(1) New Fingerprint and FCVS Requirements for First-Time Physician Applicants

First-time, full physician applicants who have never previously held a Georgia medical license must now complete a fingerprint and criminal background check through both the Georgia Crime Information Center (GCIC) and the FBI, along with a Federation Credentials Verification Service (FCVS) report through the Federation of State Medical Boards. The Board clarified this applies only to initial licensure, not to license renewals.

(2) Medical Cannabis Patient Registry Reporting (SB 395)

Effective July 1, 2026, the Low THC Oil Patient Registry has been renamed the Medical Cannabis Patient Registry. Physicians involved with patients on the registry are now required to submit certain information directly to GCMB as part of the registry process. The Board indicated full details are available on its Rules & Laws page.

(3) Compact Physicians and APRN Protocol Agreements

The Board offered a reminder for physicians licensed through the Interstate Medical Licensure Compact (IMLC): under Georgia’s nurse protocol rules, a physician’s principal place of practice must be located in Georgia or within 50 miles of where the protocol will be used. As a result, a compact physician who practices entirely out of state cannot enter into an APRN protocol agreement in Georgia, regardless of licensure status.

(4) Telemedicine Standard of Care Refresher

The Board reiterated that the standard of care for a telemedicine visit is the same as for an in-person visit. Physicians generally must examine a patient in person before an initial prescription for controlled substances, unless an exception under Board Rule 360-3-.07 applies, and practitioners must make diligent efforts to have the patient examined in person at least annually by a Georgia-licensed physician, PA, or nurse practitioner. Out-of-state physicians treating Georgia patients must generally hold either a full Georgia medical license or a Georgia telemedicine license; a telemedicine license holder is strictly limited to telemedicine practice and may not treat patients in person in Georgia.

(5) FY27 Rules Preview

The Board flagged several bills passed during the 2026 legislative session that will shape upcoming Board rules:

• Medical cannabis: Rules will be updated to reflect the shift from “low THC oil” to “medical cannabis,” including new possession limits and expanded qualifying conditions.
• Psychedelic-assisted treatment: GCMB will establish licensing and safety standards for psychedelic-assisted treatment clinics, including provider qualifications and prescribing protocols.
• Radiologist assistants: A new licensing framework is coming for radiologist assistants, including an advisory committee, continuing education standards, and a defined scope of practice under physician supervision.
• Internationally trained physicians: A provisional license pathway is being developed for internationally trained physicians to help address provider shortages in rural and underserved areas, though the Board noted this program is on hold pending funding.

The Board indicated it will share additional detail on each of these as rulemaking progresses.

(6) What the Board Says Puts a License at Risk

The newsletter included the Board’s own list of conduct that can jeopardize a license, which is a useful checkpoint for practices to review internally:

• Scope of practice: Practicing outside one’s scope, including APRNs practicing without a valid delegating physician or protocol agreement.
• Agreements and documentation: Failing to maintain required agreements, documentation, or supervision.
• Prescribing: Prescribing medications inappropriately or outside accepted standards of care.
• Renewals: Allowing a license to lapse by missing renewal deadlines.
• Conduct: Engaging in unprofessional or unethical conduct, including boundary violations or inappropriate patient relationships.
• Board communications: Ignoring Board communications or requests for information.
• Accuracy: Submitting false, misleading, or incomplete information.
• Compliance generally: Violating Board rules, regulations, or state law.

If you would like to discuss how any of these updates may affect your license, practice, or compliance obligations, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.

(1) The Quarterly Evaluation Requirement

Under O.C.G.A. § 43-34-25(c)(9) and GCMB Rule 360-32-.02(5)(d), a delegating or designated physician who authorizes an APRN to prescribe controlled substances pursuant to a nurse protocol agreement must ensure that the patient receives a physician evaluation at least quarterly, with, according to the Medical Board, at least one of those evaluations conducted in person.

