Leaves, twigs, and nuts near a mortar and pestle


21 USC 353b provides, inter alia:

“(a) In general Sections 352(f)(1), 355, and 360eee-1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met:

(8) Prohibition on wholesaling
The drug will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug. This paragraph does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 353(b)(1) of this title.

(d) Definitions:
4)(A) The term “outsourcing facility” means a facility at one geographic location or address that–
(i) is engaged in the compounding of sterile drugs;
(ii) has elected to register as an outsourcing facility; and
(iii) complies with all of the requirements of this section.
(B) An outsourcing facility is not required to be a licensed pharmacy.
(C) An outsourcing facility may or may not obtain prescriptions for identified individual patients.
(5) The term “sterile drug” means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law.”

“Pharmacies cannot compound medications or dosage forms that are commercially available and they cannot sell compounded products to other pharmacies for resale. A pharmacy may, however, sell a compounded product to a practitioner or an institutional pharmacy if it is to be administered to patients in the practitioner’s office or institution.”

“Although an outsourcing facility may send prescription drugs to health care facilities without obtaining prescriptions for identified individual patients, drugs produced by outsourcing facilities remain subject to the requirements in section 503(b) of the FD&C Act. Therefore, an outsourcing facility cannot dispense a prescription drug to a patient without a prescription. ”

By Al Mohajerian | Published April 29, 2016 | Posted in FDA  | Tagged 21 USC 353bcompounding pharmaciesProhibition on wholesaling |

Filed Under: FDAPharmaceuticals