GLP-1 Weight Loss Drug Compounding in Medical Practice Office Settings

GLP-1 weight loss medications such as semaglutide and tirzepatide have experienced a surge in demand coupled with a nationwide supply shortage[1], resulting in a proliferation of both 503B outsourcing facility and 503A pharmacy compounding. Increasingly, we are being asked to provide guidance for many office and clinic-based medical specialties such as gastroenterology physicians, naturopaths and other medical practitioners looking to compound these agents.  Frier Levitt offers assistance where federal and state rules for medical office compounding (where they exist) create a confusing regulatory environment.

Rules and Enforcement

Section 503A of the Drug Quality and Security Act (DQSA) regulates “physician office-based” compounding[2], requiring a valid prescription for an individual identified patient or in limited quantities in anticipation of a practice requiring compounded prescriptions for its patients. As 503A compounders, physicians are expected to follow FDA Guidance, USP standards, and state compounding rules. However, the status of oversight for 503A compounding in settings other than pharmacies, such as physician offices is not clear. On a federal level, FDA has expressed “concerns” over compounding under insanitary conditions in settings other than pharmacies but it has not issued any new rules or guidance for physician compounding. On the state level, approximately ten (10) states have laws and regulations regarding physician compounding. Other states leave enforcement to the state Medical Boards, which have mostly been reactive to patient complaints or adverse reaction reports. Additionally, while USP standards are incorporated by reference into state laws and regulations in a majority of states, most states still do not enforce compounding laws against physicians.  With regard to GLP-1 drug compounding, several state Boards of Pharmacy (e.g. California and Mississippi) have either issued warnings or have attempted to restrict compounding, and it is essential for clinicians to be aware of their state restrictions.

Key Areas for GLP-1 Drug Compounding

Since physician compounders are 503A compounders, GLP-1 compounding must adhere to USP <797> and <795>, for sterile and nonsterile compounding, respectively.  Key changes from previous versions include batch sizes, beyond use date (BUD), and frequency of personnel requalification (including media fill, gloved fingertip and thumb sampling, and surface sampling).[3] For physician practices, this means the need for more resources, including an incubator, media and access to a microbiologist if they have action levels exceeded. Some key areas for GLP-1 compounding include vetting of Active Pharmaceutical Ingredient (API) manufacturers; receipt of an appropriate Certificate of Analysis (COA); use of semaglutide base (not salt or acetate) for compounding; and avoidance of all mention of tradenames or Safety or Efficacy comparisons to brand products in advertising.

Administration vs Dispensing

As 503A compounders, physicians are limited to compounding GLP-1s for their own patients and cannot provide compounded products to other entities, including other medical practices “for office use.”  Additionally, large scale compounding for retail sale could fall under the definition of manufacturing.[4]  If the compound is not administered in office but rather dispensed to the patient for self-administration as is common with GLP-1 medications, state Board of Pharmacy dispensing may apply, which in many states involves a registration requirement. For example Ohio requires physician compounders to obtain a “Terminal Distributor of Dangerous Drugs” license.[5]

Supervision/Delegation of GLP-1 Compounding

In general, clear guidelines, standards and training should be available for any staff who assist with compounding or the supervision of the compounding. There are many regulatory considerations with regard to physician oversight/delegation of the actual compounding to nurses or other support personnel. For example, 503A requires that physician compounding be performed by the physician or be under the immediate onsite supervision of the physician. USP <797> does not permit remote supervision. As another example, physicians cannot delegate compounding to pharmacy technicians.

How Can Frier Levitt Help

If you are contemplating compounding GLPs in a medical practice office setting, contact Frier Levitt today. We can assist if you need a detailed review of the regulatory aspects of “physician office-based” compounding, or a particular scenario. Furthermore, GLP-1 compounding presents a myriad of regulatory compliance issues for clinicians. We develop P&Ps, conduct mock compounding inspections, review labeling and advertising, and assist many clients in meeting full regulatory compliance in the GLP-1 503A compounding space.

[1] At the time of preparation of this articles, both drugs remain on the FDA 506e shortage list, meaning they may be compounded as ‘essentially a copy’ since they are not considered commercially available.

[2] 21 U.S.C. § 353a.

[3] USP <797> Pharmaceutical Compounding- Sterile Preparations. Effective Nov. 1, 2023.

[4] FDA Guidance. Prescription Requirements Under Section 503A of the Federal Food, Drug & Cosmetic Act. CDER. Dec 2016.

[5] Ohio Rev. Code Ann. §4729.54.