(2) The Recurring Question for Acute-Care Practices

For practices structured around episodic or urgent care, this ambiguity raises a practical concern: if an NP prescribes a short-term course of a controlled substance for an acute condition, and the patient is otherwise discharged with no further planned treatment, does the quarterly evaluation requirement obligate the practice to recall that patient for a physician evaluation solely to remain in compliance? Practices have understandably been cautious in the absence of clear guidance, given the potential licensing exposure for both the physician and the NP if the requirement is read literally.

(3) The Board’s Response

Little Health Law raised this scenario directly with GCMB Legal Services. The Board responded the quarterly physician evaluation requirement is intended to apply where a patient continues to receive controlled substances pursuant to a nurse protocol agreement — not to require an otherwise discharged patient to return solely to satisfy the quarterly examination requirement after a single, short-term prescription for an acute condition.

According to the Board, if the patient receives no additional controlled substance prescriptions under the protocol and has no ongoing course of treatment with the practice, there is no expectation that the patient be recalled solely for a quarterly evaluation. For patients who do continue to receive controlled substances under the protocol, the delegating or designated physician remains responsible for ensuring the statutory and regulatory evaluation schedule is met, including at least one in-person evaluation each quarter.

(4) Open Considerations for Practices

The Board frames this interpretation as consistent with the underlying purpose of the statute and rule — physician oversight of ongoing controlled substance management, rather than a blanket recall obligation for isolated acute encounters. That said, several practical questions remain for practices to work through in applying this guidance to their own protocols, including how a practice documents that a patient has in fact been discharged with no anticipated further CS prescribing, how ongoing course of treatment should be defined within an individual nurse protocol agreement, and how these determinations should be reflected in the practice’s recordkeeping in the event of a future licensing board inquiry.

If you would like to discuss quarterly physician evaluation requirements, nurse protocol agreements, or controlled substance prescribing compliance for your practice, or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship. All digital presentations by our firm or its attorneys are provided as a public informational resource. Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations. We do not routinely update such information. To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney. Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced. Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states. For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.

State Law and Ethics Rules Govern How a Provider Can Lawfully and Ethically Terminate the Patient-Provider Relationship.

States have laws governing how providers can terminate the patient-provider relationship. If states do not have such laws, then the Ethics Rules from the American Medical Association (AMA) are a good guidepost. The AMA Ethics Rules state that when terminating the patient-provider relationship, the provider must (1) notify the patient or patient’s decisionmaker long enough in advance to allow the patient to secure another provider; and (2) facilitate transfer of care when appropriate. If a provider immediately terminates care with a patient without adequate notice, the provider runs the risk of committing unprofessional conduct for patient abandonment. The Georgia Medical Board echoes this sentiment, stating physicians generally have the right to terminate the patient-physician relationship but should give the patient adequate written notice of the termination, preferably through certified mail, and adequate notice and a reasonable amount of time for the patient to find another healthcare provider. The Board then specifies that 30 days is generally considered “adequate notice.”

States like Georgia give providers discretion on how they can discharge patients from their practice. If a provider reasonably determines that a patient is being disruptive to a provider or a provider’s staff or that the patient poses a risk of harm to the provider or staff, the provider may have grounds to terminate the patient-provider relationship immediately, but the provider should document the reasons for such immediate termination so as to reduce the risk of patient abandonment.

If you are trying to discharge patients from your practice or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

As we have discussed in prior blog posts, ketamine has been administered off-label to treat patients with treatment-resistant depression, and ketamine has gained popularity recently as a possible treatment option for treatment-resistant depression. Ketamine is a schedule III controlled substance, so ketamine is within the DEA’s and the Food and Drug Administration (FDA)’s purview. In June and July 2026, the FDA sent warning letters to several online sellers of ketamine. The warning letters state these online ketamine sellers are selling non-FDA-approved, misbranded ketamine products and are putting consumers at serious risk of harm. The DEA has been investigating whether at-home ketamine use and telehealth appointments used to prescribe ketamine are medically necessary. If the DEA finds merit to these investigations, the DEA can impose severe penalties, including revoking a provider’s DEA registration. The investigations are ongoing, and our Firm will continue to monitor developments into these investigations.

