Compounded drugs are not Food and Drug Administration (FDA)-approved. Accordingly, the FDA does not verify an individual compounded drug’s safety and effectiveness profile.asserting that they made false and misleading claims about their drugs. The FDA alleged a failure to substantiate their claims. There is, therefore, a need to clarify the metes and bounds for claims by 503A compounding facilities and 503B outsourcing facilities.
These individualized needs were met by compounding pharmacies.
Compounding pharmacies generally operated as “mom and pop” stores, overseen by the state Boards of Pharmacy, until the New England Compounding Center (NECC) tragedy.leading to the Drug Quality and Security Act (DQSA) of 2013.
503A Compounding Pharmacies
Drugs compounded in a 503A pharmacy are subject to all provisions of the Food, Drug, & Cosmetic Act (FD&C Act) that apply to conventionally manufactured drugs except:
- Current Good Manufacturing Practice regulations (cGMPs) (Section 501(a)(2)(B)),
- Labeling with adequate directions for use (section 502(f)(1)), and
503B Outsourcing Facilities
Unlike 503A facilities, 503B pharmacies, also known as outsourcing facilities (OF), meet patient needs by addressing needs that neither traditional drug manufacturers nor compounding pharmacies are able to meet. Unlike 503A pharmacies, OFs:
- Must comply with cGMPs,
- Are inspected by the FDA according to a risk-based schedule, and
However, unlike generic manufacturers, OFs must compound drugs under the direct supervision of a licensed pharmacist. Drugs compounded by a 503B OF are exempt from:
- Labeling with adequate directions for use (section 502(f)(1)),
- New drug approval requirements (section 505), and
Types of Drug Advertisements
This article explores whether compounded drug producers can make promotional and non-promotional claims similar to a drug approved by the FDA.The Office of Prescription Drug Promotion (OPDP) is responsible for the oversight of drug claims.
Curent Regulations Governing 503As and 503Bs Sharing Information About Their Drugs
The process of drug development is lengthy, time-consuming, and costly. Drug development can take decades of research with no guarantee of regulatory approval by the FDA or other regulatory agency. Accordingly, it is imperative that pharmaceutical companies be able to recoup their investment by compliantly promoting their drug to patients and healthcare providers (HCPs). Drug advertising guidances from the OPDP are generally directed at drugs subject to a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or their equivalent. Fortunately, while intended for a distinctly different regulatory strategy, these guidances can serve as promotional compliance guide posts for compounding pharmacies to follow.
Therefore, it is necessary to define the FDA’s authority to regulate drug compounding promotions. Due to the legal uncertainty, while pharmacies may survive a court challenge, most simply want to follow FDA requirements to avoid being challenged in the first place.
Even though the restrictions on advertising and promotion were held unconstitutional in Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002), a In the context of prescription drugs, the FDA identifies at least three different types of prescription drug-related advertisements:
- Reminder advertisements,
- Help-seeking advertisements, and
If done properly, reminder advertisements are regulated by the FTC. Reminder advertisements serve only to remind the public that such a drug exists. Such advertisements give the name of the drug, but do not talk about the drug’s risks or its benefits. It is important to note that a reminder advertisement should not include any words or pictures that might suggest the use of the drug. For example, a reminder advertisement might include a statement like “ask your doctor about” and then the drug’s brand and generic name.There is no reason either 503A or 503B facilities cannot use reminder advertisements about their compounded/ manufactured products.
Scientific Exchange Between Manufacturers/Compounders and HCPs
It is presently unclear whether scientific discussions between a manufacturer (in this case, a compounder of drugs) and HCPs about an unapproved/uncleared drug or about off-label uses of a drug should be regarded as free speech or commercial speech. This distinction is important to determine the extent to which the FDA regulates such speech. Nevertheless, the FDA suggests that it can significantly regulate scientific discussions about unapproved/ uncleared drugs or about off-label uses of drugs, such as with the use of appropriate disclaimers.cases suggest that the FDA may be more limited and can intervene only if the manufacturer is sharing false or misleading information.
In conclusion, the dynamic landscape of compounding pharmacies presents a multitude of opportunities to effectively market to healthcare practitioners and patients. Additionally, the legal decisions in the Coronia, Amarin, and Pacira cases have underscored the importance of protected scientific discourse, opening the door for compounding pharmacies to engage in more robust, evidence-based discussions with healthcare professionals. These verdicts highlight the FDA’s limitations in regulating promotional speech and offer an opportunity for pharmacies to more freely share information about drugs compounded in 503A and 503B facilities, provided that the information is truthful and not misleading.
As we move forward, the continued growth and success of compounding pharmacies will largely depend on their ability to effectively navigate these changes, harnessing the power of scientific dialogue and innovative marketing strategies to build lasting relationships with healthcare practitioners and patients alike.