 y OFFICE   OF THE ATTORNEY   GENFRAL   . STATE OF TEXAS

   JOHN     C~RNYN




                                              September 20,200l




Charles E. Bell, M.D.                                      Opinion No. JC-0412
Executive Deputy Commissioner
Texas Department of Health                                 Re: Whether, in accordance with section 439.022
1100 West 49th Street                                      of the Health and Safety Code, the Texas Board of
Austin, Texas 78756-3 199                                  Health must adopt rules providing for a nursing
                                                           home to recycle certain prescription drugs that are
                                                           scheduled to be destroyed (RQ-0371 -JC)


Dear Dr. Bell:

         Under section 439.021 of the Health and Safety Code, a nursing home’s “consulting
pharmacist . . . may select, from a supply of drugs due” to be destroyed, certain drugs to ship to a
foreign country. TEX. HEALTH &SAFETY CODE ANN. 4 439.021(a) (Vernon 2001). Section 439.022
requires the Texas Board of Health (the “Board’) to adopt rules “consistent with federal and state
law” to implement this directive. Id. 8 439.022(a). Assuming that “[flederal law seems to prohibit
the recycling of prescription drugs except for physicians’ samples,“’ you ask, on behalf of the Board,                .
whether the Board is “preempted by federal law from adopting rules” in accordance with section
439.022, except to the extent that the drugs involved are physician samples. Request Letter, note
1, at 1. The federal Food and Drug Administration’s Department of Health and Human Services has
informed us that sample and nonsample prescription drug products may be donated to foreign
countries in certain limited circumstances .* We accordingly conclude that federal law does not
preempt the Board’s responsibility to adopt the required rules. The rules must comport with federal
limitations on the class of prescription drugs that may be recycled, however. See TEX. HEALTH &
SAFETY CODE ANN. 8 439.022(a) (Vernon 2001) (requiring Board to adopt rules “consistent with
federal and state law”).

        Chapter 439, subchapter C of the Health and Safety Code, which consists of sections 439.02 1
through 439.023, concerns preserving and distributing certain unused drugs. See id. $3 439.021-


         ‘Letter from Charles E. Bell, M.D., Executive Deputy Commissioner,   Texas Department of Health, to
Honorable John Comyn, Attorney General of Texas (Mar. 26, 2001) (on file with Opinion Committee) [hereinafter
Request Letter].

         2See Letter from Dennis E. Baker, Associate Commissioner for Regulatory Affairs, United States Department
of Health and Human Services, Food and Drug Administration,          to Charles E. Bell, M.D., Executive Deputy
Commissioner, Texas Department of Health (July 5,200 1) (on tile with Opinion Corumittee) [hereinafter FDA Letter].
Charles E. Bell, M.D. - Page 2                    (JC-0412)




.023. Section 439.021 authorizes a nursing home’s consulting pharmacist to select certain unused
drugs that would otherwise be destroyed to ship to a foreign country:

                       (a) A consulting pharmacist of a nursing home may select,
               from a supply of drugs due for destruction, certain drugs to be used
               for shipment to a foreign country as provided by this subchapter.

                        (b) The supply of drugs due for destruction are those drugs
               accumulated because of the death of a resident of the nursing home
               or because a physician has ordered the use of the drug to be
               discontinued.

                       (c) Quarterly, before the drugs are destroyed, the consulting
               pharmacist may, in the pharmacist’s professional judgment, select the
               drugs to be used under this subchapter and seal them in a box for
               shipment.

                       (d) The consulting pharmacist shall account to the Texas
               Department of Health for all drugs selected for shipment under this
               subchapter.    -

                        (e) This subchapter does not apply if the unused drug is a
               controlled substance as defined by Chapter 481 [of the Health and
               Safety Code] (Texas Controlled Substances Act).

Id. 8 439.021. The Board is required to adopt rules that are consistent with state and federal law to
implement the subchapter and to specify the foreign countries that may receive the drugs:

                       (a) The. . . Board..   . shall adopt rules consistent with federal
               and state law to implement     this subchapter, including rules relating
               to:

                           (1) the packaging    and inventory of drugs for shipment;

                         (2) the manner of shipment of the drugs from original
               shipment under this subchapter until the final destination; and

                          (3) safeguards to ensure the proper handling            of and
               accounting for all drugs shipped.