If you are being investigated by the DEA, the DEA has approached your practice, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

The DEA has implemented storage and recordkeeping regulations to protect against theft and diversion of controlled substances. The DEA requires Schedule II-V controlled substances to be stored in a “securely locked, substantially constructed cabinet.” As another requirement to protect against theft and diversion of controlled substances, the DEA prohibits practices and providers from employing anyone convicted of a drug-related felony or anyone who previously had a DEA registration denied, revoked, or surrendered for cause (e.g., surrendering a DEA registration as a result of or in lieu of an investigation related to the handling of controlled substances).

If a practice or provider experiences a possible theft or diversion, the DEA requires the practice or provider to notify the local DEA Field Division Office in writing of the theft or significant loss of any controlled substances within one business day of discovering the loss or theft and must file a DEA Form 106 within 45 days after discovering the theft or loss. The DEA lists six factors in determining whether a loss is “significant,” ranging from the quantity of controlled substances lost to the likelihood that the specific controlled substances in question are candidates for diversion.

Generally speaking, providers who prescribe or administer controlled substances in the lawful course of professional practice are not required to keep records of controlled substances. However, DEA regulations require practitioners who regularly dispense or administer controlled substances and charge patients, either separately or together with charges for other professional services, for controlled substances that are dispensed or administered to keep records of Schedule II-V controlled substances that are administered in the lawful course of professional practice. For each controlled substance your practice acquires and administers, the DEA requires practices and providers to include the following contents in the records: (1) the name of the controlled substance and its finished form/strength (e.g., 10-mg tablet or 10-mg concentration per fluid ounce or milliliter); (2) the date, quantity, and supplier (name, address, and DEA registration number) for each acquisition; (3) the date administered, the quantity/volume administered, and the patient to whom it was administered; (4) the written or typewritten name or initials of the person who administered it; and (5) the date, quantity, and manner of any disposal (including destruction), if applicable.

If your practice requires controlled substances to be destroyed, the practice is required to maintain a record of destruction on DEA Form 41. The regulations do not require the practice or provider to file a DEA Form 41 for a substance “dispensed by a practitioner for immediate administration at the practitioner’s registered location, when the substance is not fully exhausted,” such as when a substance remains in a vial, tube, or syringe after administration but cannot or may not be further used. Such a substance must be recorded according to the requirements in the above paragraph, though.

If you are being investigated by the DEA, the DEA has approached your practice, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

Our healthcare law firm works with many providers and healthcare practices who are facing an investigation from the Drug Enforcement Administration (DEA). This blog covers how the DEA adjudicates cases against healthcare practitioners being investigated for potential DEA violations. If you are being investigated by the DEA, the DEA has approached your practice, or you would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Federal law allows the DEA to suspend or revoke a practitioner’s DEA registration for several reasons, including if the practitioner has committed an act that would render the practitioner’s DEA registration “inconsistent with the public interest.” The DEA determines what the public interest is based on a variety of factors, including (1) the recommendation of the appropriate state licensing board or professional disciplinary authority; (2) the practitioner’s experience in dispensing or prescribing controlled substances; (3) the practitioner’s conviction record related to controlled substances; (4) the practitioner’s compliance with applicable laws related to controlled substances; and (5) such other conduct that may threaten public health and safety. 21 U.S.C. § 823(g). The DEA weighs these factors on a case-by-case basis, so some factors may weigh more than others depending on the case’s facts.

If the DEA finds a practitioner’s conduct is inconsistent with the public interest, then the DEA will issue a sanction, which also depends on the facts. In determining what sanction to impose, the DEA looks at several factors, including acceptance of responsibility, credibility of such acceptance, nature of the misconduct, and the DEA’s interest in deterring similar conduct. Corrective measures are also an important factor, but the DEA considers them only where the practitioner has accepted responsibility.

If you are being investigated by the DEA, the DEA has approached your practice, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

To prescribe controlled substances, practitioners must apply for a registration with the DEA. The DEA has the authority under federal law to suspend or revoke a practitioner’s DEA registration if the practitioner materially falsified any application for a DEA registration, including renewal applications. A falsity becomes material if it would affect the DEA’s decision in whether to grant or deny a DEA registration application, which involves the DEA to determine whether the issuance of a DEA registration is inconsistent with the public interest. Some examples include questions related to a practitioner’s licensing history or controlled substance history. However, merely answering a question wrong does not mean that a statement on a DEA registration application is materially false. Instead, when determining whether a statement is materially false, the DEA looks to see if the practitioner knew, or should have known that the statement was false, or that information was omitted and the DEA application required disclosure of such information.

