Specific federal law re: pharmacies-medication
packaging-tamper-proof-law governing return by customer of unused
medication.

Hello.

The specific federal "rule" on this is Food & Drug Administration
(FDA) Compliance Policy Guide # 7132.09:
 
"Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock
(CPG 7132.09)
POLICY:
  A pharmacist should not return drugs products to his stock once they
have been out of his possession. It could be a dangerous practice for
pharmacists to accept and return to stock the unused portions of
prescriptions that are returned by patrons, because he would no longer
have any assurance of the strength, quality, purity or identity of the
articles.
  Many state boards of pharmacy have issued regulations specifically
forbidding the practice. We endorse the actions of these State boards
as being in the interest of public health.
 The pharmacist or doctor dispensing a drug is legally responsible for
all hazards of contamination or adulteration that may arise, should he
mix returned portions of drugs to his shelf stocks. Some of our
investigations in the past have shown that drugs returned by patrons
and subsequently resold by the pharmacist were responsible for
injuries.
Issued: 10/1/80"
source: Food & Drug Administration
http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-300.html


There has been some litigation over whether "rules" in the FDA's
Compliance Policy Guide are binding or not.  For example, see:
PROFESSIONALS and PATIENTS FOR CUSTOMIZED CARE, v. DONNA SHALALA, ET
AL.,
Hosted by UScourts.gov
http://www.ca5.uscourts.gov/opinions/pub/94/94-20402-cv0.htm

search strategy:
"return of", "prescription drugs", pharmacy

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Note the disclaimer below. Google Answers provides general
information. In no way should the information provided here be
considered a substitute for professional legal advice.

I hope this helps.  If anything is unclear, please let me know via the
"request clarification" feature. Thanks.

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Request for Answer Clarification by fig-ga on 25 Oct 2003 17:21 PDT

Can you elaborate on situations when for some change in clinical
situation, the customer returns unused medication that was
specifically packaged as tamper-proof--the same day or following day.
In other words the package was obviously UNOPENED and customer seeks
refund and brings a another prescription to correct some error in the
original? Is this strictly a case-by case decision
for the pharmacist? Would the pharmacist break a law by granting a
refund ?

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Clarification of Answer by juggler-ga on 25 Oct 2003 18:04 PDT

As indicated above, "Many state boards of pharmacy have issued
regulations specifically forbidding the practice."

Thus, in some states, it is apparently illegal for pharmacists to take
returns, regardless of the reason.  Are you interested in laws for a
particular state?
 
Absent a relevant state law, though, it does NOT seem to be illegal
under federal law for a pharmacist to give a refund for returned
prescription drugs. Compliance Policy Guide # 7132.09 is "advice."  It
doesn't impose penalties for non-compliance.

Again, this is NOT legal advice. I hope it helps, though.