Pharmacy Rules and Regulations

Compounding pharmacies are regulated on a state and federal level. On the federal level we follow guidelines as set forth by the United States Pharmacopeia (USP), specifically 795 and 797 for non sterile and sterile compounded products. Both the DEA and FDA have some jurisdiction however historically the FDA regulates pharmaceutical manufacturers and not pharmacy. The state boards of pharmacy govern pharmacies within each state and while the regulations vary slightly state to state they are the main regulatory local body. Most pharmacies are subject to random site visits by the state and those that choose to become PCAB certified are held to an even higher standard and are subject to yearly survey visits.

The Occupational Safety Health Administration (OSHA) governs the guidelines that keep our employees safe from hazardous materials and other workplace safety hazards.

For MedQuest to fill a prescription we require the prescriber’s name, address, phone number and DEA number. We also need the patient’s name, address, date of birth, phone number and date of issuance. Lastly the medication, dose, dosage form, quantity and refills must be present. Specific directions for use are required on all controlled substances.

A handful of hints as to what compounding pharmacies cannot do include the following:

• Compound commercially available products.
• Advertise individual prescription compounds or prices of compounds.
• Compound medications without the anticipation of a prescription.
• Sell compounded products to other pharmacies.
• Make claims on the efficacy of certain compounds for certain patient groups.
• Purchase raw material not approved by the FDA from other countries or purchase from a non FDA approved facility.
• Compound prescription medication to be dispensed from a doctor’s office without specific patient information.

Who can write prescriptions?
A practitioner authorized to prescribe drugs and medicine under the laws of this state or under the laws of another state having similar standards.

Lastly, a prescription may not be issued for an individual practitioner to obtain controlled substances for the purpose of general dispensing to patients. In addition a practitioner licensed under this chapter may not prescribe or administer dosages of a controlled substance in excess of medically recognized quantities necessary to treat the ailment, malady, or condition of the ultimate user.

If you have further questions regarding compound pharmacy prescribing please contact us at support@mqrx.com.