For Pharmacies

FDA & Medical Counsel helps its clients understand and comply with pharmaceutical compounding regulatory requirements. While compliance is running smoothly, we work with our clients – in a practical, business-minded manner – to keep it that way. When FDA issues arise, we work on your behalf to minimize negative regulatory enforcement attempts. And all of the time, we provide broad legal support for employing best practices in operating a 503A or 503B pharmacy. Moreover, FDAmc understands that every facility is unique because it must start from where it is; thus, each FDA compliance strategy is tailored to fit.

FDA

FDA & Medical Counsel is a third party liaison between clients and the FDA. It has been our experience that detailed, expert legal and/or scientific responses to enforcement demands can stop FDA from pursuing weak claims – and move on to a facility that may bend more easily. FDAmc has also worked extensively within FDA to resolve both regulatory and scientific issues.

COMPOUNDING QUALITY ACT

FDA & Medical Counsel explains, interprets, and advises clients on FDA compliance with the contours of the 2013 Compounding Quality Act, or DQSA, which sets out conditions for qualifying as a 503A, such as no office use and nominal out-of-state sales, but exempts traditional pharmacies from GMP, labeling, and NDA requirements. If a facility cannot meet those conditions, or otherwise violates the Food, Drug & Cosmetic Act, it must register as a 503B outsourcing facility and meet higher GMP, labeling, recordkeeping, and reporting standards; in exchange, however, a 503B may dispense for office use and with no limit on out-of-state sales. requirements for both 503A traditional pharmacies and 503B outsourcing facilities.

Since the enactment of DQSA, FDA has issued numerous Guidances For Industry setting out its positions on specific points of law, its expectations, and its enforcement priorities. There remain gray areas and significant pushback from industry. FDAmc can guide your facility through this ever-changing obstacle course.

Our practical, actionable advice is also based on FDA’s own enforcement history – a guidepost to achieving real world compliance. As the practices, precedent, and guidance surrounding the new law continue to evolve, so do our services.

503B - cGMP

FDA & Medical Counsel advises clients deciding whether and how to evolve from 503A to 503B. Options include separating sterile, full conversion, or selectively changing business practices. Each facility’s individual compliance posture will determine the resources and risk involved with different choices. FDAmc lays out the options, the pros and cons, all the while providing tailored analysis to support your ultimate business judgment.

503A STERILE COMPOUNDING

One of the most hotly-contested area of FDA’s enforcement is sterile compounding by traditional, state licensed, 503A pharmacies. FDA has taken the unilateral position that has the authority to inspect and ultimately determine whether a facility can remain a 503A. FDAmc has experience counseling clients seeking to avoid FDA interaction in this arena and represents facilities during enforcement attempts.

503A VERSUS 503B

FDA & Medical Counsel advises clients who are deciding whether to convert their traditional pharmacy to an outsourcing facility. We lay out the pros and cons and provide tailored analyses to aid in the decision-making process. The differences in FDA compliance requirements and state and federal pharmacy law will guide your ultimate decision.

OFFICE USE

Our FDA legal services surrounding office use include advising clients on FDA compliance when compounding for office use in the sterile/non-sterile and 503A/ 503B spaces.

INSPECTION

Our FDA legal services include working with clients in advance, preparing SOPs, training, and consulting to prepare for ever-more-inevitable inspections. FDAmc is also on call to participate in real time during the inspection and closeout meeting as well.

483s AND WARNING LETTERS

Compounding pharmacy 483s and Warning Letters have become increasingly commonplace as FDA ramps up enforcement in this heavily-regulated industry.FDA & Medical Counsel is experienced in advising pharmacy clients on the form and substance of Written Responses geared toward resolving the Agency’s concerns as quickly, effectively, and unobtrusively as possible. Our experience in pharmacy law, FDA compliance, and the enforcement regulatory process is unparalleled.

RECALLS

FDAmc counsels clients when product recall issues arise, either internally, from patients, or through FDA. Our in-house MD JD MS can help you determine the realistic significance of the issue and dispute product testing results. If a recall has already been established, we work directly with CDER and the District Office Recall Coordinator to facilitate efficient completion, from working with FDA on the critical details of a recall, such as time frame, classification, press release, customer letter, recall level, quarantine and destruction requirements, and ultimate closeout. FDAmc can also work with clients through crisis management remediation and strategic communications

CONSENT DECREES

FDA & Medical Counsel represents clients facing, or operating under, Consent Decrees. In doing so, our FDArc’s services include presenting all available options, assessing potential outcomes and negotiating with the government realistically to resolve pharmacy compliance concerns and keep your business operating.

MARKETING - MEDICAL SCIENCE LIAISON - MEDICAL AFFAIRS

FDA & Medical Counsel is experienced in providing FDA compliance advice for pharmacies navigating the specific compliance issues involved with product claims, advertising, off-label, contract marketer, physician-participant, prescription pad and product/service marketing methods. Our in-house physician can function as your Medical Science Liaison, Medical Affairs Department, and otherwise educate prescribers on expanded uses of your compounds.

LABELING

FDAmc advises clients on the intricacies of FDA compliance with different labeling requirements for individual patients, office use, and advance compounding under both the 503A and 503B regulations.

SOPs

FDA & Medical Counsel can provide template and custom SOPs to guide pharmacy staff on day-to-day FDA compliance

INTERSTATE COMPOUNDING: 30% RULE, MOU, AND ‘DISTRIBUTION’ VERSUS ‘DISPENSING’

FDA & Medical Counsel advises clients on operating a compliant cross-border pharmacy practice under the current regime, where the rules regarding permissible interstate compounding are still under debate by FDA and the states.

VETERINARY COMPOUNDING

The practice of compounding for companion animals is under intense scrutiny by FDA. Since the Franck’s polo horse decision was vacated in 2012, FDA has continued to push against veterinary compounding from bulk API. Our FDA legal services include providing experienced advice to veterinary pharmaceutical compounders on the evolving state of risk and regulation.

FDA RISK MITIGATION

FDA & Medical Counsel provides risk mitigation FDA legal services that help clients operate using best practices and temper FDA regulatory risk on an ongoing basis. We are constantly monitoring FDA enforcement databases for precedent and applying FDA’s own methodology/trends to help clients avoid non-compliance.

Clinical/Significant Difference

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