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Provider Agreement and Disclosure:
Las Colinas Pharmacy is a 503A compounding pharmacy. All prescriptions must be sent with a valid provider-patient relationship. Compounded medications cannot be written for office-use but must be written with a patient-specific prescription order, including patient name, date of birth, patient phone number, patient address, and any known drug allergies. Compounded prescription orders cannot be written for excessive quantities or directions that a single patient could not safely and reasonably use as it relates to the dose, beyond-use-date, or multi-dose vial 28-day puncture rule. Las Colinas Pharmacy will only dispense medications within a practitioner's scope of practice and within their skill level in prescribing and administering, or if applicable, as outlined in their Collaborative/Medical Director Practice Agreement. Las Colinas Pharmacy cannot fill controlled substance prescriptions written for the provider as the patient and will not deliver compounded controlled substances to a provider's practicing address.

Direct Clinic Billing - also known as "office pay" - refers to a 503A compounding pharmacy billing a provider or clinic directly for dispensing a patient-specific prescription written by a prescriber for a compounded medication. The pharmacy is paid by the prescriber or clinic for that prescription, then the provider or clinic bills the patient directly for the exact cost of the drug. The prescribed compounded medication may be delivered to the clinic or to the patient by the pharmacy and is intended only for that specific patient's use. The medication is then administered to the patient in the prescriber's office or sent home with the patient (in this circumstance, the provider acts as a "pick-up location" for the drug.) A few examples of when this practice is appropriate is if the patient does not have a permanent address, the office procedure requires a preparation that is not appropriate for at-home administration by patient and must be administered in the prescriber's office, the drug is administered as part of a research clinical trial, the prescriber deems it appropriate for in-office training and observation of first dose before sending patient home with the drug, clinic acts as a "pick-up location" for the patient for convenience reasons, compounded preparation is intended to be a "continuation of care" after an in-office or in-hospital procedure and wouldn't be appropriate for the patient to use otherwise. Direct Clinic Billing should not be confused with distribution of drugs by 503B outsourcing facilities to clinics for "office administration" – also known as "office use" – to patients without a prescription. 503B outsourcing facilities are allowed in federal law to distribute drugs without a patient-specific prescription.

With this information in mind, I attest that the compounded medication is only for use by the patient to whom it was prescribed and dispensed. No portion of the drug will be administered or dispensed to anyone other than the individual person to whom it was prescribed. Any excess in the container that is not intended to be sent home with the patient will be discarded. In accordance with federal and state laws and regulations, we will not "upcharge" for the compounded medication and will only collect from the patient the fee the clinic was billed by the pharmacy for the medication. (This does not prohibit a prescriber from charging a patient for consultative, diagnostic, administrative, or other services billed as part of the care they provide for the patient.)

If the order is billing to the clinic, then please have your patients refrain from calling the pharmacy. They will be directed to your office with any questions regarding the order. When shipping to individual patients we ask that the provider verifies the patient’s address is correct. If the address provided to the pharmacy is incorrect, the pharmacy will not be responsible for replacing the order at our expense.

No claims will be made, in person, print, or online about any compounded drug in regard to the ability to cure or treat a health condition or make claims that compounded drugs are "safe" or "effective." ("Safe" and "effective" have legal definitions in federal law and may not be used with regard to compounded medications.) Compounded medications are not and should not be marketed or referenced as "generic" medications or as equivalent to any generic or Brand Name medications. Compounded drugs are not the same as generic or brand name drugs. Compounded medications are not required to go through FDA study approval processes that brand name or generic medications are required and therefore cannot make these claims or equate a compounded medication to a brand name or generic drug in that manner.