                       (b) The. . . Board. . . by rule shall determine, in consultation
               with the United States Department of State and other appropriate
               federal agencies, the foreign countries to receive the drugs.
Charles E. Bell, M.D. - Page 3                    (JC-0412)




                        (c) The salvaging of drugs under this subchapter is not
                subject to Chapter 43 1 (Texas Food, Drug and Cosmetic Act).

Id. 8 439.022. The state Department of Health may contract with other entities, such as local
governments and civic organizations, to implement the subchapter and may accept gifts, grants, and
other funds to implement the subchapter. See id. fj 439.023.

         Although we have not located any current Board regulation regarding the recycling of drugs
authorized by sections 439.021 and 439.022 of the Health and Safety Code, we have located
regulations of other state agencies that appear to apply. A regulation adopted by the State Board of
Pharmacy, for example, prohibits a licensed pharmacist to “accept any unused prescription or drug,
in whole or part, after it has been dispensed or sold, for the purpose of re-dispensing or resale to any
person.” 22 TEX. ADMIN. CODE 6 291.8(a) (2001) (Bd. of Pharmacy, Return of Prescription Drugs).
Violations “shall be dealt with as a violation of pharmacy law.” Id. 8 291.8(b). A Department of
Human Services regulation requires that medications of deceased nursing-home                  residents,
medications that have expired, and discontinued medications “be disposed of according to federal
and state laws or rules on a quarterly basis.” 40 TEX. ADMIN. CODE 8 19.1504(h) (2001) (Dep’t of
Human Services, Drug Security).

         You suggest that federal law prohibits recycling drugs in accordance with section 439.021
except to the extent that the drugs to be recycled are physician samples. See Request Letter, supra
note 1, at 1. You cite in particular FDA Compliance Policy Guide No. 7 132.08, which, as you quote
it, recommends that “sample drugs . . . be collected from [a] physician’s office” and, before being
shipped overseas, be sorted and screened by “the responsible collection agency . . . , under the
supervision of a registered pharmacist or licensed physician . . . to eliminate all recalled, outdated
and investigational drugs.” See id. at l-2 (quoting FDA Compliance Policy Guide No. 7132.08).
You also cite sections 38 1(e) and 382(f) of title 2 1 of the United States Code. Taking these sections
in reverse order, section 382(f) prohibits the export of an adulterated or misbranded drug. 21 U.S.C.
6 382(f)(3) (1994 & Supp. V). Section 38 1(e) states that a drug intended for export is not adulterated
or misbranded if it:

                        (A) accords to the specification   of the foreign purchaser;

                         (B) is not in conflict with the laws of the country to which it
                is intended for export;

                         (C) is labeled on the outside of the shipping package that it
                is intended for export, and

                        (D) is not sold or offered for sale in domestic commerce.
Charles E. Bell, M.D. - Page 4                    (JC-0412)




Id. 0 3 8 1(e)( 1). None of the federal statutes or materials you cite appear to prohibit the collection
and shipment to a foreign country of a nursing home’s unused prescription drugs.

        Moreover, the federal Food and Drug Administration’s Department of Health and Human
Services (the FDA) indicates that federal law permits the practice with certain limitations. See FDA
Letter, supra note 2, at 1. According to the FDA, prescription drug samples may be donated in
accordance with 21 C.F.R. 9 203.39, which requires that:

                samples be in their original packaging;

                samples be delivered in a sealed container;

                the recipient will prepare a donation record that includes the donor’s
                identity; the manufacturer, brand name, quantity, and lot number of
                the sample; and the date the recipient receives the sample;

                a licensed practitioner or pharmacist will examine each sample unit
                prior to distribution to determine that the donation record accurately
                describes the drug sample and that the drug sample has not been
                recalled, is not outdated, or is not otherwise unsuitable for human use;

                unsuitable sample drugs be destroyed or returned to the supplier to be
                destroyed;

                the recipient will keep for at least three years complete and accurate
                records of drug sample donation, receipt, examination, inventory,
                dispensing, redistribution, destruction, and returns;

                the recipient annually inventories all drug samples, prepares a report
                of the inventory reconciling the results with the results of the most
                recent prior inventory, and investigates and reports to the FDA any
                inventory discrepancies;

                any theft or significant   loss of drug samples will be reported to the
                FDA; and

                samples are appropriately    stored.

