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What You Need to Know About FDA Inspections of Compounding Pharmacies

The great majority of compounding pharmacies that are presently operating in the United States are state-licensed sites that are categorized as such under section 503A of the United States Federal Food, Drug, and Cosmetic Act (also known as either the FDCA, FFDCA, or FD&C). The FFDCA is a class of federal laws which were first executed by the U.S. Congress in 1938 and accorded authority to the U.S. Food and Drug Administration (FDA) to supervise the safety of all foods, medications and drugs, medical apparatuses, as well as cosmetics that are sold within the U.S. Initially substituting the previous Pure Food and Drug Act of 1906 after more than one hundred deaths were the results of a sulfanilamide preparation where diethylene glycol was used to disintegrate the drug and create a liquid form (occasionally referred to as an “Elixir Sulfanilamide Disaster”), the FFDCA has been revised many times, not long ago the requirements were added about bioterrorism preparations.

What defines a 503a compounding pharmacy?

A 503a pharmacy is permitted to merge drugs which are not FDA-approved, do not submit to the requirement that labels display sufficient instructions for use, and do not submit to CGMP requirements, as well as dispensing to patients based on an only-as-needed basis that requires valid Rx and prescription. 503a pharmacies are mainly under the authority of their domicile state’s Board of Pharmacy (BoP) or the like and are subject to the specific rules and regulations concerning compounding. The majority of states have espoused in full or in part the United States Pharmacopeia (USP) issued guidelines (Chapters 71, 85, 795, 797, and 1116) as the rules concerning compounding. Furthermore, a freshly added chapter 800 has been published and is presently being assessed by each BoP to consider its possible acquisition and incorporation.

Is a compounding pharmacy’s adherence adequate?

A good deal of pharmacists believe that commitment to state rules, statutes, regulations, and all applicable USP guidelines is the scope of their regulatory obligation. Unfortunately, these pharmacists would be mistaken.

The FDA has authority wherever drug products are prepared, packed, or handled concerning “Insanity Conditions,” which encompasses all 503a pharmacies. The FDA has utilized this scant clause to attain entry to all 503a pharmacies lately, with inspectors of the local state BoP accompanying them to “assess operating conditions exhibited at present” by compounding pharmacies. These evaluations have “discovered” the operations of a great deal of 503a compounding pharmacies every year, and the quantities, rates of occurrences, and momentum of these examinations are increasing rapidly and intensifying. FDA inspectors spend several days assessing and examining the pharmacy’s compounding procedures. Nonetheless, it’s crucial to bear in mind that the FDA inspectors aren’t judging the pharmacy on the USP guidance or the individual state rules and regulations but are instead focusing on the far more rigorous Current Good Manufacturing Practices (cGMP).

What are the Current Good Manufacturing Practices?

The Food and Drug Administration created official rules and regulations known as Current Good Manufacturing Practices (cGMP) that include all of the design, control, monitoring, and maintenance of manufacturing procedures and premises functioning in the U.S. Note that the actual accordance to law by the facility is regulated the FDA and are precisely the same regulations all drug manufacturers must comply with. When the practical examination is finished, any issues by the investigators and any discovered deviations are recorded on the FDA form 483 (Observations) and posted to the FDA website. Based on the nature of the discoveries, pharmacies are obliged to propose a corrective plan of action and be subjected to a follow-up examination, typically twelve-to-eighteen months after the first inspection had transpired. Had the investigations initially conducted been deemed as “significant” or the 503a compounding pharmacy did not correctly respond or produce a feasible plan to rectify the initial observations that were recorded, the FDA has several alternatives available with which to meet with such as a drug recall, a Warning Letter, and/or a Consent Decree for the compounding pharmacy found deficient and in violation. A Consent Decree is also commonly known as the “Death Penalty” for the pharmacy that receives it.

How do I prepare my compounding pharmacy for an FDA inspection?

No matter how cautious you are with the way that you conduct business, you may need an Atlanta compounding pharmacy FDA inspection attorney from The Hasson Law Group LLP to ensure that you are prepared for what may lie ahead. We can offer you expert attorneys with extensive knowledge of both the cGMP and USP requirements, as well as the genuine FDA examination expectations. From evaluating every 483 that’s been issued to both 503a pharmacies and 503b outsourcing facilities, our skilled advisers are highly conscious of the FDA expectations and know the “procedure,” and they are at the ready to help you be prepared. They will recognize the individual areas of danger for compounding pharmacies such as the issue that you may be in, as well as assisting your management team in both the remedial activity planning that’s compulsory and its implementation, reducing the likelihood of possible “observations” occurring by FDA examiners should they “visit” your pharmacy.

Here at Hasson Law Group LLP, we advise this “improved” survey for all sterilized compounding pharmacies medium to large as a means of reducing the consequences of an unexpected FDA inspection. We’ve personally witnessed numerous 503a pharmacies surprised by the FDA showing up unexpectedly in their lobbies, demanding prompt access inside, and the aftermath of such scenarios. That’s why we believe an Atlanta pharmacy FDA inspection attorney can help you even before you are faced with an inspection because throughout the process; they will ensure that you comply with all the rules and regulations and that you are handling matters within the pharmacy appropriately, avoiding any issues that might arise and should a problem arise that leads to an inspection, ensuring that you control the investigation with cognizance and intent. This is preventative maintenance and could well be worth the effort.

Hasson Law Group LLP offers 503a compounding pharmacies with client-oriented and scalable competent evaluations to help you prepare for upcoming inspections and to ensure that you comply with rules and regulations. The key to success is transparency. When meeting with the Atlanta pharmacy FDA inspection attorney, the best opportunity for you to learn more about the attorney and conversely for the firm to learn more about your situation and the needs of your pharmacy so that you may be better assisted. By providing one of our expert attorneys with as much information as possible, you are expediting the process of getting started and ensuring that your attorney has the information necessary to help you as much as they possibly can. Any documentation that you might have relative to an upcoming inspection, as well as information about your pharmacy, will facilitate the attorney in getting on the same page as you faster. Even if you may think the details are irrelevant, don’t leave them out and let the attorney be the judge of that.

Call an Atlanta Pharmacy FDA Inspection Attorney Today

We bring our prestigious large law firm and government service backgrounds to a small firm setting to offer you our extensive expertise in a personal, individualized approach where each case gets our full attention and our clients know they’re our priority. It’s with this personalized and customized attention that we can help protect your business against any risk by being proactive. By waiting to call an attorney, you could be jeopardizing your business by leaving it vulnerable. Consult with an Atlanta pharmacy FDA inspection attorney to get ahead of the circumstances and avoid complications. We welcome you to call Hasson Law Group LLP at (678) 701-2869 to speak with an expert attorney who has the experience required to keep you in good standing and safeguard your license. We are proud to serve the Atlanta, Georgia area since 2013.

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    Hasson Law Group LLC

    The Hasson Law Group, LLP, is an Atlanta, GA law firm dedicated to two principal practice areas: winning high stakes disputes in the areas of business litigation, insurance recovery, and complex criminal defense, and tax, corporate and regulatory law mechanisms affecting family businesses, tax-exempt organizations and the individuals who support or serve them.

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