Sections 503A and 503B are significant new laws pertaining to the compounding of pharmaceuticals.
As such, any pharmaceutical that manufactures compounded substances or ingredients should understand what they are and how they apply to their operation.
We've answered some basic questions regarding these new laws below:
What Are Sections 503A and 503B?
Sections 503A and 503B are parts of the Federal Drug and Cosmetic Act that contain stipulations for compounded pharmaceuticals and the registration of outsourced compounding facilities.
Section 503A
Sections 503A describes the conditions under which pharmaceuticals compounded by a pharmacist or a physician would be exempt from the provisions of the Federal Drug and Cosmetic Act regarding Good Manufacturing Practices, labeling requirements, and approval via New Drug Applications and abbreviated New Drug Applications.
Before 2002, Section 503A also contained provisions that restricted advertising or a particular compounded drug or classes and types of drugs. Soliciting prescriptions for compounded drugs was also prohibited. However, these restrictions were challenged and determined to be unconstitutional. Section 503A was eventually amended to remove these provisions.
According to Section 503A, a compounded pharmaceutical is exempt if a valid prescription for an individual patient has been issued. The pharmaceutical must also be compounded by a licensed pharmacist in a pharmacy licensed by the state or in a federal facility.
If the pharmaceutical is compounded before a prescription is issued, a licensed pharmacist or a licensed physician must compound it in limited quantities. The compounding must be based on previous prescriptions for the same pharmaceutical and a previous therapeutic relationship between the patient and the physician or the pharmacist.
The pharmaceutical should also be compounded in accordance with the United States Pharmacopeia. Bulk substances manufactured by a registered facility should be used to compound the pharmaceutical. Valid certificates of analysis should accompany the bulk substances.
If bulk substances are not used, they must comply with the standards in a monograph issued by the United States Pharmacopeia or the National Formulary. The pharmaceutical must not have been on a list of medications withdrawn from the market because of lack of efficacy or safety or a list of medications difficult to compound.
Section 503B
Section 503B refers to the registration of outsourcing compounding facilities.
According to the regulation, a facility can elect to register with the Food and Drug Administration as an outsourced compounder. After registering, outsourced compounders must report information about the pharmaceuticals that they compound to the FDA.
After they register with the FDA, they must continue to do so once a year for every year that they wish to remain an outsourcing facility. If the facility complies with the requirements, the pharmaceuticals that it compounds are exempt from the requirements for approval (submission of New Drug Applications and abbreviated New Drug Applications) and labeling regarding including adequate directions for use.
However, they will be subject to all other regulations under the Federal Drug and Cosmetic Act.
Implications of Sections 503A and 503B for Manufacturers
With respect to compliance with Section 503A, manufacturers should determine whether a pharmaceutical meets the definitions of a compounded substance under the law.
If the pharmaceuticals meet those definitions, manufacturers must make certain that they conform to the standards and associated monographs issued by the United States Pharmacopeia or the National Formulary as applicable.
If bulk substances are used, manufacturers should make certain that a registered facility produces them and that they have the appropriate certificates of analysis.
What happens if the requirements are not met?
If the pharmaceutical does not meet the requirements under Section 503A, manufacturers should determine whether they should register as an outsourcing facility under Section 503B.
Registration as an outsourcing facility is not required under Section 503B; however, manufacturers that choose to register under Section 503A must go through the appropriate registration processes and make certain that their registrations are current.
If manufacturers choose not to register and do not meet the stipulations for compounded pharmaceuticals under Section 503A, the pharmaceuticals that they produce are subject to all other requirements under the Federal Drug and Cosmetic Act.
As such, manufacturers who decide not to register must make certain that the pharmaceuticals meet the definitions of a compounded substance under Section 503A. Otherwise, the manufacturers may have to go through the approval process of conducting preclinical studies, submitting an Investigational New Drug application, conducting clinical studies, submitting a New Drug Application, and conducting postmarketing surveillance to be able to market the pharmaceutical.
Also, pharmaceuticals that do not meet the requirements under Section 503A or Section 503B must have the appropriate labeling and be produced according to Good Manufacturing Practices.
Although compounded drugs are exempt from the requirements of the Federal Drug and Cosmetic Act that pertain to Good Manufacturing Practices, labeling requirements, and the approval via New Drug Applications and abbreviated New Drug Applications per Section 503A, they are subject to all other provisions under the act. Manufacturers should make certain that they comply with those provisions. As such, consultation with the appropriate legal departments is essential.
Conclusion
By understanding Sections 503A and 503B, pharmaceutical executives can use the mechanism to avoid some of the standard issues associated with the manufacture of compounded pharmaceuticals. This can result in faster time to market and increased revenue.
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