# Agency Cell Repair Rx Important Safety Information > Please read this first Agency Cell Repair Rx is a compounded prescription medication Agency Cell Repair Rx is a compounded prescription medication It is p Source: https://support.agencyskin.com/en_us/agency-cell-repair-rx-important-safety-information-Hk_uiMUvGg Last updated: 2026-08-22T14:25:17.924Z **Please read this first: Agency Cell Repair Rx is a compounded prescription medication** **Agency Cell Repair Rx is a compounded prescription medication.** It is prepared for you by a state-licensed compounding pharmacy operating under Section 503A of Federal Food, Drug & Cosmetic Act (“Section 503A”), pursuant to a prescription drug order issued by your prescribing licensed medical provider for a determined clinical need. **Compounded prescription medications are not FDA-approved.** The FDA has not evaluated Agency Cell Repair Rx for safety or efficacy through its drug approval process. Agency Cell Repair Rx’s combination of ingredients each individually comply with Section 503A, but the combination compounded medication has not been evaluated or approved by the FDA for safety and efficacy. Agency makes no claims of safety and efficacy with respect to Agency Cell Repair Rx. **What Agency Cell Repair Rx is for** Agency Cell Repair Rx is a compounded prescription drug treatment that aims to target skin concerns such as fine lines, texture, uneven tone, redness, and loss of firmness.  _Results may vary. Product and ingredients are subject to medical evaluation and patient consultation whereby the medical provider determines the compounded prescription medication is appropriate for use._ **The use of sirolimus (rapamycin) for signs of aging on the skin is an off-label use.** The FDA has approved a prescription topical gel only for facial angiofibroma in tuberous sclerosis complex. No sirolimus (rapamycin) drug products are FDA-approved for treatments related to skin aging. **Before you start** Consult with your dermatology provider about any medical conditions and all medications you are taking before using this compounded prescription medication. Rapamycin (sirolimus), one of the active pharmaceutical ingredients in Agency Cell Repair Rx, has numerous drug-drug, drug-supplement, and drug-food interactions that must be taken into consideration during patient drug counseling prior to dispensing and administration. Agency Cell Repair Rx will be assigned a beyond use date in accordance with Section 503A and United States Pharmacopeia (USP) standards. Do not use this medication after the date listed on the prescription bottle. **Who should not use Agency Cell Repair Rx** Do not use Agency Cell Repair Rx, and tell your medical provider, if any of the following apply to you: * You are trying to conceive, pregnant, or nursing. Rapamycin (sirolimus) can harm an unborn baby. If you are able to become pregnant, use effective contraception during treatment and for at least 12 weeks after your last dose. If you become pregnant, stop use and contact your medical provider. * You have had an allergic or hypersensitivity reaction to sirolimus (rapamycin), or any other mTOR inhibitor. * You are taking an mTOR inhibitor by mouth or by injection, including sirolimus, everolimus, or temsirolimus. * You have received an organ transplant, or you are taking any medication that suppresses your immune system. * You have, or have had symptoms of, interstitial lung disease. * You have, or have ever had, cancer of any kind, including skin cancer. * You have an active skin infection, skin inflammation, or a wound that is not healing well at the area where you would apply the medication. * You have had a facial procedure within the past 4 weeks, including surgery, a chemical peel, laser treatment, microneedling, or dermabrasion. * You drink grapefruit juice or take St. John’s Wort. Resveratrol is structurally similar to estrogens and has been classified as a phytoestrogen. If you have any condition that can worsen with exposure to estrogen, talk with your medical provider before using this medication. **Medications that can interact with sirolimus (rapamycin)** Tell your provider about every medication and supplement you take. Medications that can interact include: * Antifungal medications such as ketoconazole, itraconazole, or voriconazole * Antibiotics such as clarithromycin or erythromycin * HIV medications such as ritonavir and other protease inhibitors * Rifampin or rifabutin * Seizure medications such as phenytoin, carbamazepine, or phenobarbital * Cyclosporine (Neoral, Sandimmune, Gengraf) * Tacrolimus (Prograf) * Cannabidiol (Epidiolex or CBD products) * St. John’s Wort * Grapefruit juice **Active pharmaceutical ingredients (API) within Agency Cell Repair Rx** The APIs within Agency Cell Repair Rx are selected and prescribed by your appropriately state-licensed medical provider. Prescription drug products and APIs are subject to medical consultation. The APIs used within the compounded prescription medication will be listed on your Agency Cell Repair Rx bottle label in accordance with state and federal law. Ask your medical provider if you have questions about the APIs included within the compounded prescription medications. Please inform your medical provider of all allergies, including allergies to ingredients that may be in the Agency Cell Repair Rx. These may include: * Sirolimus (rapamycin) * Resveratrol **Base inactive ingredients in Agency Cell Repair Rx** The base inactive ingredients for each Agency Cell Repair Rx formula include: C13-15 Alkane, Caprylyl Methicone, Cyclopentasiloxane, Diethylene Glycol Monoethyl Ether, Dimethicone, Dimethyl Isosorbide, Moringa Oil/Hydrogenated Moringa Oil Esters, Passiflora Edulis Seed Oil, PEG-12 Dimethicone/PPG-20 Crosspolymer, Pentaerythrityl Tetraisostearate, Polysilicone-11, Tocopherol, Tocopheryl Acetate, and Butylated Hydroxytoluene (BHT). **Please review the base ingredients if you have allergies, as we do not screen for allergies to the product base.** **Agency Cell Repair Rx is not recommended for use in patients younger than 18 years of age.