01 September

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The Future of Peptides: What Patients and Providers Should Know

By: Zoey Chotiner

What are peptides, and how do they work?

Peptides have become increasingly popular in medicine, wellness, and weight loss. Peptides are short chains of amino acids, which are the building blocks of proteins, and they can have a wide range of effects on the body. They can be thought of as smaller and simpler versions of proteins that can help regulate hormone activity, immune defenses, tissue repair, and growth. Peptides are used in some FDA-approved medications to treat disorders such as diabetes and obesity. For instance, injectable insulin and GLP-1 medications are examples of peptide-based drugs. Many people also use peptide injections and supplements to enhance their health and fitness goals.

Federal Law and Peptides

At the federal level, the Food and Drug Administration (FDA) regulates peptide drugs. They are regulated under the same general framework as other drugs. Usually, a drug must receive FDA approval after studies of its safety and effectiveness before it can be marketed for treatment. However, there is an exception for certain compounded medications. A compounded medication is essentially a custom drug created by a pharmacist or physician who combines or alters ingredients to fit the specific needs of a patient. A drug may be compounded for a patient who cannot be appropriately treated with an FDA-approved medication. However, compounded drugs are not reviewed or approved by the FDA for safety and effectiveness in the same way as FDA-approved drugs.

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, pharmacists and physicians are not allowed to choose any peptide they want and compound it for patients. They may only compound drug products using bulk drug substances that comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, are components of FDA-approved drug products if an applicable USP or NF monograph does not exist, or appear on the FDA’s list of bulk drug substances that may be used in compounding. Bulk drug substances must also be accompanied by a valid certificate of analysis and manufactured by an establishment registered with the FDA.

Many peptides are marketed or labeled as “for research use only” or “not for human consumption.” This generally means they are being sold for laboratory or experimental purposes rather than as approved medical treatments. However, some suppliers market research peptides directly to consumers in ways that suggest human use. This can create legal risks, especially when the products are promoted as providing health, wellness, or other medical benefits.

Florida Law and Peptides

In Florida, peptide use is regulated by a combination of federal FDA rules and state healthcare regulations. The Florida Board of Medicine oversees physicians who prescribe or administer peptide treatments, while the Florida Board of Pharmacy regulates pharmacies and compounding practices. The Florida Department of Health oversees these professional boards and helps enforce state healthcare laws.

Florida does not currently have a separate law that specifically regulates all peptides as one category. Instead, peptides are generally managed by existing Florida drug, pharmacy, prescribing, and professional practice rules. This means the legal status of a peptide may depend on what the substance is, whether it requires a prescription, whether it is FDA-approved, how it is compounded, and how it is being sold or marketed.

Recent FDA Developments

Recently, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted in favor of adding six peptides—BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax—to the list of bulk drug substances that may be used under Section 503A. This is a major development for the compounding industry. These peptides have been proposed for uses involving ulcerative colitis, insomnia, wound healing, migraines, and other conditions. However, this does not mean the peptides are FDA-approved. The process can take time, and the FDA still has to decide whether to formally allow these peptides to be used in compounding. If the FDA does move forward, patients may have a clearer way to access them through licensed physicians and compounding pharmacies instead of relying on unregulated online vendors.

Some view this as a victory for patients and personalized medicine, while others are concerned that there is not enough data on the peptides’ safety and effectiveness to support wider access. Just because a peptide is being considered for addition to the compounding list does not mean it has full FDA approval. The FDA has raised concerns about the available information regarding the safety, effectiveness, and quality of some of these substances. Now, the FDA must decide what to do with the advisory committee’s recommendations while considering those concerns. The committee’s recommendations can carry significant weight in the FDA’s decision-making process, but they are advisory rather than binding. Ultimately, it is up to the FDA whether it chooses to follow recommendations.

Future of Peptides

In the future, peptides could become easier to access through licensed physicians and compounding pharmacies if the FDA allows more of them to be legally compounded. This could make patients less likely to rely on unregulated websites or “research use only” products. At the same time, newer drugs show how much potential peptide-based treatments may have in certain areas of health.

However, greater access will likely come with more rules and regulations. The FDA will most likely continue to focus on safety, product quality, clinical evidence, and how these drugs are marketed. Ultimately, peptides may become a much larger part of mainstream medicine, but their future will depend on stronger research, clearer legal pathways, and tighter regulation.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice; it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please get in touch with me using the contact information listed above.

All information and references to laws, rules, regulations, and advisory opinions were accurate as of this time, but laws are constantly evolving. Please get in touch with me to ensure that the law governing your business is up to date. Thank you.

30 December

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How Can A Foreign Trained Doctor Obtain A Florida Medical License?

