| (VII) Other methods. Any other method approved by the department. (4) Premises. Prescription drugs distributed by a manufacturer or wholesale distributor may be delivered only to the premises listed on the license, except as listed in paragraph (5) of this subsection. A manufacturer or wholesale distributor may distribute prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if: (A) the identity and authorization of the recipient is properly established; and (B) delivery is made only to meet the immediate needs of a particular patient of the authorized person. (5) Delivery to hospital pharmacies. Prescription drugs may be distributed to a hospital pharmacy receiving area if a pharmacist or an authorized receiving person signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesale distributor not later than the next business day after the date of delivery to the pharmacy receiving area. (g) Prescription drug labeling. Prescription drugs sold by wholesale distributors shall meet the labeling requirements of the Act and those adopted in §229.420(a) of this title. (h) Prescription drugs that are combination products. Any prescription drug that is a combination product as described in §229.424(c) of this title (relating to Licensure Requirements) is also subject to the applicable requirements in Subchapter X of this chapter (relating to Licensing of Device Distributors and Manufacturers). (i) Prescription drugs that are also cosmetics. Any prescription drug that is also a cosmetic or component thereof is also subject to the applicable requirements of Subchapter D of this chapter (relating to Regulation of Cosmetics). (j) Nonprescription drugs. Nonprescription drugs offered for sale by wholesale distributors of prescription drugs shall be in compliance with the applicable requirements of Subchapter O of this chapter (relating to Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices). |
