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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
Prepared to a prescriber's order for one patient. Not FDA-approved.
This is a compounded topical gel containing glycolic acid, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved.
These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.
No FDA-approved (NDA or ANDA) product containing glycolic acid is listed. Products containing it are filed in the directory as over-the-counter monograph drugs, in liquid, lotion and patch forms. None of the listed products containing glycolic acid is in gel form.
Gel bases can be aqueous or nonaqueous, and USP <795> classifies the preparation by its water activity. Aqueous preparations carry shorter default beyond-use dates than nonaqueous ones. The date printed on the label is the one to follow.
Glycolic acid is an alpha hydroxy acid exfoliant applied to the skin; compounding pharmacies prepare it by prescription.
Glycolic acid is an alpha hydroxy acid (AHA), a small, weak organic acid with a hydroxyl group on the alpha carbon, found naturally in sugarcane. AHAs loosen the bonds between surface skin cells so the outer layer sheds, and FDA notes that the effect depends on the type and concentration of the acid, the product's pH and its other ingredients. FDA notes that AHA products are marketed for purposes such as smoothing fine lines and surface wrinkles, and that products intended to treat disease, such as acne treatments and skin lighteners, are drugs. StatPearls describes glycolic acid as a common chemical peel agent that needs a neutralizing agent to stop its action. A prescriber might order glycolic acid compounded for a concentration, vehicle or combination not available commercially. Compounded preparations are not FDA-approved and require a prescription.
FDA has received reports of burning, rash, swelling and skin color changes with AHA products, and the more serious reactions occurred most often with products that cause the most peeling. AHAs can increase the skin's sensitivity to the sun: in studies FDA cites, four weeks of AHA cream increased reddening from UV light and roughly doubled UV-induced cell damage, effects that reversed within a week of stopping. FDA recommends a "Sunburn Alert" label advising sunscreen, protective clothing and limited sun exposure during use and for a week afterward. For chemical peels, StatPearls lists cautions including active infection, open wounds, current isotretinoin treatment and allergy to a peeling agent, and lists pregnancy and breastfeeding among precautions for medium and deep peels. Stop use and talk to your prescriber or pharmacist if you develop burning, swelling, blistering or lasting redness.
AHAs reduce corneocyte cohesion just above the granular layer, promoting desquamation of the stratum corneum; the Tang and Yang review also describes increased glycosaminoglycan synthesis and skin thickening, and notes that concentration, pH, exposure time and the amount of free acid govern both response and irritation. Dermal absorption of AHAs is not well characterized. StatPearls lists low-potency glycolic acid among very light peel agents and higher-strength glycolic acid among light peels; chemical peels are used for acne, melasma, postinflammatory pigmentation, actinic keratosis and wrinkles, and glycolic acid is one option for skin priming before a peel. These are not FDA-approved drug indications. FDA summarizes the Cosmetic Ingredient Review panel's finding that glycolic and lactic acid products are safe for consumers within limits on concentration and pH and with sun protection. Concentration, pH and contact time are per prescriber. Monitor for irritation, postinflammatory pigmentation and sun protection. FDA states it continues to review data on AHA sun sensitivity; a National Toxicology Program study found glycolic acid did not affect photocarcinogenesis in mice.
Wash your hands. Apply the amount on your label to clean, dry skin and spread it in a thin layer. For a metered pump, your label states the number of presses. For a dosing syringe, push the plunger to the mark. Let the gel dry before covering with clothing. Wash your hands afterward and keep the site from touching other people until it has dried. Do not apply to broken skin unless told to.
A gel can have a nonaqueous or a water-based base, and USP <795> sets its default beyond-use date by water content, not by the word gel. A nonaqueous gel usually carries a beyond-use date of up to 180 days at room temperature or refrigerated. A water-based gel carries up to 35 days with a preservative, or 14 days refrigerated without one. Your label states which applies. Keep the container closed, away from heat and open flame if it contains alcohol, out of reach of children, and discard after the beyond-use date on your label.
This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.
Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.
Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.
Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.
Apply topically to affected area(s)
