keangkong
Research Enthusiast
Here is some background law that may be useful in explaining why what Ousia did is illegal. I’m not going to discuss the illegality of Ousia compounding medications itself since the Florida Board of Pharmacy has already stated its opinion on that matter. Ousia Complaint. Dr. Brokish claims that 503B pharmacies filled the more recent prescriptions sent from Ousia Pharmacy. 2024-12-20 Letter from SlimDownRx.
Disclaimer: I am an attorney. That means what I wrote here might seem smart. However, this is FAR outside my area of expertise. Treat what I write the same way you’d treat medical advice for yourself that you received from your friend, a veterinarian. The advice could easily be right. Or it might be very wrong. Despite being a lawyer, I’m not going to get into the facts of what happened. That’s because the actual facts are still much in dispute. I don’t have any special insights to offer as to facts.
The Food Drug & Cosmetic Act contains a prohibition on 503B pharmacies (aka “outsourcing facilities” or central fill pharmacies) distributing to places to other places except under certain situations. Food Drug & Cosmetic Act § 503B (21 U.S.C. § 353b)(a)(8). While there is a prohibition on wholesaling, the prohibition on wholesaling does not apply to a 503B pharmacies providing a drug to another pharmacy pursuant to a prescription for a specific patient. “[T]he prohibition on wholesaling does not apply to . . . dispensing a compounded drug pursuant to a prescription . . .” FDA, Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry (Draft, June 2023). Any drug produced by a 503B pharmacy must bear a label stating that it is a compounded drug, the contact information for the 503B pharmacy (including its name, address, and phone number), and the statement “Not for resale.” Food Drug & Cosmetic Act § 503B (21 U.S.C. § 353b)(a)(10)(A). The container for the medication must show, if not present on the label of the medication, a description of both active and inactive ingredients in the medication. The container for the medication must also provide a specific phone number and website in order to facilitate adverse event reporting. Food Drug & Cosmetic Act § 503B (21 U.S.C. § 353b)(a)(10)(B).
Florida law similarly permits central fill pharmacies to fill a specific patient prescription and then forward the medication to originating pharmacies from which they received the prescription. Fla. Admin. Code r. 64B16-28.450. While federal law, as noted above, requires the 503B pharmacy (translation: central fill pharmacy) to include the name, address, and phone number of the central fill pharmacy on the label, Florida law contains no such requirement. Rather, “[t]he central fill pharmacy may be identified by a code available at the originating pharmacy.” Fla. Admin. Code r. 64B16-28.450(4). Practically speaking, I know of no reason that the originating pharmacy, in our case case, Ouisa, simply keeping a record by prescription number of the originating pharmacy would not fulfill the state requirement. However, I also know of no reason why the federal labelling requirement would be preempted by state law. The general rule is that federal laws supersede contrary state law. “[T]he Laws of the United States . . . shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the . . . Laws of any State to the Contrary notwithstanding.” U.S. Const., art. VI, cl. 2. This is known as the Supremacy Clause. However, the contrary state law does suggest that you will likely face trouble asking Florida state authorities to enforce the contrary state law. State authorities generally are not required to enforce federal laws so long as the federal law does not demand state authorities enforce that law. For example, a state without a state income tax doesn’t have to help the IRS catch people not paying their income tax. You will likely fare better with reporting violations of Florida law when contacting the Florida Board of Pharmacy. Florida law requires the central fill pharmacy to keep a copy of the prescription that it dispensed to the originating pharmacy. Fla. Admin. Code r. 64B16-28.450(4)(b).
To make a complaint, use the Florida Department of Health Online Complaint Form. You may also wish to report a violation to your own state board of pharmacy if you live in a different state. For instance, here are California Board of Pharmacy Complaints site.
Disclaimer: I am an attorney. That means what I wrote here might seem smart. However, this is FAR outside my area of expertise. Treat what I write the same way you’d treat medical advice for yourself that you received from your friend, a veterinarian. The advice could easily be right. Or it might be very wrong. Despite being a lawyer, I’m not going to get into the facts of what happened. That’s because the actual facts are still much in dispute. I don’t have any special insights to offer as to facts.
The Food Drug & Cosmetic Act contains a prohibition on 503B pharmacies (aka “outsourcing facilities” or central fill pharmacies) distributing to places to other places except under certain situations. Food Drug & Cosmetic Act § 503B (21 U.S.C. § 353b)(a)(8). While there is a prohibition on wholesaling, the prohibition on wholesaling does not apply to a 503B pharmacies providing a drug to another pharmacy pursuant to a prescription for a specific patient. “[T]he prohibition on wholesaling does not apply to . . . dispensing a compounded drug pursuant to a prescription . . .” FDA, Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry (Draft, June 2023). Any drug produced by a 503B pharmacy must bear a label stating that it is a compounded drug, the contact information for the 503B pharmacy (including its name, address, and phone number), and the statement “Not for resale.” Food Drug & Cosmetic Act § 503B (21 U.S.C. § 353b)(a)(10)(A). The container for the medication must show, if not present on the label of the medication, a description of both active and inactive ingredients in the medication. The container for the medication must also provide a specific phone number and website in order to facilitate adverse event reporting. Food Drug & Cosmetic Act § 503B (21 U.S.C. § 353b)(a)(10)(B).
Florida law similarly permits central fill pharmacies to fill a specific patient prescription and then forward the medication to originating pharmacies from which they received the prescription. Fla. Admin. Code r. 64B16-28.450. While federal law, as noted above, requires the 503B pharmacy (translation: central fill pharmacy) to include the name, address, and phone number of the central fill pharmacy on the label, Florida law contains no such requirement. Rather, “[t]he central fill pharmacy may be identified by a code available at the originating pharmacy.” Fla. Admin. Code r. 64B16-28.450(4). Practically speaking, I know of no reason that the originating pharmacy, in our case case, Ouisa, simply keeping a record by prescription number of the originating pharmacy would not fulfill the state requirement. However, I also know of no reason why the federal labelling requirement would be preempted by state law. The general rule is that federal laws supersede contrary state law. “[T]he Laws of the United States . . . shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the . . . Laws of any State to the Contrary notwithstanding.” U.S. Const., art. VI, cl. 2. This is known as the Supremacy Clause. However, the contrary state law does suggest that you will likely face trouble asking Florida state authorities to enforce the contrary state law. State authorities generally are not required to enforce federal laws so long as the federal law does not demand state authorities enforce that law. For example, a state without a state income tax doesn’t have to help the IRS catch people not paying their income tax. You will likely fare better with reporting violations of Florida law when contacting the Florida Board of Pharmacy. Florida law requires the central fill pharmacy to keep a copy of the prescription that it dispensed to the originating pharmacy. Fla. Admin. Code r. 64B16-28.450(4)(b).
To make a complaint, use the Florida Department of Health Online Complaint Form. You may also wish to report a violation to your own state board of pharmacy if you live in a different state. For instance, here are California Board of Pharmacy Complaints site.
