Much of this blog has been devoted to criminal defense attorney analysis of the ambiguities of controlled substance internet pharmacy law; however, the law governing online pharmacies selling non-controlled substances is just as vague and unclear. This post will serve as an initial background discussion of non-controlled substance internet pharmacy law, much like my equivalent, initial discussion of the Controlled Substances Act and the Ryan Haight Act many months ago.
While controlled substances are primarily regulated by the Controlled Substances Act, non-controlled substances are regulated by the Federal Food, Drug and Cosmetics Act. This act provides that a drug intended for human use which
because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug . . . shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.
21 U.S.C. 353. While it is awkward to classify issuing drugs without prescriptions as misbranding, the Federal Food, Drug and Cosmetic Act classifies a number of illicit activities under the same title including, but not limited to, making false or misleading labels, failing to provide for adequate warning instructions on a label, making drugs susceptible to deterioration, failing to include required information in prescription advertisements, and developing dangerous drugs. 21 U.S.C. 352.
Any misbranding is subject to criminal penalties. 21 U.S.C. 331. Misbranding alone is subject to not more than one year imprisonment, not more than a $1,000 fine, or both. However, a second conviction or a first-time conviction in which misbranding is committed “with the intent to defraud or mislead” is subject to not more than three years imprisonment, not more than a $10,000 fine, or both. 21 U.S.C. 333. Of course, in these types of cases, the potential penalty is often much more significant, since felony misbranding can be grouped with counts for conspiracy to misbrand and money laundering.
Many misbranding cases involve situations in which non-controlled substances were dispensed without any form of a prescription or where prescriptions were signed by non-U.S. licensed physicians. However, some do involve business models similar to those selling controlled substances and prosecuted under the Controlled Substances Act — the only difference is that the drug is non-controlled (e.g. an internet pharmacy utilizing a U.S. licensed physician who issues prescriptions in response to health questionairres, medical records, an online consultation, or all of the above.
For example, the Affpower case in the Southern District of California charges the defendants with dispensing both controlled and non-controlled substances (Soma etc.). Besides the traditional counts for the distribution of controlled substances under the Controlled Substances Act, the defendants are also charged with felony misbranding and conspiracy to misbrand under the Federal Food, Drug and Cosmetic Act. The government alleges that Affpower customers filled out a questionnaire via an internet pharmacy and a doctor either approved or denied a prescription based solely upon the health questionnaire. Felony misbranding is alleged due to the failure to issue “valid written prescription[s].”
Interestingly, however, the statute does not say “valid prescription.” Instead, it merely says “prescription.” One could, of course, argue that a prescription is not a prescription if it is invalid. In other words, one might argue that “valid” is implicitly read into the provision. However, this can’t be true. If using the word valid was unnecessary, one must ask why Congress chose to use it in the Controlled Substances Act, the Ryan Haight Amendment and, most importantly, elsewhere in the Federal Food, Drug and Cosmetic Act (FFDCA). The FFDCA also proscribes regulations for pharmacy compounding. In these provisions, the statute provides that:
Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section.
21 U.S.C. 353(a). Canons of statutory interpretation suggest that every word has meaning and that the presence of a word in one area and its absence in another is supposed to add to the statute’s interpretation. Thus, the fact that Congress chose not to add the word “valid” to the provision on misbranding could indicate that the statute only requires some form of written prescription rather than one deemed valid by state medical boards. Of course, courts may read this differently (and prosecutors obvously do given the Affpower indictment noted above), but the absence of valid is more than interesting and a very important argument for criminal defense lawyers.
Moreover, even if the statute explicitly required a “valid” prescription, what does that mean? Unlike the Controlled Substances Act, the Federal Food, Drug and Cosmetic Act does not have associated regulations that define what constitutes a valid prescription. Moreover, the Ryan Haight Act only defines valid prescription with reference to controlled substances (it is an amendment to the Controlled Substances Act and specifically states that it is only applicable to controlled substances). Thus, how would a website owner, pharmacist, doctor, or web affiliate clearly determine what is permissible and what is prohibited? Are health questionnaires enough? Medical records? Online consultations? Or, like the Ryan Haight Act, are face to face medical examinations required?
It is not surprising that the gray area associated with non-controlled substances is just as big, if not bigger, than with controlled substances. Over the next several weeks, I will be writing more on this subject.
The content on this post does not constitute legal advice and is for informational purposes only. You should not act upon the information presented on this website without seeking the advice of legal counsel. Should you wish to speak to an experienced criminal defense attorney knowledgeable in internet pharmacy, prescription, and drug law, please feel free to contact me directly.
Category: Internet Pharmacy Law