Inspections, Compliance, Enforcement, and Criminal Investigations
CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer
1. Compounding in Hospitals - Registration
We interpret Section 510 of the Federal Food, Drug, and Cosmetic Act as not requiring registration by the hospital pharmacy that compounds medication for inpatient dispensing, outpatient dispensing (sale or free), mailing to a patient within the State or out of the State, or for transferral to another unit of the same hospital (within the State or in another State) for dispensing by that unit of the hospital. However, if the hospital pharmacy compounds medication which it sells to another hospital or a drugstore, such sale is not at "retail" and registration is required.
2. Application of the "current good manufacturing practices" regulations to hospital pharmacies.
Section 501(a)(2)(B) of the Act provides that a drug shall be deemed to be adulterated if "the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to current good manufacturing practice..." This section, through the operation of Section 301(k) is applicable to hospital pharmacies, as well as to manufacturers, whether or not the establishments are required to register with FDA under Section 510. However, the CGMP regulations set forth in 21 CFR 211 apply to those establishments which are both required to register under Section 510 and which prepare dosage forms. Therefore, if the hospital pharmacy is not required to register as described in paragraph one above, 21 CFR 211 does not apply. It is the policy of FDA not to routinely inspect such pharmacies for compliance with Section 501(a)(2)(B) if they operate within state or local laws governing the practice of pharmacy. However, when a hospital pharmacy is engaged in repacking or relabeling operations that are beyond the usual conduct of dispensing or selling drugs at retail, the exemptions in the Act cease to apply; the establishment is required to register and is subject to regular inspections under Section 704 of the Act.
3. Labeling of "prepackaged drugs"
We believe that drugs packaged for use as ward stock should be labeled with the information required by regulation 201.100(b).
4. Investigational drugs
We do not believe that preparation of investigational drugs by a hospital pharmacy for use by an investigator in the hospital or in another hospital, requires registration under Section 510 of the Act. However, if the new drug has been or is to be shipped in interstate commerce for clinical trials, the "sponsor" of the investigation should file a "Notice of Claimed Investigational Exemption for a New Drug" before the shipment is made or the trials started. This "Notice" would necessarily include the name and address of the pharmacy and provide information regarding manufacture of the new drug by the pharmacy.
Submission of Forms FD-1571, 1572, and 1573 is only required when the finished new drug or the "new drug substance" used in its manufacture, is in interstate commerce.
When interstate commerce is involved and the various forms must be submitted, the hospital or some other responsible person may act as the "sponsor" and file the Form FD-1571. Such "sponsor" should obtain completed Form FD-1572 or 1573 as appropriate from the actual investigators.
The physician-investigator may delegate to a hospital pharmacist responsible to him, or any other person responsible to him, the maintenance of the required records concerning the use of the investigational drug.
5. New drug applications
We recognize that a physician may prescribe an unusual preparation that requires compounding by the pharmacy from drugs readily available for other uses and which is not generally regarded as safe and effective for the intended use. If the pharmacy merely acts to fill each individual prescription as received, it is our opinion that clearance under the "new drug" provisions of the Act is not required.
If the hospital prepares a bulk quantity of an unusual drug in anticipation of prescriptions from the physician who developed the formula, or from other physicians who have been induced to use the unusual medication, we believe the situation would then differ from the one described in the preceding paragraph. If such drug is shipped interstate or a major ingredient used in manufacturing the drug is received from an out-of-state supplier, we would regard the article as a "new drug" in interstate commerce and therefore subject to the investigational new drug regulations.
We do not believe that "prepackaging" by the hospital pharmacy for dispensing within the hospital, or for outpatient dispensing, or for transferral to another unit of the hospital, would require registration under Section 510 of the Act. However, repacking of a drug which is sold to another hospital, whether or not such other hospital is under the control of the same corporation, would require registration under Section 510.
7. Antibiotic Certification
Hospital pharmacies are not exempt from the antibiotic certification regulations. Antibiotic preparations compounded by the hospital pharmacy are subject to the applicable regulations, regardless of whether the item that is compounded by the hospital pharmacy is available in the usual commercial channels. However, we point out that the pharmacist may, without further certification, compound an antibiotic preparation on the basis of a prescription issued by a licensed practitioner, if the antibiotic ingredient used for compounding the prescription is taken from a certified container packaged for dispensing. The compounded prescription is exempt from certification "for a reasonable time to permit the delivery of the drug compounded on such prescription."