After the DEA finds a statement is materially false in a practitioner’s application, the DEA determines what punishment is appropriate on a case-by-case basis.  To determine what punishment is appropriate, the DEA looks to several factors, including lack of intent to deceive, history of licensure, and acceptance of responsibility for the materially false statements.

If you are being investigated by the DEA, need assistance filing your DEA registration application, the DEA has denied your registration application, or you would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney. 

(1) Three Categories of Outcome

The NCMB resolves investigations in three general ways: no formal action, private Board action, or public Board action. The outcome in any individual case depends on the unique facts and circumstances of that case, as well as any mitigating or aggravating factors the Board considers relevant—including, for example, whether the licensee has prior history with the Board.

It is worth noting that the Board’s statistics offer some context: on average, approximately 60 percent of matters investigated are closed with no formal action but retained in the licensees file, about 24 percent result in private action, and roughly 10 percent result in public action.

(2) Accept as Information (AAI): No Formal Action

When the Board concludes that no violation of the Medical Practice Act (N.C.G.S. Chapter 90) has occurred, the case is closed as “Accept as Information” (AAI). The matter is retained in the licensee’s confidential permanent file but does not result in any Board action and is not publicly reported. Complainants are notified that the case has been closed and receive general information about how it was resolved, but the details remain private.

An AAI closure does not necessarily mean the matter disappears entirely—investigations may be disclosed to other licensing authorities and credentialing bodies, and the existence of a prior investigation can be a factor in how the Board evaluates any future matters involving the same licensee.

(3) Private Board Action

Where the Board does not find a violation warranting public action but has concerns about some aspect of the licensee’s conduct or performance, it may take private action. Private actions are not reported on the NCMB’s public website and are not visible to the general public. Examples include a confidential letter of concern, a requirement that the licensee complete a remedial continuing medical education course, or a request that the licensee attend a confidential interview with Board members to discuss their conduct.

While private actions do not carry the same immediate reputational consequences as public action, they are not without significance. Depending on the nature of the action and any applicable disclosure requirements, a private Board action may need to be reported in response to credentialing applications, on insurance applications, to the National Practitioner Data Bank, or in response to inquiries from other state licensing boards.

(4) Public Board Action

Public Board action is taken when the Board determines that a violation of the Medical Practice Act warrants remedial and/or disciplinary action. Public actions cover a wide spectrum. On the less severe end, the Board may issue a public letter of concern, which it characterizes as non-disciplinary. Moving along the spectrum, the Board may impose a fine, issue a formal reprimand, or place limitations on the licensee’s scope of practice. At the more serious end, the Board may suspend or revoke the license entirely. All public actions are posted on the NCMB’s public website and are accessible through the individual licensee’s Licensee Information page.

When the Board’s review indicates that public action may be warranted, the case may ultimately be resolved through a public hearing or, more commonly, through a negotiated settlement agreement known as a consent order. If the Board votes to initiate public action, the licensee may request a confidential, informal pre-charge conference in writing before formal charges are filed. The terms of any consent order—and whether to agree to one—involve considerations that are specific to the facts of each case and the licensee’s individual circumstances.

If you are a North Carolina licensee facing a Board investigation and have questions about how these outcomes may apply to your situation—or if you would like to understand your options at any stage of the process—we would be glad to discuss your matter with you. You may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.

Background of FDA Announcement

On April 15, 2026, the FDA announced it would hold a meeting from July 23-24, 2026, to discuss popular peptides, including BPC-157, TB-500, KPV, and MOTs-C, for inclusion on the 503A Bulks List. If these peptides are included on the 503A Bulks List, this means that the FDA has reclassified them into Category 1, which means compounding pharmacies can freely compound drugs with these peptides pursuant to a valid prescription without risk of an enforcement action, but it does not mean that these peptides are now FDA-approved. Our firm will continue to monitor the results of this meeting.