Posted by Jamaal R. Jones, Esq.

in Blog

Doctors from around the world may decide that they would like to practice medicine in the State of Florida. Maybe it’s because of the beautiful weather and white sandy beaches, no state income taxes, its proximity to Latin America and the Caribbean, large immigrant and tourist population and Florida’s world-renowned hospitals and healthcare providers. No matter the reason, the process of moving to Florida to practice medicine has its challenges. These challenges may seem insurmountable without guidance from experienced attorneys. There’s a two-step process to practicing medicine in Florida: (1) the immigration visa process and (2) obtaining your license to practice medicine in Florida.

Certification and Residency Programs

Foreign Doctors wishing to practice clinical medicine in an unsupervised setting must be licensed by the Florida Board of Medicine (or Board of Osteopathic Medicine). All Doctors including those trained outside the U.S. are required to pass all four tests of the United States Medical Licensing Exam (USMLE) in order to obtain their Florida Medical License. International Medical Graduates (IMG) must be certified by the Educational Commission for Foreign Medical Graduates (ECFMG). To become certified by ECFMG, an IMG must pass three USMLE exams, consisting of 1 multiple choice exam and two separate exams testing clinical knowledge and clinical skills.

Once a doctor receives ECFMG certification, she may apply for a hospital residency. The Electronic Residency Application Service (ERAS) is the most common way for doctors to enter into a residency program, which can last from three to eight years depending on the specialty that the IMG is seeking. Doctors have to complete a residency program regardless of their overseas training. IMGs who have received a visa are eligible to apply for a residency program in the United States.

Doctors are encouraged to apply to a minimum of 20 or more programs to increase their odds of “matching” or being accepted into a residency program. Registration can be completed through the National Resident Matching Program (NRMP), which can match you to a residency program based on individual preferences.

Licensure by Examination

According to Fla. Stat. §458.311, Any person desiring to be Florida licensed physician, who does not hold a valid license in any state may submit an application to the Florida Department of Health (DOH). The DOH has to certify that the person has: (a) completed the application form and paid the application fee; (b) is at least 21 years of age; (c) is of good moral character; (d) has not committed any act or offense in this or any other jurisdiction which would constitute the basis for disciplining a physician; and (e) if you graduated from medical school after October 1, 1992 you can prove that you have completed the equivalent of 2 academic years of pre-professional, post-secondary education prior to entering medical school.

Additionally, there are several medical education and postgraduate training requirements. A foreign doctor may satisfy this requirement if they can show that they graduated from an allopathic (or osteopathic) foreign medical school registered with the World Health Organization and certified pursuant to Florida statute as having met the standards required to accredit medical schools in the United States or reasonably comparable standards. If the language of instruction of the foreign medical school is other than English, the doctor must demonstrate competency in English through presentation of the ECFMG English proficiency certificate or by a satisfactory grade on the Test of Spoken English of the Educational Testing Service or similar test approved by the rule of the board. Finally, they must have completed an approved residency of at least 1 year.

Alternatively, if the doctor graduated from an allopathic foreign medical school which has not been certified pursuant to Florida statute, she may still be eligible if she has had her medical credentials evaluated by the ECFMG, holds an active, valid certificate issued by the ECFMG and has passed the examination used by the ECFMG. The doctor is also required to have completed an approved residency of at least 1 year, unless they graduated after October 1, 1992, then the applicant is required to have completed and approved residency or fellowship of at least 2 years in one specialty area.

The applicant also has to submit their fingerprints to the DOH for a criminal background check to be conducted. The Board of Medicine will not certify to the DOH any applicant for licensure who is under investigation in another jurisdiction for an offense which would constitute a violation of the laws pertaining to medical doctors until the investigation is completed. Finally, the applicant has to obtain a passing score on the USMLE.

In spite of those doctors who have graduated from foreign medical schools which have not been certified pursuant to Florida statute, a graduate of a foreign medical school is not required to present the certificate issued by the ECFMG or pass the examination utilized by the ECFMG if they have: (a) received a bachelor’s degree from an accredited United States college or university; (b) studied at a medical school which is recognized by the World Health Organization; (c) completed all of the formal requirements of the foreign medical school, except the internship or social service requirements, and has passed part I of the National Board of Medical Examiners examination or the ECGMG examination equivalent; and (d) has completed an academic year of supervised clinical training in a hospital affiliated with a medical school approved by the Council on Medical Education of the American Medical Association and upon completion has passed part II of the National Board of Medical Examiners examination or the ECFMG examination equivalent.

Licensure by Endorsement

According to Fla. Stat. §458.313, a doctor can obtain a Florida medical license by endorsement if they apply and the board certifies that: (a) she has met the requirements of paragraphs (b)-(g) for licensure by examination; (b) obtained a passing score on the USMLE after January 1, 2000; and (c) has submitted evidence of active licensed practice of medicine in another jurisdiction, for at least 2 of the immediately preceding 4 years, or evidence of successful completion of either a board-approved postgraduate program within 2 years preceding filing of an application or a board-approved clinical competency examination within the year preceding the filing of an application for licensure.

