names Mounjaro® and Zepbound®) continue to circulate between family members and friends but also on TV, social media, and almost every other information exchange medium that exists. Many patients have experienced significant weight loss while taking these medications, making them desirable for many patient populations. The manufacturers of the brand name products listed above have not been able to keep pace with public demand, landing both Semaglutide and Tirzepatide on the FDA’s drug shortage list. When a drug product exists on the FDA’s drug shortage list, FDA guidance documents and verbiage from the Food, Drug and Cosmetic Act allow compounding pharmacies to create “copies” of a back-ordered product until that product is no longer on the shortage list.

This temporary drug shortage has created a treatment gap for thousands of patients nationwide. In an attempt to help fill that gap, compounding pharmacies from coast to coast have been making legal compounded copies of Semaglutide and Tirzepatide drug products that are either identical to the commercial versions of the drugs or similar to the commercial versions of the drugs with slight modifications like different strengths or slightly different ingredients. 

The spike in production of compounded copies of Semaglutide and Tirzepatide drug products has shifted the media’s attention toward compounding pharmacies. Compounders have received tons of press, most of it negative, surrounding compounded GLP-1 Agonists over the past year.  Some articles raise valid concerns about product quality and safety but many articles are grossly misinformed about the legality of compounding drugs on the FDA’s drug shortage list and misinformed about compounding in general. Knowing that it is sometimes difficult for patients to find high quality information on the internet, the following bullet points are provided for information purposes for patients who are interested in or considering starting therapy with compounded Semaglutide or Tirzepatide:

  • Section 503A of the Food, Drug and Cosmetic Act as well as a guidance document published by the FDA titled: “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug and Cosmetic Act,” clearly define the circumstances that allow compounding pharmacies to compound Semaglutide and Tirzepatide due to their status as drugs on the FDA’s Drug Shortage List.
    • The FDA does not consider a drug product to be “commercially available” if it exists on the FDA’s Drug Shortage List
  • Semaglutide and Tirzepatide “base” (not their salt forms) exist on the FDA drug shortage list, therefore compounding pharmacies should not use Semaglutide or Tirzepatide “salt forms” for compounding
  • Provisions of the FD&C act describe that when compounders use bulk powdered active pharmaceutical ingredients, they must source them from FDA registered establishments therefore compounding pharmacies must verify a supplier’s status as an FDA registered establishment when making a purchase of bulk Semaglutide or Tirzepatide
    • Many suppliers of bulk pharmaceutical ingredients obtain additional certifications (beyond what is required by the FDA) such as the National Association of Boards of Pharmacy’s Drug Distributor Accreditation. Compounders should strongly consider doing business with suppliers who go above and beyond what the FDA requires to ensure the highest quality pharmaceutical powders are sourced for compounding.
  • Patients should always confirm that their compounding pharmacy of choice is testing their injectable products for sterility, potency and endotoxin. These tests, especially sterility, are vital to ensuring a safe product is dispensed.

In times of drug shortages, compounding pharmacies will always aim to fulfill gaps in our healthcare system at large by increasing patient access to back-ordered medications. However, patients must be selective and do their due diligence when dealing with compounding pharmacies, especially ones that offer their services exclusively online. Economics always plays into a patient’s healthcare decisions but whenever possible, patients should choose a reputable pharmacy that they trust over an online pharmacy offering the lowest possible price. 

William Kenward, CPhT

project manager

Team member since 2015

Chris Gralian, CPhT

Quality Control Lead

Team member since 2019

Rose Hood, CPhT

Quality Control Lead

Team member since 2016

Matthew Peterson, CPhT

Quality Control Lead

Team member since 2016

Helen Dubintsov, CPhT

Quality Control Lead

Team member since 2016

Shannon Kimball, PharmD

Compounding Pharmacist

Doctor of Pharmacy, Pacific University 2022

B.S. Biohealth Science, Oregon State University 2019

Team member since 2018

Mark Liu, PharmD

Compounding Pharmacist

Doctor of Pharmacy, Oregon State University 2005

BA Biology, Reed College 1998

12 years of retail experience

Team member since January 2017

Jill Snyder, RPh

Compounding Pharmacist

B.S. Pharm. 1994 Oregon State University

5 years of retail pharmacy experience

17 years of long-term care experience

Certificate in Veterinary Pharmacy, 2016

Team member since May 2016

Scott Williams, RPh

Compounding Pharmacist

B.S. Pharm. 1992 Oregon State University

24 years of experience in Retail Pharmacy

Team member since November 2015

Certificates in CPR, Diabetes Management, Immunization, Cholesterol Management and Medication Therapy Management

Bob Templin, RPh

Director of Training

B.S. Pharm. 1976 Oregon State University

Certificate in Veterinary Pharmacy, 2019

Over 37 years of pharmacy experience

Over 33 years as a Pharmacy Manager

Team member since February 2013

Megan Gustafson, PharmD

Director of Training

Doctor of Pharmacy, Oregon State University 2021

B.S. Bio-Health Sciences, Oregon State University 2017

Team member since 2016

Sam Llona, PharmD

Director of Sterile Operations

Doctor of Pharmacy, Creighton University 2019

B.S. Biology, Santa Clara University

Certificate in Aseptic Compounding, PCCA 2014

Certificate in Human Compounding, PCCA, 2016

Certificate in Veterinary Compounding, PCCA, 2017

Team member since September 2019

Vivian Pham, PharmD

Senior Operations Manager,
Director of Accounting

Doctor of Pharmacy, Oregon State University 2016

Has worked as a technician, bookkeeper, pharmacy intern and now pharmacist for Northwest Compounders

Team member since May 2008

Jessie Vo, PharmD

Pharmacy Manager,
Director of Quality Assurance

Doctor of Pharmacy, Pacific University 2011

Preceptor for Pacific University SOP, Oregon State SOP

Team member since January 2006

Luke Eilers, PharmD

Chief Executive Officer

Doctor of Pharmacy, Pacific University 2014

B.S. General Science, Oregon State University 2011

Certificate in Veterinary Pharmacy, 2018

Certificate in Basic Compounding, PCCA 2014

Certificate in Aseptic Compounding, PCCA 2014

Preceptor for Pacific University SOP, Oregon State SOP

Team member since October 2005

Tom Eilers, RPh

Founder, Chairman

B.S. Pharm. 1976 Oregon State University

Founder, Northwest Compounders 2005

Member, International Academy of Compounding Pharmacists

Member, PCCA (Professional Compounding Centers of America)

Certificate in Basic Compounding Techniques, PCCA, 2001

Certificate in Aseptic Compounding, PCCA 2005

Preceptor for Pacific University SOP, Oregon State SOP, Washington State SOP

Filter products by drug name.