FDA Committee Meeting and Its Significance

The FDA’s Pharmacy Compounding Advisory Committee recommended that six of the seven peptides be included on the 503A Bulks List. The peptides recommended to be included are BPC-157, KPV, TB-500, MOTs-C, Epitalon, and Semax, and the only peptide recommended not to be included was Emideltide. The Committee’s recommendation is only a recommendation and does not mean that these six peptides can be used for compounding. The recommendation goes to the FDA for a full vote, and only the FDA has the authority to implement regulations to place these peptides on the 503A Bulks List, which would greenlight compounding pharmacies to use these peptides when compounding drugs. Our Firm will continue to monitor the FDA’s vote.

If you need assistance setting up a med spa that offers peptides, have questions about whether your practice is compliant with the various laws and regulations surrounding peptides, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.

(1) The Board Is Actively Inspecting, and Plans to Continue

The Board has indicated it intends to keep conducting unannounced visits. The Board has also indicated it plans to (a) put the industry on notice regarding existing licensure and scope-of-practice requirements, and (b) seek new legislation that would impose additional legal limits and registration requirements on med spas and IV treatment facilities. Practices that have not already reviewed their compliance posture should treat this as a signal to do so now, rather than during a visit.

(2) General Areas Inspectors May Focus On

While every inspection will vary, based on the Board’s public statements and reported findings, the following general categories of compliance appear to be areas of ongoing focus. This list is not exhaustive, and it is not a substitute for an individualized compliance review.

• Required postings and licensing: Whether current, required notices and licensure documents are physically posted at the practice.
• Physician oversight and delegation: The nature of the relationship between the practice and any supervising or collaborating physician, and how that relationship is documented.
• Chart review compliance: How, and how consistently, required physician chart reviews are being documented for APRNs and PAs.
• Scope of practice: Whether tasks performed by each staff member, licensed or unlicensed, align with that individual’s legal scope of practice.
• Controlled substances and DEA registration: How controlled substances, such as testosterone, are provided to patients, and whether DEA requirements are met.
• Compounded medications and pharmacy sourcing: Where medications and other pharmacy-sourced products come from and whether the providers are compounding on site.
• On-hand medications and IV formulations: What medications and IV formulation components are kept and used on site.
• Adverse event tracking: Whether and how the practice documents adverse events or patient reactions to treatment.
• Sharps and medication disposal: How sharps and medications are disposed of, and whether disposal arrangements are current and continuous.
• Emergency protocols: Whether written protocols exist for responding to allergic reactions or other treatment-related emergencies.

(3) Practical Next Steps

Because these inspections are unannounced, the most effective time to identify and correct compliance gaps is before a visit occurs. Practices offering med spa, IV hydration, hormone, or aesthetic services should consider conducting an internal review of the areas above, updating any outdated postings, agreements, or protocols, and confirming that documentation, rather than informal practice or verbal understanding, exists to support each area of compliance.

If you would like to discuss your practice’s compliance with Georgia Composite Medical Board requirements or how to prepare for a potential inspection, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

*Disclaimers: Thoughts shared here do not constitute legal advice nor do they form an attorney-client relationship.  All digital presentations by our firm or its attorneys are provided as a public informational resource.  Although intended to be correct and up to date as of the date posted, we cannot guarantee the accuracy of posted information, especially as it relates to individual situations.  We do not routinely update such information.  To determine up-to-date information about the subject matter of this information and proper application to a specific situation, it is important that you consult your healthcare attorney.  Our communications of information through the Internet shall not constitute “presence,” “doing business” or the practice of law in any location, even when a specific state or its laws/rules are referenced.  Our firm maintains offices in Georgia and no other state. Our attorneys are licensed in some, but not all, states.  For each client engagement we accept, our firm undertakes best efforts to ensure we are aware of and adhere to applicable jurisdictional requirements, which may include reviewing local rules, conducting relevant research and collaborating with, or referring a matter to, a local attorney.