See FDA Letter, supra note 2, at l-2; see also 21 C.F.R. 5 203.39 (2001). Prescription drugs that
are not samples but that are in the original packaging also may be donated in accordance with FDA
recommendations:
Charles E. Bell, M.D. - Page 5                   (JC-0412)




       l
               The donor must verify that the requesting charity is legitimate.

       l
               A physician or pharmacist must screen all of the donated drugs to
               eliminate recalled, outdated, or otherwise unsuitable drugs.

       l
               Unsuitable   drug products    must be destroyed     or returned    to the
               supplier.

       l
               Adequate inventory, accountability, and security systems must be in
               place to prevent loss, theft, or diversion of the donated drugs.

       l
               Previously   dispensed drugs may not be donated.

       l
               Requirements    of the federal Food, Drug, and Cosmetic Act, 21
               U.S.C. chapter 9 ($8 301- 397), and Wholesaler Licensing Guideline
               regulations, 21 C.F.R. part 205 must be met.

FDA Letter, supra note 2, at 2. Given that the FDA is authorized to adopt regulations to enforce the
relevant federal drug laws, see 21 U.S.C. 8 371(a) (1994 & Supp. V), we presume that the FDA has
correctly interpreted those laws.

         Although federal law limits the class of prescription drugs that can be collected and shipped
to foreign countries, it does not preempt state law as you suggest. See Request Letter, supra note
1, at 1. State law is preempted only when Congress has expressed an intent to preempt; when state
law stands as an obstacle to accomplishing and executing Congress’ purposes and objectives; or
when it is impossible to comply with both state and federal law. See U.S. CONST. art. VI, cl. 2;
Zachly-Dillingham     v. Am. President Lines, Ltd., 739 S.W.2d 420, 422 (Tex. App.-San Antonio
1987, writ denied); Tex. Att’y Gen. Op. Nos. JC-0007 (1999) at 2; MW-463 (1982) at 3 (quoting
Hines v. Davidowitz, 312 U.S. 52,67 (1941)). We have not found any congressional expression of
an intent to preempt the state’s statute in this matter, nor have we found that the state law, when it
is construed to incorporate the federal limitations, obstructs federal policy or makes it impossible
to comply with federal law.

         In accordance with the FDA’s interpretation, we conclude that federal law permits, with
certain limitations, the collection and shipment to foreign countries of prescription drugs that are no
longer needed by nursing-home residents, where those drugs are samples or are in the original
packaging. As section 439.022 of the Texas Health and Safety Code directs, therefore, the Board
must adopt regulations that provide for the recycling of such drugs and distribution to foreign
countries. TEX. HEALTH& SAFETYCODEANN. 5 439.022(a) (Vernon 2001). The regulations must
comport with the FDA’s interpretation of federal law, as well as with any other applicable state law.
See id.
Charles E. Bell, M.D. - Page 6                  (JC-0412)




                                       SUMMARY

                        As the federal Food and Drug Administration        interprets
               applicable federal law, federal law permits, with certain limitations,
               the collection    and shipment to foreign countries of unused
               prescription   drugs that are no longer needed by nursing-home
               residents, where the drugs are samples or are in the original
               packaging. In accordance with section 439.022 of the Texas Health
               and Safety Code, the state Board of Health must adopt regulations
               that provide for the collecting of such drugs, sample and nonsample,
               and shipment to foreign countries. See Tex. HEALTH & SAFETY CODE
               ANN. 5 439.022(a) (Vernon 2001). The regulations must comport
               with federal law, as well as with any other applicable state law. See
               id.




                                              Attorney General of Texas




HOWARD G. BALDWIN, JR.
First Assistant Attorney General

NANCY FULLER
Deputy Attorney General-General    Counsel

SUSAN D. GUSKY
Chair, Opinion Committee

Kyrnberly K. Oltrogge
Assistant Attorney General, Opinion Committee