** **Warnings** Skin irritation may occur as a side effect of this medication. This can include dryness, irritation at the application site, itching, and acne or acne-like bumps. Please contact your prescribing medical provider if this occurs. **Skin checks.** Annual skin exams are recommended. Tell your medical provider right away if you notice a new or changing mole, growth, or sore that does not heal. **Facial procedures and wound healing.** Stop using Agency Cell Repair Rx at least 2 weeks before any facial procedure and coordinate with the medical provider performing the procedure. Do not use this medication on skin that is healing. **Sun exposure.** The API within this compounded prescription medication can make you more sensitive to the sun. Limit your exposure to sunlight and to ultraviolet light, including tanning beds and UV light therapy, while using it. Use a broad-spectrum sunscreen with at least SPF 30 daily, and wear protective clothing. **Vaccinations.** Vaccines may be less effective while you are using topical sirolimus (rapamycin). Complete all age-appropriate vaccinations recommended by current immunization guidelines before starting treatment, and avoid live vaccines during treatment. Coordinate with your in-person medical provider. **Application.** External use only. Avoid your eyes and mouth. Do not cover, wrap, bandage, or apply a dressing to the treated area. To reduce the risk of skin irritation, avoid other products that may irritate the skin. This includes the use of abrasive soaps, exfoliants, and related chemicals or obtaining facial treatments including but not limited to waxing and electrolysis. **Common side effects** Dry skin or peeling may occur. Do not use if trying to conceive, pregnant, or breastfeeding. Do not use Agency Cell Repair Rx if you are allergic to any ingredients or if an allergic reaction occurs. Dry skin, irritation at the application site, itching, acne or acne-like bumps, and increased sensitivity to the sun may occur. Serious side effects are considered very rare with topical use. Topical sirolimus (rapamycin) is generally not absorbed into the bloodstream at levels high enough to cause whole-body effects, though long-term use is still being studied. The following side effects have been reported in people taking sirolimus by mouth: serious allergic reactions, infections, cancer (including lymphoma and skin cancer), increased cholesterol, increased triglycerides, infertility in men and women, and lung or breathing problems. **Contact your medical provider right away if you experience swelling of the face, eyes, or mouth, trouble breathing, chest pain or tightness, fever or chills, shortness of breath, or a new or worsening cough.** Do not use if you are allergic to this medication or any of its ingredients. Stop use and contact your medical provider right away if you develop symptoms of an allergic reaction such as rash, hives, itching, shortness of breath, wheezing, cough, or swelling of your face, lips, tongue, or throat. **Please tell your medical provider if** * You are pregnant, nursing, or trying to get pregnant. * You take any medication or supplement, including over-the-counter products, vitamins, and herbal supplements. * You have a personal or family history of cancer of any kind, including skin cancer. * You have any lung or breathing condition. * You have any condition that affects your immune system, or you take a medication that suppresses your immune system. * You have a facial procedure scheduled, or have had one in the past 4 weeks. * You are due for any vaccinations. * You have had any allergic reactions to skin care products. * If you have been diagnosed with rosacea. * If you have a history of eczema, perioral dermatitis, skin cancer, or other skin conditions. * You are taking any other medications that make you more sensitive to sunlight. **How to use** This compounded prescription medication treatment was designed to be applied once daily in the evening. Apply a thin layer to clean, dry skin on your face and neck, using no more than two pumps, then follow with moisturizer. Do not use elsewhere on the body. Do not use more than your medical provider has instructed you to use. If your provider has also prescribed Agency Night Renew Rx, they may advise you how to layer the two treatments accordingly. Do not swallow and avoid sensitive areas such as eyes, lips, mucous membranes, and inside your mouth/nose. Do not use on cuts, scrapes, damaged (broken/chapped/cut/irritated/scraped) skin, recently shaved areas of the skin, or sunburned skin. Doing any of these things may increase the chance of undesirable side effects. Please always follow your prescribing medical provider’s specific directions on how to use your Agency Cell Repair Rx. **Important summary** This page does not list every possible risk, side effect, warning, or interaction associated with Agency Cell Repair Rx, and it is not a substitute for a full consultation and patient counseling with your prescribing medical provider. Your prescribing medical provider knows your medical history and prescribed the compounded prescription medication specifically to meet your clinical needs. Talk with your medical provider before you start, stop, or change how you use this compounded prescription medication, and tell them about all of your medical conditions and allergies, and all medications and supplements you take, including over-the-counter products. **Reporting a side effect** If you experience a side effect, contact your Agency prescribing medical provider through your account. If you think you are having a medical emergency, call 911 or go to the nearest emergency room. **Who compounds this medication:** Agency Cell Repair Rx is compounded and dispensed by Personalized Skin Solutions, Inc., a state-licensed compounding pharmacy operating in compliance with Section 503A located at 155 Solar Drive, Imperial, PA 15126 (1-888-210-4777). Agency does not manufacture or compound this medication. Questions about how your prescription was compounded, or about your specific ingredient list, can be directed to your medical provider through your account or the pharmacy at the number above.