“Active licensed practice of medicine” means the practice of medicine by physicians, including those employed by any governmental entity in community or public health, medical directors who are practicing medicine, and active teaching faculty of an accredited medical school. The Board of Medicine may require an application for licensure by endorsement to take and pass the appropriate licensure examination prior to certifying the applicant as eligible for licensure.

Conclusion

There are tens of thousands of unlicensed foreign-trained doctors throughout the U.S. who have medical training and experience but are unable to practice in the United States. By the year 2030, experts anticipate that the US will be facing a shortage of roughly 100,000 doctors throughout the country. Spanish-speaking doctors and other foreign language speaking doctors are in high demand. Unfortunately, thousands of foreign doctors living in the US are working as waiters, parking garage attendants and other jobs that don’t utilize their medical training because they are unable to obtain their license. Florida lawmakers have used Fla. Stat. §456.021(1) to express their desire to encourage the use of foreign-speaking Florida residents duly qualified to become actively qualified in their professions so that all people of this state may receive better services. To this end, legislators passed a law stating that all persons who have successfully completed their studies and are deemed qualified for examination for a professional license must take that examination in English unless 15 or more applicants request that examination be administered in their native language. If you are able to obtain a Florida medical license you would be helping to alleviate the physician shortage and provide healthcare services to those who are in desperate need of doctors who speak the same language and have similar cultural backgrounds.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

21 December

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Can A Florida Licensed Nurse Administer Botox Injections?

Posted by Jamaal R. Jones, Esq.

in Videos

02 August

3 Comments

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Can a Registered Nurse Administer Botox?

Posted by Jamaal R. Jones, Esq.

in Blog

**UPDATE: AS OF 09/13/2023**

A Declaratory Statement has been issued by the Florida Board of Nursing allowing for a nurse with the appropriate level of education, training, and experience to administer Botox under the supervision of a physician. A declaratory statement is not the appropriate means for determining the conduct of another person or for obtaining a policy statement of general applicability. The issuance of this Declaratory Statement does not mean that all registered nurses can administer Botox, rather that determination must be made on a case-by-case basis. See article here.

Those who run med spas, dental or dermatology practices are concerned about whether a registered nurse on staff can administer Botox without their direct supervision. Allowing them to do so would free up the physician’s schedule so that he can perform other procedures that his personnel is not permitted to do.

According to the Florida Board of Medicine, there are no laws and rules that address who can and cannot administer Botox injections in the state of Florida.

However, a 2017 Board of Nursing case[1] involved a Florida licensed Registered Nurse who was alleged to have violated Florida Statutes 456 and/or 464. In March 2016, the nurse administered Botox to multiple patients on multiple occasions. The Board of Nursing found that the nurse did not perform the Botox injections pursuant to a valid physician’s order. The Board of Nursing held that performing Botox injections without a physician’s order is beyond the scope permitted by law. Further, the nurse had reason to know that she was not competent to perform the Botox injections.

The Board referenced Florida Statute 464.018(1)(h) in its decision by stating that unprofessional conduct as defined by the board is grounds for disciplinary action. The Board also referred to Florida Administrative Code Rule 64B9-8.005(13), which provides that unprofessional conduct includes practicing beyond the scope of the licensee’s license, educational preparation or nursing experience. (emphasis added). Finally, the Board stated that the nurse engaged in unprofessional conduct by practicing beyond the scope of her license, educational preparation and/or nursing experience by performing Botox injections without a valid physician’s order.

In Florida, practicing medicine without a license is considered a 2nd degree misdemeanor. Additionally, the nurse could have had the following actions taken against her:

license suspended or permanently revoked;
restriction of practice;
imposition of an administrative fine;
issuance of reprimand;
probation;
refund of fees billed or collected;
remedial education; and/or
any other relief that he Board deemed appropriate.

Two things should be taken away from the decision in this case. First, just because there isn’t a specific law on the books regarding Botox injections doesn’t make it legal for a registered nurse to administer it to patients. Second, I thought that it was interesting that the Board stated that the nurse was not performing the Botox injections pursuant to a physician’s order. Many would view this sentence as specifically allowing a nurse to administer Botox injections only in situations where the nurse is doing so pursuant to a physician’s orders (not an NP, PA, ARNP). I don’t believe that to be true because the Board went on to state that even pursuant to a physician’s orders a registered nurse does not possess the requisite educational preparation to perform the procedure and that doing so would be practicing beyond the scope of her nursing license.

[1] Department of Health v. Trisha Lorraine White, R.N. Case Number 2016-13884

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services please contact me using the contact information listed above.

All of the information and references made to laws, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.