Frequently asked questions

Star Health USA is a clinic supply program based in Las Vegas, Nevada, that connects med spas and medical practices with independently licensed compounding pharmacies. It is not a pharmacy and does not compound, store or dispense medication: a licensed prescriber writes each order and a licensed pharmacy fills it. Star Health USA is not an insurance company and is not affiliated with Star Health and Allied Insurance. Read the compliance overview.

Yes, verified clinics can order the hormone and peptide preparations on the Star Health formulary, which are prescription peptides and hormones compounded by licensed pharmacies. Every order is tied to a licensed prescriber, and Star Health, based in Las Vegas, Nevada, works with 503A pharmacies for patient-specific prescriptions and 503B outsourcing facilities for office-use stock. Availability depends on pharmacy licensure in your state and is confirmed during verification. See the formulary.

A 503A pharmacy compounds based on a valid prescription for an identified individual patient, while a 503B outsourcing facility is registered with the FDA and can also distribute compounded drugs in response to a provider's order that is not for an identified individual patient, for example office stock. The numbers refer to two sections of the Federal Food, Drug, and Cosmetic Act. Star Health works with 503A pharmacies for patient-specific prescriptions and 503B outsourcing facilities for office-use stock. Read the 503A vs 503B guide.

A 503A pharmacy is a state-licensed pharmacy that compounds under section 503A of the Federal Food, Drug, and Cosmetic Act and is not registered with the FDA as an outsourcing facility. Compounding under section 503A must be based on a valid prescription for an identified individual patient. Generally, state boards of pharmacy have primary responsibility for day-to-day oversight of these pharmacies, and the FDA also conducts surveillance and for-cause inspections. For a clinic, each order starts with a prescription written by a licensed prescriber for a specific person.

A 503B outsourcing facility is a compounder that has registered with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act, compounds sterile drugs and must meet all of the conditions of that section. Outsourcing facilities must comply with current good manufacturing practice requirements and are inspected by the FDA on a risk-based schedule. They can distribute compounded drugs for office stock in response to a provider's order. Registration means only that the FDA has received the required information; their compounded drugs are not FDA-approved.

Neither is better across the board, because 503A and 503B describe two different ways a compounder can operate and the right one depends on the type of order. Patient-specific prescriptions are filled by state-licensed 503A pharmacies, and office-use stock comes from FDA-registered 503B outsourcing facilities. Which one fills your order changes how you order, what paperwork you keep, and whether you can hold stock in the clinic. Compounded drugs are not FDA-approved, whether they come from a 503A pharmacy or a 503B outsourcing facility.

No, not every compounder operates under section 503A: some register with the FDA as 503B outsourcing facilities. Section 503A applies to compounding by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician, that is not registered with the FDA as an outsourcing facility. Outsourcing facilities are a voluntary category created when section 503B was added in 2013. An outsourcing facility is not required to be a licensed pharmacy, but compounding must be done by or under the direct supervision of a licensed pharmacist.

Compounded drugs are drugs prepared by a licensed pharmacist in a state-licensed pharmacy, by a licensed physician, or by an FDA-registered outsourcing facility, under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Compounded drugs are not FDA-approved: the FDA does not review them for safety, effectiveness or quality before they are marketed. In the Star Health program, compounded products are prepared, labeled and dispensed by independently licensed pharmacies against a valid prescription or office-use order.

Yes for a 503A pharmacy: compounding under section 503A must be based on a valid prescription for an identified individual patient. A 503B outsourcing facility can also distribute compounded drugs in response to an order from a health care provider that is not for an identified individual patient, for example office stock. In the Star Health program every order is tied to a licensed prescriber, and nothing ships without a valid prescription or office-use order.

NAD+ (nicotinamide adenine dinucleotide) is a coenzyme present in every living cell. On the Star Health formulary, compounded NAD+ is prepared as a sterile injectable by licensed pharmacies. Verified clinics request it in the portal, a licensed prescriber signs each patient-specific prescription or office-use order, and a state-licensed pharmacy compounds, labels and ships it. Infusion and injection protocols are set by your prescriber. See NAD+ on the formulary.

A clinic can check a compounding pharmacy by asking for the license or registration number that covers shipments into its state and checking it on the state board of pharmacy's website. For a 503B outsourcing facility, confirm that it appears on the FDA's list of registered outsourcing facilities, which includes the date of each facility's last inspection. The FDA also publishes compounding inspection, recall and warning letter documents. A vendor that will ship without asking for prescriber details is a warning sign.

Before choosing a pharmacy partner, a clinic should ask whether each item is filled by a 503A pharmacy or a 503B outsourcing facility, and whether the pharmacy is licensed for the clinic's state. Also ask who signs orders and where that is recorded, what comes with each shipment, whether the clinic can keep stock, how recalls and quality notices are sent, and what happens when a product's status changes. Write the answers down and file them in your vendor file. Read the 503A vs 503B guide.

A med spa adding a pharmacy program should review the vendor against a written checklist covering ten areas: business basics, licensing and registration, prescriber requirements, product sourcing, pricing and terms, documentation, shipping and receiving, quality notices and recalls, sales reps and marketing, and data and privacy. Repeat the review once a year for every active vendor, and sooner if the vendor changes pharmacies, terms or ownership. Read the vendor checklist for med spas.

Lead time on a pharmacy order depends on how quickly the prescriber signs, the pharmacist's review, the preparation schedule, any release testing, shipping cutoffs and holidays. Lead times vary by item, by pharmacy and by season, and a missing signature or an expired license stops an order until it is fixed. The signature is the step the clinic controls most directly, so agree a regular signing window and ask your account contact for the current estimate on each item you order often. Read the lead times and cold-chain guide.

Cold-chain shipping keeps items that need refrigeration within their temperature range in transit: they usually ship in an insulated container with refrigerant packs, and some shipments also include a temperature indicator or a data logger. The packaging is designed to hold its temperature range for a limited time, so many pharmacies ship refrigerated orders only on certain days to keep packages from sitting in a depot over a weekend. Read the pharmacy's instructions on what to do if a package arrives late.

When a cold-chain shipment arrives, the clinic should record the date and time, check the outer box for damage, open the shipper right away and note the condition of the refrigerant packs and any temperature indicator. Then count the items against the packing slip, check that lot numbers and beyond-use or expiration dates match the paperwork, move items that need refrigeration into the refrigerator promptly and complete the receiving log. If something is wrong, contact the pharmacy the same day; the pharmacy decides whether a product can be used.

A clinic should ask a pharmacy program which carriers and service levels it uses, how refrigerated items are packed, and what the shipping cutoff days are. Also ask what to do if a package arrives late, damaged or warm, whether the vendor can ship to your state and to which addresses, and whether shipping and cold-chain packaging charges are shown separately. At Star Health, orders ship with lot numbers and order records on file, and a dedicated account contact helps with timing and shipping questions.